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Investor releaseQuarter not tagged2026-09-03Pacira (PCRX) Up 6.9% Since Last Earnings Report: Can It Continue?
Zacks
Pacira (PCRX) Up 6.9% Since Last Earnings Report: Can It Continue?
It has been about a month since the last earnings report for Pacira (PCRX). Shares have added about 6.9% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Pacira due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important drivers. Pacira reported second-quarter 2026 adjusted earnings of 73 cents per share, beating the Zacks Consensus Estimate of 64 cents. In the year-ago quarter, the company had reported adjusted earnings of 74 cents per share. Second-quarter revenues of $192.4 million increased 6.2% from the year-ago quarter and beat the Zacks Consensus Estimate of $190 million. Top-line growth was supported by momentum across the commercial portfolio, highlighted by continued demand for Exparel and incremental revenues from Zilretta and iovera sales. Exparel volume growth was 4% in the quarter. Total product sales reached $190.5 million in the quarter, increasing 5.7% on a year-over-year basis. Exparel remained the largest contributor, with net product sales rising 3% year over year to $147.8 million. Exparel’s volume growth was partly offset by an unfavorable vial mix and discounting tied to the company’s group purchasing organization contract. Zilretta net product sales increased 4% year over year to $32.6 million in the reported quarter. Management attributed the improvement to commercial initiatives launched last year, including a dedicated sales force and the company’s partnership with Johnson & Johnson. Second-quarter iovera net product sales climbed 22% year over year to $6.8 million. Sales of bupivacaine liposome injectable suspension to third-party licensees came in at $3.2 million during the second quarter compared with $0.5 million in the year-ago period. Meanwhile, royalty revenues increased to $1.9 million in the second quarter from $0.8 million in the year-ago period. Adjusted research and development (R&D) expenses rose 9.7% year over year to $27.1 million, mainly due to the advancing phase II study of PCRX-201 and label-expansion programs. Adjusted selling, general and administrative (SG&A) expenses increased 5.3% year over year to $81.3 million, partly due to nonrecurring costs related to the contested director election. Pac…Read full documentShow less
It has been about a month since the last earnings report for Pacira (PCRX). Shares have added about 6.9% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Pacira due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important drivers. Pacira reported second-quarter 2026 adjusted earnings of 73 cents per share, beating the Zacks Consensus Estimate of 64 cents. In the year-ago quarter, the company had reported adjusted earnings of 74 cents per share. Second-quarter revenues of $192.4 million increased 6.2% from the year-ago quarter and beat the Zacks Consensus Estimate of $190 million. Top-line growth was supported by momentum across the commercial portfolio, highlighted by continued demand for Exparel and incremental revenues from Zilretta and iovera sales. Exparel volume growth was 4% in the quarter. Total product sales reached $190.5 million in the quarter, increasing 5.7% on a year-over-year basis. Exparel remained the largest contributor, with net product sales rising 3% year over year to $147.8 million. Exparel’s volume growth was partly offset by an unfavorable vial mix and discounting tied to the company’s group purchasing organization contract. Zilretta net product sales increased 4% year over year to $32.6 million in the reported quarter. Management attributed the improvement to commercial initiatives launched last year, including a dedicated sales force and the company’s partnership with Johnson & Johnson. Second-quarter iovera net product sales climbed 22% year over year to $6.8 million. Sales of bupivacaine liposome injectable suspension to third-party licensees came in at $3.2 million during the second quarter compared with $0.5 million in the year-ago period. Meanwhile, royalty revenues increased to $1.9 million in the second quarter from $0.8 million in the year-ago period. Adjusted research and development (R&D) expenses rose 9.7% year over year to $27.1 million, mainly due to the advancing phase II study of PCRX-201 and label-expansion programs. Adjusted selling, general and administrative (SG&A) expenses increased 5.3% year over year to $81.3 million, partly due to nonrecurring costs related to the contested director election. Pacira ended the quarter with $251 million in cash, cash equivalents and available-for-sale investments compared with $202.2 million as of March 31, 2026. Following the July 31 closing of the iovera divestiture to Zimmer Biomet, Pacira lowered its 2026 total revenue guidance from $745-$770 million to $735-$760 million. The revised range includes iovera sales only through the transaction closing date. The company also reduced its adjusted SG&A expense forecast to $310-$330 million from $320-$340 million. The adjusted R&D expenses guidance remained unchanged in the range of $105-$115 million. Stock-based compensation guidance was tightened from $54-$62 million to $54-$59 million. Pacira maintained its 2026 Exparel net product sales outlook of $600-$620 million. Management said the second half assumes continued macroeconomic softness, with growth expected from outpatient settings and procedures viewed as more resilient to economic pressure. In the past month, investors have witnessed a downward trend in fresh estimates. Currently, Pacira has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with a D. However, the stock has a grade of A on the value side, putting it in the top quintile for value investors. Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Pacira has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Pacira belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Astrazeneca (AZN), has gained 0.1% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Astrazeneca reported revenues of $15.38 billion in the last reported quarter, representing a year-over-year change of +6.4%. EPS of $2.63 for the same period compares with $2.18 a year ago. Astrazeneca is expected to post earnings of $2.60 per share for the current quarter, representing a year-over-year change of +9.2%. Over the last 30 days, the Zacks Consensus Estimate has changed -1.3%. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Astrazeneca. Also, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pacira BioSciences, Inc. (PCRX) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-09-02Krystal Biotech (KRYS) Up 12% Since Last Earnings Report: Can It Continue?
Zacks
Krystal Biotech (KRYS) Up 12% Since Last Earnings Report: Can It Continue?
A month has gone by since the last earnings report for Krystal Biotech, Inc. (KRYS). Shares have added about 12% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Krystal Biotech due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts. Krystal Q2 Earnings & Sales Beat Estimates, Pipeline in Focus Krystal reported second-quarter 2026 earnings per share (EPS) of $1.79, which surpassed the Zacks Consensus Estimate of $1.70. The company recorded an EPS of $1.29 in the year-ago quarter.Revenues of $119.2 million rose 24.14% year over year in the reported quarter, marginally beating the Zacks Consensus Estimate of $119 million. Revenues came in solely from Vyjuvek sales. Q2 Results in Detail The top line comprises product revenues from Krystal’s only marketed drug, Vyjuvek.Krystal generated $119.2 million in product revenues from Vyjuvek, up from $96 million in the year-ago quarter, driven by strong patient uptake.The gross margin in the reported quarter was 95%.Research and development (R&D) expenses were approximately $14.5 million, including stock-based compensation and where roughly consistent with the prior-year quarter. Selling, general and administrative (SG&A) expenses totaled $39.9 million, including stock-based compensation, up 13.6% from the year-ago level. This increase was primarily due to increased headcount and marketing costs to support the global launches of Vyjuvek.As of June 30, 2026, cash, cash equivalents and investments totaled $1.1 billion compared with approximately $1 billion as of March 31, 2026. KRYS’ 2026 Guidance Krystal reiterated its non-GAAP combined R&D and SG&A expense guidance of $175 million to $195 million for full-year 2026. Since the earnings release, investors have witnessed a upward trend in estimates review. At this time, Krystal Biotech has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock has a grade of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score…Read full documentShow less
A month has gone by since the last earnings report for Krystal Biotech, Inc. (KRYS). Shares have added about 12% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Krystal Biotech due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts. Krystal Q2 Earnings & Sales Beat Estimates, Pipeline in Focus Krystal reported second-quarter 2026 earnings per share (EPS) of $1.79, which surpassed the Zacks Consensus Estimate of $1.70. The company recorded an EPS of $1.29 in the year-ago quarter.Revenues of $119.2 million rose 24.14% year over year in the reported quarter, marginally beating the Zacks Consensus Estimate of $119 million. Revenues came in solely from Vyjuvek sales. Q2 Results in Detail The top line comprises product revenues from Krystal’s only marketed drug, Vyjuvek.Krystal generated $119.2 million in product revenues from Vyjuvek, up from $96 million in the year-ago quarter, driven by strong patient uptake.The gross margin in the reported quarter was 95%.Research and development (R&D) expenses were approximately $14.5 million, including stock-based compensation and where roughly consistent with the prior-year quarter. Selling, general and administrative (SG&A) expenses totaled $39.9 million, including stock-based compensation, up 13.6% from the year-ago level. This increase was primarily due to increased headcount and marketing costs to support the global launches of Vyjuvek.As of June 30, 2026, cash, cash equivalents and investments totaled $1.1 billion compared with approximately $1 billion as of March 31, 2026. KRYS’ 2026 Guidance Krystal reiterated its non-GAAP combined R&D and SG&A expense guidance of $175 million to $195 million for full-year 2026. Since the earnings release, investors have witnessed a upward trend in estimates review. At this time, Krystal Biotech has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock has a grade of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Krystal Biotech has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Krystal Biotech belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Astrazeneca (AZN), has gained 4.4% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Astrazeneca reported revenues of $15.38 billion in the last reported quarter, representing a year-over-year change of +6.4%. EPS of $2.63 for the same period compares with $2.18 a year ago. For the current quarter, Astrazeneca is expected to post earnings of $2.60 per share, indicating a change of +9.2% from the year-ago quarter. The Zacks Consensus Estimate has changed -1.3% over the last 30 days. Astrazeneca has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-09-02TEZSPIRE’s Positive EoE Phase 3 Results Could Be A Game Changer For Amgen (AMGN)
Simply Wall St.
TEZSPIRE’s Positive EoE Phase 3 Results Could Be A Game Changer For Amgen (AMGN)
Amgen and AstraZeneca recently reported positive Phase 3 CROSSING results showing TEZSPIRE improved histologic remission and dysphagia symptoms in patients with eosinophilic esophagitis, with effects sustained through week 52 and a safety profile broadly consistent with prior use. Because EoE remains poorly controlled for nearly half of patients on existing therapies, TEZSPIRE’s epithelial-targeting mechanism could meaningfully expand its role beyond severe asthma and nasal polyps if regulators ultimately grant an additional indication. We’ll now explore how TEZSPIRE’s encouraging EoE Phase 3 data might influence Amgen’s existing investment narrative around pipeline execution. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own Amgen, you generally need to believe its broad biologics portfolio and late‑stage pipeline can offset pricing pressure, biosimilar erosion, and rising R&D and manufacturing spend. TEZSPIRE’s strong EoE Phase 3 data is encouraging for pipeline execution, but it does not clearly change the near‑term balance between new launches as a growth catalyst and intensifying biosimilar and pricing risks as the biggest overhangs right now. In this context, the recent Repatha VESALIUS‑CV results, showing reduced death risk in high‑risk adults without prior heart attack or stroke, feel especially relevant. Together with TEZSPIRE’s EoE readout, they highlight how clinical outcomes data could influence how much of Amgen’s future growth story rests on expanding indications for existing biologics versus entirely new assets. Yet, against these medical wins, investors still need to weigh emerging regulatory threats around key rare‑disease assets that could materially affect... Read the full narrative on Amgen (it's free!) Amgen's narrative projects $41.5 billion revenue and $10.3 billion earnings by 2029. Uncover how Amgen's forecasts yield a $371.93 fair value, a 15% downside to its current price. Some of the lowest‑priced analysts were assuming roughly flat revenue near US$38.9 billion and earnings of about US$8.7 billion, which is far more cautious than believing TEZSPIRE’s EoE success and your chosen catalyst can easily offset long term pricing and biosimilar pressure. Explore 5 other fair value estimates on Amgen - why the stock might be worth 18% less than the current price! Disag…Read full documentShow less
Amgen and AstraZeneca recently reported positive Phase 3 CROSSING results showing TEZSPIRE improved histologic remission and dysphagia symptoms in patients with eosinophilic esophagitis, with effects sustained through week 52 and a safety profile broadly consistent with prior use. Because EoE remains poorly controlled for nearly half of patients on existing therapies, TEZSPIRE’s epithelial-targeting mechanism could meaningfully expand its role beyond severe asthma and nasal polyps if regulators ultimately grant an additional indication. We’ll now explore how TEZSPIRE’s encouraging EoE Phase 3 data might influence Amgen’s existing investment narrative around pipeline execution. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own Amgen, you generally need to believe its broad biologics portfolio and late‑stage pipeline can offset pricing pressure, biosimilar erosion, and rising R&D and manufacturing spend. TEZSPIRE’s strong EoE Phase 3 data is encouraging for pipeline execution, but it does not clearly change the near‑term balance between new launches as a growth catalyst and intensifying biosimilar and pricing risks as the biggest overhangs right now. In this context, the recent Repatha VESALIUS‑CV results, showing reduced death risk in high‑risk adults without prior heart attack or stroke, feel especially relevant. Together with TEZSPIRE’s EoE readout, they highlight how clinical outcomes data could influence how much of Amgen’s future growth story rests on expanding indications for existing biologics versus entirely new assets. Yet, against these medical wins, investors still need to weigh emerging regulatory threats around key rare‑disease assets that could materially affect... Read the full narrative on Amgen (it's free!) Amgen's narrative projects $41.5 billion revenue and $10.3 billion earnings by 2029. Uncover how Amgen's forecasts yield a $371.93 fair value, a 15% downside to its current price. Some of the lowest‑priced analysts were assuming roughly flat revenue near US$38.9 billion and earnings of about US$8.7 billion, which is far more cautious than believing TEZSPIRE’s EoE success and your chosen catalyst can easily offset long term pricing and biosimilar pressure. Explore 5 other fair value estimates on Amgen - why the stock might be worth 18% less than the current price! Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Amgen research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision. Our free Amgen research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Amgen's overall financial health at a glance. Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: The latest GPUs need a type of rare earth metal called Dysprosium and there are only 29 companies in the world exploring or producing it. Find the list for free. Uncover the next big thing with 22 elite penny stocks that balance risk and reward. Find 50 companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AMGN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-28AstraZeneca (LSE:AZN) Reports Positive TEZSPIRE Phase 3 Results, Is The Discount Too Wide?
Simply Wall St.
AstraZeneca (LSE:AZN) Reports Positive TEZSPIRE Phase 3 Results, Is The Discount Too Wide?
Amgen and AstraZeneca (LSE:AZN) reported positive top line Phase 3 results for TEZSPIRE in eosinophilic esophagitis, with clinically meaningful improvements through week 52. That kind of readout often prompts investors to revisit AstraZeneca stock. Even with a steady stream of late stage trial updates around TEZSPIRE, Tagrisso combinations and Enhertu, AstraZeneca’s share price has drifted, with a year to date share price return down 10.87% at £121.14. The 5 year total shareholder return of 56.06% points to a stronger longer term record, with momentum that currently looks more muted. Compare AstraZeneca's current setup with other large caps in a similar position by scanning our hand picked list of solid balance sheet and fundamentals (20 results). With AstraZeneca shares drifting despite a stream of positive trial updates, the gap between the current £121.14 price and fair value estimates near £156 creates a wide spread. How does that range really stack up? The most followed AstraZeneca narrative points to a fair value of £159.11 against the latest £121.14 close, which is a sizeable gap for a large cap. Read the complete narrative. Want to understand why this narrative supports a higher AstraZeneca valuation? It leans on steady top line expansion, rising margins and a richer earnings multiple over time. Result: Fair Value of £159.11 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this AstraZeneca narrative could be knocked off course if key late stage trials disappoint, or if tighter price controls hit blockbuster drugs harder than expected. Find out about the key risks to this AstraZeneca narrative. With the AstraZeneca story pulling in both optimism and concern, it makes sense to look at the full picture quickly and form your own view. You can weigh both sides in one place by checking the 4 key rewards and 1 important warning sign. If you stop at AstraZeneca, you could miss other opportunities that fit your style. Use the Simply Wall St screener to quickly surface ideas worth a closer look. Target potential value opportunities by scanning our hand picked 11 high quality undervalued stocks that combine quality fundamentals with prices that may not fully reflect them. Prioritise resilience by reviewing a 7 resilient stocks with low risk scores that focuses on companies with sturdier risk profiles when m…Read full documentShow less
Amgen and AstraZeneca (LSE:AZN) reported positive top line Phase 3 results for TEZSPIRE in eosinophilic esophagitis, with clinically meaningful improvements through week 52. That kind of readout often prompts investors to revisit AstraZeneca stock. Even with a steady stream of late stage trial updates around TEZSPIRE, Tagrisso combinations and Enhertu, AstraZeneca’s share price has drifted, with a year to date share price return down 10.87% at £121.14. The 5 year total shareholder return of 56.06% points to a stronger longer term record, with momentum that currently looks more muted. Compare AstraZeneca's current setup with other large caps in a similar position by scanning our hand picked list of solid balance sheet and fundamentals (20 results). With AstraZeneca shares drifting despite a stream of positive trial updates, the gap between the current £121.14 price and fair value estimates near £156 creates a wide spread. How does that range really stack up? The most followed AstraZeneca narrative points to a fair value of £159.11 against the latest £121.14 close, which is a sizeable gap for a large cap. Read the complete narrative. Want to understand why this narrative supports a higher AstraZeneca valuation? It leans on steady top line expansion, rising margins and a richer earnings multiple over time. Result: Fair Value of £159.11 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this AstraZeneca narrative could be knocked off course if key late stage trials disappoint, or if tighter price controls hit blockbuster drugs harder than expected. Find out about the key risks to this AstraZeneca narrative. With the AstraZeneca story pulling in both optimism and concern, it makes sense to look at the full picture quickly and form your own view. You can weigh both sides in one place by checking the 4 key rewards and 1 important warning sign. If you stop at AstraZeneca, you could miss other opportunities that fit your style. Use the Simply Wall St screener to quickly surface ideas worth a closer look. Target potential value opportunities by scanning our hand picked 11 high quality undervalued stocks that combine quality fundamentals with prices that may not fully reflect them. Prioritise resilience by reviewing a 7 resilient stocks with low risk scores that focuses on companies with sturdier risk profiles when markets feel uncertain. Spot potential future standouts early by checking a 9 high quality undiscovered gems that highlights quality businesses still flying under most investors' radar. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AZN.L. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-28What Is AstraZeneca (LSE:AZN) Signaling With Its Latest Late Stage Trial Results?
Simply Wall St.
What Is AstraZeneca (LSE:AZN) Signaling With Its Latest Late Stage Trial Results?
AstraZeneca (LSE:AZN) reported positive high level results across several late stage oncology and immunology trials, including TEZSPIRE in eosinophilic esophagitis. Phase 3 TEZSPIRE data in eosinophilic esophagitis met key clinical goals, while DESTINY-Lung04 and SAFFRON trials in non small cell lung cancer showed encouraging progress. The company started a pivotal Phase 3 trial of Datroway in high risk muscle invasive urothelial cancer and ended an underperforming lung cancer study as part of pipeline prioritisation. Consider widening your research to other large cap healthcare stocks that focus on resilient earnings and lower clinical development risk through 7 resilient stocks with low risk scores. AstraZeneca is a large GB-based pharmaceuticals company with a £187.9b market cap, focused on discovering and commercialising prescription medicines across multiple therapy areas. These late stage oncology and immunology programmes sit at the centre of its effort to expand its treatment portfolio in serious diseases. 4 things going right for AstraZeneca that this headline doesn't cover. The AstraZeneca Narrative is built on the idea that a broad late stage oncology and immunology pipeline can support long term revenue growth as older blockbusters face pressure. This cluster of TEZSPIRE, Enhertu, TAGRISSO combinations and Datroway updates goes directly to that bet. Read the full AstraZeneca narrative to see the case behind these numbers These readouts show AstraZeneca leaning into antibody drug conjugates and complex immunology biologics as its answer to patent and pricing pressure on existing blockbusters. Positive high level data for Enhertu in first line HER2 mutant NSCLC and TAGRISSO plus savolitinib in EGFR mutant disease reinforce oncology as the main engine of the growth story versus competitors such as Roche and Novartis. At the same time, the eVOLVE Lung02 termination highlights the Narrative risk that not every late stage asset will support those US$10b plus pipeline ambitions. The new Datroway urothelial trial and TEZSPIRE expansion in eosinophilic esophagitis show management reweighting capital toward programs with clearer commercial niches and potential share gains against existing standard of care. For AstraZeneca this news only really matters in the context of whether you believe the broader story that a high spend, oncology focused pipeline can o…Read full documentShow less
AstraZeneca (LSE:AZN) reported positive high level results across several late stage oncology and immunology trials, including TEZSPIRE in eosinophilic esophagitis. Phase 3 TEZSPIRE data in eosinophilic esophagitis met key clinical goals, while DESTINY-Lung04 and SAFFRON trials in non small cell lung cancer showed encouraging progress. The company started a pivotal Phase 3 trial of Datroway in high risk muscle invasive urothelial cancer and ended an underperforming lung cancer study as part of pipeline prioritisation. Consider widening your research to other large cap healthcare stocks that focus on resilient earnings and lower clinical development risk through 7 resilient stocks with low risk scores. AstraZeneca is a large GB-based pharmaceuticals company with a £187.9b market cap, focused on discovering and commercialising prescription medicines across multiple therapy areas. These late stage oncology and immunology programmes sit at the centre of its effort to expand its treatment portfolio in serious diseases. 4 things going right for AstraZeneca that this headline doesn't cover. The AstraZeneca Narrative is built on the idea that a broad late stage oncology and immunology pipeline can support long term revenue growth as older blockbusters face pressure. This cluster of TEZSPIRE, Enhertu, TAGRISSO combinations and Datroway updates goes directly to that bet. Read the full AstraZeneca narrative to see the case behind these numbers These readouts show AstraZeneca leaning into antibody drug conjugates and complex immunology biologics as its answer to patent and pricing pressure on existing blockbusters. Positive high level data for Enhertu in first line HER2 mutant NSCLC and TAGRISSO plus savolitinib in EGFR mutant disease reinforce oncology as the main engine of the growth story versus competitors such as Roche and Novartis. At the same time, the eVOLVE Lung02 termination highlights the Narrative risk that not every late stage asset will support those US$10b plus pipeline ambitions. The new Datroway urothelial trial and TEZSPIRE expansion in eosinophilic esophagitis show management reweighting capital toward programs with clearer commercial niches and potential share gains against existing standard of care. For AstraZeneca this news only really matters in the context of whether you believe the broader story that a high spend, oncology focused pipeline can offset pressure on current blockbusters and reshape long run earnings, To ensure you're always in the loop on how the latest news impacts the investment narrative for AstraZeneca, head to the community page for AstraZeneca to never miss an update on the top community narratives. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AZN.L. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-27TEZSPIRE demonstrates positive Phase III results in eosinophilic esophagitis across both co-primary and all key secondary endpoints
Business Wire
TEZSPIRE demonstrates positive Phase III results in eosinophilic esophagitis across both co-primary and all key secondary endpoints
Statistically significant and clinically meaningful disease and symptom improvements compared to placebo maintained through week 52 Efficacy in a third epithelial-driven inflammatory disease supports broad potential of TEZSPIRE WILMINGTON, Del., August 27, 2026--(BUSINESS WIRE)--Positive high-level results from the Phase III CROSSING trial in patients with eosinophilic esophagitis (EoE) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) demonstrated statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing) compared to placebo. The safety profile of TEZSPIRE in the trial was generally consistent with its approved indications. CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy.1 In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue.1 The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean change from baseline in DSQ score.1 EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the US, with the prevalence increasing five-fold since 2009.2,3 The inflammation of the esophagus can lead to dysphagia, food impaction and esophageal narrowing.2 Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.4-6 For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.7 Arjan Bredenoord, MD, Gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, The Netherlands, and primary investigator in the trial, said: "Despite the availability of first-line therapies or dietary interventions, many patients…Read full documentShow less
Statistically significant and clinically meaningful disease and symptom improvements compared to placebo maintained through week 52 Efficacy in a third epithelial-driven inflammatory disease supports broad potential of TEZSPIRE WILMINGTON, Del., August 27, 2026--(BUSINESS WIRE)--Positive high-level results from the Phase III CROSSING trial in patients with eosinophilic esophagitis (EoE) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) demonstrated statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing) compared to placebo. The safety profile of TEZSPIRE in the trial was generally consistent with its approved indications. CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy.1 In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue.1 The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean change from baseline in DSQ score.1 EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the US, with the prevalence increasing five-fold since 2009.2,3 The inflammation of the esophagus can lead to dysphagia, food impaction and esophageal narrowing.2 Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.4-6 For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.7 Arjan Bredenoord, MD, Gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, The Netherlands, and primary investigator in the trial, said: "Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food, and emotional and daily-life impacts of the disease. The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating this disease, with the potential to help more patients achieve remission and symptom improvement." Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said: "The positive results of the Phase III CROSSING trial reinforce our confidence in the differentiated mechanism of action of TEZSPIRE, which has now demonstrated clinically meaningful efficacy in a third epithelial-driven inflammatory disease. Epithelial science represents an important and rapidly evolving area in respiratory and immunology medicine, and we look forward to sharing these results at an upcoming medical meeting and with regulatory authorities as quickly as possible." Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. TEZSPIRE is a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, China, Japan and more than 70 countries across the globe, and for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in the US, EU, China and Japan. The Phase III JOURNEY and EMBARK trials evaluating TEZSPIRE in chronic obstructive pulmonary disease (COPD) are ongoing.8,9 IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to tezepelumab-ekko or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Abrupt Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) Infection It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 3%) are: Asthma: pharyngitis, arthralgia, and back pain. Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. INDICATION TEZSPIRE is indicated for: the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) Please see accompanying full Prescribing Information, including Patient Information and Instructions for Use. You may report side effects related to AstraZeneca products. Notes Eosinophilic Esophagitis (EoE) EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus with prevalence growing across the world.2,3 It is characterized by inflammation, remodeling and esophageal epithelial dysfunction.2 Epithelial dysfunction and inflammation are important characteristics of EoE and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment.2 The most common symptoms of EoE include difficulty and pain when swallowing, food becoming stuck in the esophagus (which may require emergency medical interventions), nausea and vomiting, abdominal or chest pain, poor appetite and difficulty sleeping.2,10,11 Many patients, including adolescents, experience a substantial impact on their quality of life including significant anxiety related to swallowing and choking, depression, and decreased work/school productivity.12,13 Patients are often treated with proton pump inhibitors or swallowed topical corticosteroids to manage inflammation.2,4 Nearly half of patients with EoE will not respond to standard first-line therapies or dietary treatment.5,6 Existing treatment options, including those targeting downstream mediators, may not fully address epithelial-driven inflammation.14,15 CROSSINGCROSSING is a randomized, double-blind, placebo-controlled, multi-center, parallel-group, Phase III trial designed to evaluate the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks, compared to placebo in patients aged 12-80 years with symptomatic and histologically active EoE.1 A total of 368 patients were randomized in a 1:1:1 ratio to receive either a low or high dose of TEZSPIRE or placebo.1 The co-primary endpoints analyzed at Week 24 were the proportion of patients with histologic remission, defined as a peak esophageal eosinophil count less than or equal to six eosinophils per high-power field, and mean changes from baseline in the DSQ.1 The peak eosinophil count is obtained when biopsies of the tissue of the esophagus are examined under a microscope.1 A count of 15 or more peak eosinophils per high power microscopic field measured by esophageal biopsy is often the cutoff used to diagnose EoE.16,17 The DSQ captures the presence and severity of dysphagia symptoms in a daily diary with a four-item patient-reported questionnaire; the score is calculated over 14-day periods, ranging from zero to 84, with a higher score indicating more severe dysphagia.1 Key secondary endpoints assessed histologic remission and dysphagia symptoms at Week 52; changes in endoscopic disease features (EoE-EREFS) and histologic severity and extent (EoE-HSS) at Weeks 24 and 52; as well as endoscopic response, inflammatory remission and total endoscopic remission at Week 52.1 In the trial, patients were allowed to remain on background medications for EoE, including proton pump inhibitors and swallowed topical corticosteroids, provided that they were stable prior to entry and during the treatment period.1 Tezepelumab and TSLPTezepelumab is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades.18 TSLP is critical in the initiation and persistence of allergic, eosinophilic and other types of epithelial-driven inflammation associated with severe asthma, CRSwNP, COPD and EoE.19-20 TSLP is released by the epithelium in response to environmental triggers.18 Across these disease states, the expression of TSLP is increased and correlates with disease severity.18-22 TEZSPIRE is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US, EU, China and Japan. Since 2021, more than 100,000 patients have been treated with TEZSPIRE for severe asthma.23 In October 2021, TEZSPIRE was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of EoE.24 Beyond EoE, TEZSPIRE is also being explored in Phase III trials in COPD.8,9 Amgen CollaborationThe 2012 Collaboration Agreement between Amgen and AstraZeneca has been amended and updated over time. For TEZSPIRE, both companies continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the agreement, Amgen and AstraZeneca jointly commercialize TEZSPIRE in the US. Amgen records product sales in the US, with AZ recording its share of US profits as Alliance Revenue. Outside of the US, AstraZeneca records product sales. AstraZeneca in Respiratory & ImmunologyRespiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References ClinicalTrials.gov. Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227. [Last accessed August 2026]. Biedermann L. & Straumann A. Mechanisms and clinical management of eosinophilic oesophagitis: an overview. Nature Reviews Gastroenterol & Hepatol. 2023;20(2):101-119. Thel HL, et al. Prevalence and costs of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2025;23(2):272-280.e8. Hirano I, et al. AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158(6):1776-1786. Strauss AL, Falk GW. Refractory eosinophilic esophagitis: what to do when the patient has not responded to proton pump inhibitors, steroids and diet. Curr Opin Gastroenterol. 2022;38(4):395-401. Lucendo AJ, et al. Efficacy of proton pump inhibitor drugs for inducing clinical and histologic remission in patients with symptomatic esophageal eosinophilia: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2016; 14(1):13-22.e1. Ho CN, et al. Patient experience with eosinophilic esophagitis symptoms and impacts on daily life based on in-trial qualitative interviews. J Patient Rep Outcomes. 2025;9(1):3. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007) (JOURNEY). Available at: https://clinicaltrials.gov/study/NCT06878261. [Last accessed August 2026]. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) (EMBARK). Available at: https://clinicaltrials.gov/study/NCT06883305. [Last accessed August 2026]. Gold BD, et al. Health-Related Quality of Life and Perceived Stigma in Eosinophilic Esophagitis: A Real-World, US, Web-Based Survey. Gastro Hep Adv. 2024;3(8):1087-97. MedlinePlus. Eosinophilic esophagitis. Bethesda (MD): National Library of Medicine (US). Available at: https://medlineplus.gov/eosinophilicesophagitis.html. [Last accessed August 2026]. Taft TH, et al. Anxiety and depression in eosinophilic esophagitis: a scoping review and recommendations for future research. J Asthma Allergy. 2019;12:389–99. Harris RF, et al. Psychosocial dysfunction in children and adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2013;57:500–5. Underwood B, et al. Breaking down the complex pathophysiology of eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2023;130(1):28-39 Gautam R, et al. Eosinophilic esophagitis: mechanisms of disease and approach to treatment. Curr Allergy Asthma Rep. 2026;26:21. Lucendo AJ, et al. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut. 2022;71(8):1459-1487. Dellon ES, et al. ACG Clinical Guideline: Diagnosis and Management of Eosinophilic Esophagitis. Am J Gastroenterol. 2025;120(1):31-59. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595. Calderon AA, et al. Targeting interleukin-33 and thymic stromal lymphopoietin pathways for novel pulmonary therapeutics in asthma and COPD. Eur Respir Rev. 2023;32(167):220144. Nagarkar DR, et al. Thymic stromal lymphopoietin activity is increased in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2013;132(3):593-600.e12. Ying, S, et al. Thymic stromal lymphopoietin expression is increased in asthmatic airways and correlates with expression of Th2-attracting chemokines and disease severity. J Immunol 2005;174:8183-8190. Sherrill JD, et al. Preferential Secretion of Thymic Stromal Lymphopoietin (TSLP) by Terminally Differentiated Esophageal Epithelial Cells: Relevance to Eosinophilic Esophagitis. PLoS One. 2016;11(2): e0148216. AstraZeneca Data on File. 2025. REF-278452. AstraZeneca press release. Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html. [Last accessed: August 2026]. Matthew BowdenCompany SecretaryAstraZeneca PLC View source version on businesswire.com: https://www.businesswire.com/news/home/20260827018870/en/ Contacts Media Inquiries Fiona Cookson +1 212 814 3923Lauren-Jey McCarthy +1 347 918 7001US Media Mailbox: [email protected]
Investor releaseQuarter not tagged2026-08-27TEZSPIRE® DEMONSTRATES POSITIVE PHASE 3 RESULTS IN EOSINOPHILIC ESOPHAGITIS ACROSS BOTH CO-PRIMARY AND ALL KEY SECONDARY ENDPOINTS
PR Newswire
TEZSPIRE® DEMONSTRATES POSITIVE PHASE 3 RESULTS IN EOSINOPHILIC ESOPHAGITIS ACROSS BOTH CO-PRIMARY AND ALL KEY SECONDARY ENDPOINTS
Statistically Significant and Clinically Meaningful Disease and Symptom Improvements Compared to Placebo Maintained Through Week 52 Efficacy in a Third Epithelial-Driven Inflammatory Disease Supports Broad Potential of TEZSPIRE THOUSAND OAKS, Calif., Aug. 27, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). The safety profile of TEZSPIRE was generally consistent with its approved indications. EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the U.S., with the prevalence increasing five-fold since 2009.1,2 Esophageal inflammation can lead to dysphagia, food impaction and esophageal narrowing.2 For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.3 Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.4-6 "We're pleased that TEZSPIRE showed efficacy in a third epithelial-driven inflammatory condition, eosinophilic esophagitis," said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. "In this Phase 3 trial, TEZSPIRE improved both the underlying inflammation and the swallowing difficulties that can make eosinophilic esophagitis so disruptive for patients. That combination is important for patients and builds confidence in TEZSPIRE as a potential new treatment for people struggling with EoE." CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as…Read full documentShow less
Statistically Significant and Clinically Meaningful Disease and Symptom Improvements Compared to Placebo Maintained Through Week 52 Efficacy in a Third Epithelial-Driven Inflammatory Disease Supports Broad Potential of TEZSPIRE THOUSAND OAKS, Calif., Aug. 27, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). The safety profile of TEZSPIRE was generally consistent with its approved indications. EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the U.S., with the prevalence increasing five-fold since 2009.1,2 Esophageal inflammation can lead to dysphagia, food impaction and esophageal narrowing.2 For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.3 Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.4-6 "We're pleased that TEZSPIRE showed efficacy in a third epithelial-driven inflammatory condition, eosinophilic esophagitis," said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. "In this Phase 3 trial, TEZSPIRE improved both the underlying inflammation and the swallowing difficulties that can make eosinophilic esophagitis so disruptive for patients. That combination is important for patients and builds confidence in TEZSPIRE as a potential new treatment for people struggling with EoE." CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue. The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean change from baseline in DSQ score.7 "Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food and emotional and daily-life impacts of the disease," said Arjan Bredenoord, M.D., gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, the Netherlands, and primary investigator in the trial. "The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating EoE, with the potential to help more patients achieve remission and symptom improvement." Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. TEZSPIRE® (tezepelumab-ekko) U.S. Indication TEZSPIRE is indicated for: the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). TEZSPIRE® (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONSKnown hypersensitivity to tezepelumab-ekko or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity ReactionsHypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Acute Asthma Symptoms or Deteriorating DiseaseTEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Abrupt Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) InfectionIt is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 3%) are: Asthma: pharyngitis, arthralgia, and back pain. Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia. USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Please see the full Prescribing Information including Patient Information and Instructions for Use. You may report side effects related to AstraZeneca products by clicking here. About TEZSPIRE® (tezepelumab-ekko) TEZSPIRE is a first-in-class human monoclonal antibody that works on a primary source of inflammation: the airway and gut epithelia, which are the first points of contact for many viruses, allergens, pollutants and other environmental triggers and insults. Specifically, TEZSPIRE targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of epithelial-driven inflammation associated with severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).7,8-11 TSLP is released by the epithelium in response to inhaled or swallowed environmental inflammatory triggers. Across these disease states, the expression of TSLP is increased and correlates with disease severity.8-12 TEZSPIRE is currently approved for the treatment of severe asthma in the U.S., EU, China, Japan and more than 70 countries across the globe, and for the treatment of inadequately controlled CRSwNP in the U.S., EU, China and Japan. Beyond severe asthma and CRSwNP, TEZSPIRE is also in development for other potential indications including COPD and EoE.13-15 About Eosinophilic Esophagitis (EoE) EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus with prevalence growing across the world.1,2 It is characterized by inflammation, remodeling and esophageal epithelial dysfunction. Epithelial dysfunction and inflammation are important characteristics of EoE and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment.2 The most common symptoms of EoE include difficulty and pain swallowing, food becoming stuck in the esophagus (which may require emergency medical interventions), nausea and vomiting, abdominal or chest pain, poor appetite and difficulty sleeping.2,16,17 Many patients, including adolescents, experience a substantial impact on their quality of life including significant anxiety related to swallowing and choking, depression and decreased work/school productivity.18,19 Patients are often treated with proton pump inhibitors or swallowed topical corticosteroids to manage inflammation.2,4 Nearly half of patients with EoE will not respond to standard first-line therapies or dietary treatment.5,6 Existing treatment options, including those targeting downstream mediators, may not fully address epithelial-driven inflammation.20,21 About the Phase 3 CROSSING Trial CROSSING is a randomized, double-blind, placebo-controlled, multi-center, parallel-group, Phase 3 trial designed to evaluate the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks, compared to placebo in patients aged 12-80 years with symptomatic and histologically active EoE. A total of 368 patients were randomized in a 1:1:1 ratio to receive either a low or high dose of TEZSPIRE or placebo.7 The co-primary endpoints analyzed at week 24 were the proportion of patients with histologic remission, defined as a peak esophageal eosinophil count less than or equal to six eosinophils per high-power field, and mean changes from baseline in the Dysphagia Symptom Questionnaire (DSQ). The peak eosinophil count is obtained when biopsies of the tissue of the esophagus are examined under a microscope. A count of 15 or more peak eosinophils per high power microscopic field measured by esophageal biopsy is often the cutoff used to diagnose EoE.22,23 The DSQ captures the presence and severity of dysphagia symptoms in a daily diary with a four-item patient-reported questionnaire; the score is calculated over 14-day periods, ranging from zero to 84, with a higher score indicating more severe dysphagia. Key secondary endpoints assessed histologic remission and dysphagia symptoms at week 52; changes in endoscopic disease features (EoE-EREFS) and histologic severity and extent (EoE-HSS) at weeks 24 and 52, as well as endoscopic response, inflammatory remission and total endoscopic remission at week 52.7 In the trial, patients were allowed to remain on background medications for EoE, including proton pump inhibitors and swallowed topical corticosteroids, provided that they were stable prior to entry and during the treatment period.7 About the Amgen and AstraZeneca Collaboration Amgen is in a collaboration with AstraZeneca for the development and commercialization of TEZSPIRE. Under the collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca leads global development. In North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada. AstraZeneca leads commercialization for TEZSPIRE outside North America. Amgen manufactures and supplies TEZSPIRE worldwide. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average® and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads. Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. Any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media)Casey Capparelli, 805-447-1746 (investors) REFERENCES Biedermann L. & Straumann A. Mechanisms and clinical management of eosinophilic oesophagitis: an overview. Nature Reviews Gastroenterol & Hepatol. 2023;20(2):101-119. Thel HL, et al. Prevalence and costs of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2025;23(2):272-280.e8. Cleveland Clinic. Eosinophilic Esophagitis (EoE): Symptoms & Treatment. Available at: https://my.clevelandclinic.org/health/diseases/14321-eosinophilic-esophagitis. [Last accessed August 2026.] Hirano I, et al. AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158(6):1776-1786. Strauss AL, Falk GW. Refractory eosinophilic esophagitis: what to do when the patient has not responded to proton pump inhibitors, steroids and diet. Curr Opin Gastroenterol. 2022;38(4):395-401. Lucendo AJ, et al. Efficacy of proton pump inhibitor drugs for inducing clinical and histologic remission in patients with symptomatic esophageal eosinophilia: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2016;14(1):13-22.e1. ClinicalTrials.gov. Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227. [Last accessed August 2026.] Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595. Ying S, et al. Thymic stromal lymphopoietin expression is increased in asthmatic airways and correlates with expression of Th2-attracting chemokines and disease severity. J Immunol. 2005;174:8183-8190. Calderon AA, et al. Targeting interleukin-33 and thymic stromal lymphopoietin pathways for novel pulmonary therapeutics in asthma and COPD. Eur Respir Rev. 2023;32(167):220144. Nagarkar DR, et al. Thymic stromal lymphopoietin activity is increased in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2013;132(3):593-600.e12. Sherrill JD, et al. Preferential Secretion of Thymic Stromal Lymphopoietin (TSLP) by Terminally Differentiated Esophageal Epithelial Cells: Relevance to Eosinophilic Esophagitis. PLoS One. 2016;11(2):e0148216. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007) (JOURNEY). Available at: https://clinicaltrials.gov/study/NCT06878261. [Last accessed August 2026]. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) (EMBARK). Available at: https://clinicaltrials.gov/study/NCT06883305. [Last accessed August 2026]. ClinicalTrials.gov. Tezepelumab COPD Exacerbation Study (COURSE). Available at: https://clinicaltrials.gov/ct2/show/NCT04039113. [Last accessed: August 2026]. Gold BD, et al. Health-Related Quality of Life and Perceived Stigma in Eosinophilic Esophagitis: A Real-World, US, Web-Based Survey. Gastro Hep Adv. 2024;3(8):1087-97. MedlinePlus. Eosinophilic esophagitis. Bethesda (MD): National Library of Medicine (US). Available at: https://medlineplus.gov/eosinophilicesophagitis.html. [Last accessed August 2026]. Taft TH, et al. Anxiety and depression in eosinophilic esophagitis: a scoping review and recommendations for future research. J Asthma Allergy. 2019;12:389–99. Harris RF, et al. Psychosocial dysfunction in children and adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2013;57:500–5. Underwood B, et al. Breaking down the complex pathophysiology of eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2023;130(1):28-39 Gautam R, et al. Eosinophilic esophagitis: mechanisms of disease and approach to treatment. Curr Allergy Asthma Rep. 2026;26:21. Lucendo AJ, et al. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut. 2022;71(8):1459-1487. Dellon ES, et al. ACG Clinical Guideline: Diagnosis and Management of Eosinophilic Esophagitis. Am J Gastroenterol. 2025;120(1):31-59. View original content to download multimedia:https://www.prnewswire.com/news-releases/tezspire-demonstrates-positive-phase-3-results-in-eosinophilic-esophagitis-across-both-co-primary-and-all-key-secondary-endpoints-302861404.html
Investor releaseQuarter not tagged2026-08-23AstraZeneca’s Earnings Beat Shows Momentum, But Can its Pipeline Deliver $80 Billion in Revenue?
Insider Monkey
AstraZeneca’s Earnings Beat Shows Momentum, But Can its Pipeline Deliver $80 Billion in Revenue?
AstraZeneca PLC (NYSE:AZN) investors received a reassuring earnings report at a sensitive point in the company’s growth story. H1 2026 core operating profit and core EPS rose 11%, while total revenue rose 6%, supported by double-digit growth in oncology and rare disease. Q2 core EPS came in at $2.63, exceeding expectations of $2.48. The company aims to generate $80 billion in annual revenue by 2030, which JPMorgan analysts believe is an achievable target after Q2 profit exceeded analyst expectations and sales came in as expected. The results demonstrate continued commercial momentum, particularly in oncology and rare diseases. However, recent clinical setbacks have increased the importance of AstraZeneca’s (NYSE:AZN) remaining pipeline readouts. AstraZeneca (NYSE:AZN) delivered an optimistic profit beat in the quarter, easing drug pipeline worries. The stronger core performance helped reassure investors that the company can continue expanding earnings while investing heavily in research and commercial execution. Growth was also supported by AstraZeneca’s (NYSE:AZN) two largest innovation-led areas. During the first half, oncology revenue increased 16% at constant exchange rates to $14.1 billion, representing 46% of companywide revenue. Rare Disease revenue grew 11% to $4.9 billion. This matters because AstraZeneca (NYSE:AZN) is generating growth across multiple established medicines instead of depending entirely on a single blockbuster. The company’s regulatory activity provides another source of optimism. AstraZeneca (NYSE:AZN) recorded 30 approvals in major markets since reporting its Q4 2025 results. It also reported six positive Phase III programmes during the first half, while its broader pipeline contains 183 projects, including 21 new molecular entities in late-stage development and four under regulatory review. Management maintained its 2026 outlook following the quarter. At constant exchange rates, AstraZeneca (NYSE:AZN) expects total revenue to increase by a mid-to-high-single-digit percentage and core EPS to grow by a low-double-digit percentage. Reaffirming that forecast despite recent pipeline disappointments indicates that management does not currently expect those setbacks to derail near-term performance. The principal concern is that AstraZeneca’s (NYSE:AZN) commercial performance must compensate for uncertainty within its pipeline. The Phase…Read full documentShow less
AstraZeneca PLC (NYSE:AZN) investors received a reassuring earnings report at a sensitive point in the company’s growth story. H1 2026 core operating profit and core EPS rose 11%, while total revenue rose 6%, supported by double-digit growth in oncology and rare disease. Q2 core EPS came in at $2.63, exceeding expectations of $2.48. The company aims to generate $80 billion in annual revenue by 2030, which JPMorgan analysts believe is an achievable target after Q2 profit exceeded analyst expectations and sales came in as expected. The results demonstrate continued commercial momentum, particularly in oncology and rare diseases. However, recent clinical setbacks have increased the importance of AstraZeneca’s (NYSE:AZN) remaining pipeline readouts. AstraZeneca (NYSE:AZN) delivered an optimistic profit beat in the quarter, easing drug pipeline worries. The stronger core performance helped reassure investors that the company can continue expanding earnings while investing heavily in research and commercial execution. Growth was also supported by AstraZeneca’s (NYSE:AZN) two largest innovation-led areas. During the first half, oncology revenue increased 16% at constant exchange rates to $14.1 billion, representing 46% of companywide revenue. Rare Disease revenue grew 11% to $4.9 billion. This matters because AstraZeneca (NYSE:AZN) is generating growth across multiple established medicines instead of depending entirely on a single blockbuster. The company’s regulatory activity provides another source of optimism. AstraZeneca (NYSE:AZN) recorded 30 approvals in major markets since reporting its Q4 2025 results. It also reported six positive Phase III programmes during the first half, while its broader pipeline contains 183 projects, including 21 new molecular entities in late-stage development and four under regulatory review. Management maintained its 2026 outlook following the quarter. At constant exchange rates, AstraZeneca (NYSE:AZN) expects total revenue to increase by a mid-to-high-single-digit percentage and core EPS to grow by a low-double-digit percentage. Reaffirming that forecast despite recent pipeline disappointments indicates that management does not currently expect those setbacks to derail near-term performance. The principal concern is that AstraZeneca’s (NYSE:AZN) commercial performance must compensate for uncertainty within its pipeline. The Phase III CARDIO-TTRansform trial evaluating Wainua in transthyretin-mediated amyloid cardiomyopathy failed to meet its primary efficacy endpoint. AstraZeneca’s (NYSE:AZN) experimental breast-cancer treatment camizestrant has also faced questions from a U.S. regulatory advisory panel over its trial design. Neither development invalidates AstraZeneca’s (NYSE:AZN) entire pipeline, but they illustrate the clinical risk embedded in the company’s $80 billion revenue ambition. With more than 20 Phase III readouts expected over the following 18 months, individual successes and failures could materially influence investors’ confidence in the 2030 target. Growth was also uneven across the portfolio. First-half BioPharmaceuticals revenue declined 5% at constant exchange rates to $11.2 billion. Within that division, Cardiovascular, Renal, and Metabolism revenue fell 12%, while Infectious Disease declined 26%. Revenue from China, AstraZeneca’s (NYSE:AZN) second-largest market, also decreased 13% during the second quarter because of generic competition and policy changes. AstraZeneca’s (NYSE:AZN) Q2 results support the bullish case that its commercial engine remains healthy. Oncology and rare diseases delivered strong growth, core EPS surpassed expectations, and management maintained its near- and long-term targets. Nevertheless, reaching $80 billion in annual revenue by 2030 requires continued pipeline delivery alongside existing-product growth. Recent clinical setbacks, weakness in parts of BioPharmaceuticals, and declining revenue in China suggest that the path might not be uniform. AstraZeneca (NYSE:AZN) remains operationally strong, but upcoming late-stage trial results will be crucial in determining whether its ambitious long-term target remains credible. While we acknowledge the potential of AZN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: Can Eli Lilly Catch Novo Nordisk in the Oral GLP-1 Race? AND Abbott vs. Intuitive Surgical: Is Consistent Growth Better Than Premium Growth? Disclosure: None. This article is originally published at Insider Monkey.
Investor releaseQuarter not tagged2026-08-19AstraZeneca (LSE:AZN) Reports Positive Phase III Lung Cancer Trial Results
Simply Wall St.
AstraZeneca (LSE:AZN) Reports Positive Phase III Lung Cancer Trial Results
Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. AstraZeneca (LSE:AZN) reports positive late-stage results for TAGRISSO plus savolitinib in the SAFFRON Phase III trial in difficult-to-treat NSCLC. ENHERTU meets key goals in the DESTINY-Lung04 Phase III trial with survival benefits in NSCLC patient groups with limited options. The company discontinues development of lung cancer candidate volrustomig after trial results show a lack of efficacy. These moves highlight how fast lung cancer treatment and related technologies are changing, so it can be worth looking at the wider set of companies working at the intersection of healthcare and AI through 6 healthcare AI stocks. AstraZeneca is a large GB based pharmaceuticals company with a £183.1b market cap that focuses on discovering, developing, manufacturing and commercialising prescription medicines. Lung cancer sits within its core oncology efforts, so late-stage trial outcomes can materially shape its research priorities and product mix over time. We've flagged 2 risks for AstraZeneca. See which could impact your investment. The TAGRISSO plus savolitinib data from SAFFRON and ENHERTU’s DESTINY-Lung04 outcome both speak to AstraZeneca targeting defined genetic subgroups in non small cell lung cancer where treatment options are limited. That supports a larger addressable lung cancer opportunity across multiple lines of therapy and mechanisms, including EGFR and HER2 driven disease. The mixed update largely supports the existing AstraZeneca Narrative, which leans on a strong late stage oncology pipeline but flags execution risk. Positive lung data for TAGRISSO combinations and ENHERTU align with the idea of multiple new high margin oncology products, while the volrustomig discontinuation is an example of the trial setbacks and R&D productivity risk highlighted in that Narrative. If we take a look at the community Narrative for AstraZeneca, we can see how this news fits into the bigger investment story. The key signposts now are regulatory milestones and label decisions for TAGRISSO plus savolitinib and ENHERTU in NSCLC, along with any disclosed uptake trends or guidance commentary once approvals are granted. Those updates will indicate whether these assets can offset earlier trial disappointme…Read full documentShow less
Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. AstraZeneca (LSE:AZN) reports positive late-stage results for TAGRISSO plus savolitinib in the SAFFRON Phase III trial in difficult-to-treat NSCLC. ENHERTU meets key goals in the DESTINY-Lung04 Phase III trial with survival benefits in NSCLC patient groups with limited options. The company discontinues development of lung cancer candidate volrustomig after trial results show a lack of efficacy. These moves highlight how fast lung cancer treatment and related technologies are changing, so it can be worth looking at the wider set of companies working at the intersection of healthcare and AI through 6 healthcare AI stocks. AstraZeneca is a large GB based pharmaceuticals company with a £183.1b market cap that focuses on discovering, developing, manufacturing and commercialising prescription medicines. Lung cancer sits within its core oncology efforts, so late-stage trial outcomes can materially shape its research priorities and product mix over time. We've flagged 2 risks for AstraZeneca. See which could impact your investment. The TAGRISSO plus savolitinib data from SAFFRON and ENHERTU’s DESTINY-Lung04 outcome both speak to AstraZeneca targeting defined genetic subgroups in non small cell lung cancer where treatment options are limited. That supports a larger addressable lung cancer opportunity across multiple lines of therapy and mechanisms, including EGFR and HER2 driven disease. The mixed update largely supports the existing AstraZeneca Narrative, which leans on a strong late stage oncology pipeline but flags execution risk. Positive lung data for TAGRISSO combinations and ENHERTU align with the idea of multiple new high margin oncology products, while the volrustomig discontinuation is an example of the trial setbacks and R&D productivity risk highlighted in that Narrative. If we take a look at the community Narrative for AstraZeneca, we can see how this news fits into the bigger investment story. The key signposts now are regulatory milestones and label decisions for TAGRISSO plus savolitinib and ENHERTU in NSCLC, along with any disclosed uptake trends or guidance commentary once approvals are granted. Those updates will indicate whether these assets can offset earlier trial disappointments and support the lung cancer contribution to AstraZeneca’s wider oncology plans. For the full picture including more risks and rewards, check out the complete AstraZeneca analysis. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AZN.L. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-17AstraZeneca Reports Positive Results with Lung Cancer Drugs
MT Newswires
AstraZeneca Reports Positive Results with Lung Cancer Drugs
AstraZeneca (AZN) said Monday its lung cancer treatment, Tagrisso plus Orpathys, demonstrated a stat
Investor releaseQuarter not tagged2026-08-07Ironwood Q2 Earnings Beat Estimates, Revenues Lag, 2026 View Raised
Zacks
Ironwood Q2 Earnings Beat Estimates, Revenues Lag, 2026 View Raised
Ironwood Pharmaceuticals IRWD reported adjusted earnings of 31 cents per share for the second quarter of 2026, surpassing the Zacks Consensus Estimate of 26 cents. The company had reported adjusted earnings of 14 cents per share in the year-ago quarter. Total revenues in the second quarter were $113 million, which missed the Zacks Consensus Estimate of $120 million. Revenues, however, surged by around 32.6% year over year. Year to date, shares of Ironwood have risen 26.4% against the industry’s decline of 3.7%. Image Source: Zacks Investment Research As reported by its partner AbbVie ABBV, Ironwood’s sole marketed product, Linzess (linaclotide), generated net sales of $282.3 million in the United States, up 14% year over year. Linzess sales were boosted by higher demand and better pricing, helped by the removal of inflation-related rebates and the favorable timing of rebate adjustments. Total prescription demand for Linzess increased 4% year over year during the second quarter. IRWD and ABBV share Linzess’ brand collaboration profits and losses equally. Ironwood’s share of net profit from sales of Linzess in the United States (included in collaborative revenues) totaled $110 million, reflecting a 28% year-over-year increase. Ironwood also has agreements with two partners, Astellas Pharma and AstraZeneca AZN, related to the development and commercialization of Linzess in Japan and China, respectively. Astellas and AstraZeneca have exclusive rights to develop and market the drug in their respective territories. Both companies are liable to pay royalties to Ironwood on net Linzess revenues earned in their regions. Ironwood's royalties and other revenues were $3 million in the second quarter of 2026. In the year-ago quarter, the company recorded royalties and other revenues of negative $0.5 million. Total cost and expenses (including research and development expenses, selling, general and administrative expenses and restructuring expenses) in the second quarter were $33.7 million, down 15.5% from the year-ago quarter. Ironwood recorded adjusted EBITDA of $83 million in the reported quarter, up 65.7% year over year. As of June 30, 2026, Ironwood had cash and cash equivalents worth $79.1 million compared with $220.5 million as of March 31, 2026. Ironwood raised its full-year 2026 revenue guidance, reflecting higher demand for Linzess. The company now expects total…Read full documentShow less
Ironwood Pharmaceuticals IRWD reported adjusted earnings of 31 cents per share for the second quarter of 2026, surpassing the Zacks Consensus Estimate of 26 cents. The company had reported adjusted earnings of 14 cents per share in the year-ago quarter. Total revenues in the second quarter were $113 million, which missed the Zacks Consensus Estimate of $120 million. Revenues, however, surged by around 32.6% year over year. Year to date, shares of Ironwood have risen 26.4% against the industry’s decline of 3.7%. Image Source: Zacks Investment Research As reported by its partner AbbVie ABBV, Ironwood’s sole marketed product, Linzess (linaclotide), generated net sales of $282.3 million in the United States, up 14% year over year. Linzess sales were boosted by higher demand and better pricing, helped by the removal of inflation-related rebates and the favorable timing of rebate adjustments. Total prescription demand for Linzess increased 4% year over year during the second quarter. IRWD and ABBV share Linzess’ brand collaboration profits and losses equally. Ironwood’s share of net profit from sales of Linzess in the United States (included in collaborative revenues) totaled $110 million, reflecting a 28% year-over-year increase. Ironwood also has agreements with two partners, Astellas Pharma and AstraZeneca AZN, related to the development and commercialization of Linzess in Japan and China, respectively. Astellas and AstraZeneca have exclusive rights to develop and market the drug in their respective territories. Both companies are liable to pay royalties to Ironwood on net Linzess revenues earned in their regions. Ironwood's royalties and other revenues were $3 million in the second quarter of 2026. In the year-ago quarter, the company recorded royalties and other revenues of negative $0.5 million. Total cost and expenses (including research and development expenses, selling, general and administrative expenses and restructuring expenses) in the second quarter were $33.7 million, down 15.5% from the year-ago quarter. Ironwood recorded adjusted EBITDA of $83 million in the reported quarter, up 65.7% year over year. As of June 30, 2026, Ironwood had cash and cash equivalents worth $79.1 million compared with $220.5 million as of March 31, 2026. Ironwood raised its full-year 2026 revenue guidance, reflecting higher demand for Linzess. The company now expects total revenues to be in the range of $460 to $485 million in 2026 compared with the previous expectation of $450 to $475 million. U.S. sales of Linzess (to be recorded by AbbVie) are now expected to be in the range of $1.15-$1.20 billion versus the earlier projection of $1.13-$1.18 billion in 2026. Ironwood now expects to deliver an adjusted EBITDA of more than $310 million in 2026, indicating effective cost management. Previously, the company expected to deliver an adjusted EBITDA of more than $300 million. In May 2026, the FDA approved the expanded use of Linzess for the treatment of functional constipation (FC) in pediatric patients aged two years and older. The therapy was previously approved for FC in children and adolescents aged six to 17 years. Linzess is the only FDA-approved daily treatment for pediatric FC. Linzess is already approved for the treatment of irritable bowel syndrome with constipation in adults and pediatric patients aged seven years and above. The drug is also approved for chronic idiopathic constipation in adults. Ironwood is developing its next-generation GLP-2 analog, apraglutide, for treating patients with short bowel syndrome (“SBS”) with intestinal failure (“IF”) who are dependent on parenteral support (“PS”). The confirmatory phase III STARS-2 study evaluating apraglutide in short bowel syndrome with intestinal failure (SBS-IF) is now actively recruiting patients. The primary endpoint of the STARS-2 study will check the relative change from baseline in actual weekly PS volume at week 24 in the given patient population. Ironwood acquired the rights to develop and commercialize apraglutide following the acquisition of VectivBio in June 2023. Ironwood Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Ironwood Pharmaceuticals, Inc. Quote Ironwood currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Liquidia Corporation LQDA, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ironwood Pharmaceuticals, Inc. (IRWD) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-05Royalty Pharma reports second quarter 2026 results
GlobeNewswire
Royalty Pharma reports second quarter 2026 results
Portfolio Receipts growth of 6% to $773 million; Royalty Receipts growth of 14% Net cash provided by operating activities of $728 million Raised full year 2026 guidance: Portfolio Receipts expected to be $3,400 million to $3,500 million NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for the second quarter of 2026 and raised full year 2026 guidance for Portfolio Receipts. “Royalty Pharma delivered strong second quarter results with Royalty Receipts growth of 14%,” said Pablo Legorreta, Royalty Pharma’s Chief Executive Officer and Chairman of the Board. “Our transaction pipeline remains exciting and we continued to bolster our development-stage pipeline in recent months, bringing total Capital Deployment to over $1 billion so far in 2026. Following our acquisition of a royalty on AstraZeneca’s cliramitug, our development-stage pipeline now totals 19 potential therapies. Lastly, our strong financial performance has allowed us to raise our top-line guidance for the second time this year, driven by the strength of our diversified portfolio. The fundamental tailwinds supporting our business are compelling and we remain well positioned as a premier capital allocator in life sciences to deliver consistent, compounding growth.” Double-digit growth in Royalty Receipts in the second quarter of 2026 Royalty Receipts grew 14% to $768 million, driven by Tremfya, Voranigo, Imdelltra and Evrysdi. Portfolio Receipts increased by 6% to $773 million, reflecting lower milestones and other contractual receipts. Strong transaction activity Acquired royalty on AstraZeneca’s cliramitug for transthyretin amyloidosis with cardiomyopathy in July 2026. Announced value of transactions of $1.7 billion and Capital Deployment of $1.1 billion as of August 4, 2026. Positive portfolio updates Revolution Medicines’ NDA for daraxonrasib in pancreatic cancer accepted for review by FDA and the EMA has started its accelerated review; Gilead’s Trodelvy received FDA and EC approval for first-line metastatic triple-negative breast cancer; GSK’s Jideytro received FDA approval for ROS1+ non-small cell lung cancer; Amgen’s Imdelltra received EC approval for small cell lung cancer. GSK completed the acquisition of Nuvalent (Jideytro and neladalkib for lung cancer); Teva completed the acquisition of Emalex Biosciences (ecopipam for Tourette s…Read full documentShow less
Portfolio Receipts growth of 6% to $773 million; Royalty Receipts growth of 14% Net cash provided by operating activities of $728 million Raised full year 2026 guidance: Portfolio Receipts expected to be $3,400 million to $3,500 million NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for the second quarter of 2026 and raised full year 2026 guidance for Portfolio Receipts. “Royalty Pharma delivered strong second quarter results with Royalty Receipts growth of 14%,” said Pablo Legorreta, Royalty Pharma’s Chief Executive Officer and Chairman of the Board. “Our transaction pipeline remains exciting and we continued to bolster our development-stage pipeline in recent months, bringing total Capital Deployment to over $1 billion so far in 2026. Following our acquisition of a royalty on AstraZeneca’s cliramitug, our development-stage pipeline now totals 19 potential therapies. Lastly, our strong financial performance has allowed us to raise our top-line guidance for the second time this year, driven by the strength of our diversified portfolio. The fundamental tailwinds supporting our business are compelling and we remain well positioned as a premier capital allocator in life sciences to deliver consistent, compounding growth.” Double-digit growth in Royalty Receipts in the second quarter of 2026 Royalty Receipts grew 14% to $768 million, driven by Tremfya, Voranigo, Imdelltra and Evrysdi. Portfolio Receipts increased by 6% to $773 million, reflecting lower milestones and other contractual receipts. Strong transaction activity Acquired royalty on AstraZeneca’s cliramitug for transthyretin amyloidosis with cardiomyopathy in July 2026. Announced value of transactions of $1.7 billion and Capital Deployment of $1.1 billion as of August 4, 2026. Positive portfolio updates Revolution Medicines’ NDA for daraxonrasib in pancreatic cancer accepted for review by FDA and the EMA has started its accelerated review; Gilead’s Trodelvy received FDA and EC approval for first-line metastatic triple-negative breast cancer; GSK’s Jideytro received FDA approval for ROS1+ non-small cell lung cancer; Amgen’s Imdelltra received EC approval for small cell lung cancer. GSK completed the acquisition of Nuvalent (Jideytro and neladalkib for lung cancer); Teva completed the acquisition of Emalex Biosciences (ecopipam for Tourette syndrome). Raising financial guidance for full year 2026 (excludes contribution from future transactions) Royalty Pharma now expects 2026 Portfolio Receipts to be between $3,400 million and $3,500 million (previously $3,325 million to $3,450 million), representing expected Royalty Receipts growth of 7% to 10%. Financial & Liquidity Summary *See “Liquidity and Capital Resources” section. Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures calculated in accordance with the credit agreement. 2026 Financial Outlook Royalty Pharma has provided guidance for full year 2026, excluding new transactions and borrowings announced after the date of this release, as follows: Portfolio Receipts is defined as the sum of Royalty Receipts and Milestones and other contractual receipts. The above Portfolio Receipts guidance provided on August 5, 2026 includes expected Royalty Receipts growth of 7% to 10% in 2026. Royalty Pharma’s full year 2026 guidance reflects an estimated foreign exchange impact of approximately +1% to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2026. Payments for operating and professional costs in 2026 are expected to decrease as a percentage of Portfolio Receipts, compared to 8.9% in 2025, primarily due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025. Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedules for the term loan assumed as part of the internalization transaction and borrowings under our revolving credit facility. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 million to $360 million. Interest paid in the third quarter of 2026 is anticipated to be approximately $175 million, with a de minimis amount anticipated in the fourth quarter of 2026. These projections reflect repayment of the $380 million term loan in July 2026 and assume no additional debt financing in 2026. In the second quarter of 2026, Royalty Pharma collected interest of $5 million on its cash and cash equivalents, which partially offset interest paid. Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release. Amounts shown in the table may not add due to rounding. Royalty Receipts was $768 million in the second quarter of 2026, an increase of 14% compared to $672 million in the second quarter of 2025. The increase was primarily driven by Tremfya, Voranigo, Imdelltra and Evrysdi, partially offset by declines from Promacta due to U.S. generic competition and from Imbruvica. Royalty Receipts from Evrysdi included the benefit of the additional royalties acquired in December 2025. Portfolio Receipts was $773 million in the second quarter of 2026, an increase of 6% compared to $727 million in the second quarter of 2025, primarily driven by the same Royalty Receipts increases noted above, partially offset by lower Milestones and other contractual receipts due to a one-time distribution received in the prior year period. Liquidity and Capital Resources Royalty Pharma’s liquidity and capital resources are summarized below: As of June 30, 2026, Royalty Pharma had cash and cash equivalents of $812 million and total debt with principal value of $9.2 billion. In July 2026, Royalty Pharma repaid the $380 million term loan upon maturity. In the second quarter of 2026, Royalty Pharma paid a quarterly dividend of $0.235 per share, equating to $135 million in dividends and distributions. Royalty Pharma repurchased approximately 0.9 million Class A ordinary shares for $45 million in the second quarter and two million Class A ordinary shares for $96 million for the first six months of 2026. The weighted-average number of diluted Class A ordinary shares outstanding for the second quarter of 2026 was 557 million, a decline of 1% as compared to 562 million for the second quarter of 2025. Liquidity Summary Amounts may not add due to rounding. Adjusted EBITDA (non-GAAP) was $736 million in the second quarter of 2026. Payments for operating and professional costs were 4.8% of Portfolio Receipts. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs. Portfolio Cash Flow (non-GAAP) was $736 million in the second quarter of 2026. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments. Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities. Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $349 million in the second quarter of 2026, consisting primarily of royalty funding for daraxonrasib and R&D funding for JNJ‑4804 and litifilimab. The table below details Capital Deployment by category: Capital Deployment Amounts may not add due to rounding. Royalty Transactions As of August 4, 2026, Royalty Pharma has announced new transactions of up to $1.7 billion, which reflects the entire amount of potential capital committed for new transactions, including potential future milestones. In July 2026, Royalty Pharma acquired a portion of Neurimmune AG’s royalty interest in AstraZeneca’s cliramitug for up to $425 million, including $125 million upfront. Cliramitug is a Phase 3 first-in-class transthyretin (TTR)-fibril-depleting antibody designed to remove amyloid deposits in patients with TTR amyloidosis with cardiomyopathy, a progressive, degenerative and fatal disease caused by misfolded proteins that accumulate in the heart. The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com. Key Developments Relating to the Portfolio The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products. Financial Results Call Royalty Pharma will host a conference call and simultaneous webcast to discuss its second quarter of 2026 results today at 8:00 a.m., Eastern Time. Please visit the “Investors” page of the company’s website at https://www.royaltypharma.com/investors/events to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days. About Royalty Pharma plc Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta and Alyftrek, GSK’s Trelegy, Biogen’s Tysabri and Spinraza, Roche’s Evrysdi, Astellas and Pfizer’s Xtandi, Johnson & Johnson’s Tremfya, AbbVie and Johnson & Johnson’s Imbruvica, Servier’s Voranigo, Gilead’s Trodelvy, Amgen’s Imdelltra and Alnylam’s Amvuttra, among others, and 19 development-stage product candidates. Forward-Looking Statements The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This document contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharma’s strategies, financing plans, growth opportunities, market growth and plans for capital deployment, plus the benefits of the internalization transaction, including expected accretion, enhanced alignment with shareholders, increased investment returns, expectations regarding management continuity, transparency and governance, and the benefits of simplification to its structure. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. Certain information contained in this document relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company’s own internal estimates and research. While the company believes these third-party sources to be reliable as of the date of this document, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this document involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the company believes its own internal research is reliable, such research has not been verified by any independent source. For further information, please reference Royalty Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission (“SEC”) by visiting EDGAR on the SEC’s website at www.sec.gov. Portfolio Receipts Portfolio Receipts is a key performance metric that represents Royalty Pharma’s ability to generate cash from Royalty Pharma’s portfolio investments, the primary source of capital that is deployed to make new portfolio investments. Portfolio Receipts is defined as the sum of Royalty Receipts and Milestones and other contractual receipts. Royalty Receipts includes variable payments based on sales of products, net of contractual payments to the legacy non-controlling interests, that are attributed to Royalty Pharma. Milestones and other contractual receipts include sales-based or regulatory milestone payments and other fixed contractual receipts, net of contractual payments to legacy non-controlling interests, that are attributed to Royalty Pharma. Portfolio Receipts does not include royalty receipts and milestones and other contractual receipts that were received on an accelerated basis under the terms of the agreement governing the receipt or payment. Portfolio Receipts also does not include proceeds from equity securities or proceeds from purchases and sales of marketable securities, both of which are not central to Royalty Pharma’s fundamental business strategy. 2025 Portfolio Receipts does not include the $511 million of proceeds from the sale of the MorphoSys Development Funding Bonds, as the transaction was treated as an asset sale. Portfolio Receipts is calculated as the sum of the following line items from Royalty Pharma’s GAAP condensed consolidated statements of cash flows: Cash collections from financial royalty assets, Cash collections from intangible royalty assets, Other royalty cash collections, Proceeds from available for sale debt securities and Distributions from equity method investees less Distributions to legacy non-controlling interests - Portfolio Receipts, which represent contractual distributions of Royalty Receipts, milestones and other contractual receipts to the Legacy Investors Partnerships. Use of Non-GAAP Measures Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures that exclude the impact of certain items and therefore have not been calculated in accordance with GAAP. Management believes that Adjusted EBITDA and Portfolio Cash Flow are important non-GAAP measures used to analyze liquidity because they are key components of certain material covenants contained within Royalty Pharma’s credit agreement. Royalty Pharma cautions readers that amounts presented in accordance with the definitions of Adjusted EBITDA and Portfolio Cash Flow may not be the same as similar measures used by other companies or analysts. These non-GAAP liquidity measures have limitations as analytical tools, and you should not consider them in isolation or as a substitute for the analysis of Royalty Pharma’s results as reported under GAAP. The definitions of Adjusted EBITDA and Portfolio Cash Flow used by Royalty Pharma are the same as the definitions in the credit agreement. Noncompliance with the interest coverage ratio, leverage ratio and Portfolio Cash Flow ratio covenants under the credit agreement could result in lenders requiring the company to immediately repay all amounts borrowed. If Royalty Pharma cannot satisfy these covenants, it would be prohibited under the credit agreement from engaging in certain activities, such as incurring additional indebtedness, paying dividends, making certain payments, and acquiring and disposing of assets. Consequently, Adjusted EBITDA and Portfolio Cash Flow are critical to the assessment of Royalty Pharma’s liquidity. Adjusted EBITDA and Portfolio Cash Flow are used by management as key liquidity measures in the evaluation of the company’s ability to generate cash from operations. Management uses Adjusted EBITDA and Portfolio Cash Flow when considering available cash, including for decision-making purposes related to funding of acquisitions, debt repayments, dividends and other discretionary investments. Further, these non-GAAP liquidity measures help management, the audit committee and investors evaluate the company’s ability to generate liquidity from operating activities. The company has provided reconciliations of these non-GAAP liquidity measures to the most directly comparable GAAP financial measure, being net cash provided by operating activities in Table 4. Royalty Pharma Investor Relations and Communications +1 (212) [email protected] Amounts may not add due to rounding. EPAs: Equity Performance Awards. Amounts may not add due to rounding. EPAs: Equity Performance Awards. Amounts may not add due to rounding. Notes (1) Portfolio Receipts is defined above in the section entitled “Portfolio Receipts.” (2) Adjusted EBITDA is defined under the credit agreement as Portfolio Receipts minus payments for operating and professional costs. Operating and professional costs reflect Payments for operating and professional costs from the GAAP condensed consolidated statements of cash flows. See GAAP to Non-GAAP reconciliation in Table 4. (3) Portfolio Cash Flow is defined under the credit agreement as Adjusted EBITDA minus interest paid or received, net. See GAAP to Non-GAAP reconciliation in Table 4. Portfolio Cash Flow reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases or utilized for other discretionary investments. (4) Capital Deployment is calculated as the summation of the following line items from Royalty Pharma’s GAAP condensed consolidated statements of cash flows: Investments in equity method investees, Purchases of available for sale debt securities, Acquisitions of financial royalty assets, Acquisitions of other financial assets, Milestone payments, Development-stage funding payments less Contributions from legacy non-controlling interests - R&D. (5) Other products primarily include Royalty Receipts on the following products: Crysvita, Erleada, Farxiga/Onglyza, Nesina, Niktimvo, Nurtec ODT, Orladeyo, Prevymis and distributions from the Legacy SLP Interest, which is presented as Distributions from equity method investees on the GAAP condensed consolidated statements of cash flows. (6) The table below shows the line item for each adjustment and the direct location for such line item on the GAAP condensed consolidated statements of cash flows. (7) The condensed consolidated statement of operations for 2025 has been recast to reflect the adoption of ASU 2025-07 by removing the losses previously recognized on derivative.

