AGIO

Agios Pharmaceuticals AGIO reported a loss of $1.69 per share for the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of $1.86. In the year-ago quarter, the company had incurred a loss of $1.93 per share. Total revenues for the quarter came in at $44.7 million, significantly beating the Zacks Consensus Estimate of $23 million. Revenues surged 259.3% year over year, primarily driven by continued strong growth in Pyrukynd sales and robust demand for Aqvesme since the U.S. commercial launch in January this year. The company’s lead drug, mitapivat, is marketed under two brand names in the United States, Pyrukynd and Aqvesme. While Pyrukynd is approved for the treatment of hemolytic anemia in adult patients with pyruvate kinase (PK) deficiency, Aqvesme is approved to treat anemia in adults with alpha- or beta-thalassemia. Aqvesme received approval in the United States in December 2025 and was subsequently launched in January 2026, following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios reported a strong initial uptake, with 442 prescriptions written as of June 30, 2026. Outside the United States, mitapivat continues to be marketed as Pyrukynd for PK deficiency and thalassemia indications. In May, Pyrukynd received approval for thalassemia in the European Union. Agios’ partner, Avanzanite Bioscience B.V., will commercialize and distribute Pyrukynd across the European Economic Area, the United Kingdom and Switzerland. The top line entirely comprises product revenues from Pyrukynd and Aqvesme. Agios generated $40.9 million of product revenues in the United States, up 235.2% year over year, driven by strong early momentum of the U.S. commercial launch of Aqvesme for thalassemia. The company added $3.8 million from ex-U.S. territories, driven by anticipated demand for Pyrukynd following its approval for thalassemia in Europe, as well as continued steady early demand across the Gulf Cooperation Council countries. Research and development expenses increased by approximately 9.6% year over year to $100.8 million in the quarter. The increase was primarily driven by the $25.0 million upfront payment related to the licensing agreement with Oscotec for cevidoplenib. Selling, general and administrative expenses totaled $51.5 million, up around 12.4% year over year, driven by higher spending associated with the commercial launch of Aqvesme. As of June 30, 2026, cash, cash equivalents and marketable securities totaled $964.8 million compared with $1.0 billion as of March 31, 2026. Management expects its existing cash balance, together with anticipated product revenues, to be sufficient to support the potential launch of mitapivat in sickle cell disease (SCD) if approved and advance its clinical pipeline. For full-year 2026, Agios expects to generate $45 million to $50 million in U.S. sales from Pyrukynd for PK deficiency.The company reiterated that full-year operating expenses are expected to remain approximately flat compared with 2025, excluding the $25 million upfront payment related to the cevidoplenib in-licensing agreement recognized in the second quarter. Beyond the marketed indications, Agios is also developing mitapivat for sickle cell disease (SCD). Earlier this month, the FDA accepted its supplemental new drug application (sNDA) seeking approval for mitapivat in SCD. The sNDA was submitted under the FDA’s accelerated approval pathway in May. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on Nov. 1, 2026. If approved, mitapivat is likely to become the first oral PK activator to be approved for patients with SCD. Agios had been developing another candidate, tebapivat, a novel PK activator, for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) and SCD in separate mid-stage studies. However, the company has discontinued the development of tebapivat across all indications following setbacks in the clinical programs. In June, the company halted the candidate's development for LR-MDS after a phase II dose-finding study failed to demonstrate sufficient clinical benefit, despite showing biological activity and a favorable safety profile. Subsequently, in July, Agios also discontinued the SCD program after phase II data failed to demonstrate meaningful clinical differentiation from existing PK activators. These decisions marked the complete termination of the tebapivat development program. Despite the earnings beat, shares of AGIO were down 6.4% on Thursday, likely due to investor concern about the loss of tebapivat as a pipeline asset, which narrowed the company's growth prospects and increased its reliance on mitapivat, with its upcoming FDA decision now serving as the key catalyst. Image Source: Zacks Investment Research Year to date, the stock has risen 20.4% compared with the industry’s 3.6% growth. In early June, the company entered into an agreement with Oscotec, a South Korea-based biotech to in-license exclusive global rights to develop and commercialize cevidoplenib for immune thrombocytopenia (ITP). Cevidoplenib is a next-generation, late-stage, highly selective oral spleen tyrosine kinase inhibitor being developed for the treatment of patients with ITP, a rare autoimmune disorder characterized by low platelet counts and an elevated risk of bleeding. The agreement expands and diversifies Agios’ rare hematology portfolio by adding a potential treatment for ITP, with an estimated peak annual U.S. sales potential of up to $1 billion. Agios intends to advance cevidoplenib into a phase III study for ITP, with initiation expected in the first half of 2028. Per the agreement, Agios will fund all future development and commercialization costs associated with cevidoplenib. Agios Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Agios Pharmaceuticals, Inc. Quote Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Neurocrine Biosciences NBIX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 90 days, earnings per share estimates for Harmony Biosciences have decreased from $3.34 to $3.30 for 2026. Over the same period, estimates for earnings per share increased from $3.79 to $3.87 for 2027. HRMY shares have lost 4.2% year to date. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $5.31 from $2.91. LQDA shares have gained 151.7% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.00 to $9.09. Over the same period, EPS estimates for 2027 have increased from $9.48 to $10.81. NBIX shares have gained 30.8% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%. 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 Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Mitapivat (PYRUKYND® and AQVESME™) delivered worldwide net revenues of $44.7 million in the second quarter of 2026, compared to $12.5 million in the second quarter of 2025 Strong U.S. commercial launch of AQVESME in thalassemia, with 442 cumulative prescriptions written as of June 30, 2026 sNDA for mitapivat granted FDA Priority Review in sickle cell disease with PDUFA goal date of November 1, 2026 Diversified and expanded late-stage pipeline with licensing of cevidoplenib for immune thrombocytopenia and advancement of AG-236 into Phase 2/3 development for polycythemia vera $964.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026; well capitalized to support commercial execution and pipeline advancement CAMBRIDGE, Mass., July 30, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced financial results and updates for the second quarter ended June 30, 2026. “Our second-quarter performance reflects continued execution across the key priorities that will drive sustainable growth for Agios: strong commercial momentum, pipeline diversification, and strategic portfolio discipline,” said Brian Goff, Chief Executive Officer, Agios. “We are encouraged by the ongoing U.S. commercial launch of AQVESME in thalassemia, which continues to see robust engagement from both physicians and patients. We also progressed mitapivat toward a potential new indication in sickle cell disease, highlighted by the FDA granting Priority Review for our sNDA. Beyond these milestones, we strengthened our hematology pipeline with the licensing of cevidoplenib and advancement of AG-236 into Phase 2/3 development, while maintaining disciplined capital allocation. Together, these achievements underscore our ability to deliver meaningful innovation for patients and long-term shareholder value.” Second Quarter 2026 and Recent Corporate Highlights Mitapivat (PYRUKYND® and AQVESME™) Commercial Performance and Update – Business Development – Research and Development (R&D) Highlights Mitapivat (pyruvate kinase [PK] activator) AG-236 (siRNA targeting TMPRSS6) AG-181 (phenylalanine hydroxylase [PAH] stabilizer) Tebapivat (PK activator) Second Quarter 2026 Financial Results For the quarter ended June 30, 2026, net loss was $100.7 million, compared to net loss of $112.0 million for the quarter ended June 30, 2025. Net product revenue from U.S. sales of mitapivat (PYRUKYND and AQVESME) for the second quarter of 2026 was $40.9 million, compared to $12.2 million for the second quarter of 2025. Net product revenue from ex-U.S. sales of mitapivat (PYRUKYND) for the second quarter of 2026 was $3.8 million, compared to $0.3 million for the second quarter of 2025. Cost of sales for the second quarter of 2026 was $3.0 million. Research and Development (R&D) expenses were $100.8 million for the second quarter of 2026, compared to $91.9 million for the second quarter of 2025, driven primarily by the $25.0 million up-front payment associated with the agreement with Oscotec to license cevidoplenib. Selling, General and Administrative (SG&A) expenses were $51.5 million for the second quarter of 2026, compared to $45.9 million for the second quarter of 2025, due to an increase in activities related to the U.S. commercial launch of AQVESME in thalassemia. Cash, cash equivalents and marketable securities were $964.8 million as of June 30, 2026, compared to $1.2 billion as of December 31, 2025. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to execute the U.S. commercial launch of AQVESME in thalassemia, prepare for the potential U.S. commercial launch of mitapivat in sickle cell disease, advance the company’s existing clinical programs, and opportunistically expand its pipeline through both internally- and externally-discovered assets. Second Quarter 2026 Conference Call Information Agios will host a conference call and live webcast today, July 30, 2026, at 8:00 a.m. ET to discuss the company’s second quarter 2026 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the “Events & Presentations” tab. A replay of the webcast will be available on the company’s website approximately two hours after the event. About Agios: Fueled by Connections to Transform Rare Diseases™ At Agios, our vision is to redefine the future of rare disease treatment. Fueled by connections, we build trusted partnerships with communities – collaborating to develop and deliver innovative medicines that have the potential to transform lives. With a foundation in hematology, we combine biological expertise with real-world insights to advance a growing pipeline of rare disease medicines that reflect the priorities of the people we serve. Agios is a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts. To learn more, visit www.agios.com and follow us on LinkedIn and X. Available Information about Agios To achieve broad dissemination, Agios may disclose information to the public through a variety of disclosure channels including press releases, SEC filings, and public conference calls and webcasts. Some of the information distributed through these disclosure channels may be considered material information. Investors and others should note that Agios plans to use its website (www.agios.com) as a distribution channel to announce and give notice of Agios’ upcoming events and presentations (including, but not limited to, presentations at medical or healthcare conferences). Such information, which may be deemed material, will be available on the Investors section of the company’s website under the “Events & Presentations” tab. In addition, you may sign up to automatically receive email alerts about Agios’ upcoming events and presentations (“Calendar Alerts”) by visiting the “Email Alerts” option under the “IR Resources” tab of the Investors section of the company’s website and submitting your email address. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of PYRUKYND® (mitapivat), AQVESME™ (mitapivat), tebapivat, AG-236, AG-181 and cevidoplenib; Agios’ plans, strategies and expectations for its preclinical, clinical and commercial advancement of its drug development, including mitapivat, tebapivat, AG-236, AG-181 and cevidoplenib; Agios’ expectations for the review of marketing applications for mitapivat by regulatory agencies, including the FDA and European Commission; Agios’ strategic vision and goals; and the potential benefits of Agios’ strategic plans and focus. The words “anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,” “potential,” “possible,” “strategy,” “will,” “vision,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. For example, there can be no guarantee that any product candidate Agios is developing will successfully commence or complete necessary preclinical and clinical development phases, or that development of any of Agios’ product candidates will successfully continue. There can be no guarantee that any positive developments in Agios’ business will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including, without limitation: risks and uncertainties related to the impact of pandemics or other public health emergencies to Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; Agios’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios' ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios’ ability to establish and maintain key collaborations; uncertainty regarding any royalty payments related to the sale of its oncology business or any milestone or royalty payments related to its in-licensing of AG-236 and cevidoplenib, and the uncertainty of the timing of any such payments; uncertainty of the results and effectiveness of the use of Agios’ cash and cash equivalents; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in Agios’ public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. *June 30, 2026 balance includes $5.6 million of long-term inventory included in other non-current assets within our condensed consolidated balance sheets. Contacts:Investor ContactMorgan Sanford, Vice President, Investor Relations Agios [email protected] Media ContactEamonn Nolan, Senior Director, Corporate CommunicationsAgios [email protected]

Interested in Agios Pharmaceuticals, Inc.? Here are five stocks we like better. Mitapivat revenue reached $44.7 million in Q2 2026, while Agios reported a $100.7 million net loss and ended June with approximately $1 billion in cash and marketable securities. The company maintained its 2026 U.S. pyruvate kinase deficiency revenue outlook of $45 million to $50 million. AQVESME’s U.S. thalassemia launch continued to expand, with 442 cumulative prescriptions and payer coverage for roughly 75% of patient lives. Agios plans to stop reporting prescription counts after Q3 and use revenue as its primary commercial metric. The FDA set Nov. 1 as the decision date for mitapivat in sickle cell disease, though Agios does not expect a material 2026 revenue contribution. The company is also advancing pipeline programs in immune thrombocytopenia, polycythemia vera and phenylketonuria. Agios Pharmaceuticals (NASDAQ:AGIO) reported second-quarter 2026 mitapivat net revenue of $44.7 million, including $40.9 million in the United States and $3.8 million outside the U.S., as the company continued the U.S. thalassemia launch of AQVESME and prepared for a potential sickle cell disease approval later this year. The company recorded a net loss of $100.7 million for the quarter, compared with a $112 million loss in the prior-year period. Agios ended June with approximately $1 billion in cash equivalents and marketable securities. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Chief Executive Officer Brian Goff said the company is pursuing several growth drivers, including the thalassemia launch, a potential expansion of mitapivat into sickle cell disease, and pipeline programs in rare hematology and other rare diseases. Cost of sales totaled $3 million during the quarter. Research and development expense rose to $100.8 million from $91.9 million a year earlier, primarily reflecting a $15 million increase in process research and development tied to the company’s agreement with Oscotec, including a $25 million upfront payment associated with the cevidoplenib licensing transaction. → 3 Value ETFs to Consider as Growth Stocks Lag Behind Selling, general and administrative expense increased to $61.5 million from $45.9 million in the second quarter of 2025, which Chief Financial Officer Cecilia Jones attributed to commercial activities associated with the February launch of AQVESME. Agios maintained its outlook for approximately $45 million to $50 million in 2026 U.S. revenue from pyruvate kinase deficiency. The company expects full-year operating expenses to be approximately flat compared with 2025, excluding the $25 million cevidoplenib upfront payment. Its expense outlook includes investment to prepare for a possible sickle cell disease launch. → 5 AI Stocks Are Pulling Back—Which Growth Catalysts Still Look Strongest? Agios reported 442 cumulative AQVESME prescriptions from REMS-certified physicians as of June 30, including 200 additional prescriptions during the second quarter. The metric represents unique prescriptions for patients with completed START forms from REMS-certified physicians. Chief Commercial Officer Tsveta Milanova said second-quarter revenue included about $5 million in one-time benefits related to thalassemia stocking, along with modest favorable gross-to-net dynamics. The company continues to expect gross-to-net adjustments in a 10% to 20% range, though it cautioned that results can vary by quarter. Approximately 75% of thalassemia patient lives are now covered under payer policies, according to Milanova. She said the mix of prescriptions is increasingly shifting toward non-transfusion-dependent thalassemia patients, who may have less frequent interactions with health-care providers and more deliberate treatment discussions. Agios said time from demand to treatment initiation has begun moving toward its anticipated 10- to 12-week range as adoption broadens. The company expects it to move within that range as it further penetrates the non-transfusion-dependent population. The company plans to stop reporting prescriptions from REMS-certified physicians after the third quarter and instead use revenue as its primary commercial performance measure. Milanova said revenue better incorporates new patient starts, treatment initiation timing, refills and persistence on therapy as the launch matures. Management said the earliest AQVESME patients are approaching six months of treatment, a point at which physicians may assess clinical benefit and determine whether therapy should continue. In response to analyst questions, Chief Medical Officer and Head of Research and Development Sarah Gheuens said more than 90% of patients in the ENERGIZE study continued treatment into its open-label extension, while noting that real-world persistence is still in the early stages of assessment. The Food and Drug Administration accepted Agios’ supplemental new drug application for mitapivat in sickle cell disease and granted priority review, setting a Prescription Drug User Fee Act goal date of Nov. 1. Agios recently dosed the first patient in REIGNITE, its Phase III confirmatory trial in sickle cell disease. Gheuens said data presented at the European Hematology Association meeting showed hemoglobin responses in the RISE UP Phase III study, with responders experiencing improvements in sickle cell pain crisis-related endpoints and fatigue. The company also presented data on reductions in transfusion burden and red blood cell units transfused. Agios is initially focusing its potential sickle cell launch on roughly 25,000 patients who are actively treated or need therapy. Management said sickle cell disease has a higher Medicaid mix than its existing commercial markets, which would lead to higher gross-to-net adjustments because of mandatory Medicaid rebates. Gheuens said the company had not disclosed which brand name would be used for sickle cell disease if approved. She added that hepatocellular injury was not observed among sickle cell trial participants and that a REMS program may not be warranted, though the company said it is prepared to launch with or without one. Agios does not expect sickle cell disease to materially contribute to 2026 revenue given the November decision date. During the quarter, Agios in-licensed cevidoplenib, a selective oral Syk inhibitor being developed for immune thrombocytopenia. The company said it intends to engage with the FDA in coming months to align on advancement to Phase III. Gheuens said available Phase II data showed dose-dependent activity, no dose-limiting toxicity through Phase II and evidence of durable platelet responses. Agios also plans to initiate the Phase II portion of an operationally seamless Phase II/III program for AG-236 in polycythemia vera during the second half of 2026. The program is designed to identify an optimal dose and advance efficiently into a registrational stage. Elsewhere, the company expects Phase Ib proof-of-mechanism data for AG-181 in phenylketonuria during the second half of the year. Goff said Agios is prioritizing investments in programs it believes can support long-term growth across rare disease markets that management estimates could exceed $10 billion in 2030. Agios Pharmaceuticals, Inc is a biopharmaceutical company founded in 2008 as a spin-out from research at Dana-Farber Cancer Institute and the Broad Institute. Headquartered in Cambridge, Massachusetts, Agios focuses on understanding and targeting cellular metabolism to develop novel therapies for cancer and rare genetic diseases. The company's scientific platform integrates genomic discovery, metabolic profiling and precision medicine approaches to identify and advance small-molecule candidates that correct or exploit metabolic dysfunction. Agios's lead products are IDH (isocitrate dehydrogenase) inhibitors that target specific cancer mutations. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Agios Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

This article first appeared on GuruFocus. Total Mitapivat Net Revenue: $44.7 million for Q2 2026, including $40.9 million in the US and $3.8 million outside the US. AQVESME Prescriptions: 442 cumulative prescriptions from REMS-certified physicians as of June 30, 2026, with 200 new prescriptions added in Q2. Cost of Sales: $3 million for Q2 2026. Research and Development (R&D) Expense: $100.8 million for Q2 2026, compared to $91.9 million in Q2 2025. Selling, General, and Administrative (SG&A) Expense: $61.5 million for Q2 2026, compared to $45.9 million in Q2 2025. Net Loss: $100.7 million for Q2 2026, compared to a net loss of $112 million for Q2 2025. Cash, Cash Equivalents, and Marketable Securities: Approximately $1 billion as of the end of Q2 2026. 2026 US PK Deficiency Revenue Outlook: Expected to be approximately $45 million to $50 million. 2026 Full-Year Operating Expenses Outlook: Expected to remain approximately flat versus 2025, excluding the $25 million upfront payment for the cevidoplenib license. Gross to Net (GtN) Guidance: Expected to remain within the previously guided 10% to 20% range. Warning! GuruFocus has detected 4 Warning Signs with AGIO. Is AGIO fairly valued? Test your thesis with our free DCF calculator. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Strong commercial momentum with $44.7 million in total net revenue and 442 cumulative AQVESME prescriptions for REMS-certified physicians. FDA acceptance of mitapivat sNDA for sickle cell disease with priority review and a PDUFA goal date of November 1, 2026. Pipeline diversification through in-licensing of cevidoplenib, a next-generation oral SYK inhibitor for immune thrombocytopenia (ITP). Advancement of AG-236 into an operationally seamless Phase 2/3 program for polycythemia vera, with Phase 2 initiation planned for H2 2026. Strong financial position with approximately $1 billion in cash, cash equivalents, and marketable securities, providing flexibility for growth. Net loss of $100.7 million for Q2 2026, though improved from $112 million loss in Q2 2025. Revenue growth expected to moderate as launch shifts to non-transfusion-dependent patients with longer time-to-treatment initiation (10-12 weeks). Potential patient discontinuation risk as first cohort approaches six-month treatment evaluation point in H2 2026. Higher gross-to-net dynamics expected for sickle cell disease due to larger Medicaid mix, impacting net revenue per patient. Quarter-to-quarter revenue variability anticipated due to order timing, inventory movements, and gross-to-net fluctuations. Here are the key highlights from the Agios Pharmaceuticals Inc (NASDAQ:AGIO) Q2 2026 earnings call. Q: What is the outlook for the AQVESME launch in thalassemia, and how should we think about the transition from prescription reporting to revenue as the primary metric? A: Tsveta Milanova, Chief Commercial Officer, stated that the launch is progressing well with 442 cumulative prescriptions. As the launch matures and adoption expands into the non-transfusion-dependent (NTDT) population, the correlation between new prescriptions and revenue will decrease due to longer time-to-treatment initiation (expected to settle at 10-12 weeks). Therefore, the company will stop reporting prescription metrics after Q3 2026 and transition to revenue as the primary measure of commercial performance, especially with a potential sickle cell disease launch on the horizon. Q: What are the key dynamics to watch in the second half of 2026 for the thalassemia launch? A: Tsveta Milanova noted that the first half of the year benefited from highly motivated patients and prescribers. In the second half, the focus will shift to the broader NTDT population, where treatment decisions take longer. A critical milestone will be the six-month treatment mark for early patients, where physicians will assess clinical response and determine continuation. The company expects time-to-treatment initiation to move well within the 10- to 12-week range as the patient mix shifts. Q: What is the potential for mitapivat in sickle cell disease, and what are the launch preparations? A: Brian Goff, CEO, highlighted the FDA acceptance of the sNDA with priority review and a PDUFA goal date of November 1, 2026. The company is actively preparing for a potential launch, focusing on approximately 25,000 actively treated patients. Tsveta Milanova added that the team is leveraging capabilities from the thalassemia launch and is ready to execute, with pricing to be determined based on the label and market environment at the time of approval. Q: What is the significance of the in-licensing of cevidoplenib, and how does it fit into the pipeline? A: Brian Goff explained that cevidoplenib is a next-generation, highly selective oral SYK inhibitor for immune thrombocytopenia (ITP). This expands the company's rare hematology franchise beyond PK activation. Sarah Gheuens, Chief Medical Officer, added that the drug was designed to address limitations of the SYK inhibitor class, with encouraging clinical data showing dose-dependent activity and durable platelet responses. The company plans to engage with the FDA to align on a Phase 3 program. Q: What is the progress on AG-236 for polycythemia vera? A: Sarah Gheuens stated that AG-236, an siRNA TMPRSS6 inhibitor, is advancing into an operationally seamless Phase 2/3 program. The molecule has shown hepcidin induction and favorable effects on iron parameters, supporting a potential every-six-month dosing regimen. The Phase 2 portion is designed to identify the optimal dose and is expected to begin in the second half of 2026. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Neurocrine Biosciences NBIX is scheduled to report second-quarter 2026 results on July 30, after market close. We expect investors to focus on the sales performance of NBIX’s marketed products and other pipeline updates when the company reports quarterly results. The Zacks Consensus Estimate for second-quarter 2026 revenues is pegged at $901.54 million, while the same for earnings is pegged at $2.26 per share. Over the past six months, shares of NBIX have risen 30.5% against the industry’s 4.1% decline. Image Source: Zacks Investment Research Let’s see how things might have shaped up for NBIX in the to-be-reported quarter. Neurocrine’s top line primarily comprises product sales from Ingrezza and Crenessity with only a modest contribution from other revenue streams. Ingrezza, the company's flagship VMAT2 inhibitor, continues to anchor revenue growth with its leadership in the tardive dyskinesia market, while benefiting from its expanded indication in Huntington's disease chorea. Meanwhile, Crenessity is emerging as an important growth driver following its FDA approval in late 2024 for use as an adjunctive treatment for classic congenital adrenal hyperplasia (CAH) in adults and children aged four years and older. We expect Ingrezza to sustain its solid commercial momentum in the upcoming quarter, supported by robust prescription demand. Management's reaffirmation of its full-year sales guidance of $2.7-$2.8 billion reflects continued confidence in the product's growth trajectory. Meanwhile, Crenessity is expected to deliver another quarter of sequential growth, driven by increasing physician adoption, expanding reimbursement coverage and rising patient uptake. Collectively, these products are likely to underpin Neurocrine's second-quarter commercial performance. Beyond its commercial portfolio, investors are likely to focus on updates across Neurocrine's diversified neuroscience pipeline, which remains a key driver of the company's long-term growth strategy. Particular attention will be on the phase III development of direclidine for schizophrenia, alongside its mid-stage evaluation in bipolar mania, as well as the late-stage development of osavampator for major depressive disorder with cognitive impairment. Investors will also look for updates on Crenessity's expansion, following the initiation of a phase II study in younger pediatric patients (less than four years) with classic CAH and the completion of enrollment in a separate phase II study in the European Union involving children from birth to under two years of age. Another area of focus will be the Soleno Therapeutics acquisition, completed in May 2026. The transaction added Vykat XR (diazoxide choline), the first and only FDA-approved treatment for hyperphagia associated with Prader-Willi syndrome in adults and pediatric patients aged four years and older, to Neurocrine's commercial portfolio. Supported by patent protection extending into the mid-2040s, the acquisition is expected to strengthen the company's commercial platform and enhance its long-term growth profile. Neurocrine Biosciences, Inc. price-consensus-chart | Neurocrine Biosciences, Inc. Quote Neurocrine has a mixed history of earnings surprises. The company’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, delivering an average surprise of 9.08%. In the last reported quarter, the company delivered an earnings surprise of 15.48%. Our proven model does not conclusively predict an earnings beat for NBIX this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter. Earnings ESP: Neurocrine has an Earnings ESP of -7.61% as the Most Accurate Estimate currently stands at $2.08 per share and the Zacks Consensus Estimate of earnings is pegged at $2.26. Zacks Rank: Neurocrine currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here. Here are a few stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle. Harmony Biosciences HRMY has an Earnings ESP of +14.14% and sports a Zacks Rank #1 at present. Shares of HRMY have lost 4.2% over the past six months. The company’s earnings missed estimates in each of the trailing four quarters, delivering a negative average surprise of 25.16%. ACADIA Pharmaceuticals ACAD has an Earnings ESP of +25.00% and carries a Zacks Rank #2 at present. Shares of ACAD have lost 3.1% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 20.83%. Agios Pharmaceuticals AGIO has an Earnings ESP of +12.67% and holds a Zacks Rank #3 at present. Shares of AGIO have risen 28.4% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 2.39%. 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 Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The second-quarter 2026 reporting cycle for the Medical sector is picking up pace. The sector primarily comprises pharma/biotech and medical device companies. The earnings season for the Medical sector kicked off earlier this month when pharma bellwether Johnson & Johnson posted encouraging earnings results. J&J also raised its 2026 outlook for the second time this year, driven by the strong performance of its Innovative Medicines/Pharma segment. Another large-cap company that recently reported impressive earnings results was Novartis, driven by strong demand for key growth brands. The Earnings Trends report indicates that, as of July 22, 10.2% of the companies in the Medical sector, representing about 25% of the sector’s market capitalization, have reported quarterly earnings. So far, all participants have outperformed both earnings and revenues. While earnings rose 14.6% year over year, sales increased 2.3%. Overall, second-quarter earnings are expected to fall 17.4% year over year, while revenues are expected to rise 5.2%. We have highlighted five biotech companies — Harmony Biosciences HRMY, Acadia Pharmaceuticals ACAD, Biogen BIIB, Insmed INSM and Agios Pharmaceuticals AGIO — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance of delivering an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. HRMY is a commercial-stage company that develops and commercializes therapies for sleep/wake disorders and rare neurological diseases. The company has an Earnings ESP of +14.14% and a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. The Zacks Consensus Estimate for second-quarter earnings is pegged at 97 cents per share. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. It is scheduled to report earnings on Aug. 4, before the opening bell. Harmony Biosciences Holdings, Inc. price-eps-surprise | Harmony Biosciences Holdings, Inc. Quote A commercial-stage company, ACAD, is focused on developing and marketing therapies for central nervous system disorders and rare diseases. The company has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at 6 cents per share. Acadia Pharmaceuticals beat on earnings in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 20.83%. The company is scheduled to release results on Aug. 4, after the market closes. ACADIA Pharmaceuticals Inc. price-eps-surprise | ACADIA Pharmaceuticals Inc. Quote BIIB is one of the world’s leading biotechs, focusing on developing innovative therapies for treating serious neurological and neurodegenerative diseases. The company has an Earnings ESP of +220.79% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at 94 cents per share. Biogen beat on earnings in each of the trailing four quarters, delivering an average surprise of 26.87%. It is scheduled to report earnings on July 29, before the opening bell. Biogen Inc. price-eps-surprise | Biogen Inc. Quote INSM is a commercial-stage biopharmaceutical company focused on the development of therapies targeting serious and rare indications. The company has an Earnings ESP of +22.32% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at a loss of 69 cents per share. Insmed missed on earnings in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 22.93%. The company is scheduled to release results on Aug. 6, before the opening bell. Insmed, Inc. price-eps-surprise | Insmed, Inc. Quote AGIO is a biopharmaceutical company focused on the development of treatments for rare genetic metabolic disorders, a subset of orphan genetic metabolic diseases. The company has an Earnings ESP of +12.67% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for second-quarter earnings is pegged at a loss of $1.86 per share. Agios beat on earnings in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 2.39%. It is scheduled to report earnings on July 30, before the opening bell. Agios Pharmaceuticals, Inc. price-eps-surprise | Agios Pharmaceuticals, Inc. Quote 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 Biogen Inc. (BIIB) : Free Stock Analysis Report Insmed, Inc. (INSM) : Free Stock Analysis Report Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Wall Street expects a year-over-year increase in earnings on higher revenues when Agios Pharmaceuticals (AGIO) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on July 30, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly loss of $1.86 per share in its upcoming report, which represents a year-over-year change of +3.6%. Revenues are expected to be $22.68 million, up 82.2% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Agios Pharmaceuticals, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +12.67%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Agios Pharmaceuticals will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Agios Pharmaceuticals would post a loss of$1.81 per share when it actually produced a loss of -$1.69, delivering a surprise of +6.63%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Agios Pharmaceuticals appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Adaptive Biotechnologies (ADPT), is soon expected to post loss of $0.13 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +23.5%. This quarter's revenue is expected to be $66.27 million, up 12.6% from the year-ago quarter. The consensus EPS estimate for Adaptive Biotechnologies has remained unchanged over the last 30 days. However, an equal Most Accurate Estimate has resulted in an Earnings ESP of 0.00%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Adaptive Biotechnologies will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. 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 Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Agios submitted the application under the accelerated approval pathway based on positive data from its Phase 2 and Phase 3 trials. The FDA is expected to make its decision by November 1, 2026. RBC Capital raised its price target to $32 from $28 while maintaining a ‘Sector Perform’ rating, according to The Fly. Shares of Agios Pharmaceuticals (AGIO) jumped more than 14% to their highest level in over seven months after the company secured a key regulatory milestone for its sickle cell disease therapy, while upbeat Wall Street expectations ahead of second-quarter earnings further boosted investor sentiment. AGIO shares also clocked their biggest single-day gains in over three months. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox On Tuesday, the U.S. Food and Drug Administration (FDA) granted Priority Review to Agios’ supplemental New Drug Application (sNDA) for Mitapivat in sickle cell disease. If approved, Mitapivat would become the first oral pyruvate kinase (PK) activator available for patients with the condition, with the FDA expected to make its decision by Nov. 1, 2026. The Priority Review designation shortens the FDA’s review timeline from the standard 10 months to six months for therapies that could offer meaningful improvements for serious diseases. Agios submitted the application under the accelerated approval pathway based on positive data from its Phase 2 and Phase 3 Rise Up trials in patients aged 16 and older with sickle cell disease. The biotech firm is also conducting a separate Phase 3 confirmatory trial to support approval. In November 2025, the company reported that Mitapivat met the study’s primary endpoint by significantly improving hemoglobin response compared with placebo. However, it did not significantly reduce sickle cell pain crises or improve fatigue. Wall Street turned increasingly positive on Agios ahead of the second-quarter earnings season. According to The Fly, RBC Capital raised its price target to $32 from $28 while maintaining a ‘Sector Perform’ rating, citing expectations for a “seasonally strong” biotech earnings season. Agios is expected to report its Q2 earnings on July 30. Meanwhile, BofA lifted its price target on the stock to $46 from $40 and reiterated a ‘Buy’ rating. The firm said consensus revenue expectations of $26.9 million appear achievable, given that Mitapivat generated $20.7 million in worldwide revenue in Q1. However, the brokerage said reimbursement trends and the conversion of prescriptions into paid sales are the key factors to watch. Retail sentiment surrounding AGIO on Stocktwits remained ‘bullish’ over the past 24 hours, amid ‘high’ message volumes. AGIO shares have gained more than 56% so far this year. Also read: Trump Reignites Greenland Push At NATO Summit – ‘Greenland Should Be Controlled By The United States, Not By Denmark’ For updates and corrections, email newsroom[at]stocktwits[dot]com. Arnab Paul has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: NFLX, DIS, YouTube Want FIFA's World Cup US Rights — Why A $2B Bidding War Is Brewing FCEL Stock Plummets After-Hours On $200M Share Offering US Launches Heavy Retaliatory Airstrikes On Iran Following Series Of Attacks On Ships