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RGEN

RepligenC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-09-03
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Earnings documents stored for RGEN.

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Investor releaseQuarter not tagged2026-09-03

Why Is ImmunityBio (IBRX) Up 9.7% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for ImmunityBio (IBRX). Shares have added about 9.7% 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 ImmunityBio due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent drivers for ImmunityBio, Inc. before we dive into how investors and analysts have reacted as of late. ImmunityBio reported an adjusted loss of 8 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 9 cents. The loss improved 20% compared with the year-ago period’s loss of 10 cents. Total revenues surged nearly 94% year over year to $51.2 million, beating the Zacks Consensus Estimate of $48.5 million. The top-line performance reflected continued adoption of the company’s sole marketed drug, Anktiva, among U.S. urologists and strong market access. Net product revenues, which accounted for nearly all quarterly revenues, reached a record $50.7 million, rising 92% year over year and 15% sequentially. The product performance marked ImmunityBio’s eighth consecutive quarter of sequential net product revenue growth since Anktiva’s commercial launch. Other revenues totaled $0.6 million. Total operating costs and expenses increased about 16% year over year to around $113 million. Research and development expenses grew 10% to nearly $61 million. The increase reflected higher personnel-related costs, clinical trial expenses and external manufacturing and distribution costs. Selling, general and administrative expenses climbed 22% year over year to about $52 million. The increase stemmed mainly from higher professional services, personnel-related and commercial expenses. In the past month, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted 6.25% due to these changes. At this time, ImmunityBio has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. Following the exact same course, the stock has a score of F on the value side, putting it in the fifth quintile 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. Estimat…Read full document

A month has gone by since the last earnings report for ImmunityBio (IBRX). Shares have added about 9.7% 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 ImmunityBio due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent drivers for ImmunityBio, Inc. before we dive into how investors and analysts have reacted as of late. ImmunityBio reported an adjusted loss of 8 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 9 cents. The loss improved 20% compared with the year-ago period’s loss of 10 cents. Total revenues surged nearly 94% year over year to $51.2 million, beating the Zacks Consensus Estimate of $48.5 million. The top-line performance reflected continued adoption of the company’s sole marketed drug, Anktiva, among U.S. urologists and strong market access. Net product revenues, which accounted for nearly all quarterly revenues, reached a record $50.7 million, rising 92% year over year and 15% sequentially. The product performance marked ImmunityBio’s eighth consecutive quarter of sequential net product revenue growth since Anktiva’s commercial launch. Other revenues totaled $0.6 million. Total operating costs and expenses increased about 16% year over year to around $113 million. Research and development expenses grew 10% to nearly $61 million. The increase reflected higher personnel-related costs, clinical trial expenses and external manufacturing and distribution costs. Selling, general and administrative expenses climbed 22% year over year to about $52 million. The increase stemmed mainly from higher professional services, personnel-related and commercial expenses. In the past month, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted 6.25% due to these changes. At this time, ImmunityBio has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. Following the exact same course, the stock has a score of F on the value side, putting it in the fifth quintile 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 this revision looks promising. Notably, ImmunityBio has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. ImmunityBio belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Repligen (RGEN), has gained 9.1% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Repligen reported revenues of $204.13 million in the last reported quarter, representing a year-over-year change of +11.9%. EPS of $0.54 for the same period compares with $0.37 a year ago. For the current quarter, Repligen is expected to post earnings of $0.46 per share, indicating no change from the year-ago quarter. The Zacks Consensus Estimate has changed -0.1% over the last 30 days. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #1 (Strong Buy) for Repligen. Also, the stock has a VGM Score of F. 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 ImmunityBio, Inc. (IBRX) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-09-02

Why Is Jazz (JAZZ) Down 6.9% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for Jazz Pharmaceuticals (JAZZ). Shares have lost about 6.9% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Jazz due for a breakout? 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 catalysts. Jazz Pharmaceuticals reported second-quarter 2026 adjusted EPS of $5.71, which missed the Zacks Consensus Estimate of $6.04. This shortfall primarily reflected $77 million in acquired IPR&D expenses, which reduced adjusted EPS by 94 cents. In the year-ago quarter, the company posted an adjusted loss of $8.25 per share, largely due to a one-time charge of $905.4 million related to the acquisition of clinical-stage biotech Chimerix. Total revenues rose 16% year over year to $1.21 billion, which beat the Zacks Consensus Estimate of $1.11 billion. This uptick was driven by the better-than-expected sales performance of its oncology and neuroscience products. Net product sales totaled $1.16 billion, up 17% year over year. The reported figure beat both the Zacks Consensus Estimate of $1.08 billion and our model estimate of $1.05 billion. High-sodium oxybate authorized generic (AG) royalty revenues fell 22% year over year to $42 million. Other royalty and contract revenues increased 67% to $10 million, though they remained a relatively small contributor to total revenues. Net product sales for the combined oxybate business, comprising Xyrem and Xywav, rose 11% to nearly $502 million. This figure beat both the Zacks Consensus Estimate of about $455 million and our model estimate of $441 million. Xywav sales increased 13% year over year to $471 million, supported by continued demand across approved indications. Jazz added approximately 525 net Xywav patients during the second quarter, marking its highest quarterly increase in a year. The company exited June with around 17,125 active patients, including 11,275 narcolepsy patients and 5,850 IH patients. Management said the uptake of competing high-sodium generics remained limited, supporting its expectation for double-digit Xywav growth in 2026. Xyrem sales continued their downward trajectory, declining 14% year over year to $30.5 mil…Read full document

A month has gone by since the last earnings report for Jazz Pharmaceuticals (JAZZ). Shares have lost about 6.9% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Jazz due for a breakout? 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 catalysts. Jazz Pharmaceuticals reported second-quarter 2026 adjusted EPS of $5.71, which missed the Zacks Consensus Estimate of $6.04. This shortfall primarily reflected $77 million in acquired IPR&D expenses, which reduced adjusted EPS by 94 cents. In the year-ago quarter, the company posted an adjusted loss of $8.25 per share, largely due to a one-time charge of $905.4 million related to the acquisition of clinical-stage biotech Chimerix. Total revenues rose 16% year over year to $1.21 billion, which beat the Zacks Consensus Estimate of $1.11 billion. This uptick was driven by the better-than-expected sales performance of its oncology and neuroscience products. Net product sales totaled $1.16 billion, up 17% year over year. The reported figure beat both the Zacks Consensus Estimate of $1.08 billion and our model estimate of $1.05 billion. High-sodium oxybate authorized generic (AG) royalty revenues fell 22% year over year to $42 million. Other royalty and contract revenues increased 67% to $10 million, though they remained a relatively small contributor to total revenues. Net product sales for the combined oxybate business, comprising Xyrem and Xywav, rose 11% to nearly $502 million. This figure beat both the Zacks Consensus Estimate of about $455 million and our model estimate of $441 million. Xywav sales increased 13% year over year to $471 million, supported by continued demand across approved indications. Jazz added approximately 525 net Xywav patients during the second quarter, marking its highest quarterly increase in a year. The company exited June with around 17,125 active patients, including 11,275 narcolepsy patients and 5,850 IH patients. Management said the uptake of competing high-sodium generics remained limited, supporting its expectation for double-digit Xywav growth in 2026. Xyrem sales continued their downward trajectory, declining 14% year over year to $30.5 million due to patients switching to Xywav and generic erosion. Epidiolex/Epidyolex sales increased 16% year over year to $292 million. Management attributed the performance primarily to strong underlying demand across pediatric and adult treatment settings. Oncology sales increased 32% year over year to $362 million. Zepzelca revenues surged 42% to nearly $106 million, driven by adoption in first-line maintenance treatment for extensive-stage SCLC. This figure beat the Zacks Consensus Estimate of more than $93 million and our model estimate of $81 million. During the conference call, Jazz announced plans to submit a labeling supplement to remove Zepzelca’s second-line metastatic SCLC indication. The proposed removal will not affect its first-line maintenance indication. Rylaze/Enrylaze posted sales of $99.5 million, down 1% year over year. Modeyso generated $48 million in sales compared with $41 million in the previous quarter. More than 600 patients had received the brain tumor treatment through the end of the second quarter since its launch last year. Vyxeos sales declined 30% to more than $31 million, while Defitelio revenues rose 29% to $62 million. Ziihera contributed $15.4 million in the reported quarter compared with $13.3 million in the previous quarter. Adjusted gross margin contracted 60 basis points year over year to 92.1%. The decline reflected higher sales of Modeyso and Zepzelca, which carry third-party royalty obligations. Adjusted selling, general and administrative expenses rose 11% to more than $343 million, reflecting higher marketing investments and compensation-related expenses. Adjusted research and development costs also increased 11% to about $185 million, primarily due to higher clinical study expenses related to Ziihera. The quarter included $77 million in acquired IPR&D expenses related to agreements with AbCellera Biologics and Werewolf Therapeutics. Jazz raised its 2026 revenue guidance to $4.60-$4.75 billion from $4.25-$4.50 billion. The revision reflects stronger Xywav performance and expected double-digit growth from the epilepsy and oncology franchises. The company now expects rare sleep revenues of $2.03-$2.13 billion. Adjusted SG&A expense guidance was increased to $1.33-$1.37 billion from $1.26-$1.32 billion, while adjusted R&D expense guidance was maintained at $725-$775 million. The adjusted effective tax rate is expected to remain between 11.5% and 13.5%. Since the earnings release, investors have witnessed a upward trend in fresh estimates. Currently, Jazz has a strong Growth Score of A, though it is lagging a lot on the Momentum Score front with a D. However, the stock has a score of A on the value side, putting it in the top 20% 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 trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Jazz has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Jazz belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Repligen (RGEN), has gained 13.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Repligen reported revenues of $204.13 million in the last reported quarter, representing a year-over-year change of +11.9%. EPS of $0.54 for the same period compares with $0.37 a year ago. Repligen is expected to post earnings of $0.46 per share for the current quarter, representing no change from the year-ago quarter. Over the last 30 days, the Zacks Consensus Estimate has changed -0.1%. Repligen has a Zacks Rank #1 (Strong Buy) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F. 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 Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-09-01

JAZZ Rises on Updated OS Results From Gastric Cancer Study

Zacks
Jazz Pharmaceuticals JAZZ announced second interim top-line overall survival (OS) results from the phase III HERIZON-GEA-01 study, which evaluated different combination regimens involving its marketed drug, Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The HERIZON-GEA-01 study evaluated two regimens — Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines’ (formerly BeiGene) PD-1 inhibitor Tevimbra plus chemotherapy — against the current standard of care (SoC) treatment, trastuzumab plus chemotherapy, in the given population. The second interim analysis has now demonstrated that the two-drug regimen of Ziihera plus chemotherapy led to a statistically significant and clinically meaningful improvement in OS versus trastuzumab plus chemotherapy (SoC), strengthening the clinical profile of Ziihera in first-line HER2-positive GEA. Importantly, the OS hazard ratio improved from the first interim analysis, indicating a stronger survival benefit with longer follow-up. The latest results represent an important update to the first interim analysis. In the first interim analysis reported in November 2025, the results had only shown a strong trend toward statistical significance. Management also reported that with longer follow-up, Ziihera plus Tevimbra and chemotherapy resulted in an improvement in the OS hazard ratio compared with the first interim analysis. Jazz said the updated findings further demonstrate a statistically significant, clinically meaningful and durable OS benefit for the three-drug regimen. Shares of Jazz were up 2.5% yesterday following the announcement of the updated OS results. The stock has rallied 47.5% so far this year, compared with the industry’s increase of 9.7%. Image Source: Zacks Investment Research The updated OS results follow the FDA’s recent label expansion of Ziihera as the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic GEA. Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without Tevimbra, in this patient population. The approval significantly expands the addressable market for Ziihera beyond its existing use in previously treated HER2-positive biliary tract cancer (BTC). The expanded indication represents a much larger commercial opportunity than Zi…Read full document

Jazz Pharmaceuticals JAZZ announced second interim top-line overall survival (OS) results from the phase III HERIZON-GEA-01 study, which evaluated different combination regimens involving its marketed drug, Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The HERIZON-GEA-01 study evaluated two regimens — Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines’ (formerly BeiGene) PD-1 inhibitor Tevimbra plus chemotherapy — against the current standard of care (SoC) treatment, trastuzumab plus chemotherapy, in the given population. The second interim analysis has now demonstrated that the two-drug regimen of Ziihera plus chemotherapy led to a statistically significant and clinically meaningful improvement in OS versus trastuzumab plus chemotherapy (SoC), strengthening the clinical profile of Ziihera in first-line HER2-positive GEA. Importantly, the OS hazard ratio improved from the first interim analysis, indicating a stronger survival benefit with longer follow-up. The latest results represent an important update to the first interim analysis. In the first interim analysis reported in November 2025, the results had only shown a strong trend toward statistical significance. Management also reported that with longer follow-up, Ziihera plus Tevimbra and chemotherapy resulted in an improvement in the OS hazard ratio compared with the first interim analysis. Jazz said the updated findings further demonstrate a statistically significant, clinically meaningful and durable OS benefit for the three-drug regimen. Shares of Jazz were up 2.5% yesterday following the announcement of the updated OS results. The stock has rallied 47.5% so far this year, compared with the industry’s increase of 9.7%. Image Source: Zacks Investment Research The updated OS results follow the FDA’s recent label expansion of Ziihera as the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic GEA. Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without Tevimbra, in this patient population. The approval significantly expands the addressable market for Ziihera beyond its existing use in previously treated HER2-positive biliary tract cancer (BTC). The expanded indication represents a much larger commercial opportunity than Ziihera’s existing BTC indication. GEA encompasses stomach, gastroesophageal junction and esophageal cancers and is the fifth most common cancer globally. Approximately 20% of GEA patients have HER2-positive disease, a subgroup associated with particularly poor outcomes in advanced and metastatic settings. In metastatic disease, the five-year survival rate remains below 10%, highlighting the need for more effective treatment options. The latest findings could help Jazz establish Ziihera-based regimens as an important treatment option in the first-line setting and support the company's efforts to position Ziihera as the preferred HER2-targeted backbone therapy. Jazz plans to present the updated results at a medical meeting in the fourth quarter of 2026 and submit the same to regulatory authorities worldwide. With its approval across HER2-positive disease regardless of PD-L1 status, Ziihera could address a broader patient population than regimens that require PD-L1 expression. Ziihera was added to JAZZ’s portfolio as part of a 2022 licensing agreement with Zymeworks ZYME. Per the agreement, JAZZ has exclusive rights to develop and market Ziihera in all territories except Asia-Pacific territories (where the drug has been licensed to BeOne Medicines). Zymeworks is eligible to receive tiered royalties on sales of the drug. JAZZ is developing the drug in separate late-stage studies across first-line BTC and metastatic breast cancer. Ziihera is being evaluated across multiple clinical studies for the treatment of HER2-positive solid tumors. Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Repligen RGEN and Anika Therapeutics ANIK, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.5% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 117.2% year to date. Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%. 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 Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Anika Therapeutics Inc. (ANIK) : Free Stock Analysis Report Zymeworks Inc. (ZYME) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-28

Why Is Viking Therapeutics (VKTX) Up 2.3% Since Last Earnings Report?

Zacks
It has been about a month since the last earnings report for Viking Therapeutics, Inc. (VKTX). Shares have added about 2.3% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Viking Therapeutics due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent catalysts for Viking Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. Viking reported a second-quarter 2026 loss of $1.10 per share, narrower than the Zacks Consensus Estimate of a loss of $1.21. The reported loss, however, widened from a loss of 58 cents per share in the year-ago quarter due to higher operating expenses. Currently, Viking does not have any approved products in its portfolio. It has yet to generate revenues. Research and development expenses surged 92.4% year over year to $115.8 million. The rise primarily reflected higher spending on clinical studies, salaries and benefits, stock-based compensation and third-party consultants. General and administrative expenses climbed 16.8% to $16.8 million. Higher consultant, legal and patent-service costs, salaries and benefits were partly offset by lower stock-based compensation. Viking ended the June quarter with $502 million in cash, cash equivalents and short-term investments compared with $603 million at the end of first-quarter 2026. Management described the current period as the heaviest phase of cash usage for the VANQUISH studies. It expects spending to taper and reiterated that existing resources should fund operations into 2028. Since the earnings release, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 8.26% due to these changes. At this time, Viking Therapeutics has a poor Growth Score of F, however its Momentum Score is doing a lot better with an A. However, the stock was allocated a score 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 broadly trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Viking Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line…Read full document

It has been about a month since the last earnings report for Viking Therapeutics, Inc. (VKTX). Shares have added about 2.3% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Viking Therapeutics due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent catalysts for Viking Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. Viking reported a second-quarter 2026 loss of $1.10 per share, narrower than the Zacks Consensus Estimate of a loss of $1.21. The reported loss, however, widened from a loss of 58 cents per share in the year-ago quarter due to higher operating expenses. Currently, Viking does not have any approved products in its portfolio. It has yet to generate revenues. Research and development expenses surged 92.4% year over year to $115.8 million. The rise primarily reflected higher spending on clinical studies, salaries and benefits, stock-based compensation and third-party consultants. General and administrative expenses climbed 16.8% to $16.8 million. Higher consultant, legal and patent-service costs, salaries and benefits were partly offset by lower stock-based compensation. Viking ended the June quarter with $502 million in cash, cash equivalents and short-term investments compared with $603 million at the end of first-quarter 2026. Management described the current period as the heaviest phase of cash usage for the VANQUISH studies. It expects spending to taper and reiterated that existing resources should fund operations into 2028. Since the earnings release, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 8.26% due to these changes. At this time, Viking Therapeutics has a poor Growth Score of F, however its Momentum Score is doing a lot better with an A. However, the stock was allocated a score 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 broadly trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Viking Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Viking Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Repligen (RGEN), has gained 26.8% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Repligen reported revenues of $204.13 million in the last reported quarter, representing a year-over-year change of +11.9%. EPS of $0.54 for the same period compares with $0.37 a year ago. For the current quarter, Repligen is expected to post earnings of $0.46 per share, indicating no change from the year-ago quarter. The Zacks Consensus Estimate has changed +1.2% over the last 30 days. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #1 (Strong Buy) for Repligen. Also, the stock has a VGM Score of F. 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 Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-27

Why Is Repligen (RGEN) Up 27.7% Since Last Earnings Report?

Zacks
It has been about a month since the last earnings report for Repligen (RGEN). Shares have added about 27.7% 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 Repligen 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 most recent earnings report in order to get a better handle on the important drivers. Repligen reported second-quarter 2026 adjusted earnings per share of 54 cents, which beat the Zacks Consensus Estimate of 45 cents. In the year-ago quarter, the company reported adjusted earnings of 37 cents per share. Total revenues in the second quarter were $204.1 million, up 12% year over year on a reported basis. Excluding the impact of acquisitions and currency exchange, revenues rose 13% organically. Revenues also beat the Zacks Consensus Estimate of $202 million. The company’s top line comprises product revenues and negligible royalties and other revenues. Product revenues were $204.1 million, up almost 12% from the year-ago level. Royalty and other revenues amounted to $0.04 million, up around 16% year over year. Repligen records revenues from its business franchisees that can be categorized as filtration, chromatography, proteins and process analytics. Total orders remained strong, like some previous quarters, with all the franchises witnessing year-over-year growth during the second quarter. Filtration revenues grew slightly on a reported basis in the quarter, driven by consumable demand, including fluid management and flat sheet cassettes. Chromatography revenues increased in low double digits during the quarter, driven by growth in OPUS columns. Proteins grew 50% year over year. Biopharma revenues also grew during the second quarter, driven by growth from emerging biotech. CDMO revenues also witnessed strong growth year over year during the quarter. In the reported quarter, Process Analytics revenues grew more than 30% year over year, led by strength across consumables, services and capital equipment. Adjusted gross margin was 53.9%, reflecting an increase of 280 basis points year over year. Adjusted operating income totaled $34 million, reflecting an increase of 55% year over year. Adjusted operating margin was 16.7% in the second quarter, higher than 12% in…Read full document

It has been about a month since the last earnings report for Repligen (RGEN). Shares have added about 27.7% 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 Repligen 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 most recent earnings report in order to get a better handle on the important drivers. Repligen reported second-quarter 2026 adjusted earnings per share of 54 cents, which beat the Zacks Consensus Estimate of 45 cents. In the year-ago quarter, the company reported adjusted earnings of 37 cents per share. Total revenues in the second quarter were $204.1 million, up 12% year over year on a reported basis. Excluding the impact of acquisitions and currency exchange, revenues rose 13% organically. Revenues also beat the Zacks Consensus Estimate of $202 million. The company’s top line comprises product revenues and negligible royalties and other revenues. Product revenues were $204.1 million, up almost 12% from the year-ago level. Royalty and other revenues amounted to $0.04 million, up around 16% year over year. Repligen records revenues from its business franchisees that can be categorized as filtration, chromatography, proteins and process analytics. Total orders remained strong, like some previous quarters, with all the franchises witnessing year-over-year growth during the second quarter. Filtration revenues grew slightly on a reported basis in the quarter, driven by consumable demand, including fluid management and flat sheet cassettes. Chromatography revenues increased in low double digits during the quarter, driven by growth in OPUS columns. Proteins grew 50% year over year. Biopharma revenues also grew during the second quarter, driven by growth from emerging biotech. CDMO revenues also witnessed strong growth year over year during the quarter. In the reported quarter, Process Analytics revenues grew more than 30% year over year, led by strength across consumables, services and capital equipment. Adjusted gross margin was 53.9%, reflecting an increase of 280 basis points year over year. Adjusted operating income totaled $34 million, reflecting an increase of 55% year over year. Adjusted operating margin was 16.7% in the second quarter, higher than 12% in the year-ago quarter. As of June 30, 2026, Repligen had cash and cash equivalents worth $810 million compared with $785 million as of March 31, 2026. Repligen increased its full-year 2026 revenue guidance as well as EPS outlook. The company now expects total revenues in the range of $813-$835 million in 2026, compared with the previous expectation of $803-$833 million. Importantly, Repligen now expects reported revenue growth of 10-13% and organic revenue growth of 10.5%-13.5% in 2026. Previously, the company expected reported as well as organic revenue growth of 9%-13%. Adjusted EPS is now anticipated to be between $2.03 and $2.09 for full-year 2026, up from the previous expectation of $1.97 and $2.05. Adjusted gross margin is expected to be between 53.7% and 54.2% for 2026, unchanged from the previous expectation. Adjusted operating income is now expected in the range of $128-$134 million, up from the earlier expectation of $124-$132 million. It turns out, fresh estimates have trended upward during the past month. At this time, Repligen has a poor Growth Score of F, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock has a grade of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions indicates a downward shift. It comes with little surprise Repligen has a Zacks Rank #1 (Strong Buy). We expect an above average return from the stock in the next few months. 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 Repligen Corporation (RGEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-17

Unpacking Q2 Earnings: Repligen (NASDAQ:RGEN) In The Context Of Other Drug Development Inputs & Services Stocks

StockStory
Quarterly earnings results are a good time to check in on a company’s progress, especially compared to its peers in the same sector. Today we are looking at Repligen (NASDAQ:RGEN) and the best and worst performers in the drug development inputs & services industry. Companies specializing in drug development inputs and services play a crucial role in the pharmaceutical and biotechnology value chain. Essential support for drug discovery, preclinical testing, and manufacturing means stable demand, as pharmaceutical companies often outsource non-core functions with medium to long-term contracts. However, the business model faces high capital requirements, customer concentration, and vulnerability to shifts in biopharma R&D budgets or regulatory frameworks. Looking ahead, the industry will likely enjoy tailwinds such as increasing investment in biologics, cell and gene therapies, and advancements in precision medicine, which drive demand for sophisticated tools and services. There is a growing trend of outsourcing in drug development for nimbleness and cost efficiency, which benefits the industry. On the flip side, potential headwinds include pricing pressures as efforts to contain healthcare costs are always top of mind. An evolving regulatory backdrop could also slow innovation or client activity. The 8 drug development inputs & services stocks we track reported a very strong Q2. As a group, revenues beat analysts’ consensus estimates by 4.1% while next quarter’s revenue guidance was 0.8% above. Luckily, drug development inputs & services stocks have performed well with share prices up 10.3% on average since the latest earnings results. With over 13 strategic acquisitions since 2012 to build its comprehensive bioprocessing portfolio, Repligen (NASDAQ:RGEN) develops and manufactures specialized technologies that improve the efficiency and flexibility of biological drug manufacturing processes. Repligen reported revenues of $204.1 million, up 11.9% year on year. This print exceeded analysts’ expectations by 1.1%. Overall, it was a very strong quarter for the company with a beat of analysts’ EPS and organic revenue estimates. Olivier Loeillot, President and Chief Executive Officer of Repligen said, “We were very pleased to deliver 13% organic growth in the second quarter, reflecting sequential acceleration and continued market outperformance. This reflects the str…Read full document

Quarterly earnings results are a good time to check in on a company’s progress, especially compared to its peers in the same sector. Today we are looking at Repligen (NASDAQ:RGEN) and the best and worst performers in the drug development inputs & services industry. Companies specializing in drug development inputs and services play a crucial role in the pharmaceutical and biotechnology value chain. Essential support for drug discovery, preclinical testing, and manufacturing means stable demand, as pharmaceutical companies often outsource non-core functions with medium to long-term contracts. However, the business model faces high capital requirements, customer concentration, and vulnerability to shifts in biopharma R&D budgets or regulatory frameworks. Looking ahead, the industry will likely enjoy tailwinds such as increasing investment in biologics, cell and gene therapies, and advancements in precision medicine, which drive demand for sophisticated tools and services. There is a growing trend of outsourcing in drug development for nimbleness and cost efficiency, which benefits the industry. On the flip side, potential headwinds include pricing pressures as efforts to contain healthcare costs are always top of mind. An evolving regulatory backdrop could also slow innovation or client activity. The 8 drug development inputs & services stocks we track reported a very strong Q2. As a group, revenues beat analysts’ consensus estimates by 4.1% while next quarter’s revenue guidance was 0.8% above. Luckily, drug development inputs & services stocks have performed well with share prices up 10.3% on average since the latest earnings results. With over 13 strategic acquisitions since 2012 to build its comprehensive bioprocessing portfolio, Repligen (NASDAQ:RGEN) develops and manufactures specialized technologies that improve the efficiency and flexibility of biological drug manufacturing processes. Repligen reported revenues of $204.1 million, up 11.9% year on year. This print exceeded analysts’ expectations by 1.1%. Overall, it was a very strong quarter for the company with a beat of analysts’ EPS and organic revenue estimates. Olivier Loeillot, President and Chief Executive Officer of Repligen said, “We were very pleased to deliver 13% organic growth in the second quarter, reflecting sequential acceleration and continued market outperformance. This reflects the strength and diversification of our portfolio and our disciplined execution. The order momentum from the first quarter continued into the second quarter. Our strong first half results and improved line of sight to the second half give us the confidence to increase our full year guidance.” Repligen delivered the weakest performance against analyst estimates and weakest full-year guidance update of the whole group. Interestingly, the stock is up 29.4% since reporting and currently trades at $169.56. Is now the time to buy Repligen? Access our full analysis of the earnings results here, it’s free. Serving as the guardian of some of medicine's most valuable materials, Azenta (NASDAQ:AZTA) provides biological sample management, storage, and genomic services that help pharmaceutical and biotechnology companies preserve and analyze critical research materials. Azenta reported revenues of $161.2 million, up 12% year on year, outperforming analysts’ expectations by 8%. The business had an incredible quarter with a beat of analysts’ EPS estimates. The market seems happy with the results as the stock is up 10.6% since reporting. It currently trades at $33.33. Is now the time to buy Azenta? Access our full analysis of the earnings results here, it’s free. Created from the 2016 merger of Quintiles (a clinical research organization) and IMS Health (a healthcare data specialist), IQVIA (NYSE:IQV) provides clinical research services, data analytics, and technology solutions to help pharmaceutical companies develop and market medications more effectively. IQVIA reported revenues of $4.37 billion, up 8.7% year on year, exceeding analysts’ expectations by 1.5%. It was a satisfactory quarter as it also posted full-year revenue guidance slightly topping analysts’ expectations. Interestingly, the stock is up 11% since the results and currently trades at $236.60. Read our full analysis of IQVIA’s results here. Named after the Massachusetts river where it was founded in 1947, Charles River Laboratories (NYSE:CRL) provides non-clinical drug development services, research models, and manufacturing support to pharmaceutical and biotechnology companies. Charles River Laboratories reported revenues of $1.00 billion, down 2.7% year on year. This print surpassed analysts’ expectations by 2.5%. Overall, it was a very strong quarter as it also logged a solid beat of analysts’ organic revenue estimates and a beat of analysts’ EPS estimates. The stock is up 19.6% since reporting and currently trades at $280.01. Read our full, actionable report on Charles River Laboratories here, it’s free. Founded in 1923 and serving as a critical link in the pharmaceutical supply chain, West Pharmaceutical Services (NYSE:WST) manufactures specialized packaging, containment systems, and delivery devices for injectable drugs and healthcare products. West Pharmaceutical Services reported revenues of $872.3 million, up 13.8% year on year. This number topped analysts’ expectations by 3.5%. It was a very strong quarter as it also produced an impressive beat of analysts’ full-year EPS guidance estimates and a beat of analysts’ EPS estimates. The stock is down 2.5% since reporting and currently trades at $349.60. Read our full, actionable report on West Pharmaceutical Services here, it’s free. Over the past year, investors have been forced to repeatedly answer the same question: what is the market’s biggest risk? The answer has changed several times, and each shift has reshaped market leadership. Late in 2025 and early 2026, artificial intelligence became the market’s primary uncertainty. Investors questioned whether AI would erode software pricing power and weaken competitive moats as AI made it easier to replicate once-differentiated products. By the spring, technology took a back seat to geopolitics. The U.S. conflict with Iran briefly became the market’s dominant narrative, raising concerns about oil prices, inflation, and global growth. But as energy markets remained orderly and fears of a prolonged supply disruption faded, investors quickly turned their focus back to fundamentals. Want to invest in winners with rock-solid fundamentals? Check out our Top 6 Stocks and add them to your watchlist. These companies are poised for growth regardless of the political or macroeconomic climate.

Investor releaseQuarter not tagged2026-08-14

CRMD Stock Up as Q2 Earnings & Sales Beat on DefenCath, Melinta Gains

Zacks
CorMedix Therapeutics CRMD delivered second-quarter 2026 adjusted earnings of 29 cents per share, which increased 4% year over year from 28 cents reported in the year-ago quarter. The reported figure beat the Zacks Consensus Estimate of 26 cents. Consolidated revenues were $101.9 million, which rose 157% from $39.7 million a year ago and came above the Zacks Consensus Estimate of $95 million. Results reflected continued DefenCath utilization among large outpatient dialysis customers and a full-quarter contribution from the acquired Melinta portfolio. Management also lifted its full-year EBITDA outlook following the better-than-expected second-quarter 2026 results. The stock gained 14.7% on Thursday following the earnings release. DefenCath remained the largest revenue source in the quarter, generating $66.1 million in sales. Management said continued utilization by large outpatient dialysis customers supported performance, while the year-over-year increase was driven largely by the onboarding of a large dialysis organization in mid-2025. CorMedix also signed a multi-year commercial supply agreement for DefenCath with another large dialysis organization, bringing its commercial supply agreements to all five of the top U.S. dialysis providers. The customer placed an initial order and is set to begin a pilot in the third quarter, giving CRMD another potential avenue for broader DefenCath utilization. The acquired Melinta portfolio contributed $35.8 million to second-quarter revenues. The Melinta acquisition closed in August 2025, so the second quarter of 2025 included revenues only from DefenCath, making the year-over-year revenue comparison structurally different. Shares of CorMedix have plunged 30% so far this year against the industry’s 5.8% growth. Image Source: Zacks Investment Research Total operating expenses were $34.2 million in the second quarter, up about 87% from $18.3 million a year earlier. The increase mainly reflected a full quarter of expenses from the Melinta acquisition and the combined company's larger cost structure. R&D expenses rose significantly to $6.7 million from $2.4 million, driven primarily by higher personnel and clinical study services supporting ongoing programs. Selling and marketing expenses increased about 95% to $12.4 million, while general and administrative expenses rose about 59% to $15.1 million. CorMedix ended the secon…Read full document

CorMedix Therapeutics CRMD delivered second-quarter 2026 adjusted earnings of 29 cents per share, which increased 4% year over year from 28 cents reported in the year-ago quarter. The reported figure beat the Zacks Consensus Estimate of 26 cents. Consolidated revenues were $101.9 million, which rose 157% from $39.7 million a year ago and came above the Zacks Consensus Estimate of $95 million. Results reflected continued DefenCath utilization among large outpatient dialysis customers and a full-quarter contribution from the acquired Melinta portfolio. Management also lifted its full-year EBITDA outlook following the better-than-expected second-quarter 2026 results. The stock gained 14.7% on Thursday following the earnings release. DefenCath remained the largest revenue source in the quarter, generating $66.1 million in sales. Management said continued utilization by large outpatient dialysis customers supported performance, while the year-over-year increase was driven largely by the onboarding of a large dialysis organization in mid-2025. CorMedix also signed a multi-year commercial supply agreement for DefenCath with another large dialysis organization, bringing its commercial supply agreements to all five of the top U.S. dialysis providers. The customer placed an initial order and is set to begin a pilot in the third quarter, giving CRMD another potential avenue for broader DefenCath utilization. The acquired Melinta portfolio contributed $35.8 million to second-quarter revenues. The Melinta acquisition closed in August 2025, so the second quarter of 2025 included revenues only from DefenCath, making the year-over-year revenue comparison structurally different. Shares of CorMedix have plunged 30% so far this year against the industry’s 5.8% growth. Image Source: Zacks Investment Research Total operating expenses were $34.2 million in the second quarter, up about 87% from $18.3 million a year earlier. The increase mainly reflected a full quarter of expenses from the Melinta acquisition and the combined company's larger cost structure. R&D expenses rose significantly to $6.7 million from $2.4 million, driven primarily by higher personnel and clinical study services supporting ongoing programs. Selling and marketing expenses increased about 95% to $12.4 million, while general and administrative expenses rose about 59% to $15.1 million. CorMedix ended the second quarter with cash and cash equivalents of $256.7 million, excluding restricted cash, up from $178.1 million at the end of the first quarter of 2026. Management believes its existing resources are sufficient to fund operations for at least 12 months from the issuance of the company’s second-quarter Form 10-Q. Management maintained its full-year 2026 consolidated revenue guidance of $325-$345 million. It also reiterated DefenCath's revenue guidance of $175-$195 million, with management noting that the franchise was tracking toward the middle to upper end of that range. CorMedix raised its full-year adjusted EBITDA guidance to $125-$140 million. Management also said recent customer contract amendments covering third- and fourth-quarter 2026 pricing, and in some cases 2027 pricing and volume commitments, improved visibility into utilization through year-end. CorMedix Inc price-consensus-eps-surprise-chart | CorMedix Inc Quote CorMedix, with partner Mundipharma, expects to submit a supplemental new drug application for Rezzayo in prophylaxis of invasive fungal disease in the third quarter of 2026. The phase III ReSPECT study of the drug met its primary FDA endpoint of fungal-free survival at day 90 and demonstrated non-inferiority versus the standard antifungal regimen. If the filing is accepted for review, the company expects FDA action in the first half of 2027. CorMedix is also advancing its phase III DefenCath study in patients with total parenteral nutrition, having submitted a protocol amendment to narrow certain exclusion criteria. The company continues to expect study completion in 2028. CorMedix currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals AMRX, Repligen RGEN and AC Immune ACIU. AMRX and RGEN currently sport a Zacks Rank #1 (Strong Buy) each, while ACIU carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 37% year to date. Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62. RGEN shares have lost 2.2% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have plunged 18.2% year to date. AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%. 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 CorMedix Inc (CRMD) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report AC Immune (ACIU) : Free Stock Analysis Report AMNEAL PHARMACEUTICALS, INC. (AMRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-13

Allogene Therapeutics' Q2 Earnings Beat Estimates on Lower R&D Costs

Zacks
Allogene Therapeutics ALLO incurred a second-quarter 2026 loss of 13 cents per share, narrower than the Zacks Consensus Estimate of a loss of 16 cents. Lower research and development (R&D) spending supported the narrower loss. In the year-ago period, the company reported a loss of 23 cents. Allogene recorded $4.6 million in collaboration revenues from related parties. It did not record any sales in the year-ago period. Shares of Allogene were up in after-market trading yesterday, likely due to the better-than-expected results. Year to date, the stock has risen 51% compared with the industry’s nearly 6% growth. Image Source: Zacks Investment Research R&D expenses were $30.7 million, down 23.5% year over year. In contrast, general and administrative (G&A) expenses rose 45.9% to $20.8 million. Total operating expenses declined 9.3% to $51.6 million. As of June 30, 2026, cash, cash equivalents and investments totaled $423.6 million compared with $266.9 million in the previous quarter. This uptick was due to the completion of a public offering in April that generated gross proceeds of $200.4 million. Based on its June-end liquidity, management expects a cash runway into 2029. The company maintained operating expenses guidance for full-year 2026 at about $225 million, including non-cash stock-based compensation expense of nearly $35 million. Allogene’s main focus is the pivotal phase II ALPHA3 study, which evaluates the lead drug cema-cel as a potential first-line treatment for patients with newly diagnosed large B-cell lymphoma (LBCL) who are likely to relapse and require further therapy. In April, the company reported an interim futility analysis from the study, showing 58.3% MRD negativity at day 45 in patients treated with cema-cel versus 16.7% with observation. Management reported no treatment-related serious adverse events at the cutoff and said most patients were managed on an outpatient basis. The company surpassed its 2026 goal of activating more than 80 ALPHA3 sites about six months early. It now expects approximately 100 sites to be active by year-end, with most in the United States and additional locations in Canada, Australia and South Korea. Despite faster site activation, Allogene still expects to provide an interim analysis on the primary endpoint of event-free survival (EFS) in mid-2027. The ALPHA3 study is expected to randomize about 220 particip…Read full document

Allogene Therapeutics ALLO incurred a second-quarter 2026 loss of 13 cents per share, narrower than the Zacks Consensus Estimate of a loss of 16 cents. Lower research and development (R&D) spending supported the narrower loss. In the year-ago period, the company reported a loss of 23 cents. Allogene recorded $4.6 million in collaboration revenues from related parties. It did not record any sales in the year-ago period. Shares of Allogene were up in after-market trading yesterday, likely due to the better-than-expected results. Year to date, the stock has risen 51% compared with the industry’s nearly 6% growth. Image Source: Zacks Investment Research R&D expenses were $30.7 million, down 23.5% year over year. In contrast, general and administrative (G&A) expenses rose 45.9% to $20.8 million. Total operating expenses declined 9.3% to $51.6 million. As of June 30, 2026, cash, cash equivalents and investments totaled $423.6 million compared with $266.9 million in the previous quarter. This uptick was due to the completion of a public offering in April that generated gross proceeds of $200.4 million. Based on its June-end liquidity, management expects a cash runway into 2029. The company maintained operating expenses guidance for full-year 2026 at about $225 million, including non-cash stock-based compensation expense of nearly $35 million. Allogene’s main focus is the pivotal phase II ALPHA3 study, which evaluates the lead drug cema-cel as a potential first-line treatment for patients with newly diagnosed large B-cell lymphoma (LBCL) who are likely to relapse and require further therapy. In April, the company reported an interim futility analysis from the study, showing 58.3% MRD negativity at day 45 in patients treated with cema-cel versus 16.7% with observation. Management reported no treatment-related serious adverse events at the cutoff and said most patients were managed on an outpatient basis. The company surpassed its 2026 goal of activating more than 80 ALPHA3 sites about six months early. It now expects approximately 100 sites to be active by year-end, with most in the United States and additional locations in Canada, Australia and South Korea. Despite faster site activation, Allogene still expects to provide an interim analysis on the primary endpoint of event-free survival (EFS) in mid-2027. The ALPHA3 study is expected to randomize about 220 participants, with enrollment anticipated to be completed by year-end 2027. The company is also exploring the potential of allogeneic CAR T cell therapies in autoimmune diseases. It is enrolling patients in the phase I basket study (called RESOLUTION) evaluating ALLO-329 across autoimmune indications, including systemic lupus erythematosus, idiopathic inflammatory myopathies and systemic sclerosis. With enrollment remaining brisk, Allogene expects a clinical and translational data update in the fourth quarter of 2026. Management said the readout should include at least the 20-million, 40-million and 80-million cell-dose cohorts, along with safety, efficacy and translational findings. Allogene currently carries a Zacks Rank #3 (Hold). Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote Some better-ranked stocks in the biotech sector are Anika Therapeutics ANIK and Repligen Corporation RGEN, each 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 30 days, earnings per share (EPS) estimates for Anika Therapeutics have risen from 41 cents to $1.05 for 2026. Over the same period, EPS estimates have increased from 46 cents to 95 cents for 2027. ANIK shares have skyrocketed 129% year to date. Anika Therapeutics missed on earnings in each of the trailing four quarters, delivering an average surprise of 950%. Over the past 30 days, estimates for Repligen’s 2026 EPS have increased to $2.06 from $1.99. Over the same period, EPS estimates for 2027 have risen from $2.57 to $2.62. RGEN shares have gained 1% so far this year. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. 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 Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Anika Therapeutics Inc. (ANIK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-13

LQDA Q2 Earnings Top, Strong Yutrepia Sales Fuel Top-Line Growth

Zacks
Liquidia Corporation LQDA reported second-quarter 2026 earnings per share (EPS) of 74 cents, which topped the Zacks Consensus Estimate of 70 cents. In the year-ago quarter, the company reported a loss per share of 49 cents. Total revenues surged to $171.7 million from $8.8 million in the year-ago quarter and beat the Zacks Consensus Estimate of $165 million. The quarterly performance was powered by continued adoption of lead drug Yutrepia. However, shares were down 10% following the second-quarter results. Shares of LQDA have surged 128.5% year to date compared with the industry’s growth of  5.9%. Image Source: Zacks Investment Research Yutrepia is a dry-powder inhaled formulation of treprostinil delivered through a compact, easy-to-use device. It is approved to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise capacity. Yutrepia net product sales reached $170.4 million in the second quarter, up from $6.5 million a year earlier driven by higher Yutrepia volume. Product sales increased 31.0% sequentially. LQDA began commercial shipments of Yutrepia in the United States in June 2025, shortly after receiving full FDA approval on May 23, 2025. As of July 31, 2026, Liquidia had received approximately 5,900 unique prescriptions since launch and started more than 5,000 patients on therapy. More than 1,100 physicians had prescribed Yutrepia since launch as of July 31, and more than 30% of them had written prescriptions for at least five patients. The prescription-to-start conversion rate remained above 85%. LQDA also generates service revenues through its promotion agreement with Sandoz, under which the companies share profits from U.S. sales of Treprostinil Injection. Service revenues totaled $1.3 million in the second quarter, down from $2.3 million in the prior-year quarter mainly due to unfavorable gross-to-net adjustments. Research and development expenses skyrocketed 185% year over year to $17.2 million. The increase primarily reflected higher L606 program spending, greater Yutrepia research activity and increased personnel costs. Selling, general and administrative expenses increased 48.0% to $57.4 million, caused by higher personnel costs, increased stock-based compensation expenses, and commercial and consulting costs. Net income was $74.7 million in the quarter. The…Read full document

Liquidia Corporation LQDA reported second-quarter 2026 earnings per share (EPS) of 74 cents, which topped the Zacks Consensus Estimate of 70 cents. In the year-ago quarter, the company reported a loss per share of 49 cents. Total revenues surged to $171.7 million from $8.8 million in the year-ago quarter and beat the Zacks Consensus Estimate of $165 million. The quarterly performance was powered by continued adoption of lead drug Yutrepia. However, shares were down 10% following the second-quarter results. Shares of LQDA have surged 128.5% year to date compared with the industry’s growth of  5.9%. Image Source: Zacks Investment Research Yutrepia is a dry-powder inhaled formulation of treprostinil delivered through a compact, easy-to-use device. It is approved to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise capacity. Yutrepia net product sales reached $170.4 million in the second quarter, up from $6.5 million a year earlier driven by higher Yutrepia volume. Product sales increased 31.0% sequentially. LQDA began commercial shipments of Yutrepia in the United States in June 2025, shortly after receiving full FDA approval on May 23, 2025. As of July 31, 2026, Liquidia had received approximately 5,900 unique prescriptions since launch and started more than 5,000 patients on therapy. More than 1,100 physicians had prescribed Yutrepia since launch as of July 31, and more than 30% of them had written prescriptions for at least five patients. The prescription-to-start conversion rate remained above 85%. LQDA also generates service revenues through its promotion agreement with Sandoz, under which the companies share profits from U.S. sales of Treprostinil Injection. Service revenues totaled $1.3 million in the second quarter, down from $2.3 million in the prior-year quarter mainly due to unfavorable gross-to-net adjustments. Research and development expenses skyrocketed 185% year over year to $17.2 million. The increase primarily reflected higher L606 program spending, greater Yutrepia research activity and increased personnel costs. Selling, general and administrative expenses increased 48.0% to $57.4 million, caused by higher personnel costs, increased stock-based compensation expenses, and commercial and consulting costs. Net income was $74.7 million in the quarter. The company had reported a net loss of $41.6 million in the year-ago quarter. Strong Yutrepia sales drove its fourth consecutive quarter of increasing profitability. Cash and cash equivalents totaled $284.2 million as of June 30, up from $222.8 million at the end of the first quarter. Management said cash flow from the commercial business allows Liquidia to fund expanded clinical investment alongside ongoing commercialization. Liquidia now has 10 clinical studies, between Yutrepia and L606, either underway or planned to start over the next 12 months. L606 is a twice-daily, liposomal formulation of treprostinil delivered through a next-generation nebulizer and is being evaluated in PAH and PH-ILD. The phase III Re-Spire study on L606 is currently enrolling. The company also plans to explore Yutrepia in additional indications, including pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis and Raynaud’s phenomenon associated with systemic sclerosis. Liquidia said it is confident that it is on track for more than $1 billion in net revenues in 2027 while continuing to grow profitability. Management expects revenues to keep increasing in line with the quarterly growth trajectory seen since launch. LQDA expects second-half 2026 R&D spending to be double the first-half level and to increase again in 2027 as Re-Spire enrollment and other studies ramp up. SG&A expenses are expected to rise as the company scales commercially, with certain costs increasing in line with revenues. LQDA topped both revenue and earnings estimates in the second quarter. Yutrepia has emerged as a leading player in the inhaled prostacyclin market for PAH and PH-ILD. Liquidia Corporation price-consensus-eps-surprise-chart | Liquidia Corporation Quote Liquidia’s solid commercial performance is strengthening its financial position, with cash and equivalents reaching $284.2 million at quarter-end. The differentiated tolerability and dosing profiles of both Yutrepia and L606 should enable the company to tap into incremental opportunity in the PAH market. Management expects revenues to exceed $1 billion in 2027, supporting a favorable long-term growth outlook. Yutrepia’s primary competitor is United Therapeutics' UTHR Tyvaso (treprostinil), the long-established inhaled therapy approved for PAH in 2009 and PH-ILD in 2021. United Therapeutics highlighted two major regulatory filings — ralinepag tablets for PAH and nebulized Tyvaso for IPF — as potentially significant catalysts for long-term growth. Additional planned filings for ralinepag DPI and treprostinil SMI could further expand UTHR’s pipeline and growth opportunities. LQDA currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the biotech sector is Repligen RGEN, which carries a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while those for 2027 EPS have increased from $2.57 to $2.62 during the same time. RGEN shares have gained 1.1% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. 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 Liquidia Corporation (LQDA) : Free Stock Analysis Report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-12

TNGX Stock Dips 5% as Q2 Earnings Miss Estimates on Higher Expenses

Zacks
Tango Therapeutics TNGX incurred a loss of 37 cents per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 31 cents. The company had reported a loss of 35 cents per share in the year-ago quarter. Collaboration revenues were zero compared with $3.2 million a year earlier. Tango shares were down 4.8% on Tuesday, likely due to investor disappointment over the earnings miss. Higher operating expenses weighed on the result. In the absence of a marketed product, Tango has no regular source of income. The company instead reports collaboration revenues periodically, depending on the terms and progress of its collaboration arrangements. All remaining deferred revenues from upfront and research option-extension payments under the Gilead collaboration were recognized during 2025. This followed the truncation of the collaboration agreement, which concluded all research activities. Consequently, Tango recorded no collaboration revenues in the reported quarter. Research and development expenses increased 13% year over year to $37.2 million in the second quarter of 2026. The increase primarily reflected higher spending related to the advancement of the vopimetostat and TNG456 clinical programs. The rise was partly offset by lower spending resulting from Tango's portfolio prioritization efforts. Year to date, TNGX stock has skyrocketed 197.3% compared with the industry’s 5.5% growth. Image Source: Zacks Investment Research General and administrative expenses almost doubled year over year to $22.6 million, mainly due to higher personnel-related costs, including share-based compensation. Vopimetostat is Tango's lead pipeline candidate and an MTAP-selective, once-daily PRMT5 inhibitor. In June, the company reported initial data from a phase I/II study evaluating vopimetostat in combination with Revolution Medicines' RAS(ON) inhibitors daraxonrasib or zoldonrasib in patients with MTAP-deleted, RAS-mutant pancreatic cancer. Per the data readout, the combo achieved a 92% objective response rate and 90% six-month progression-free survival rate in this patient population, with a generally well-tolerated safety profile. The findings strengthened Tango's focus on advancing vopimetostat in pancreatic cancer. The company is working internally and has begun discussions with regulators and Revolution Medicines toward developing a registrational plan…Read full document

Tango Therapeutics TNGX incurred a loss of 37 cents per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 31 cents. The company had reported a loss of 35 cents per share in the year-ago quarter. Collaboration revenues were zero compared with $3.2 million a year earlier. Tango shares were down 4.8% on Tuesday, likely due to investor disappointment over the earnings miss. Higher operating expenses weighed on the result. In the absence of a marketed product, Tango has no regular source of income. The company instead reports collaboration revenues periodically, depending on the terms and progress of its collaboration arrangements. All remaining deferred revenues from upfront and research option-extension payments under the Gilead collaboration were recognized during 2025. This followed the truncation of the collaboration agreement, which concluded all research activities. Consequently, Tango recorded no collaboration revenues in the reported quarter. Research and development expenses increased 13% year over year to $37.2 million in the second quarter of 2026. The increase primarily reflected higher spending related to the advancement of the vopimetostat and TNG456 clinical programs. The rise was partly offset by lower spending resulting from Tango's portfolio prioritization efforts. Year to date, TNGX stock has skyrocketed 197.3% compared with the industry’s 5.5% growth. Image Source: Zacks Investment Research General and administrative expenses almost doubled year over year to $22.6 million, mainly due to higher personnel-related costs, including share-based compensation. Vopimetostat is Tango's lead pipeline candidate and an MTAP-selective, once-daily PRMT5 inhibitor. In June, the company reported initial data from a phase I/II study evaluating vopimetostat in combination with Revolution Medicines' RAS(ON) inhibitors daraxonrasib or zoldonrasib in patients with MTAP-deleted, RAS-mutant pancreatic cancer. Per the data readout, the combo achieved a 92% objective response rate and 90% six-month progression-free survival rate in this patient population, with a generally well-tolerated safety profile. The findings strengthened Tango's focus on advancing vopimetostat in pancreatic cancer. The company is working internally and has begun discussions with regulators and Revolution Medicines toward developing a registrational plan and path forward for vopimetostat plus daraxonrasib in MTAP-deleted pancreatic cancer. The design of this impending phase III study of the combo drug in front-line pancreatic cancer is expected to be finalized later in 2026. Beyond pancreatic cancer, Tango expects to disclose phase I/II vopimetostat lung cancer monotherapy data later in 2026. The update is expected to provide another clinical readout for the company's lead PRMT5 program in a different tumor setting. The company also plans to release initial data from an early- to mid-stage study of TNG456 for glioblastoma and other cancers and to initiate a phase I/II study of vopimetostat in combination with Erasca's ERAS-0015 in patients with MTAP-deleted RAS-mutant cancers later in 2026, thereby extending development across its broader oncology pipeline. Tango Therapeutics, Inc. price-consensus-eps-surprise-chart | Tango Therapeutics, Inc. Quote Tango currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Amarin AMRN, Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. The estimate for Amarin’s 2026 loss per share is currently pegged at 65 cents, while that for 2027 is currently pegged at 51 cents. AMRN shares have gained 2.2% year to date. Amarin’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 62.27%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 3.2% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. 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 158.4% 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 Tango Therapeutics, Inc. (TNGX) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : 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 tagged2026-08-11

Rocket Pharmaceuticals Q2 Earnings Rise Y/Y, Kresladi Launch in Focus

Zacks
Rocket Pharmaceuticals RCKT reported earnings of $1.08 per share (including certain one-time items) in the second quarter of 2026 in contrast to a loss of 62 cents per share incurred in the year-ago quarter. The Zacks Consensus Estimate for the company’s bottom line was earnings of 28 cents per share. Excluding these one-time items, the company reported a loss of 40 cents per share in the second quarter of 2026. Rocket Pharmaceuticals did not record any revenues in the second quarter of 2026. However, the Zacks Consensus Estimate for the company’s top line was $1 million. Year to date, shares of Rocket Pharmaceuticals have risen 3.7% compared with the industry’s increase of 6.1%. Image Source: Zacks Investment Research In the reported quarter, general and administrative expenses declined by around 30.4% year over year to $17.4 million, owing to lower legal expenses and other expenses. Research and development expenses were $29.5 million, down 30.9% from the year-ago quarter’s figure. The decrease was primarily driven by lower manufacturing and development costs and certain other costs. As of June 30, 2026, Rocket Pharmaceuticals had cash, cash equivalents and investments of $283.7 million compared with $144.4 million as of March 31, 2026. Management noted that the company’s current cash position reflects the proceeds from the sale of the Rare Pediatric Disease Priority Review Voucher. In March 2026, the FDA granted accelerated approval to RCKT’s gene therapy Kresladi (marnetegragene autotemcel) to treat patients with severe leukocyte adhesion deficiency-I (LAD-I), an ultra-rare genetic disorder. Following the nod, Kresladi became the first gene therapy to be approved by the FDA for treating children with severe LAD-I due to biallelic variants in ITGB2 without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant. Per the company, launch preparations for Kresladi are underway, and patient onboarding is beginning in the fourth quarter of 2026. Rocket Pharmaceuticals is also developing an investigational gene therapy candidate, RP-A501, in a phase II study for treating patients with Danon disease. RP-A501 is the most advanced AAV-based candidate in the company’s pipeline. Earlier this month, the company announced positive initial safety findings from the first three patients treated with RP-A501 under a mod…Read full document

Rocket Pharmaceuticals RCKT reported earnings of $1.08 per share (including certain one-time items) in the second quarter of 2026 in contrast to a loss of 62 cents per share incurred in the year-ago quarter. The Zacks Consensus Estimate for the company’s bottom line was earnings of 28 cents per share. Excluding these one-time items, the company reported a loss of 40 cents per share in the second quarter of 2026. Rocket Pharmaceuticals did not record any revenues in the second quarter of 2026. However, the Zacks Consensus Estimate for the company’s top line was $1 million. Year to date, shares of Rocket Pharmaceuticals have risen 3.7% compared with the industry’s increase of 6.1%. Image Source: Zacks Investment Research In the reported quarter, general and administrative expenses declined by around 30.4% year over year to $17.4 million, owing to lower legal expenses and other expenses. Research and development expenses were $29.5 million, down 30.9% from the year-ago quarter’s figure. The decrease was primarily driven by lower manufacturing and development costs and certain other costs. As of June 30, 2026, Rocket Pharmaceuticals had cash, cash equivalents and investments of $283.7 million compared with $144.4 million as of March 31, 2026. Management noted that the company’s current cash position reflects the proceeds from the sale of the Rare Pediatric Disease Priority Review Voucher. In March 2026, the FDA granted accelerated approval to RCKT’s gene therapy Kresladi (marnetegragene autotemcel) to treat patients with severe leukocyte adhesion deficiency-I (LAD-I), an ultra-rare genetic disorder. Following the nod, Kresladi became the first gene therapy to be approved by the FDA for treating children with severe LAD-I due to biallelic variants in ITGB2 without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant. Per the company, launch preparations for Kresladi are underway, and patient onboarding is beginning in the fourth quarter of 2026. Rocket Pharmaceuticals is also developing an investigational gene therapy candidate, RP-A501, in a phase II study for treating patients with Danon disease. RP-A501 is the most advanced AAV-based candidate in the company’s pipeline. Earlier this month, the company announced positive initial safety findings from the first three patients treated with RP-A501 under a modified Phase 2 protocol for Danon disease. The patients received a recalibrated dose of RP-A501 (3.8 x 10¹³ GC/kg) with a refined immunomodulatory regimen, and no cases of thrombotic microangiopathy, capillary leak syndrome or other significant safety concerns were observed. RCKT is engaging with the FDA to determine the pathway for dosing additional patients and completing the pivotal phase II study, with an update on the regulatory pathway expected in the second half of 2026. Rocket Pharmaceuticals is also developing RP-A601 in an early-stage study for treating arrhythmogenic cardiomyopathy. The company also plans to start initial patient dosing in a phase I study evaluating another gene therapy candidate, RP-A701, for the treatment of dilated cardiomyopathy in the second half of 2026. Rocket Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Rocket Pharmaceuticals, Inc. Quote Rocket Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Repligen RGEN and Liquidia Corporation LQDA, each 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 Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 0.4% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. 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 163.9% 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 Rocket Pharmaceuticals, Inc. (RCKT) : Free Stock Analysis Report Repligen Corporation (RGEN) : 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 tagged2026-08-11

Axsome's Q2 Earnings Meet Estimates, Auvelity Drives Y/Y Revenues

Zacks
Axsome Therapeutics AXSM incurred a loss of 99 cents per share in the second quarter of 2026, which was in line with the Zacks Consensus Estimate. The company had reported a loss of 97 cents per share in the year-ago quarter. Axsome’s total revenues surged 46% year over year to $218.4 million in the second quarter. The increase in revenues was primarily driven by strong sales of lead drug Auvelity (AXS-05) as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million. Auvelity is approved for the treatment of major depressive disorder (MDD). In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies. Year to date, shares of Axsome have rallied 21% compared with the industry’s increase of 6.1%. Image Source: Zacks Investment Research Total revenues in the second quarter consisted of product revenues from Auvelity, Sunosi (solriamfetol) and Axsome’s newest drug, Symbravo (meloxicam and rizatriptan), as well as royalty and milestone revenues. Net product revenues were $216.4 million in the quarter, reflecting an increase of 45.2% year over year. Royalty and milestone revenues totaled $2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories. Auvelity recorded sales of $180.3 million, up 51% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $175 million. Per Axsome, around 266,000 total prescriptions were recorded for Auvelity in the second quarter, reflecting a year-over-year increase of 34%. Sunosi’s net product sales were $35.8 million in the quarter, up 20% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year to 61,000. Sunosi sales beat the Zacks Consensus Estimate of $33.4 million. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in 2022. Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States. Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $2.3 million in the second quarter, down from $4.1 million recorded in the p…Read full document

Axsome Therapeutics AXSM incurred a loss of 99 cents per share in the second quarter of 2026, which was in line with the Zacks Consensus Estimate. The company had reported a loss of 97 cents per share in the year-ago quarter. Axsome’s total revenues surged 46% year over year to $218.4 million in the second quarter. The increase in revenues was primarily driven by strong sales of lead drug Auvelity (AXS-05) as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million. Auvelity is approved for the treatment of major depressive disorder (MDD). In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies. Year to date, shares of Axsome have rallied 21% compared with the industry’s increase of 6.1%. Image Source: Zacks Investment Research Total revenues in the second quarter consisted of product revenues from Auvelity, Sunosi (solriamfetol) and Axsome’s newest drug, Symbravo (meloxicam and rizatriptan), as well as royalty and milestone revenues. Net product revenues were $216.4 million in the quarter, reflecting an increase of 45.2% year over year. Royalty and milestone revenues totaled $2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories. Auvelity recorded sales of $180.3 million, up 51% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $175 million. Per Axsome, around 266,000 total prescriptions were recorded for Auvelity in the second quarter, reflecting a year-over-year increase of 34%. Sunosi’s net product sales were $35.8 million in the quarter, up 20% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year to 61,000. Sunosi sales beat the Zacks Consensus Estimate of $33.4 million. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in 2022. Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States. Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $2.3 million in the second quarter, down from $4.1 million recorded in the prior quarter. Symbravo’s sales missed the Zacks Consensus Estimate of $7.2 million. However, total prescriptions for Symbravo grew 30% sequentially to 23,500 in the second quarter of 2026. Research and development expenses (including stock-based compensation) were $46.2 million, down 6.7% from the year-ago quarter’s level, primarily due to lower costs related to Auvelity and AXS-14. Selling, general and administrative expenses (including stock-based compensation) totaled $208.1 million, up 59.7% year over year. The increase was due to higher commercial activities for Auvelity, including the ongoing pre-launch activities for the Alzheimer’s disease agitation indication and Symbravo. As of June 30, 2026, Axsome had cash and cash equivalents worth $319.9 million compared with $305.1 million as of March 31, 2026. Management believes that its cash balance as of June-end is sufficient to fund future operations into cash flow positivity. Axsome plans to initiate a pivotal phase II/III study of AXS-05 for treating smoking cessation later in the third quarter of 2026. Other pipeline candidates include AXS-12, AXS-14 and AXS-17, which target multiple central nervous system indications. In July 2026, the FDA accepted Axsome’s new drug application (NDA) seeking approval for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. With the FDA accepting the NDA for review, a decision from the regulatory body is expected on May 1, 2027. Axsome is evaluating the efficacy and safety of AXS-14 (esreboxetine) under the phase III FORWARD study for the management of fibromyalgia. AXS-17 is another pipeline asset of Axsome, which is being developed for epilepsy. The phase II study-enabling activities for AXS-17 in epilepsy are underway. The company plans to develop AXS-20 for schizophrenia and Tourette syndrome, with phase III study-enabling activities in schizophrenia currently underway. Axsome is advancing solriamfetol across multiple phase III studies for treating attention-deficit hyperactivity disorder (ADHD), MDD, binge eating disorder (BED) and shift work disorder (SWD). The company recently dosed the first patient in the phase III FOCUS-2 study and the phase III FOCUS-3 study evaluating solriamfetol for the treatment of ADHD in children and in adolescents, respectively. The phase III CLARITY study evaluating solriamfetol for the treatment of MDD patients with excessive daytime sleepiness symptoms began in February 2026. Top-line data from the ENGAGE study evaluating solriamfetol for treating BED is expected in the fourth quarter of 2026. Top-line data from the SUSTAIN study evaluating solriamfetol for treating SWD in adults is expected in 2027. Axsome Therapeutics, Inc. price-consensus-eps-surprise-chart | Axsome Therapeutics, Inc. Quote Axsome currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Repligen RGEN and Liquidia Corporation LQDA, each 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 Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 0.4% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. 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 163.9% 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 Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As of 2026-09-05 • Updated weeklySource: Earnings sourceIngestion runbook