This week, the biotech space witnessed significant milestones, including FDA approvals, oncology drug acquisitions, and collaborations. Positive clinical trial results were reported across multiple therapeutic areas, including radiographic and non-radiographic axial spondyloarthritis, microcystic lymphatic malformations, pulmonary arterial hypertension, and obesity. Here's a closer look at the details. FDA Approvals & Rejections Armata Pharma Secures FDA QIDP Designation for AP-SA02 Armata Pharmaceuticals, ...

NEW YORK, Feb. 26, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Gossamer Bio, Inc. ("Gossamer" or the "Company") (NASDAQ: GOSS).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Gossamer and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On February 23, 2 ...

Leerink Partners sets a price target of $1 for Gossamer Bio Inc. (NASDAQ:GOSS), suggesting a potential increase of about 63.76%.The company's Phase 3 PROSERA study on seralutinib for PAH showed potential efficacy but missed a key statistical threshold.Gossamer Bio's stock has experienced a significant decrease, currently priced at $0.42, reflecting an 80.13% decrease in value.Gossamer Bio Inc. (NASDAQ:GOSS) is a biopharmaceutical company focused on developing treatments for pulmonary arterial hypertension ( ...

Core Viewpoint - Gossamer Bio Inc. announced the top line results from the PROSERA Phase III study of seralutinib for pulmonary arterial hypertension, indicating significant progress in their clinical development pipeline [2]. Group 1: Study Results - The PROSERA study is a Phase III clinical trial focused on seralutinib, which targets pulmonary arterial hypertension [2]. - The results from the study were released in a press release available on the company's Investors section of their website [2]. Group 2: Company Leadership - The call featured Gossamer executives including COO & CFO Bryan Giraudo, along with other key team members such as Faheem Hasnain, Dr. Richard Aranda, Bob Smith, Dr. Rob Roscigno, and Caryn Peterson [2].

BOSTON, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Gossamer Bio, Inc. (Nasdaq: GOSS) for potential securities law violations. Investors who have lost money in their Gossamer Bio, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/goss. What is this all about? Shares of Gossamer Bio fell more than 75% on February 23, 2026, after the company announced that its Phase 3 PROSERA trial eval ...

Gossamer Bio, Inc. (GOSS) shares collapsed 81.56 percent to $0.3929, down $1.7371 on Monday, after the company reported topline results from its Phase 3 PROSERA study of seralutinib in pulmonary arterial hypertension that narrowly missed the prespecified statistical threshold for the primary endpoint.The stock is currently trading at $0.3929, compared with a previous close of $2.1300 Nasdaq. It opened sharply lower at $0.5969 and has traded between $0.4026 and $0.6000 during the session. Trading volume has ...

Core Viewpoint - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of Gossamer Bio, Inc. due to significant stock losses following the announcement of trial results that did not meet statistical significance thresholds [1][4][5] Investigation Background - Gossamer Bio announced topline results from its Phase 3 PROSERA trial for seralutinib, showing a placebo-adjusted improvement in six-minute walk distance of +13.3 meters with a p-value of 0.0320 [3] - The trial results did not meet the prespecified statistical significance threshold of α = 0.025, preventing formal evaluation of key secondary endpoints [4] - Following this announcement, Gossamer's stock price dropped approximately 70% in pre-market trading, indicating a negative market reaction to the failed primary endpoint [4] Legal Context - Johnson Fistel is examining whether Gossamer Bio complied with federal securities laws in light of the disclosed trial results and subsequent stock decline [5] - Investors who suffered losses from Gossamer Bio stock are encouraged to contact Johnson Fistel for potential recovery options [2][5] Firm Background - Johnson Fistel, PLLP is a recognized shareholder-rights law firm with a strong track record in securities class action lawsuits, having recovered approximately $90.7 million for clients in previous cases [6][7]

Gossamer Bio Inc. (NASDAQ:GOSS) dropped during early trading on Monday after the company shared topline results from the Phase 3 PROSERA study evaluating seralutinib in pulmonary arterial hypertension.PAH is defined by high blood pressure in the lung arteries due to narrowed, damaged, or destroyed vessels, forcing the heart’s right side to overwork and potentially fail.Disappointing Trial DataAt Week 24, patients receiving seralutinib showed a median change of +28.2 meters in the Six-Minute Walk Distance (6 ...

Gossamer Bio PROSERA Phase 3 Top Line Results Call Summary Company Overview - **Company**: Gossamer Bio, Inc. - **Focus**: Development of seralutinib for the treatment of pulmonary arterial hypertension (PAH) Key Industry and Company Insights Phase 3 Study Results - **Study Name**: PROSERA - **Objective**: Evaluate the efficacy of seralutinib in patients with PAH - **Primary Endpoint**: Change in six-minute walk distance at week 24 - **Results**: - Seralutinib showed a numerical improvement of approximately 13.3 meters compared to placebo (p-value = 0.032) - Did not meet the pre-specified statistical significance threshold of 0.025, thus considered not statistically significant [4][12][28] Subgroup Analysis - **Intermediate and High-Risk Subgroup**: - 234 patients defined by REVEAL Lite 2 risk score - Demonstrated a clinically meaningful improvement of 20 meters in six-minute walk distance (p-value = 0.0207) [5][17] - 3 out of 4 key secondary endpoints favored seralutinib with p-values below 0.0125 [5] Placebo Response - **Unexpected High Placebo Response**: - The placebo group showed a larger improvement than typically seen in PAH studies, which diluted the treatment effect [12][15] - Geographic differences noted, with North America showing more typical placebo responses compared to Latin America, where the placebo response was significantly higher [16][68] Safety Profile - **Adverse Events**: - Treatment-emergent adverse events (TEAEs) reported in 86.5% of seralutinib patients vs. 80.5% in placebo [24] - Most common TEAE was cough (37% in seralutinib vs. 13.7% in placebo) [25] - Liver enzyme elevations were noted, with 13% of seralutinib patients experiencing elevations ≥3 times the upper limit of normal [26][107] Strategic Decisions - **Enrollment Pause**: - Gossamer Bio decided to pause enrollment in the SERANATA Phase 3 study to focus resources on the PROSERA dataset and engage with the FDA [9][30] - **Next Steps**: - Further analysis of PROSERA data and discussions with regulators regarding the implications of the results [31] Commercial Opportunity - **Market Potential**: - Seralutinib is viewed as a meaningful opportunity in the PAH market, particularly for high-risk patients who face significant morbidity and mortality [30] Regulatory Considerations - **FDA Engagement**: - Gossamer Bio plans to present the PROSERA results to the FDA, emphasizing the unmet medical need in the high-risk population [56][100] Additional Important Insights - **Long-Term Efficacy**: - Data suggests that seralutinib may show improved efficacy over time, particularly in patients with more severe disease [15][70] - **Comparative Analysis**: - The treatment effect of seralutinib aligns well with other approved PAH therapies, especially in patients with higher baseline disease severity [20][21] This summary encapsulates the critical findings and strategic directions from the Gossamer Bio PROSERA Phase 3 results call, highlighting both the challenges and opportunities in the development of seralutinib for PAH treatment.

Company Overview - Gossamer Bio Inc. (NASDAQ:GOSS) is a pharmaceutical company focused on the discovery, development, and marketing of treatments in the fields of immunology, inflammation, and oncology [3]. Investment Ratings - H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating on Gossamer Bio and set a price target of $10 for the stock [1]. - Barclays initiated coverage on Gossamer Bio with an Overweight rating and a price target of $9, highlighting that biotech stocks like Gossamer Bio are undervalued and could benefit from ongoing mergers and acquisitions [1]. - Cantor Fitzgerald also maintains an Overweight rating on Gossamer Bio, with expectations for results from its clinical trial of seralutinib in pulmonary arterial hypertension to be released in mid to late February [2]. Clinical Trials and Data - Gossamer Bio is expected to present additional imaging data related to its clinical trials in the second quarter of 2026 [2].