Gossamer Bio's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Gossamer Bio (GOSS).
Over the past two years, Gossamer Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
seralutinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Seralutinib FDA Regulatory Timeline and Events
Seralutinib is a drug developed by Gossamer Bio for the following indication: Treatment of Pulmonary Arterial Hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- seralutinib
- Announced Date:
- February 23, 2026
- Indication:
- Treatment of Pulmonary Arterial Hypertension
Announcement
Gossamer Bio, Inc. announced topline results for the PROSERA Phase 3 Study of seralutinib in patients with PAH. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement.
AI Summary
Gossamer Bio and the Chiesi Group announced topline results from the PROSERA Phase 3 study of seralutinib in pulmonary arterial hypertension (PAH). The trial showed a placebo‑adjusted improvement in Six‑Minute Walk Distance (6MWD) of +13.3 meters at Week 24 (p = 0.0320), narrowly missing the study's prespecified alpha of 0.025. Median change from baseline was +28.2 m for seralutinib versus +13.5 m for placebo.
In a prespecified intermediate and high‑risk subgroup (n = 234), seralutinib produced a +20.0 m placebo‑adjusted 6MWD improvement (p = 0.0207), with three of four key secondary endpoints meeting p < 0.0125. Patients with connective tissue disease–associated PAH (n = 87) had a placebo‑adjusted gain of +37.0 m (p = 0.0104). The treatment effect was strongest in North America (+25.9 m; p = 0.0573). Safety was generally well tolerated and consistent with prior experience.
Gossamer plans to meet with the U.S. FDA to discuss next steps, has paused enrollment in the SERANATA study to review regional differences, and expects CT functional respiratory imaging substudy results soon. Management will host a conference call today at 8:30 am EST.
Read Announcement- Drug:
- seralutinib
- Announced Date:
- September 22, 2025
- Indication:
- Treatment of Pulmonary Arterial Hypertension
Announcement
Gossamer Bio, Inc announced that five scientific presentations related to seralutinib will be presented at the European Respiratory Society (ERS) Congress 2025, which takes place from September 27th through October 1st in Amsterdam, Netherlands and online. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement.
AI Summary
Gossamer Bio, a clinical-stage biopharmaceutical company, announced that five scientific presentations on its investigational drug seralutinib will be featured at the European Respiratory Society (ERS) Congress 2025. These studies highlight seralutinib’s potential for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension linked to interstitial lung disease (PH-ILD). Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration.
One oral session will present single-cell transcriptomics data showing how seralutinib targets fibrotic pathways in idiopathic pulmonary fibrosis. Four poster presentations will cover its in vitro reduction of vascular inflammation, anti-fibrotic effects in patient-derived models, increased small pulmonary artery volume and reduced vessel wall remodeling via AI-driven CT imaging, and decreased endotrophin production in lung fibrosis models.
The ERS Congress 2025 runs from September 27th through October 1st in Amsterdam, Netherlands, and all sessions will be available online too.
Read Announcement- Drug:
- seralutinib
- Announced Date:
- June 16, 2025
- Indication:
- Treatment of Pulmonary Arterial Hypertension
Announcement
Gossamer Bio, Inc. announced enrollment completion for the ongoing, global registrational Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III PAH patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement.
AI Summary
Gossamer Bio, Inc. announced the successful completion of enrollment for its global registrational Phase 3 PROSERA Study. This study is evaluating seralutinib in patients with Functional Class II and III pulmonary arterial hypertension (PAH). The trial is designed as a double-blind, placebo-controlled study with patients being randomly assigned to receive either seralutinib or a placebo alongside their current PAH therapy.
The study focuses on a carefully selected patient population expected to benefit clinically, especially with improvements in the six-minute walk distance after 24 weeks. Gossamer Bio is developing seralutinib in collaboration with the Chiesi Group under a global agreement. Topline results from this Phase 3 study are anticipated in February 2026, marking a significant step forward in the development of a potential first-in-class treatment for PAH.
Read Announcement- Drug:
- seralutinib
- Announced Date:
- February 3, 2025
- Indication:
- Treatment of Pulmonary Arterial Hypertension
Announcement
Gossamer Bio, Inc presented one oral presentation and three posters related to seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress that took place January 29th through February 1st in Rio de Janeiro, Brazil.
AI Summary
Gossamer Bio, Inc., a clinical-stage biopharmaceutical company, recently showcased its work on seralutinib at the PVRI 2025 Annual Congress in Rio de Janeiro, Brazil. The congress, held from January 29th to February 1st, featured one oral presentation and three posters focused on seralutinib as a treatment option for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
The poster presentations covered various aspects of seralutinib, including its potential synergy with sotatercept in preclinical models, the sustained benefit observed in the TORREY Open-Label Extension post-hoc analysis, and its lasting effect on circulating biomarkers as demonstrated in the TORREY Phase 2 study. These presentations highlight the ongoing research and clinical progress of seralutinib, which aims to improve the lives of patients facing serious pulmonary conditions.
Read Announcement- Drug:
- seralutinib
- Announced Date:
- January 28, 2025
- Indication:
- Treatment of Pulmonary Arterial Hypertension
Announcement
Gossamer Bio, Inc announced one oral and three poster presentations related to seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress taking place January 29th through February 1st in Rio de Janeiro, Brazil.
AI Summary
Gossamer Bio, Inc. has announced that it will present one oral and three poster sessions at the PVRI 2025 Annual Congress in Rio de Janeiro, Brazil, from January 29 to February 1. These presentations will focus on seralutinib, a treatment aimed at pulmonary arterial hypertension (PAH). The research highlights preclinical evidence showing a synergistic treatment effect when seralutinib is combined with sotatercept, a recently approved PAH therapy.
The oral session is set in the Risk Stratification & Treatment in the New Era of PH Therapeutics on January 30, and the poster sessions will provide additional data on seralutinib’s sustained benefits and impact on circulating biomarkers. This offering at PVRI underscores Gossamer Bio’s commitment to advancing PAH treatment options, aiming to address the needs of patients facing this progressive disease.
Read Announcement
Gossamer Bio FDA Events - Frequently Asked Questions
As of now, Gossamer Bio (GOSS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Gossamer Bio (GOSS) has reported FDA regulatory activity for seralutinib.
The most recent FDA-related event for Gossamer Bio occurred on February 23, 2026, involving seralutinib. The update was categorized as "Positive Results," with the company reporting: "Gossamer Bio, Inc. announced topline results for the PROSERA Phase 3 Study of seralutinib in patients with PAH. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement."
Currently, Gossamer Bio has one therapy (seralutinib) targeting the following condition: Treatment of Pulmonary Arterial Hypertension.
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Companies With Recent FDA Events
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:GOSS last updated on 2/23/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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