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 and 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:
- 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
Seralutinib - FDA Regulatory Timeline and Events
Seralutinib is a drug developed by Gossamer Bio for the following indication: Pulmonary arterial hypertension (PAH).
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:
- May 3, 2024
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Gossamer Bio, Inc announced the publication of its TORREY Phase 2 study manuscript in the Lancet Respiratory Medicine journal. The paper, titled "Seralutinib in Adults with Pulmonary Arterial Hypertension (TORREY): A Randomized, Double-blind, Placebo-controlled Phase 2 Trial," details the study's significant findings in advancing the treatment of PAH.
AI Summary
Gossamer Bio, Inc., a clinical-stage biopharmaceutical company, announced the publication of its Phase 2 study manuscript in the Lancet Respiratory Medicine journal. The paper, titled “Seralutinib in Adults with Pulmonary Arterial Hypertension (TORREY): A Randomized, Double-blind, Placebo-controlled Phase 2 Trial,” shares promising results that highlight the potential of seralutinib in treating pulmonary arterial hypertension (PAH). The study showed that patients treated with seralutinib experienced significant improvements compared to those on placebo, including a notable reduction in pulmonary vascular resistance, a key measure of PAH severity.
Conducted in a rigorously designed trial across multiple centers, the TORREY study provides important insights into how seralutinib may help improve heart function and overall quality of life for PAH patients. This publication marks a significant milestone in advancing new treatment options for this challenging condition.
Read Announcement
