Gossamer Bio, Inc. GOSS
Gossamer Bio, Inc. (Nasdaq: GOSS) is a respiratory drug developer. Its lead program, seralutinib, is in Phase 3 for pulmonary arterial hypertension (PAH); PH-ILD. Its next catalyst on record is seralutinib: Potential FDA approval decision if NDA accepted (Q3 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: seralutinib — Potential FDA approval decision if NDA accepted (Q3 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| seralutinib - PAH (PROSERA Phase 3 completed; NDA planned) | pulmonary arterial hypertension | small molecule | Phase 3 |
| seralutinib - PH-ILD (SERANATA) | PH associated with interstitial lung disease | small molecule | Phase 2 |
Recent results and decisions
- Sep 23, 2026submitted Gossamer submitted its first NDA for seralutinib in PAH in September 2026, based on Phase 3 PROSERA plus Phase 2 TORREY confirmatory evidence.
announced that it submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in September 2026 for seralutinib for the treatment of pulmonary arterial hypertension
Filing - Feb 23, 2026missed Phase 3 PROSERA missed primary 6MWD endpoint at Week 24: +13.3 m Hodges-Lehmann effect vs placebo, p=0.0320 vs prespecified alpha 0.025; stronger in intermediate/high-risk subgroup (+20.0 m, p=0.0207).
+13.3 meters, with a p‑value of 0.0320, which did not meet the prespecified threshold on the primary endpoint (α = 0.025)
Filing
For subscribers
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Other phase 3 respiratory companies
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Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.