Gossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the Treatment of Pulmonary Arterial Hypertension
Gossamer Bio announced that it submitted a New Drug Application to the U.S. FDA in September 2026 for seralutinib, its candidate for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Why it matters — This NDA submission represents a significant regulatory milestone for Gossamer's lead candidate, seralutinib, moving the company's main pipeline program closer to potential approval.