Gossamer Bio submits NDA for seralutinib in PAH; FDA acceptance decision expected later 2026

Gossamer Bio, Inc.

Submitted NDA to FDA on Sept 23, 2026 for seralutinib treatment of pulmonary arterial hypertension.
First NDA submission; supported by Phase 3 PROSERA and Phase 2 TORREY studies.
FDA minutes from June 2026 Pre-NDA meeting called statistical significance a review issue, not filing issue.
Company expects FDA acceptance decision for filing later this year; approval uncertain.

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