Gossamer Bio announces FDA update and reacquires seralutinib rights
The company plans to submit an NDA for seralutinib in PAH in September 2026, reacquired worldwide rights from Chiesi, and reported cash of $57 million.
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Clinical-stage biopharmaceutical company developing therapies for pulmonary hypertension
gossamerbio.comLast updated
In short: Gossamer Bio announced plans for a September 2026 NDA filing for seralutinib and reacquired full global rights following a Phase 3 miss.
The company plans to submit an NDA for seralutinib in PAH in September 2026, reacquired worldwide rights from Chiesi, and reported cash of $57 million.
The exchange offer for $181M in existing notes closed early, with $18.9M remaining outstanding.
90.526% of existing convertible notes tendered, early settlement expected June 4, with new notes and equity issued.
The company moved the early tender deadline to June 2, 2026, with settlement on June 4, 2026.
Back in March, we noted that Gossamer Bio’s phase 3 clinical trial of seralutinib (a drug for pulmonary arterial hypertension and pulmonary hypertension associated with...
After months of regulatory uncertainty following its Phase III PROSERA study's missed statistical threshold, the FDA's feedback on seralutinib is a shot in the arm...
The plans follow a "productive" pre-application meeting with the U.S. Food and Drug Administration, the company said Monday, when shares closed almost 47% higher in...
Clinical-stage biopharmaceutical company Gossamer Bio today announced a series of significant regulatory, strategic, and corporate updates. After a productive Pre-NDA Type B meeting with the U.S. FDA and receiving the official meeting minutes, the company is proceeding as planned to advance its core drug seralutinib for the treatment of pulmonary arterial hypertension towards a New Drug Application, with a target submission date of September 2026. According to the meeting minutes, the FDA characterized the statistical significance and magnitude of treatment effect observed in the Phase III PROSERA study as a review issue rather than a filing obstacle. Based on this...
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