Gossamer Bio submits NDA for seralutinib in PAH
The submission marks years of clinical development, honoring patients and teams. Gossamer Bio remains focused on the next phase after this milestone.
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Clinical-stage biopharmaceutical company developing therapies for pulmonary hypertension
gossamerbio.comLast updated
In short: Gossamer Bio submitted seralutinib’s FDA application for pulmonary arterial hypertension.
The submission marks years of clinical development, honoring patients and teams. Gossamer Bio remains focused on the next phase after this milestone.
The submission targets pulmonary arterial hypertension, supported by Phase 3 PROSERA and Phase 2 TORREY trial data, marking the company's first NDA filing.
The company aims to regain Nasdaq compliance by raising the minimum bid price requirement. Trading begins on September 11 under symbol GOSS with adjusted share ratios.
Plans NDA submission for September 2026 after FDA meeting, reacquired global seralutinib rights from Chiesi, and reported Q2 net income of $16.9 million.
Gossamer Bio ( (GOSS)) has issued an announcement. At a special meeting held on October 27, 2026, Gossamer Bio stockholders approved a proposal under Nasdaq...
Gossamer Bio has submitted a New Drug Application to the FDA seeking approval of seralutinib for pulmonary arterial hypertension (PAH).
Gossamer Bio has submitted a New Drug Application to the FDA seeking approval of seralutinib for pulmonary arterial hypertension (PAH).
Detailed price information for Gossamer Bio Inc (GOSS-Q) from The Globe and Mail including charting and trades.
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