Gossamer Bio stock advances seralutinib NDA toward FDA review
Published on 11/12/2026 at 02:09 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSFDA filing shapes Gossamer's next phase
- Gossamer Bio submitted its first New Drug Application for seralutinib in pulmonary arterial hypertension in September.
- FDA acceptance could unlock up to USD 125 million in additional committed capital under the structured private placement.
- Seralutinib remains investigational, with a potential commercial launch targeted for 2027.
Gossamer Bio reported third-quarter results on Tuesday, November 10, 2026, and said its first New Drug Application for seralutinib had been submitted to the U.S. Food and Drug Administration in September. The company is seeking approval for pulmonary arterial hypertension, while the FDA has yet to decide whether to accept the application for filing, according to the Gossamer Bio release.
Regulatory decision remains central
The NDA is supported by the Phase 3 PROSERA study, confirmatory evidence from the Phase 2 TORREY study and additional analyses. Seralutinib is an inhaled inhibitor targeting PDGFR alpha and beta, CSF1R and c-KIT, but it remains investigational and has not been approved by any regulatory authority.
Gossamer said FDA acceptance in 2026 could trigger a second closing under its structured private placement, providing up to USD 125 million in additional gross proceeds subject to customary conditions. Warrants tied to a potential FDA approval could provide up to another USD 100 million if exercised.
Quarter shows capital pressure
Revenue from contracts with collaborators reached USD 38.431 million in the third quarter, compared with USD 13.294 million a year earlier. The company said the increase was primarily related to revenue recognized after it reacquired worldwide rights to seralutinib from Chiesi in July.
Research and development expenses fell to USD 18.828 million from USD 45.542 million, while the net loss was USD 48.072 million, or USD 7.36 per share. Cash, cash equivalents and marketable securities totaled USD 51.189 million at September 30, 2026, down from USD 57.0 million at June 30.
Business remains focused on rare diseases
Gossamer Bio is a San Diego-based clinical-stage biopharmaceutical company developing and commercializing seralutinib for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its pipeline and commercial strategy are centered on rare pulmonary vascular diseases. The company is preparing for a potential seralutinib launch in 2027 while awaiting the FDA's regulatory review.
Gossamer Bio at a glance
- Company: Gossamer Bio, Inc.
- ISIN: US38341P2011
- Ticker: GOSS
- Home exchange: Nasdaq
- Business: Clinical-stage biopharmaceutical development
- Key program: Seralutinib for pulmonary hypertension
- Third-quarter revenue: USD 38.431 million
- Third-quarter net loss: USD 48.072 million
- Cash, cash equivalents and marketable securities at September 30, 2026: USD 51.189 million
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