Gossamer Bio, Inc. announced on November 10, 2026, that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for seralutinib to treat pulmonary arterial hypertension (PAH). This marks the Company’s first NDA submission. The application is supported by the Phase 3 PROSERA Study, along with confirmatory evidence from the Phase 2 TORREY Study and additional supportive analyses.
In other corporate developments, Gossamer reacquired worldwide development and commercial rights to seralutinib from Chiesi Farmaceutici S.p.A. in July 2026 under an agreement that included a one-time payment of $5 million from Chiesi. Additionally, the Company completed a 1-for-80 reverse stock split in September 2026 to regain compliance with Nasdaq’s minimum bid price requirement.
The Company reported financial results for the quarter ended September 30, 2026. Cash, cash equivalents, and marketable securities totaled $51.2 million as of September 30, 2026, compared to $57.0 million as of June 30, 2026. Revenue from contracts with collaborators was $38.4 million for the quarter, a significant increase from $13.3 million in the same period in 2025, primarily due to revenue recognized upon the termination of the Chiesi Collaboration Agreement.
Research and development expenses were $18.8 million for the quarter, compared to $45.5 million in the prior year, while general and administrative expenses were $9.6 million. The Company reported a net loss of $48.1 million, or $7.36 per share, for the quarter ended September 30, 2026.
Gossamer also disclosed a structured private placement with total potential gross proceeds of up to approximately $250 million. The initial closing provided approximately $25 million, and the second closing provides for up to approximately $125 million upon FDA acceptance of the seralutinib NDA in PAH. Warrants related to FDA approval could provide an additional approximately $100 million of gross proceeds.
