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GOSS biotech catalysts & pipeline

GOSSAMER BIO INC · Data as of 2026-09-08

Upcoming catalysts

seralutinib — NDA/BLA submission

Sep 2026

SAN DIEGO--(BUSINESS WIRE) -- August 21, 2026 -- Gossamer Bio, Inc. (Nasdaq: GOSS) (the "Company" or "Gossamer"), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced that it has entered into a securities purchase agreement with certain new and existing institutional investors for a private placement financing expected to provide aggregate gross proceeds of up to approximately $250 million, before deducting placement agent fees and estimated offering expenses. The private placement consists of an initial closing, a committed second closing contingent upon FDA acceptance of the seralutinib new drug application (NDA) in PAH (the NDA Acceptance Milestone) and warrants exercisable upon FDA approval of seralutinib in PAH (the FDA Approval Milestone). The financing follows the Company's recent reacquisition of worldwide rights to seralutinib and is in advance of the planned NDA submission in September 2026.
Source filing

seralutinib — Regulatory decision

Q3 2027

• On that basis, the Company intends to submit an NDA supported by one adequate and well-controlled study (Phase 3 PROSERA) plus confirmatory evidence (Phase 2 TORREY and supportive analyses) in September 2026. If accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.
Source filing

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