San Diego, California, July 27, 2026
Gossamer Bio, Inc. announced a series of significant regulatory, strategic, and financial milestones that strengthen its position ahead of the planned New Drug Application (NDA) submission for seralutinib as a treatment for pulmonary arterial hypertension (PAH). Following a successful Pre-NDA Type B meeting with the U.S. Food and Drug Administration (FDA) and receipt of the agency’s official meeting minutes, the company confirmed plans to submit its NDA in September 2026. In a major strategic move, Gossamer Bio also reacquired the worldwide development and commercialization rights to seralutinib from Chiesi, giving the company full global control of the potential first-in-class therapy as it advances toward commercialization.
FDA Feedback Supports Planned September 2026 NDA Submission
The FDA’s official meeting minutes from the company’s Pre-NDA Type B meeting outlined a regulatory pathway supporting Gossamer Bio’s planned September 2026 NDA submission for seralutinib in PAH. According to the company, the FDA considered the statistical significance and treatment effect observed in the Phase 3 PROSERA trial as review issues rather than filing issues, allowing Gossamer to move forward with an application supported by the Phase 3 PROSERA study, the Phase 2 TORREY trial, and additional confirmatory analyses. If accepted for filing, the company expects a potential FDA approval decision in the third quarter of 2027. Seralutinib is an investigational inhaled PDGFR, CSF1R, and c-KIT inhibitor designed to address pulmonary vascular remodeling, offering a novel therapeutic approach for patients with pulmonary arterial hypertension.
Worldwide Rights Reacquisition Strengthens Commercial Strategy
Gossamer Bio has terminated its previous collaboration and licensing agreement with Chiesi, allowing the company to reacquire worldwide development and commercial rights to seralutinib. The agreement restores full operational control over clinical development, manufacturing, pricing, commercialization, and lifecycle management across all global markets. Under the terms of the transaction, Chiesi will provide a one-time $5 million payment to Gossamer while retaining eligibility for capped royalties on worldwide net sales and specified regulatory and commercial milestone payments. The company stated that regaining worldwide rights significantly improves its long-term economic position by replacing the previous U.S. profit-sharing arrangement and ex-U.S. royalty structure with substantially greater ownership of future revenues.
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Financial Position Enhanced as Regulatory Milestones Approach
In addition to the regulatory and licensing updates, Gossamer Bio reported that cash, cash equivalents, and marketable securities totaled approximately $57 million as of June 30, 2026. Shareholders also approved proposals supporting the company’s previously announced convertible note exchange and a potential reverse stock split, improving financial flexibility ahead of key regulatory events. The debt restructuring reduced outstanding principal debt by approximately $115.9 million, while the reverse stock split authorization is intended to help maintain Nasdaq listing compliance. Together, these strategic, regulatory, and financial developments position Gossamer Bio to accelerate the development and potential commercialization of seralutinib, which the company believes could become a first-in-class therapy for pulmonary arterial hypertension and future pulmonary hypertension indications.
Source: Gossamer Bio press release
