Gossamer Bio Inc. (NASDAQ:GOSS) stock is trading higher on Monday as the company is preparing to submit a New Drug Application (NDA) for its lead candidate, seralutinib, in September 2026 following a pre-NDA Type B meeting with the U.S. Food and Drug Administration (FDA).
The clinical-stage biopharmaceutical company announced the timeline alongside major corporate updates, including regaining full global commercial rights to the candidate and completing significant balance sheet restructuring.
FDA Alignment And Regulatory Roadmap
During the mid-June 2026 meeting, the FDA characterized the treatment effect and statistical significance observed in the Phase 3 PROSERA study as review issues rather than filing hurdles.
Gossamer Bio plans to support its NDA submission using the Phase 3 trial alongside confirmatory data from its Phase 2 TORREY study and supportive analyses.
Should the FDA accept the filing, an approval decision for the pulmonary arterial hypertension (PAH) treatment could occur in the third quarter of 2027.
Full Global Rights Reacquired From Chiesi
Gossamer Bio and Chiesi agreed to end their collaboration, giving Gossamer Bio complete operational control over development, pricing, manufacturing, and commercialization across all geographic markets.
Under the termination terms, Chiesi will make a one-time $5 million payment to Gossamer Bio to settle existing and future obligations, including second-quarter 2026 costs.
Gossamer Bio made no upfront cash payment to reclaim the rights, but Chiesi will receive capped royalties on global net sales and specified milestone payments.
Debt Reduction And Financial Balance Sheet Updates
Stockholders approved proposals at a special meeting related to exchanging 5.00% Convertible Senior Notes due 2027.
The transaction reduced the aggregate debt principal by approximately $115.9 million, bringing the remaining 2027 note balance down to $18.9 million. Shareholders also authorized a reverse stock split to support Nasdaq minimum bid price compliance.
As of June 30, 2026, the company held preliminary cash, cash equivalents, and marketable securities of about $57 million.
GOSS Price Action: Gossamer Bio shares were up 44.04% at $0.19 at the time of publication on Monday. The stock is trading near its 52-week low of $0.11, according to Benzinga Pro data.
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