Gossamer Bio Reacquires Seralutinib Rights, Plans September NDA After FDA Meeting
GOSS sits 50% above its 52-week low of $0.114.
Summary
Gossamer Bio reported Q2 2026 results and a business update that materially de-risks its lead asset. The company received FDA meeting minutes from a Pre-NDA Type B meeting, with the agency characterizing statistical significance and treatment effect as review issues rather than filing issues, clearing the path for an NDA submission in September 2026. If accepted, seralutinib could see an approval decision in Q3 2027. Gossamer also terminated its Chiesi collaboration, reacquiring worldwide rights to seralutinib for no upfront payment; Chiesi pays $5 million and receives a capped royalty, leaving Gossamer with the substantial majority of global economics. Cash of $57.0 million funds operations into Q1 2027. This follows the July 27 8-K announcing the reacquisition and the completed convertible note exchange that cut debt by $115.9 million. The FDA minutes are the key new information—they suggest the NDA is likely to be accepted for filing, a major step for a company with a market cap under $100 million.
At the time of this announcement, GOSS was trading at $0.17 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $83.3M. The 52-week trading range was $0.11 to $3.87. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.