Gossamer Bio Plans September NDA for PAH Drug, Reacquires Global Rights from Chiesi
GOSS sits 57% above its 52-week low of $0.114.
Summary
Gossamer Bio is moving toward an NDA submission for seralutinib in PAH in September 2026 after a productive Pre-NDA meeting with the FDA. The agency indicated that statistical significance and treatment effect magnitude from the Phase 3 PROSERA trial are review issues, not filing issues, clearing a key regulatory hurdle. Simultaneously, the company reacquired worldwide rights to seralutinib from Chiesi, consolidating global control and economics ahead of the potential launch. Chiesi will pay Gossamer $5 million and receive a capped royalty on future sales, with no upfront payment from Gossamer. Stockholders also approved a convertible note exchange and authorized a reverse stock split, while preliminary cash stood at approximately $57 million as of June 30. This follows a tumultuous period including a Phase 3 enrollment pause, a debt exchange, and class-action lawsuits. The NDA submission and rights reacquisition mark a potential turning point, though the company remains thinly capitalized with a market cap around $66 million. An FDA decision could come in Q3 2027 if the NDA is accepted.
At the time of this announcement, GOSS was trading at $0.18 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $66.5M. 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.