Gossamer Bio shares jump after FDA update and seralutinib rights return Fiona Craig NASDAQ:GOSS Latest News July 27 2026 9:33AM © Adobe Stock Images Gossamer Bio Inc. (NASDAQ:GOSS) shares surged 25% on Monday after the biotechnology company provided a positive regulatory update on its lead drug candidate, seralutinib, and announced it had regained full global rights to the therapy. The clinical-stage drug developer said it recently completed a Pre-NDA Type B meeting with the U.S. Food and Drug Administration, receiving formal meeting minutes that support a planned New Drug Application (NDA) submission for seralutinib in pulmonary arterial hypertension (PAH) this September. FDA feedback supports planned NDA filing According to Gossamer Bio, the FDA indicated that questions surrounding the statistical significance and treatment effect observed in the Phase 3 PROSERA trial would be considered review issues rather than obstacles to accepting the application for filing. The company intends to submit its NDA in September. If the application is accepted, a regulatory decision from the FDA could be expected during the third quarter of 2027. Company regains worldwide rights to seralutinib Gossamer Bio also announced it has reacquired the worldwide development and commercialization rights to seralutinib from Chiesi after the companies agreed to terminate their collaboration and licensing agreement. The termination ends the previous 50/50 U.S. profit-sharing arrangement and restores international rights to Gossamer Bio without requiring an upfront payment from the company. Under the agreement, Chiesi will make a one-time payment of $5 million to Gossamer Bio. In return, Chiesi will remain eligible to receive capped royalties on future global net sales of seralutinib, along with payments tied to specified regulatory and commercial milestones. Debt reduced as shareholders approve restructuring measures Earlier this month, shareholders approved proposals linked to the company’s previously completed exchange of its 5.00% Convertible Senior Notes due 2027 and authorized the board to implement a reverse stock split if required. The debt exchange reduced Gossamer Bio’s outstanding principal debt by approximately $115.9 million, strengthening its balance sheet. As of June 30, the company reported approximately $57 million in cash, cash equivalents and marketable securities to support its ongoing operations and regulatory plans. Gossamer Bio stock price Join the discussion: Connect with other investors on your favorite stocks or explore the top-talked-about stocks on our Breakout Boards . This article was written by the editorial team at InvestorsHub/ADVFN and is provided for informational purposes only. In some cases, editorial staff may use artificial intelligence–based tools to assist in the research, drafting, or editing of content, under human review and oversight. This article does not constitute investment advice, a recommendation, or an offer to buy or sell any securities. The views expressed are based on publicly available information believed to be reliable at the time of publication, but accuracy or completeness is not guaranteed. Readers should conduct their own independent research and consult a qualified financial professional before making any investment decisions. Categories: Latest News Gossamer Bio shares jump after FDA update and seralutinib rights return Gossamer Bio Inc. (NASDAQ:GOSS) shares surged 25% on Monday after the... B U Pre Login/Register Top Stories More News Delta Gold Technologies Looks Beyond Conventional Quantum Computing With a Distinctive Research Strategy US Markets Await Key Earnings and Federal Reserve Decision as AI Spending Faces Fresh Scrutiny: Dow Jones, S&P, Nasdaq, Wall Street Futures Dow Climbs as Middle East Calm Sinks Oil, While an Nvidia-Led Tech Slide Caps the Nasdaq Amazon Leo seeks FCC approval for more than 5,100 direct-to-device satellites The Odyssey reaches $140 million in global IMAX box office AMC reports record IMAX ticket sales following strong opening for The Odyssey More News GOSS Discussion View Posts 81vette 14 hours ago https://investorshub.advfn.com/stock-market/NASDAQ/gossamer-bio-GOSS/trades?_gl=1%2Atqp7pg%2A_gcl_au%2AMTczNDg4NzU3Mi4xNzc4OTg4NDY4Li0uLS4xNzg0MjI1NDA0LjcwOTA0Mzc3My4xNzg1MTU4MzA0LjE3ODUxOTA4NDQ. 👍️ 0 hondaboost 20 hours ago GOSS was $3.8 before FDA refused its submission in Dec, now it's got FDA supports for re-submission this time! 🚀 1 iHub News 22 hours ago Gossamer Bio shares jump after FDA update and seralutinib rights returnJuly 27, 2026 9:33 AM IH Market News Gossamer Bio Inc. (NASDAQ:GOSS) shares surged 25% on Monday after the biotechnology company provided a positive regulatory update on its lead drug candidate, seralutinib, and announced it had regained full global rights to the therapy. The clinical-stage drug developer said it recently completed a Pre-NDA Type B meeting with the U.S. Food and Drug Administration,