Gossamer Bio Inc (GOSS) News & EventsGOSSGossamer Bio Inc

WTI Crude Oil Rises Above $92 Amid Trump-Iran Standoff

U.N. General Assembly standoff pitting President Trump's threat to annihilate Iran against a defiant tone from Iranian President that his country will not bow down to pressure reverberated across financial markets on Wednesday, with WTI crude oil breaking a string of five consecutive declining sessions to rise above $92 per barrel.  Energy was the only sector to finish in the green, while Basic Materials and Communication Services were the biggest decliners.  Dented hopes for a diplomatic offramp also contributed to higher borrowing costs in the US - the 10-year Treasury note yield spiked 15 basis points to a multi-decade high of 5.11%.  In the opening hour of the evening session, index futures are little changed - S&P e-minis are below 7.770 and Nasdaq 100 is below 30,800.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER -Everpureup 4.9% after above-consensus FY28 revenue guidance at Investor Day presentationKnife Riverup 4.0% after WSJ report of Starboard Value taking a stakeGlossmer Bioup 1.9% after submitting NDA for seralutinibInhibrx Biosciencesup 1.4% after insider buyDOWN AFTER EARNINGS -Stitch Fixdown 17.7%HB Fullerdown 0.6%ALSO LOWER -Viking Therapeuticsdown 8.3% after $200M spot secondaryMGM Resorts Internationaldown 8.0% after Barry Diller withdrew bid for companyTransUniondown 2.4% after CFO resignation

Gossamer Bio Submits First New Drug Application

Gossamer Bio announced that it submitted a New Drug Application to the U.S. Food and Drug Administration in September 2026 for seralutinib for the treatment of PAH. This is the Company's first NDA submission. The NDA is supported by the Phase 3 PROSERA Study as one adequate and well-controlled clinical investigation, together with confirmatory evidence from the Phase 2 TORREY Study and supportive analyses. The NDA submission follows the Company's Pre-NDA Type B meeting with the FDA in June 2026 and the FDA's official written meeting minutes, in which the FDA characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as review issues rather than filing issues, and provided feedback on the format and content of the planned submission. "Submitting our first NDA is a significant milestone for Gossamer and, more importantly, for patients living with PAH," said Faheem Hasnain, Chairman, Co-Founder and Chief Executive Officer of Gossamer. "We are grateful to the patients, families, investigators and site staff who made PROSERA and TORREY possible, and to our employees for the work it took to reach this point."

Gossamer Bio Submits First New Drug Application

Gossamer Bio announced that it submitted a New Drug Application to the U.S. Food and Drug Administration in September 2026 for seralutinib for the treatment of PAH. This is the Company's first NDA submission. The NDA is supported by the Phase 3 PROSERA Study as one adequate and well-controlled clinical investigation, together with confirmatory evidence from the Phase 2 TORREY Study and supportive analyses. The NDA submission follows the Company's Pre-NDA Type B meeting with the FDA in June 2026 and the FDA's official written meeting minutes, in which the FDA characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as review issues rather than filing issues, and provided feedback on the format and content of the planned submission. "Submitting our first NDA is a significant milestone for Gossamer and, more importantly, for patients living with PAH," said Faheem Hasnain, Chairman, Co-Founder and Chief Executive Officer of Gossamer. "We are grateful to the patients, families, investigators and site staff who made PROSERA and TORREY possible, and to our employees for the work it took to reach this point."