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AI brief of an SEC Form 8-K · Gossamer Bio, Inc. (GOSS)

Gossamer Bio submits NDA for seralutinib in PAH to FDA, its first NDA filing

Neutral Impact 3 of 5 legal/regulatory Written later

Gossamer Bio said it submitted a New Drug Application to the FDA in September 2026 for seralutinib to treat pulmonary arterial hypertension, its first NDA. The application relies on the Phase 3 PROSERA study as one adequate and well-controlled investigation, supported by the Phase 2 TORREY study. The FDA has not yet decided whether to accept the application for filing, which the company expects could happen later this year.

Key points

  • NDA for seralutinib in PAH submitted to the FDA in September 2026, the company's first NDA
  • Submission follows a Pre-NDA Type B meeting with the FDA in June 2026 and the FDA's written meeting minutes
  • FDA will decide whether to accept the NDA for filing after its initial review, which the company anticipates could occur later this year

The filing

CompanyGossamer Bio, Inc. (GOSS)
Form8-K, current report
Filed with the SECSep 23, 2026, 4:05 PM ET
Accession number0001728117-26-000104

Items reported: 8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 23, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.