---
schema_version: "secwatch.filing_event.v1"
accession: "0001728117-26-000104"
form_type: "8-K"
ticker: "GOSS"
cik: "0001728117"
company_name: "Gossamer Bio, Inc."
filed_at: "2026-09-23T20:05:41+00:00"
generated_at: "2026-09-23T20:09:11.650217+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Gossamer Bio submits NDA for seralutinib in PAH; FDA acceptance decision expected later 2026

## Summary
- Submitted NDA to FDA on Sept 23, 2026 for seralutinib treatment of pulmonary arterial hypertension.
- First NDA submission; supported by Phase 3 PROSERA and Phase 2 TORREY studies.
- FDA minutes from June 2026 Pre-NDA meeting called statistical significance a review issue, not filing issue.
- Company expects FDA acceptance decision for filing later this year; approval uncertain.

## SEC filing metadata
- accession: 0001728117-26-000104
- form_type: 8-K
- ticker: GOSS
- cik: 0001728117
- company_name: Gossamer Bio, Inc.
- filed_at: 2026-09-23T20:05:41+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1728117/000172811726000104/0001728117-26-000104-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1728117/000172811726000104/goss-20260923.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001728117-26-000104
- JSON: https://secwatch.observer/filing/0001728117-26-000104.json
- Plain text: https://secwatch.observer/filing/0001728117-26-000104.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.