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Gossamer Bio (GOSS) FDA Events

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FDA Events for Gossamer Bio (GOSS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Gossamer Bio (GOSS). Over the past two years, Gossamer Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as seralutinib and Seralutinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Gossamer Bio's Drugs in FDA Review

seralutinib - FDA Regulatory Timeline and Events

seralutinib is a drug developed by Gossamer Bio for the following indication: Treatment of Pulmonary Arterial Hypertension. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Seralutinib - FDA Regulatory Timeline and Events

Seralutinib is a drug developed by Gossamer Bio for the following indication: Pulmonary arterial hypertension (PAH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Gossamer Bio FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Gossamer Bio (GOSS) has reported FDA regulatory activity for the following drugs: seralutinib and Seralutinib.

The most recent FDA-related event for Gossamer Bio occurred on June 16, 2025, involving seralutinib. The update was categorized as "Enrollment Completion," with the company reporting: "Gossamer Bio, Inc. announced enrollment completion for the ongoing, global registrational Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III PAH patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement."

Current therapies from Gossamer Bio in review with the FDA target conditions such as:

  • Treatment of Pulmonary Arterial Hypertension - seralutinib
  • Pulmonary arterial hypertension (PAH) - Seralutinib

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:GOSS) was last updated on 7/10/2025 by MarketBeat.com Staff
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