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Gyre Therapeutics (GYRE) FDA Events

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FDA Events for Gyre Therapeutics (GYRE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Gyre Therapeutics (GYRE). Over the past two years, Gyre Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Avatrombopag, F230, F351, and pirfenidone. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Gyre Therapeutics' Drugs in FDA Review

Avatrombopag - FDA Regulatory Timeline and Events

Avatrombopag is a drug developed by Gyre Therapeutics for the following indication: For the Treatment of CLD-Associated Thrombocytopenia. 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.

F230 - FDA Regulatory Timeline and Events

F230 is a drug developed by Gyre Therapeutics for the following indication: For the treatment of 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.

F351 - FDA Regulatory Timeline and Events

F351 is a drug developed by Gyre Therapeutics for the following indication: For Chronic Hepatitis B. 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.

pirfenidone - FDA Regulatory Timeline and Events

pirfenidone is a drug developed by Gyre Therapeutics for the following indication: In Oncology-Related Pulmonary Complications. 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.

Gyre Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Gyre Therapeutics (GYRE) has reported FDA regulatory activity for the following drugs: F351, F230, pirfenidone and Avatrombopag.

The most recent FDA-related event for Gyre Therapeutics occurred on June 10, 2025, involving F230. The update was categorized as "Dose Update," with the company reporting: "Gyre Therapeutics announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A ("ETA") receptor antagonist, for the treatment of pulmonary arterial hypertension ("PAH")."

Current therapies from Gyre Therapeutics in review with the FDA target conditions such as:

  • For Chronic Hepatitis B - F351
  • For the treatment of pulmonary arterial hypertension ("PAH"). - F230
  • In Oncology-Related Pulmonary Complications - pirfenidone
  • For the Treatment of CLD-Associated Thrombocytopenia - Avatrombopag

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:GYRE) was last updated on 7/9/2025 by MarketBeat.com Staff
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