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Foghorn Therapeutics (FHTX) FDA Events

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FDA Events for Foghorn Therapeutics (FHTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Foghorn Therapeutics (FHTX). Over the past two years, Foghorn Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FHD-286 and FHD-909. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Foghorn Therapeutics' Drugs in FDA Review

FHD-286 (mUM) - FDA Regulatory Timeline and Events

FHD-286 (mUM) is a drug developed by Foghorn Therapeutics for the following indication: Metastatic Uveal Melanoma (mUM). 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.

FHD-909 - FDA Regulatory Timeline and Events

FHD-909 is a drug developed by Foghorn Therapeutics for the following indication: A BRM (SMARCA2) selective inhibitor. 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.

Foghorn Therapeutics FDA Events - Frequently Asked Questions

In the past two years, Foghorn Therapeutics (FHTX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Foghorn Therapeutics (FHTX) has reported FDA regulatory activity for the following drugs: FHD-909 and FHD-286 (mUM).

The most recent FDA-related event for Foghorn Therapeutics occurred on April 28, 2025, involving FHD-909. The update was categorized as "New Data," with the company reporting: "Foghorn® Therapeutics announced new preclinical data for potential first-in-class medicines, including FHD-909, a SMARCA2 (BRM) selective inhibitor, and the Selective CBP degrader program at the 2025 American Association for Cancer Research (AACR) Annual Meeting."

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

  • A BRM (SMARCA2) selective inhibitor - FHD-909
  • Metastatic Uveal Melanoma (mUM) - FHD-286 (mUM)

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:FHTX) was last updated on 7/11/2025 by MarketBeat.com Staff
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