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Fulcrum Therapeutics (FULC) FDA Events

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FDA Events for Fulcrum Therapeutics (FULC)

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

Fulcrum Therapeutics' Drugs in FDA Review

Losmapimod (ReDUX4) - FDA Regulatory Timeline and Events

Losmapimod (ReDUX4) is a drug developed by Fulcrum Therapeutics for the following indication: Facioscapulohumeral muscular dystrophy (FSHD). 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.

pociredir - FDA Regulatory Timeline and Events

pociredir is a drug developed by Fulcrum Therapeutics for the following indication: In sickle cell disease. 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.

Fulcrum 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, Fulcrum Therapeutics (FULC) has reported FDA regulatory activity for the following drugs: Losmapimod (ReDUX4) and pociredir.

The most recent FDA-related event for Fulcrum Therapeutics occurred on May 29, 2025, involving pociredir. The update was categorized as "Upcoming presentations," with the company reporting: "Fulcrum Therapeutics announced upcoming presentations at the 5th Global Congress on Sickle Cell Disease and the 2025 European Hematology Association Congress."

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

  • Facioscapulohumeral muscular dystrophy (FSHD) - Losmapimod (ReDUX4)
  • In sickle cell disease - pociredir

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:FULC) was last updated on 7/10/2025 by MarketBeat.com Staff
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