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Fulcrum Therapeutics (FULC) FDA Approvals

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Fulcrum Therapeutics' Drugs in the FDA Approval Process

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. Select a button below to view the list of FDA events for that drug.

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

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

The most recent FDA-related event for Fulcrum Therapeutics occurred on July 29, 2025, involving pociredir. The update was categorized as "Positive Results," with the company reporting: "Fulcrum Therapeutics, today reported positive results from the 12 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD)."

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

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

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 8/2/2025 by MarketBeat.com Staff
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