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Larimar Therapeutics (LRMR) FDA Events

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FDA Events for Larimar Therapeutics (LRMR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Larimar Therapeutics (LRMR). Over the past two years, Larimar Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CTI-1601 and nomlabofusp. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Larimar Therapeutics' Drugs in FDA Review

CTI-1601 - FDA Regulatory Timeline and Events

CTI-1601 is a drug developed by Larimar Therapeutics for the following indication: Friedreich's Ataxia (FA). 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.

nomlabofusp - FDA Regulatory Timeline and Events

nomlabofusp is a drug developed by Larimar Therapeutics for the following indication: For Friedreich's Ataxia. 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.

Larimar 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, Larimar Therapeutics (LRMR) has reported FDA regulatory activity for the following drugs: CTI-1601 and nomlabofusp.

The most recent FDA-related event for Larimar Therapeutics occurred on July 8, 2025, involving nomlabofusp. The update was categorized as "Publication," with the company reporting: "Larimar Therapeutics, announced the publication of two peer-reviewed articles highlighting nonclinical data on the therapeutic potential, pharmacology, and mechanism of action of nomlabofusp as a novel frataxin (FXN) protein replacement therapy designed to address the underlying cause of Friedreich's ataxia (FA)."

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

  • Friedreich's Ataxia (FA) - CTI-1601
  • For Friedreich's Ataxia - nomlabofusp

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