Larimar Therapeutics Announces Positive Long-Term Study Results for Nomlabofusp in Friedreich’s Ataxia, Targets Accelerated FDA Approval in 2026

Reuters
09/29
Larimar <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces Positive Long-Term Study Results for Nomlabofusp in Friedreich's Ataxia, Targets Accelerated FDA Approval in 2026

Larimar Therapeutics, Inc. (Nasdaq: LRMR) announced positive data from its ongoing long-term open-label study evaluating daily subcutaneous injections of nomlabofusp for the treatment of Friedreich's ataxia $(FA)$. The study, which includes both self-administered and caregiver-administered dosing, demonstrated consistent directional improvements across four key clinical outcomes. Results from the study were presented by the company, which also provided an update on the nomlabofusp development program. The most common adverse events were local injection site reactions, generally mild to moderate, with no withdrawals due to these events. Seven participants experienced anaphylaxis and were withdrawn from the study; these events occurred mainly on the initial day or within the first six weeks of dosing, and all affected participants recovered after standard treatment. In total, 65 patients have received at least one dose of nomlabofusp across four completed studies and the ongoing open-label trial. Larimar plans to submit a Biologics License Application (BLA) seeking accelerated approval for nomlabofusp in the second quarter of 2026. The company has regularly updated the FDA on its clinical development program and has modified its starting dose regimen in consultation with experts and with FDA agreement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Larimar Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-25-221538), on September 29, 2025, and is solely responsible for the information contained therein.

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