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Investing.com - Larimar Therapeutics (NASDAQ:LRMR) has adjusted its timeline for submitting a Biologics License Application (BLA) for its Friedreich's Ataxia treatment nomlabofusp to the second quarter of 2026, according to a Monday company announcement. The stock, which InvestingPro data shows has fallen over 10% in the past week, appears undervalued based on Fair Value analysis.
The revised timeline represents a delay from the previous year-end 2025 target, following written recommendations from the FDA regarding safety database requirements and the use of skin frataxin concentrations as a surrogate endpoint for the treatment.
Leerink Partners reiterated its Outperform rating and $25.00 price target on Larimar stock despite the extended timeline, noting that the Accelerated Approval pathway remains available for the drug candidate.
The company plans to request approval for treating a broad population including adults, adolescents, and children with Friedreich's Ataxia, which influenced the FDA's recommendations on the required safety database size.
Larimar reported $158 million in cash, cash equivalents, and marketable securities at the end of the first quarter of 2025, which the company expects will provide financial runway into the second quarter of 2026, coinciding with the new BLA submission target.
In other recent news, Larimar Therapeutics has announced plans to submit a Biologics License Application (BLA) for its Friedreich's ataxia drug candidate, nomlabofusp, by the second quarter of 2026. The U.S. Food and Drug Administration (FDA) has provided guidance allowing the use of skin frataxin concentrations as a surrogate endpoint for accelerated approval. Preparations for a global Phase 3 study are underway, expected to include 100-150 ambulatory patients, which will serve as a confirmatory trial. Analyst firms have shown varying degrees of optimism, with Citizens JMP maintaining a Market Outperform rating and a $21 price target, citing key milestones in 2025. Meanwhile, Jones Trading and Citi both reiterated Buy ratings with $14 targets, focusing on the FDA's feedback regarding skin frataxin levels. H.C. Wainwright also maintained its Buy rating with a $16 target, expressing increased confidence in the drug's market potential and regulatory progress. These developments highlight significant steps in Larimar's journey toward potentially bringing nomlabofusp to market as a treatment for Friedreich's ataxia.
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