Larimar Therapeutics Inc., a clinical-stage biotechnology company, has announced new developments in its regulatory review process for the treatment of Friedreich's Ataxia $(FA)$. Following interactions with the U.S. Food and Drug Administration (FDA), the company has received clear guidelines under the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. The FDA has recommended a safety database that includes at least 30 participants with continuous exposure for six months, with a subset of at least 10 participants exposed for one year, primarily on the 50 mg dose. Larimar plans to submit its Biologics License Application $(BLA.AU)$ seeking accelerated approval in the second quarter of 2026, allowing for the inclusion of the recommended safety data. Larimar's ongoing long-term OLE study is progressing well, with high adherence rates reported. This announcement marks a significant step forward in Larimar's efforts to bring a new treatment option for FA to market.
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