Larimar gains on FDA decision on trial for Friedreich’s ataxia drug

• Larimar Therapeutics (NASDAQ:LRMR) traded higher Tuesday after the company said that the FDA cleared its plans to add a 52-mg dose group to a Phase 2 trial for its lead candidate CTI-1601, targeted at the neuronal disorder Friedreich’s ataxia (FA).
• The company expects data from the patient group, which is part of its Phase 2 dose exploration trial, in H1 2024.
• The FDA has also cleared the company’s plans to start an open label extension (OLE) trial for the candidate. The trial, designed to administer subcutaneous injections of CTI-1601 at 25 mg, is set to begin in Q1 2024, with interim data expected in Q4 2024.
• The decision comes after the FDA reviewed the data submitted by the company in relation to a partial clinical hold imposed on the trial.

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