Shares of Larimar Therapeutics, Inc. (LRMR) tanked over 40% on Wednesday morning. The company’s stock was impacted by the news that its CTI-1601 clinical program has been placed on hold by the FDA and that a previously announced private placement financing will be terminated.
LRMR is currently trading at $7.90, down $5.61 or 41.52%, on the Nasdaq.
CTI-1601 is a recombinant fusion protein being developed as a treatment for Friedreich ataxia, a rare inherited disease caused by patients’ inability to produce sufficient amounts of a protein called frataxin. Recently, the company announced positive topline data from its phase I multiple ascending dose clinical trial of CTI-1601 in Friedreich’s Ataxia.
The clinical hold follows the previous notification by Larimar to the FDA of mortalities which occurred at the highest dose levels in an ongoing 180-day non-human primate toxicology study, which is designed to support extended dosing of patients with CTI-1601.
The FDA stated it needs a full study report from the ongoing NHP study and Larimar may not initiate additional clinical trials until the company has submitted the report and received notification from the agency that additional clinical trials may commence.
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