Larimar to respond to FDA this quarter on 15-month clinical hold of PhI Friedreich's ataxia drug

More than a year after the FDA clamped down on Larimar Therapeutics with a clinical hold on its lead drug, the biotech thinks it has a way to get that lifted — and an answer could come next quarter if all goes to plan.

Amid a 15-month setback, the biotech plans on filing a complete response to the FDA’s concerns over its drug, CTI-1601, sometime this quarter, which is supposed to elicit an answer from the agency within 30 days, per the regulator.