Larimar Stock Plunges As FDA Asks For Additional Data To Resolve Clinical Hold On Friedreich's Ataxia Program

Larimar Therapeutics Inc LRMR has received feedback from the FDA regarding the clinical hold on its CTI-1601 program. 

• The FDA stated it is maintaining its clinical hold and that additional data is needed to resolve the clinical hold. 
• Larimar is further analyzing previous studies and evaluating if additional studies are warranted. 
• Larimar is currently reassessing guidance on the timing of the planned Jive open-label extension and pediatric multiple-ascending dose trials as it works to meet the agency's request.
• Related: Larimar Stock Craters After FDA Clinical Hold on Friedreich's Ataxia Program.
• "We remain committed to CTI-1601's further development and are working towards this goal with a strong cash position that provides runway at least into 2023. We intend to operate under a cost reduction plan while resolving the clinical hold to manage burn and extend our cash runway if needed," said Carole Ben-Maimon, President & CEO.
• CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich's ataxia who cannot produce enough of this essential protein. 
• Price Action: LRMR shares plunged 57% to $3.60 during the premarket session on the last check Tuesday.