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.
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