Larimar Stock Craters After FDA Clinical Hold on Friedreich's Ataxia Program

The FDA has instituted a clinical hold on Larimar Therapeutics Inc's LRMR CTI-1601 clinical program as a treatment for Friedreich's Ataxia (FA), a neurodegenerative movement disorder.
The clinical hold follows the previous notification by Larimar to the FDA of mortalities that 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 clinical hold letter cited that the agency would need a full study report from the ongoing NHP study.
Larimar will not initiate additional clinical trials until the submission of the report and receiving a go-ahead from the agency for the additional trials.
Due to the additional regulatory requirements, the company expects to initiate Jive and pediatric multiple ascending dose trials in 2022
Recently announced data from these trials indicate that repeated subcutaneous administration of CTI-1601 resulted in dose-dependent increases in frataxin (FXN) levels from baseline compared to placebo controls.
The company also terminated the previously announced private placement financing of $95 million.
As of March 31, the company has $81.4 million in cash and investments, which provides cash runway through the first half of 2022.
Price Action: LRMR shares are 37.8% at $8.41 during the premarket session on the last check Wednesday.
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