By Stephen Nakrosis


Shares of Larimar Therapeutics were trading higher in after-hours action Monday, following news the U.S. Food and Drug Administration has lifted a partial clinical hold on the nomlabofusp program in Friedreich's Ataxia, an inherited disorder of the nervous system.

After the bell, the company's stock gained 22% to $8.88. The stock ended the day's regular session with a 1.5% loss, closing at $7.27.

The partial clinical hold was removed following a review of data from a recently completed four-week, placebo-controlled Phase 2 dose exploration study, which included data from both 25 mg and 50 mg cohorts.

Nomlabofusp is a protein replacement therapy which aims to address the root cause of FA by delivering frataxin to mitochondria, the company said. Larimar also said nomlabofusp was generally well-tolerated during the four-week treatment period, and that patients with quantifiable levels at baseline and Day 14 in the 50 mg cohort saw frataxin levels in skin cells over 33% of the average level seen in healthy volunteers at Day 14. In addition, 3 patients had levels above 50% of the average healthy volunteer level.

Interim data from an ongoing open label extension study is expected in the fourth quarter of this year, the company said.


Write to Stephen Nakrosis at stephen.nakrosis@wsj.com


(END) Dow Jones Newswires

05-20-24 1710ET