10:44 AM EDT, 06/23/2025 (MT Newswires) -- Larimar Therapeutics ( LRMR ) said Monday that interactions with the US Food and Drug Administration over the past year have provided clear expectations for the path to submission of the nomlabofusp biologics license application.

The company said written FDA recommendations for safety database include a total of at least 30 participants with continuous exposure for six months.

"We now plan to submit our BLA seeking accelerated approval in the second quarter of 2026," said Chief Executive Officer Carole Ben-Maimon.

Ben-Maimon said that the company is on track to report data in September 2025, adding that nomlabofusp has the potential to be the first disease modifying therapy for Friedreich's Ataxia.

"We look forward to expanding the clinical program to patients around the world with the initiation of our global Phase 3 study."

Price: 2.62, Change: +0.03, Percent Change: +1.27