Larimar Therapeutics Shares Surge 55% After FDA Grants Breakthrough Therapy Designation
Larimar Therapeutics shares rose 55% in one month after the FDA granted breakthrough therapy designation to nomlabofusp for Friedreich’s ataxia. The company plans an FDA submission in June 2026 based on skin frataxin levels as a novel surrogate endpoint, with top-line data due Q2 2026.
1. Stock Rally
Shares of Larimar Therapeutics have climbed 55% over the past month, driven by enhanced investor optimism around nomlabofusp’s regulatory progress. This rally outpaces the industry’s breakeven growth and reflects the market’s response to potential accelerated approval and commercial prospects.
2. Breakthrough Therapy Designation
The FDA granted breakthrough therapy designation to nomlabofusp for treating adults and children with Friedreich’s ataxia, recognizing preliminary clinical data that show substantial improvements over existing therapies in frataxin protein levels and key functional outcomes.
3. Surrogate Endpoint Alignment
Larimar secured FDA agreement to use skin frataxin levels as a novel surrogate endpoint in its regulatory submission, potentially expediting the review process under accelerated approval guidelines for severe diseases.
4. Upcoming Milestones
Top-line data from the ongoing open-label study are expected in Q2 2026. Subject to positive results, Larimar plans an FDA submission in June 2026 and aims for a first commercial launch in the first half of 2027.