FDA grants Breakthrough Therapy Designation to Larimar’s nomlabofusp for Friedreich’s ataxia

Reuters02-24 20:03

FDA grants Breakthrough Therapy Designation to Larimar’s nomlabofusp for Friedreich’s ataxia

Larimar Therapeutics said the FDA granted Breakthrough Therapy Designation to nomlabofusp for the treatment of adults and children with Friedreich's ataxia. The company also reported that FDA written communications following a START meeting continued to align with using skin frataxin $(FXN)$ as a surrogate endpoint to support a planned biologics license application seeking accelerated approval, which Larimar said remains on track for submission in June 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Larimar Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602240700PRIMZONEFULLFEED9659733) on February 24, 2026, and is solely responsible for the information contained therein.

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