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Larimar Therapeutics submits first module of rolling BLA to FDA for nomlabofusp in Friedreich’s ataxia

PUBT·06/29/2026 10:30:25
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Larimar Therapeutics submits first module of rolling BLA to FDA for nomlabofusp in Friedreich’s ataxia
  • Larimar Therapeutics submitted the first module of a rolling BLA to the FDA for accelerated approval of nomlabofusp in Friedreich’s ataxia.
  • FDA pre-BLA Type B meeting minutes indicated the existing data package could support filing and review; approval hinges on FDA review.
  • Remaining BLA modules are expected in 2H 2026; the company is targeting a mid-2027 launch if approved.


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: 202606290630PRIMZONEFULLFEED9753816) on June 29, 2026, and is solely responsible for the information contained therein.