In their ongoing discussions with the FDA, Larimar is working on a potential use of frataxin as a novel surrogate endpoint. This may unlock the potential for accelerated approval. Moreover, the company is planning for a global double-blind placebo-controlled confirmatory study. The study is expected to be initiated before the potential BLA (Biologics License Application) is submitted. The targeted timeline for the submission is the second half of 2025.
Monday, March 25, 2024
Larimar Triumphs: Significant Strides Made on the Road to Treating Friedreich’s Ataxia
BALA CYNWYD, PA — Larimar Therapeutics, Inc. March 19, 2024
