Shidlovski Nomlabofusp, in phase 1 for Friedreich's ataxia from Larimar Therapeutics ( NASDAQ: LRMR ), was selected to be part of a U.S. FDA pilot program designed to accelerate development of rare disease or serious illness therapies with unmet medical needs.
The Support for Clinical Trials Advancing Rare Disease Therapeutics (START) program, which began in September 2023, gives drugmakers more frequent and rapid interactions with the FDA and will help to generate data intended to support candidate applications to the agency. A total of six candidates will be selected initially for START. Three will be chosen by the FDA's Center for Drug Evaluation and Research and the other three by the Center for Biologics Evaluation and Research.
Nomlabofusp is a recombinant fusion protein designed to deliver human frataxin -- a protein -- to the mitochondria of patients. Larimar ( LRMR ) plans to release interim data from an open label extension study of nomlabofusp in Q4. More on Larimar Therapeutics Larimar stock rallies 24% on FDA removal of partial clinical hold Seeking Alpha’s Quant Rating on Larimar Therapeutics Historical earnings data for Larimar Therapeutics Financial information for Larimar Therapeutics.
