Reneo Pharmaceuticals receives fast track designation from FDA for REN001

Reneo Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted mavodelpar, REN001, Fast Track designation for long-chain 3-hydroxyacyl-CoA dehydrogenase, LCHAD, deficiency, one of the predominant genotypes in patients with long-chain fatty acid oxidation disorder, LC-FAOD. "Receiving this Fast Track designation for a second indication continues to solidify mavodelpar as a potential therapeutic option for patients with rare mitochondrial disease," said Gregory Flesher, President and Chief Executive Officer of Reneo Pharmaceuticals. "We appreciate the continued collaboration with the FDA and look forward to their partnership in advancing the LC-FAOD program which will include patients with LCHAD as well as other genotypes." The company recently completed a natural history study and an open label study evaluating mavodelpar in patients with LC-FAOD that included multiple genotypes, including the LCHAD genotype. Mavodelpar is also being evaluated in a pivotal clinical trial in patients with primary mitochondrial myopathies with mitochondrial DNA defects. The company expects topline data from the STRIDE study in the fourth quarter of this year.