REN001 Granted Fast Track Designation by FDA for Patients with Primary Mitochondrial Myopathies

Reneo Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced that the United States Food and Drug Administration (FDA) granted Fast Track designation to REN001 for the treatment of patients with primary mitochondrial myopathies (PMM).

The Fast Track process is designed to facilitate and expedite the development of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA in addition to a rolling submission of the marketing application.

“The FDA’s decision to grant Fast Track designation to REN001 signifies an important milestone in our development program,” said Gregory J. Flesher, President and Chief Executive Officer of Reneo. “There are currently no medications approved to treat patients with PMM, and this designation underscores the importance of developing treatment options for patients who suffer from this debilitating disease.”

About REN001

REN001 is an oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in clinical development for three rare genetic mitochondrial diseases that typically present with myopathy and have high unmet medical needs: primary mitochondrial myopathies (PMM), long-chain fatty acid oxidation disorders (LC-FAOD), and glycogen storage disorder type V (McArdle disease). For more information on REN001 clinical trials, please see clinicaltrials.gov.

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