Research & Development
US FDA grants Regulus Therapeutics Orphan Drug Designation for RGLS4326
30 July 2020 -

Regulus Therapeutics Inc (Nasdaq: RGLS), a United States-based biopharmaceutical company, has received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for its RGLS4326 intended for the treatment of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD), it was reported on Wednesday.

Jay Hagan, Regulus CEO, said, 'We are pleased RGLS4326 has been granted Orphan Drug Designation by FDA, this is an important milestone for our ADPKD program and our efforts to address the significant unmet medical needs with this disease.'

The US FDA Office of Orphan Drug Products offers orphan status to drugs aimed at treating rare disorders that affect less than 200,000 people in the United States. The designation provides certain potential benefits to the drug developer, including seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials.

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