Acer Therapeutics: FDA To Review NDA For ACER-001 - Quick Facts

(RTTNews) - Acer Therapeutics Inc. (ACER) and its collaboration partner, RELIEF THERAPEUTICS Holding SA announced the FDA has accepted for filing the New Drug Application (NDA) for ACER-001 for the treatment of patients with Urea Cycle Disorders. The FDA has assigned a PDUFA target action date of June 5, 2022.

"In parallel with Acer's activities, we continue to execute on our global commercial strategy for ACER-001 which includes our intended submission of a Marketing Authorization Application for the treatment of patients with UCDs in Europe in Q2/Q3 2022," said Jack Weinstein, CFO of Relief.