Acer Therapeutics Announces U.S. FDA Approval Of OLPRUVA For Urea Cycle Disorders

(RTTNews) - Acer Therapeutics Inc. (ACER) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (RLFTF, RLFTY) said that the U.S. Food and Drug Administration has approved OLPRUVA (sodium phenylbutyrate) for oral suspension in the U.S. for the treatment of certain patients living with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase or argininosuccinic acid synthetase.

OLPRUVA's approval triggers the availability of a $42.5 million term loan to Acer under the previously announced March 2022 loan agreement the Company entered into with affiliates of Marathon Asset Management L.P. If Acer requests and receives the loan proceeds, the company believes it will have sufficient resources to fund current operations into the second-half of 2023.

Acer plans to offer Navigator by Acer Therapeutics, a suite of integrated patient support services designed to facilitate access to therapy. Navigator by Acer Therapeutics is designed to assist urea cycle disorder patients with support, access, education, and adherence.