ACER - Acer Relief Therapeutics submit ACER-001 NDA in U.S. for urea cycle disorders

Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (OTCQB:RLFTF) have submitted of a New Drug Application (NDA) to the FDA for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs). Acer expects to receive FDA notification on the potential acceptance within 60 days of submission and subsequent substantive review. The NDA submission is supported by results from two previous bioequivalence trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate and phenylacetate, compared to BUPHENYL(R) (sodium phenylbutyrate). "With the NDA now submitted, we will continue our efforts to back ACER-001's development in Europe by targeting submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of 2021," said Jack Weinstein, CFO of Relief Therapeutics.

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Acer, Relief Therapeutics submit ACER-001 NDA in U.S. for urea cycle disorders