RLFTF - Acer Therapeutics plans NDA submission for ACER-001 in Q3 2021

Acer Therapeutics (ACER) said that it plans to submit an NDA for its Urea Cycle Disorders ((UCDs)) treatment ACER-001 to the U.S. FDA in the third-quarter of this year, following a pre-NDA meeting with the health regulator.ACER-001 is a proprietary immediate release powder formulation of sodium phenylbutyrate ((NaPB)), and is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease ((MSUD)).UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia.Relief Therapeutics Holding (RLFTF) and Acer had entered into a Collaboration and License Agreement (“CLA”) for worldwide development and commercialization of ACER-001, in March.

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Acer Therapeutics plans NDA submission for ACER-001 in Q3 2021