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Acer Therapeutics, Relief Therapeutics Announce FDA Acceptance For Review Of NDA Resubmission For ACER-001 For Treatment Of UCDs

Acer Therapeutics Inc. (NASDAQ:ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF, RLFTY)) (Relief), today announced the U.S. Food and Drug Administration (FDA) has

Benzinga · 07/28/2022 08:34

Acer Therapeutics Inc. (NASDAQ:ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF, RLFTY)) (Relief), today announced the U.S. Food and Drug Administration (FDA) has accepted for review Acer's resubmitted New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs). The FDA designated the NDA as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2023.