FDA accepts Acer's resubmitted U.S. marketing application for urea cycle disorder therapy

Jul. 28, 2022 9:28 AM ETAcer Therapeutics Inc. (ACER), RLFTF, RLFTYBy: Anuron Mitra, SA News Editor

Headquarters of US Food and Drug Administration (FDA)


  • Acer Therapeutics (NASDAQ:ACER) and partner Relief Therapeutics (OTCQB:RLFTF) (OTCQB:RLFTY) on Thursday said the U.S. Food and Drug Administration (FDA) had accepted the companies' resubmission of their new drug application for their ACER-001 treatment for patients with urea cycle disorders.
  • The FDA designated the new drug application (NDA) as a class 2 resubmission and said it would review the application by Jan. 15, 2023, or the so-called Prescription Drug User Fee Act date.
  • Despite the news, ACER stock had fallen 4.2% to $1.37 in premarket trading.
  • The FDA's acceptance of the NDA comes 10 days after ACER and RLFTF resubmitted the application.
  • The NDA had been initially declined by the FDA in June as the agency's field investigator had been unable to complete inspection of ACER's third-party contract packaging manufacturer.

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