FDA accepts resubmission of NDA for Acer and Relief's urea cycle disorder drug

US pharma company Acer Therapeutics (Nasdaq: ACER) and its Switzerland-based collaboration partner Relief Therapeutics (SIX: RLF) are confident that their New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) is back on track.

The US Food and Drug Administration (FDA) has accepted for review Acer’s resubmitted NDA for the oral suspension for the treatment of patients with urea cycle disorders (UCDs), setting a target date for a decision of January 15, 2023.

In June 2022, the FDA issued Acer a CRL stating that satisfactory inspection of its third-party contract packaging manufacturer is required before the ACER-001 NDA may be approved.