Relief's partner Acer Thera resubmits NDA for ACER-001

Swiss biopharma company Relief Therapeutics H (SIX: RLF) today announced that its collaboration partner, Acer Therapeutics (Nasdaq: ACER) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs), has resubmitted its New Drug Application (NDA) for ACER-001 to the US Food and Drug Administration (FDA).

Relief has been advised by Acer that it believes that the resubmission addresses, in full, the items raised by the FDA in the Complete Response Letter (CRL).

In June 2022, as previously announced, 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. Relief is advised that Acer notified the FDA in the resubmission that the third-party contract packaging manufacturer is ready for inspection. FDA did not cite any other approvability issues in the CRL pertaining to the NDA, nor request any additional clinical or pharmacokinetic studies be conducted prior to FDA action. According to Acer, additional existing nonclinical information as requested by the FDA in the CRL but identified as “not an approvability issue,” as well as labeling and other routine updates to the original NDA, were provided in the resubmission of the NDA.