FDA Rejects Acer Therapeutics - Relief Therapeutics' Urea Cycle Disorder Candidate

  • The FDA issued a Complete Response Letter regarding the marketing application for Acer Therapeutics Inc ACER and its collaboration partner, Relief Therapeutics Holding SA's RLFTF ACER-001 (sodium phenylbutyrate), for urea cycle disorders (UCDs).
  • The CRL states: "[The FDA's] field investigator could not complete inspection of [Acer's third-party contract packaging manufacturer] because the facility was not ready for inspection. Satisfactory inspection is required before [the NDA] may be approved. Please notify us in writing when this facility is ready for inspection."
  • The FDA did not cite any other issues in the CRL about the NDA nor request that any additional clinical or pharmacokinetic studies are conducted before FDA approval. 
  • The FDA requested additional nonclinical information to be provided in the resubmission of the application.
  • Acer is actively collaborating with its third-party contract packaging manufacturer.
  • It intends to resubmit the updated application for ACER-001 in early-to-mid Q3 2022.
  • Price Action: ACER shares are down 11.40% at $1.56, and RLFTF shares are down 16.53% at $0.025 during the market session on the last check Tuesday.
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