Acer Therapeutics Stock Jumps As UCD Candidate Is Under FDA Review

The FDA has accepted for review Acer Therapeutics Inc ACER and its partner, Relief Therapeutics Holding SA's RLFTF marketing application for ACER-001 (sodium phenylbutyrate) for Urea Cycle Disorders (UCDs).
Related: Acer Therapeutics Enters Into ACER-001 Development Pact With Relief Therapeutics.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.
Acer's 505(b)(2) application is supported by results from two bioequivalence trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to the reference listed drug, Buphenyl (sodium phenylbutyrate).
Related content: Benzinga's Full FDA Calendar.
Price Action: ACER stock is up 15.30% at $2.87 during the premarket session on the last check Wednesday.