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Acer Therapeutics Stock Jumps As UCD Candidate Is Under FDA Review

Author: Vandana Singh | October 06, 2021 07:21am

The FDA has accepted for review Acer Therapeutics Inc (NASDAQ:ACER) and its partner, Relief Therapeutics Holding SA's (OTC: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.

Posted In: ACER RLFTF