Relief: Partner, Acer in Statement Re PDUFA Target Action Date

 RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet needs, reported today that its collaboration partner, Acer Therapeutics, Inc. ("Acer"), announced that it has not yet received a decision from the U.S. Food and Drug Administration ("FDA") on its 505(b)(2) New Drug Application ("NDA") for ACER-001 (sodium phenylbutyrate), for the treatment of urea cycle disorders ("UCDs"). The NDA for ACER-001 for UCDs was accepted for review by FDA on October 5, 2021, at which time FDA assigned a PDUFA target action date of Sunday, June 5, 2022. According to the press release, the FDA has informed Acer that review for ACER-001 is ongoing and the agency currently does not have a set target date. Acer reported that, under the Prescription Drug User Fee Act (PDUFA), FDA's review performance goal is to review and act on 90 percent of NDA submissions by the target action date. The related Acer press release can be accessed through the following link.\

Acer and Relief will issue a joint press release once the FDA has provided its written decision to Acer.

https://www.biospace.com/article/releases/relief-reports-that-its-collaboration-partner-acer-therapeutics-issued-a-statement-regarding-the-pdufa-target-action-date-for-acer-001/