Acer therapeutics issues statement regarding pdufa target action date for acer-001

Newton, mass., june 07, 2022 (globe newswire) -- acer therapeutics inc. (nasdaq: acer), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today 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. fda has informed acer that review for acer-001 is ongoing and the agency currently does not have a set target date. 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.
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