Acer Therapeutics stock down after FDA declines to approve urea cycle disorders treatment

Jun. 21, 2022 9:19 AM ETAcer Therapeutics Inc. (ACER), RLFTFBy: Dania Nadeem, SA News Editor1 Comment

Headquarters of US Food and Drug Administration (FDA)

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  • Acer Therapeutics (NASDAQ:ACER) and partner Relief Therapeutics (OTCQB:RLFTF) said on Tuesday that the U.S. Food and Drug Administration declined to approve its drug, ACER-001, to treat patients with urea cycle disorders, rare genetic conditions primarily diagnosed in children.
  • (ACER) stock is down 7% in premarket trading.
  • The FDA's Complete Response Letter (CRL) stated that the agency'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 said.
  • The FDA also asked the companies to provide additional existing nonclinical information in the resubmission of the NDA.
  • Acer said it was actively collaborating with its third-party contract packaging manufacturer to address the FDA’s comments as soon as reasonably possible and expects to resubmit the updated NDA in early-to-mid Q3.
  • Earlier today, Acer promoted Tanya Hayden to the position of COO.

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