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

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

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