FDA Approves NDA for Acer Therapeutics’ ACER-001; Shares Rise


Shares of Acer Therapeutics Inc. (ACER) closed 16.5% higher on Wednesday and then declined 5.51%, at the time of writing, in early trade on Thursday. The stock price moved after the pharmaceutical company and its collaboration partner, Relief Therapeutics Holding SA, received the U.S. Food and Drug Administration’s (FDA) green light to file the New Drug Application (NDA) for ACER-001.

ACER-001 (sodium phenylbutyrate) is designed for the treatment of patients with various inborn errors of metabolism, including Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD). The Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022, has been assigned by the FDA. (See Acer Therapeutics stock charts on TipRanks)

The U.S. regulator’s approval follows the results from two previously announced bioequivalence (BE) trials. Under these trials, 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), the company said.

Encouraged by the FDA approval, Acer Therapeutics CEO Chris Schelling said, “We look forward to working with the FDA during their review of our application. In addition, we continue to collaborate with our partners to ensure we are well-positioned to support a successful commercial launch of ACER-001, subject to FDA approval.”

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Two months ago, William Blair analyst Tim Lugo reiterated a Hold rating on the stock but did not assign any price target.

Investors should always be aware of the risks involved in any stock. According to the new TipRanks’ Risk Factors tool, Acer Therapeutics is at risk mainly from three factors: Tech and Innovation, Finance and Corporate, and Legal and Regulatory, which account for 30%, 27% and 22%, respectively, of the total 67 risks identified for the stock. Under the Tech and Innovation risk category, ACER has 20 risks, details of which can be found on the TipRanks website.

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