- The stock price of Acer Therapeutics Inc (NASDAQ: ACER) increased by over 15% pre-market today. This is why it happened.
The stock price of Acer Therapeutics Inc (NASDAQ: ACER) increased by over 15% pre-market today. Investors are responding positively to Acer Therapeutics and its collaboration partner RELIEF THERAPEUTICS Holding SA announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders (UCDs). And the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.
Acer’s 505(b)(2) NDA is supported by results from 2 previously announced bioequivalence (BE) trials in which 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(R) (sodium phenylbutyrate).
ACER-001 is known as an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. And there is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for the indications under investigation.
“With FDA commencing a substantive review of our NDA, ACER-001 is one step closer to potentially providing an alternative treatment option for patients with UCDs. 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.”
— Chris Schelling, Chief Executive Officer and Founder of Acer
“Our collaboration with Acer is thriving and we are pleased with the progress they have made in advancing ACER-001. In parallel with Acer’s activities, we continue to execute on our global commercial strategy for ACER-001 which includes our intended submission of a Marketing Authorization Application (MAA) for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”
— Jack Weinstein, Chief Financial Officer and Treasurer of Relief
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