FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “Acer Therapeutics Inc. and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001”
Acer Therapeutics Inc. (NASDAQ: ACER) climbed over 14% in premarket trading after the company and Relief Therapeutics announced FDA acceptance for the filing of a new drug application for ACER-001.
The FDA has accepted for filing the New Drug Application for ACER-001, to be used in the treatment of patients with Urea Cycle Disorders and has assigned a Prescription Drug User Fee Act target action date of June 5th, 2022 multidrug-resistant microorganisms, or MDROs.
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA.
For more information, please visit: Acer Therapeutics Inc.
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