Acer Therapeutics (NASDAQ: ACER) is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. The company’s late-stage clinical pipeline includes EDSIVO™ for vascular Ehlers-Danlos syndrome (vEDS) and ACER-001 for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). Currently, there are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which together impact more than 4,000 patients in the United States. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act which enables the applicant to utilize third-party data, which is expected to expedite the preparation, submission, and potential approval of a marketing application. For more information, visit the company’s website at www.acertx.com.
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