Acer Therapeutics Inc. (NASDAQ: ACER) ("Acer" or the "Company") is a pharmaceutical company headquartered in Newton, Massachusetts, focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening orphan or ultra-orphan diseases with significant unmet medical needs.
Acer applied to the FDA for approval of its lead drug EDSIVO (celiprolol) for the treatment of orphan disease vEDS in patients with a COL-3A1 mutation, utilizing the expedited regulatory pathway set out under sub-section 505 ((B))(2) of the Federal Food, Drug, and Cosmetic Act (or "FFDCA"). This allowed Acer to rely, at least