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.
Before markets opened on Tuesday, June 25, Acer announced that it had received a Complete Response Letter ("CRL") from the FDA denying approval for its lead drug candidate, EDSIVO, for the treatment of ultra-orphan disease vEDS. Worse still, the FDA is requesting a "new adequate and well-controlled clinical trial" prior to approval. This was