Acer Therapeutics says pre-commercial activities of EDSIVO have been halted
Acer Therapeutics announced a corporate restructuring and update on its pipeline programs. Acer's headcount has been reduced from 48 to 19 employees and pre-commercial activities of EDSIVO have been halted. The restructuring is expected to provide the resources needed for Acer to conduct its planned business operations through 2020. Acer intends to pursue discussions with the U.S. Food and Drug Administration regarding its previously announced Complete Response Letter for Acer's New Drug Application for EDSIVO for the treatment of vascular Ehlers-Danlos syndrome, and to continue the development of Acer's additional pipeline programs, including ACER-001 and osanetant. "While we are disappointed by the CRL, we intend to continue our dialogue with the FDA to fully understand its response and work toward our goal of approval of EDSIVO for confirmed COL3A1+ vEDS patients, who currently have no approved treatment options," said Chris Schelling, CEO and Founder of Acer. "Nevertheless, in light of the CRL it was necessary to reduce our expenses, extend our cash runway, and focus our resources on a potential path forward for EDSIVO as well as continued development of our other pipeline opportunities."