Two weeks after the U.S. FDA rejected Acer Therapeutics’ New Drug Application for Edsivo (celiprolol), the company initiated a restructuring plan that includes the elimination of 29 employees.
The U.S. FDA declined to approve Acer Therapeutics Inc.’s Edsivo for a severe, rare genetic disorder – vascular Ehlers-Danlos syndrome (vEDS) – that can cause blood vessels to fatally rupture.
Acer Therapeutics in-licensed the clinical-stage, selective, non-peptide tachykinin NK3 receptor antagonist osanetant from Sanofi. MyoKardia regained global rights to all the programs that the company had inked with Sanofi.
The U.S. Food and Drug Administration accepted for review Acer Therapeutics Inc.’s New Drug Application for Edsivo for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen mutation.