Vascular Ehlers-Danlos Syndrome (EDS) Archives

Acer Restructures, Eliminates 29 Employees

Business, Complete Response Letter, FDA, Layoffs, New Drug Applications, Product Pipeline, Restructuring, Vascular Ehlers-Danlos Syndrome (EDS)

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.

July 8, 2019/by BioSpace

FDA declines to approve Acer’s Edsivo for vEDS

Approval Rejection, Approvals, Complete Response Letter, FDA, FDA/Regulatory, Vascular Ehlers-Danlos Syndrome (EDS)

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.

June 25, 2019/by Reuters Health

Sanofi Unloads Programs to Acer Therapeutics and MyoKardia

Business, Dilated cardiomyopathy (DCM), Ehlers-Danlos Syndrome (EDS), FDA, FDA/Regulatory, Hypertrophic cardiomyopathy (HCM), New Drug Application (NDA), Rare Diseases, Schizophrenia, Selective NK3 Receptor, Vascular Ehlers-Danlos Syndrome (EDS)

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.

January 2, 2019/by BioSpace

Acer Therapeutics Announces FDA Acceptance of NDA and Priority Review for Edsivo for Treatment of vEDS

Ehlers-Danlos Syndrome (EDS), FDA, FDA/Regulatory, Hereditary Disorders, Mutations, New Drug Application (NDA), PDUFA, Priority Review, Vascular Ehlers-Danlos Syndrome (EDS)

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.

December 26, 2018/by GlobeNewswire