Phase II
The company is now waiting for the FDA to determine a path forward in resuming clinical studies.
During its financial report this morning, Pfizer released an update of its pipeline which includes the discontinued projects.
The FDA’s Breakthrough Therapy Designation for balovaptan was primarily based on efficacy findings in the VANILLA study, a Phase II trial of balovaptan in adults with ASD.
Amgen’s migraine drug Aimovig continues to impress with its efficacy in late-stage studies.
The trial was conducted at Rigshospitalet, University of Copenhagen, Denmark, one of the world’s leading centers for the treatment of SBS and top-line results were reported in June 2017
Shares of Eiger have plunged more than 47 percent this morning after the company announced it is terminating its experimental PAH treatment ubenimex after it flopped its mid-stage study.
Vivek Ramaswamy’s Axovant has egg on its face after it was forced to own up to the fact it misreported mid-stage data on a drug it hoped to take into Phase III.
Moderna unleashed a torrent of updates yesterday.
A look at the lucky drugs that have been hailed a breakthrough by the FDA.
PRESS RELEASES