FDA no longer to hold an AdCom on BioMarin's Roctavian

California, USA-based BioMarin Pharmaceutical (Nasdaq: BMRN) saw its shares leap 10.7% to $98.49 yesterday, after it announced that the US Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of Roctavian (valoctocogene roxaparvovec AAV gene therapy) for adults with severe hemophilia A would not, after all, be submitted for review by the agency’s advisory panel.

The FDA notified BioMarin that, after further consideration, at this time, the agency no longer plans to hold an advisory committee meeting to discuss the BLA for Roctavian.

Previously, the FDA said that it did intend to hold an advisory committee meeting but did not specify a date. The company says it also remains on track to host the scheduled FDA Pre-Licensure Inspection (PLI) of BioMarin's gene therapy manufacturing facility located in Novato, California.