BioMarin Pharmaceutical (BMRN) Stock Increases Over 7%: Details

By Amit Chowdhry ● Nov 23, 2022
  • The stock price of BioMarin Pharmaceutical (BMRN) increased by over 7% intraday today. This is why.

The stock price of BioMarin Pharmaceutical (BMRN) increased by over 7% intraday today.

Why: BioMarin Pharmaceutical announced the advancements in the U.S. 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.

The company was recently notified by the FDA that after further consideration, at this time, the agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review.  And the FDA communicated to the company that it did intend to hold an advisory committee meeting but did not specify a date. Plus the company also remains on track to host the scheduled FDA Pre-Licensure Inspection (PLI) of BioMarin’s gene therapy manufacturing facility located in Novato, CA.

KEY QUOTE:

“The review of a BLA is a dynamic process, and we appreciate FDA’s ongoing engagement as we work toward delivering a potentially transformative treatment choice to those patients with severe hemophilia A. We look forward to further dialogue with the Agency as it reviews our application.”

— Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin