FDA extends BLA PDUFA date for ublituximab to treat patients with RMS

Shares of US biotech TG Therapeutics (Nasdaq TGTX) were down more than 9% at $4.35 by mid-afternoon today, after it announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application (BLA) for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (RMS).

The FDA extended the PDUFA goal date to allow time to review a submission provided by the company in response to an FDA information request, which the FDA deemed a major amendment. The submission comprised an integration and summary of certain clinical information that was previously provided to the FDA by the company.

Michael Weiss, chairman and chief executive of TG Therapeutics, stated: “While we are disappointed with the extension of our PDUFA goal date for ublituximab, a delay of this duration is not unprecedented, with both of the currently marketed CD20s in MS experiencing a similar 3-month PDUFA extension prior to approval. As we were targeting a launch for late this year or early next, we do not believe this will impact our overall launch plans for ublituximab in RMS.”