Northwest Biotherapeutics says UK regulator has not rejected DCVax-L glioblastoma filing

Northwest Biotherapeutics said the U.K. Medicines and Healthcare products Regulatory Agency has not rejected its marketing application for DCVax-L in glioblastoma.

The company said the application remains in the initial regulatory review process and has not been refused, withdrawn or appealed. It said the process continues toward a first regulatory decision and described its interactions with the MHRA as constructive.

Northwest Biotherapeutics said it was moving to counter market rumors of an MHRA rejection of the filing.

The company rejected the rumors and linked them to alleged stock manipulation following the release of encouraging Phase 3 trial data.