Advaxis shares suffer on EMA setback
US biotech Advaxis (Nasdaq: ADXS) closed 8% down on Tuesday after feedback from the European Medicines Agency (EMA) led the company to announce the withdrawal of its conditional Marketing Authorization Application (MAA) for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy.
The feedback had indicated that the application will likely need additional data to support a conditional approval.
The February 2018 submission included results from the Phase II GOG-0265 study in 50 patients. Advaxis has called the data “unprecedented” and continues to argue that the results are clinically meaningful and provide proof-of-concept. But the company is looking for a partner to support the late-stage cervical cancer program.
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