shares more than doubled on Wednesday after the company said its experimental ovarian cancer drug helped extend the lives of patients in a late-stage trial.
The biotech company said the drug candidate, Elahere, also significantly prolonged the time that a patient lives without the cancer worsening, when compared with chemotherapy. The U.S. FDA had earlier given accelerated approval for Elahere, based on data from a single-arm trial in patients who had received at least one prior line of therapy that includes Swiss-based Roche Holding AG'sThe data was a "home run" for ImmunoGen and should remove any doubts that Elahere will get confirmatory approval by the FDA, Truist Securities analyst Asthika Goonewardene said in note to clients.
The company said it plans to submit a marketing application in Europe and a supplemental application in the U.S. for the conversion to a regular approval by the second half of the year. Shares of the drug developer jumped to a a near five-year high of $11.95 on Wednesday, adding roughly $1.75 billion to its market capitalization.
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