Aiming to leapfrog rivals, Merck gambles on early sBLA for Keytruda dual therapy
Merck & Co (NYSE: MRK) today announced that the US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for its dual immuno-oncological/chemotherapeutic treatment candidate.
The announcement, which was made at close of trading on the New York Stock Exchange, caused shares in the American pharma giant to rise significantly in the pre-market period, to $61.70 (+3%).
Rather than wait for Phase III trial data to support its application, Merck has chosen to utilize the FDA’s Accelerated Approval program in a more high risk, first-to-market strategy.
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