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Biotech Stocks Facing FDA Decision In April 2021

Merck
Merck

On April 29, 2021, an FDA panel will discuss whether or not to recommend converting the accelerated approvals granted to Merck’s (MRK) blockbuster drug Keytruda for two indications into regular approvals.

The two indications are recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, which won accelerated approval in September 2017, and hepatocellular carcinoma (HCC) previously treated with Sorafenib, which secured accelerated approval in November 2018.

However, since Keytruda has failed to meet the trial goals in the respective confirmatory trials, a panel meeting has been convened to discuss the next steps.

MRK closed Friday’s (Mar.26, 2021) trading at $77.39, up 1.74%.