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Biotech Stocks Facing FDA Decision In January 2020

Merck
Merck

The FDA is expected to announce its decision on Merck’s (MRK) request seeking approval of Keytruda for the treatment of patients with bacillus Calmette-Guérin-unresponsive, high-risk, nonmuscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy in January.

On December 17, 2019, an FDA panel voted 9-4 in favor of Keytruda for the above indication.

Keytruda, which received its initial approval in September 2014 for advanced melanoma, is also indicated for non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

The drug fetched an annual revenue of $7.17 billion for Merck in 2018 and $7.97 billion in the first nine months of 2019.

MRK closed Monday’s (Dec.30, 2019) trading at $91.03, down 0.51%.