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Biotech Stocks Facing FDA Decision In December

Merck
Merck

Merck (MRK) and Pfizer Inc.’s (PFE) three New Drug Applications involving investigational drug Ertugliflozin for adults with Type 2 diabetes are under FDA review, with a decision expected this month.

The Companies are seeking approval for Ertugliflozin as a monotherapy and in fixed dose combinations with Januvia and Metformin.

Ertugliflozin is Pfizer’s investigational drug while Januvia and Metformin are Merck’s approved drugs for type 2 diabetes mellitus.

In clinical studies, Ertugliflozin achieved statistically significant reductions in A1C, a measure of average blood glucose over a two- to three-month timeframe, when added to Metformin or in initial co-administration with Januvia.

MRK closed Tuesday’s (Nov.28) trading at $54.93, up 0.70%.