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Biotech Stocks Facing FDA Decision In November 2023

Merck
Merck

An FDA panel of outside experts will meet on November 17, 2023, to discuss the resubmitted New Drug Application of Merck & Co., Inc.’s (MRK) Gefapixant for the potential treatment of refractory or unexplained chronic cough.

The U.S. regulatory agency had declined to approve Gefapixant for the intended indication mentioned, citing the need for more information related to measurement of efficacy.

Addressing the concerns raised by the FDA, the company resubmitted the New Drug Application for Gefapixant in July of this year. It will now be scrutinized by the FDA panel before the regulatory agency makes a final decision on December 27, 2023.

Gefapixant was approved in Japan, under the brand name Lyfnua, for adults with refractory or unexplained chronic cough in January 2022. It is awaiting a decision from the European Commission, which is expected later this year.

MRK closed Friday’s trading at $102.82, down 2.59%.