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Biotech Stocks Facing FDA Decision In August

Merck
Merck

The FDA decision on the expanded indication for Lenvima as a potential first-line treatment of patients with unresectable hepatocellular carcinoma is slated for August 24, 2018.

Lenvima is already approved by the FDA as a monotherapy for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer, and in combination with Novartis’ Afinitor for the treatment of patients with advanced renal cell carcinoma who have failed previous therapy.

Lenvima, an orally available tyrosine kinase inhibitor was discovered by Eisai. In March of this year, Eisai and Merck (MRK) entered into a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima.

As part of the deal, the global product sales of Lenvima will be booked by Eisai, and the gross profits will be shared equally by Merck and Eisai.

For the fiscal year ended March 31, 2018, Lenvima brought home sales of 21.9 billion Yen for Eisai.

MRK closed Wednesday’s (Jul 25) trading at $64.49, up 1.69%.