Shares of Merck & Co. Inc. (NYS:MRK) gained 0.1% in premarket trading on Wednesday after it received a complete response letter from the Food and Drug Administration for an application to approve Keytruda in combination with Eisai Co. Ltd.'s (TKS:JP:4523) Lenvima for a new indication. The regulator said the data that was provided in the application for the investigational combination therapy as a first-line treatment for unresectable hepatocellular carcinoma didn't demonstrate "a meaningful advantage" over existing therapies. The companies plan to conduct a new Phase 3 trial, which is already fully enrolled. They are also testing the Keytruda/Lenvima combination in 17 other clinical trials. Merck's stock has declined 13.4% year-to-date. The S&P 500 (S&P:SPX) is down 2.6%.
July 8, 2020, 7:39 a.m. EDT