Shares of Merck & Co., Inc. (NYSE:MRK) ended Thursday session in green amid volatile trading. The shares closed up +1.03 points or 1.68% at $62.38 with 9.03 million shares getting traded. Post opening the session at $61.24, the shares hit an intraday low of $61.12 and an intraday high of $62.60 and the price vacillated in this range throughout the day. The company has a market cap of $168.73 billion and the numbers of outstanding shares have been calculated to be 2.77 billion shares.
Merck & Co., Inc. (MRK) on September 7, 2016 announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.
The submissions were based on data from the pivotal phase 3 KEYNOTE-024 study, which showed that KEYTRUDA monotherapy resulted in superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more). Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive KEYTRUDA. Merck filed for approval of KEYTRUDA in the first-line setting at a dose of 200 mg every three weeks, the dose studied in KEYNOTE-024.
“Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with KEYTRUDA compared to chemotherapy is welcome news,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We appreciate the opportunity to work with regulatory authorities to make KEYTRUDA a first-line treatment option in non-small cell lung cancer.”
Shares of Tokai Pharmaceuticals Inc (NASDAQ:TKAI) ended Thursday session in green amid volatile trading. The shares closed up +0.26 points or 25.49% at $1.28 with 8.77 million shares getting traded. Post opening the session at $1.04, the shares hit an intraday low of $1.02 and an intraday high of $1.40 and the price vacillated in this range throughout the day. The company has a market cap of $27.86 million and the numbers of outstanding shares have been calculated to be 22.63 million shares.
Tokai Pharmaceuticals Inc (TKAI) a biopharmaceutical company, focuses on developing and commercializing therapies for prostate cancer and other hormonally-driven diseases. Its lead drug candidate is galeterone, an oral small molecule that is in various clinical trials for the treatment of patients with metastatic castration-resistant prostate cancer. The companys androgen receptor degradation (ARDA) drug discovery program is focused on identifying and developing compounds for ARDA activity. Tokai Pharmaceuticals, Inc. was founded in 2004 and is based in Boston, Massachusetts.