Shares of Merck & Co., Inc. (NYSE:MRK) ended Monday session in green amid volatile trading. The shares closed up +0.70 points or 1.12% at $63.19 with 10.63 million shares getting traded. Post opening the session at $62.00, the shares hit an intraday low of $61.91 and an intraday high of $63.49 and the price vacillated in this range throughout the day. The company has a market cap of $172.66 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 Gilead Sciences, Inc. (NASDAQ:GILD) ended Monday session in green amid volatile trading. The shares closed up +0.80 points or 1.02% at $78.85 with 8.90 million shares getting traded. Post opening the session at $77.69, the shares hit an intraday low of $77.69 and an intraday high of $79.03 and the price vacillated in this range throughout the day. The company has a market cap of $102.82 billion and the numbers of outstanding shares have been calculated to be 1.32 billion shares.
Gilead Sciences, Inc. (GILD) on August 23, 2016 announced that Kelly A. Kramer has been appointed to the company’s Board of Directors and Audit Committee.
Ms. Kramer is currently Executive Vice President and Chief Financial Officer of Cisco Systems, Inc., which designs and sells products, services and solutions to securely connect everyone and everything. She previously served for 20 years in senior finance positions at General Electric, including as Chief Financial Officer of GE Healthcare’s Healthcare Systems Business. She is a member of the board of the Silicon Valley Chapter of City Year, a non-profit organization that provides educational support for at-risk students in poor communities.
“We are very pleased to welcome Kelly Kramer to the Board of Directors of Gilead Sciences,” said John Martin, PhD, Executive Chairman of Gilead’s Board of Directors. “Kelly’s deep financial expertise in the technology and healthcare industries, including mergers and acquisitions, will be valuable as Gilead continues to grow across multiple therapeutic areas and around the world. I look forward to the contributions and insights that she will bring to the Board.”