Shares of Merck & Co., Inc. (NYSE:MRK) ended Friday session in red amid volatile trading. The shares closed down -0.10 points or -0.16% at $62.28 with 12,432,293 shares getting traded. Post opening the session at $62.45, the shares hit an intraday low of $62.06 and an intraday high of $62.62 and the price vacillated in this range throughout the day. The company has a market cap of $171.94 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 Community Health Systems (NYSE:CYH) ended Friday session in green amid volatile trading. The shares closed up +1.67 points or 15.73% at $12.29 with 12,444,450 shares getting traded. Post opening the session at $10.56, the shares hit an intraday low of $10.52 and an intraday high of $13.28 and the price vacillated in this range throughout the day. The company has a market cap of $1.62 billion and the numbers of outstanding shares have been calculated to be 113.64 million shares.
Community Health Systems (CYH) on August 9, 2016 announced that Tim L. Hingtgen will be promoted to President and Chief Operating Officer, effective September 1, 2016.
Commenting on Hingtgen’s promotion, Wayne T. Smith, chairman and chief executive officer of Community Health Systems, Inc., said, “Tim is an extremely effective, results-driven healthcare executive and an experienced operator who has provided outstanding leadership for some of our most successful markets. Tim is meticulous about setting operating standards and has a track record of executing strategies that support clinical excellence, business development and growth. In his new role, I’m confident Tim will lead Community Health Systems forward as we work to achieve higher levels of performance across our organization.”
Hingtgen will succeed David L. Miller, who previously announced his plans to retire from the Company at the end of the year. Hingtgen and Miller work closely together and will ensure a smooth transition of leadership. Miller will complete his twenty-year tenure with Community Health Systems by serving as special advisor to the Chairman of the Board and Chief Executive Officer.
Hingtgen, age 48, joined Community Health Systems in 2008 as a Vice President of Operations. In January 2014, he was promoted to President of Division IV Operations, and in May 2016, he was promoted to Executive Vice President of Operations. Prior to joining Community Health Systems, Hingtgen served as a chief operating or chief executive officer of hospital facilities at another for-profit hospital system. He holds a master’s degree in business administration from the University of Nevada-Las Vegas.