On Wednesday, Shares of Merck & Co., Inc. (NYSE:MRK), remained flat at $59.66.
Merck, declared the U.S. Food and Drug Management (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the presently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015.
“Through our clinical program for KEYTRUDA we have accumulated substantial data on the role of our anti-PD-1 therapy in advanced melanoma. We look forward to the FDA’s review of each of these applications, and to delivering on our aim of assisting patients with advanced melanoma to achieve long-term disease control and survival,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
KEYTRUDA is presently indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck & Co., Inc. provides health care solutions worldwide. The company offer therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, asthma, nasal allergy symptoms, allergic rhinitis, chronic hepatitis C virus, HIV-1 infection, fungal infections, intra-abdominal infections, hypertension, arthritis and pain, inflammatory, osteoporosis, male pattern hair loss, and fertility diseases.
Shares of American Express Company (NYSE:AXP), declined -0.30% to $81.00, during its last trading session.
American Express, declared Serve Cash Back, a new prepaid debit Account option that will earn Accountholders 1% cash back on purchases. Consumers who spend in line with the 2012 – 2013 U.S. Departments of Labor national averages for gas, groceries, dining out, clothing, transportation, and entertainment using the Serve Cash Back Card could potentially earn more than $400 annually2 when earning 1% cash back.
“We know consumers are looking to stretch their budgets and get more from every dollar they spend,” said Stefan Happ, Chief Commercial Officer, Enterprise Growth, American Express. “With the American Express Serve Cash Back Card, we are defining a new standard in the prepaid industry and rewarding our customers where they’re already spending – on everyday items such as gas, groceries, and clothing.”
Earning cash back will assist customers put money aside towards future purchases. After earning cash back, customers will be able to log in to their Serve Account, view how much cash back they have earned, and elect to redeem that amount on their next purchase.
American Express Company, together with its auxiliaries, provides charge and credit payment card products and travel-related services to consumers and businesses worldwide. The company operates through four segments: U.S. Card Services, International Card Services, Global Commercial Services, and Global Network & Merchant Services.
Finally, Aeropostale Inc (NYSE:ARO), ended its last trade with 0.75% gain, and closed at $1.35.
Aeropostale, declared that Kent A. Kleeberger has been designated to serve as a director on the Company’s Board of Directors. Mr. Kleeberger was designated to serve as a director by Sycamore Partners Administration LLC, which holds designation rights associated with Aeropostale’s May 2014 planned partnership and financing transaction with Sycamore Partners.
Mr. Kleeberger joins the Aeropostale board with more than 27 years of retail, operational and financial experience. Mr. Kleeberger served as Executive Vice President and Chief Operating Officer of Chico’s FAS Inc. from February 2011 to March 2015, after serving as Executive Vice President, Chief Financial Officer and Treasurer of the retailer from November 2007 to January 2011. Preceding to that, Mr. Kleeberger served as Senior Vice President and Chief Financial Officer of Dollar Tree Stores, Inc. from July 2004 to October 2007. Additionally, Mr. Kleeberger held a number of positions at Tween Brands, Inc. (formerly Too, Inc.) from April 1998 to June 2004, counting Executive Vice President, Chief Operating Officer, Chief Financial Officer, Treasurer, and board member through February 2004. Preceding to his retail career, Mr. Kleeberger was a Certified Public Accountant with KPMG for 13 years. Mr. Kleeberger is also a member of the board of directors of Shoe Carnival, Inc., where he serves on the compensation and nominating and corporate governance committees and as chairman of the audit committee.
Aéropostale, Inc. operates as a specialty retailer of casual apparel and accessories for 14 to 17 year-old young women and men. It operates through two segments, Retail Stores and E-Commerce, and International Licensing.
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