On Friday, Exelixis, Inc. (NASDAQ:EXEL)s shares inclined 3.95% to $5.79.
Exelixis, Inc. (EXEL) declared the company has initiated submission of its rolling New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for cabozantinib for the treatment of advanced renal cell carcinoma (RCC) patients who have received one preceding therapy. Cabozantinib was granted Breakthrough Therapy Designation by the FDA in August 2015. Exelixis agreed with FDA that the submission would be a rolling NDA and the company has filed the first component of the application for potential approval of cabozantinib in the United States. The rolling NDA allows accomplished portions of an NDA to be presented and reviewed by the FDA on an ongoing basis. Exelixis plans to complete the NDA submission before the end of 2015.
The rolling NDA submission is based on results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who practiced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis declared top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival (PFS); contrast with everolimus, cabozantinib was associated with a 42% reduction in the risk of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and co presently published in The New England Journal of Medicine.
Cabozantinib is presently marketed in capsule form under the brand name COMETRIQ® in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials presently underway, Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the NDA for advanced RCC.
Exelixis, Inc., a biopharmaceutical company, develops and sells small molecule therapies for the treatment of cancer in the United States. The company offers COMETRIQ, an inhibitor of multiple receptor tyrosine kinases for the treatment of patients with progressive, metastatic medullary thyroid cancer.
Noble Energy, Inc. (NYSE:NBL)s shares dropped -1.51% to $35.93.
Noble Energy, Inc. ( NBL) declared that its wholly owned partner, Noble Midstream Partners LP (“Noble Midstream”), has filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its projected initial public offering of common units representing limited partner interests. Noble Midstream’s initial assets will comprise of certain of the Company’s DJ Basin crude oil, natural gas and water-related midstream services.
Noble Midstream intends to apply to list the common units on the New York Stock Exchange under the ticker symbol “NBLX.” The number of common units to be offered and the price range for the offering have not been determined. Noble Energy will own the general partner of Noble Midstream, all of its incentive distribution rights and anticipates to retain a majority of Noble Midstream’s limited partner interests.
Noble Energy, Inc., an independent energy company, engages in the acquisition, exploration, and production of crude oil, natural gas, and natural gas liquids worldwide. Its principal projects are located in onshore DJ Basin and Marcellus Shale, the United States; the deepwater Gulf of Mexico; offshore West Africa; and offshore Eastern Mediterranean.
At the end of Friday’s trade, Starwood Hotels & Resorts Worldwide Inc (NYSE:HOT)s shares dipped -3.40% to $67.61.
W Hotels Worldwide, part of Starwood Hotels & Resorts Worldwide, Inc. (HOT), debuted in the Netherlands with the highly anticipated opening of W Amsterdam. Owned by Europe Hotels | Private Collection, the hotel brings the W brand’s distinctive New York energy, Whatever/Whenever® service mentality and upbeat programming to the Dutch capital. Just steps away from the vibrant Dam Square and the Royal Palace, the hotel introduces WET DECK®, the city’s first rooftop pool, and electrifying culinary venues, such as THE DUCHESS and MR PORTER.
Located in the epicentre of Amsterdam’s vibrant social scene, the 238-room hotel spans two iconic buildings, one of which used to house the former Telephone Exchange (‘Exchange’) and the other was formerly home to KAS Bank (‘Bank’). W Amsterdam was designed by Office WINHOV and Baranowitz Kronenberg Architects, who collaborated with local designers to refresh the historic buildings with contemporary features inspired by their storied past.
“Amsterdam’s progressive spirit is a perfect match for W Hotels. We are thrilled to introduce a new style of modern hospitality to the Netherlands in partnership with Europe Hotels | Private Collection and its owner, Liran Wizman, who share our vision for W Hotels,” said Michael Wale, President, Starwood Hotels & Resorts Worldwide, Europe, Middle East and Africa. “W Amsterdam is our first W Hotel in the country and reinforces Starwood’s commitment to grow our presence in this important European market.”
Starwood Hotels & Resorts Worldwide, Inc., together with its auxiliaries, operates as a hotel and leisure company worldwide. The company owns, operates, and franchises luxury and upscale full-service hotels, resorts, residences, retreats, select-service hotels, and extended stay hotels under the St. Regis, The Luxury Collection, W, Westin, Le Méridien, Sheraton, Four Points, Aloft, and Element brand names.
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