On Monday, Shares of Exelixis, Inc. (NASDAQ:EXEL), gained 3.31% to $5.47.
Exelixis, declared that it has accomplished the submission of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Exelixis has requested Priority Review as part of the NDA filing.
In August 2015, the FDA granted Breakthrough Therapy designation to cabozantinib for this potential advanced RCC indication. Breakthrough Therapy designation can expedite the development and review of drugs that are intended to treat serious or life-threatening diseases, and for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically noteworthy endpoints. Drugs that receive Breakthrough Therapy designation may benefit from the involvement of FDA senior leadership in the review process, rolling submission, and other benefits. Before receiving Breakthrough Therapy designation, cabozantinib received Fast Track designation for its potential advanced RCC indication in April 2015.
“Concluding the submission of our rolling New Drug Application brings us closer to our aim of improving the treatment options for patients with advanced kidney cancer,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Following the release of positive top-line results from our phase 3 pivotal trial in July, the Exelixis team worked expeditiously to complete the U.S. regulatory filing by year end. We look forward to ongoing to work with the FDA team during the review process.”
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.
Shares of Xcel Energy Inc (NYSE:XEL), inclined 1.12% to $36.14, during its last trading session.
Xcel Energy (XEL) and SunPower Corp. (SPWR) declared the commercial operation of the 50-megawatt Hooper solar photovoltaic (PV) power plant in Colorado’s San Luis Valley. Xcel Energy is purchasing the power generated by the plant at cost-competitive rates under a power purchase agreement with SunPower. The utility estimates that the plant is generating enough electricity to serve the needs of about 13,500 average Colorado homes.
“This expansion of our renewable portfolio in Colorado is yet another example of how Xcel Energy brings solar power to its customers,” said David Eves, president of Public Service Co. of Colorado, an Xcel Energy company. “We are adding large scale solar that competes with and surpasses other forms of generation alternatives, in terms of price, over the life of the project. This benefits all of our customers - both environmentally and economically.”
SunPower designed and constructed the plant, and is now operating and maintaining it onsite, and monitoring power production from the company’s remote operations control center in Austin, Tex. More than 150 jobs were created at the project site during peak construction.
Xcel Energy Inc., through its auxiliaries, engages primarily in the generation, purchase, transmission, distribution, and sale of electricity in the United States. It operates through Regulated Electric Utility, Regulated Natural Gas Utility, and All Other segments.
Finally, ONEOK, Inc. (NYSE:OKE), remained flat at $24.12.
ONEOK, Inc. (OKE) and ONEOK Partners, L.P. (OKS) recently declared 2016 financial and volume guidance.
ONEOK Partners’ 2016 capital-growth expenditures are predictable to be about $460 million, and maintenance capital expenditures are predictable to be about $140 million.
“We expect 2016 earnings to be driven by continued natural gas and natural gas liquids volume growth across our integrated pipeline system, with strong year-end performance providing us momentum into 2016. Our substantial backlog of well connects, flared gas inventory in the Williston Basin and unaccomplished wells provides considerable visibility into our 2016 volumes,” said Terry K. Spencer, president and chief executive officer of ONEOK and ONEOK Partners. “Our commodity price outlook remains cautious for 2016. However, we expect the partnership’s 2016 earnings to improvement contrast with 2015 guidance, primarily from volume and fee-based margin improvements, resulting in raised distributable cash flow.
“At ONEOK Partners, we remain committed to maintaining our investment-grade credit ratings, sustaining our current distribution and achieving distribution coverage of 1.0 times or better in 2016 at current NYMEX future strip pricing of $40 to $45 per barrel of crude. ONEOK Partners does not expect to access the public equity markets in 2016 and well into 2017,” said Spencer. “If needed, ONEOK continues to be well-positioned to provide financial support to ONEOK Partners. We have a long history of prudent financial decision-making, as demonstrated by the $750 million of equity raised at the partnership this past summer, and we will continue to make decisions that are in the best long-term interest of our investors at both ONEOK and the partnership to create value, reduce risk and protect the partnership’s investment-grade credit rating.
ONEOK, Inc., through its general partner interests in ONEOK Partners, L.P., engages in the gathering, processing, storage, and transportation of natural gas in the United States. The company gathers, treats, fractionates, stores, and transports natural gas liquids (NGL), in addition to owns natural gas liquids gathering and distribution pipelines, natural gas liquids distribution and refined petroleum products pipelines, and terminal and storage facilities; and owns and operates interstate and intrastate regulated natural gas transmission pipelines and natural gas storage facilities, in addition to stores and distributes NGL products to petrochemical manufacturers, heating fuel users, ethanol producers, refineries, and propane distributors.
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