On Thursday, Shares of Exelixis, Inc. (NASDAQ:EXEL), gained 1.46% to $5.57.
Exelixis, 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 conpresently published in The New England Journal of Medicine.
“New treatment options are urgently needed for patients with advanced renal cell carcinoma,” said Michael M. Morrissey, Ph.D., president and CEO of Exelixis. “The initiation of the NDA submission process for cabozantinib marks an important step forward in our efforts to make a meaningful difference in the lives of people with advanced kidney cancer, and we look forward to working closely with the FDA towards the aim of making cabozantinib available to these patients and their physicians as soon as possible.”
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 Fidelity National Financial, Inc. (NYSE:FNF), inclined 0.12% to $34.44, during its last trading session.
A.M. Best has affirmed the financial strength ratings (FSR) of A (Excellent) and the issuer credit ratings (ICR) of “a” of Fidelity National Title Insurance Company (Santa Barbara, CA), Chicago Title Insurance Company, Commonwealth Land Title Insurance Company (both domiciled in Omaha, NE), National Title Insurance of New York, Inc. (New York, NY) and Alamo Title Insurance (San Antonio, TX) (collectively referred to as the Fidelity National Financial Group).
In addition, A.M. Best has downgraded the FSR to B++ (Good) from A- (Excellent) and the ICR to “bbb” from “a-” for FNF’s separately rated title insurance partner, FNF Title Insurance Company Ltd. (FNF Malta) (Malta). The outlook for both ratings is stable. Conpresently, A.M. Best has withdrawn the ratings of FNF Malta in response to the company’s request to no longer take part in A.M. Best’s interactive rating process.
The rating actions reflect Fidelity National Financial Group’s favorable risk-adjusted capitalization, driven by improved operating results and lower underwriting leverage measures, its strong market profile as the largest title insurance group in the United States, having a market share of about 33%, as of second-quarter 2015, and the note worthy improvement in its underwriting performance that has occurred over the past several years. In addition, the group achieved noteworthysurplus growth in excess of 90% in total, over the past five years, despite depressed housing and real estate market conditions, mainly due to aggressive expense administration initiatives, which allowed the enterprise to continue reporting positive operating results throughout that period.
Fidelity National Financial, Inc., together with its auxiliaries, provides title insurance, technology, and transaction services to the real estate and mortgage industries in the United States. It operates through Title, BKFS, and Restaurant Group segments.
Finally, Shares of Mobileye NV (NYSE:MBLY), ended its last trade with -1.08% loss, and closed at $46.71.
Mobileye, declared that it intends to release its financial results for the third quarter ended September 30, 2015 on Tuesday, November 3, 2015 at about 7:00 a.m. EST.
In conjunction with the release, Mobileye will host a conference call at 8:00 a.m. EST on Tuesday, November 3, 2015 to review the company’s financial results for the third quarter 2015 and to provide guidance for the remainder of fiscal year 2015.
Mobileye N.V., together with its auxiliaries, designs and develops software and related technologies for camera-based advanced driver assistance systems primarily in Israel. It operates through two segments, Original Equipment Manufacturing and After Market. The company offers proprietary software algorithms and EyeQ chips that perform detailed interpretations of the visual field to anticipate possible collisions with other vehicles, pedestrians, cyclists, animals, debris, and other obstacles; and detect roadway markings, such as lanes, road boundaries, barriers, and related items, in addition to identify and read traffic signs and traffic lights.