During Tuesday’s Morning trade, Shares of Clovis Oncology Inc (NASDAQ:CLVS), gained 3.86% to $26.70.
Bronstein, Gewirtz & Grossman, LLC reminds investors that a securities class action has been filed in the United States District Court for the District of Colorado on behalf of those who purchased shares of Clovis Oncology, Inc. (“Clovis” or the “Company”) (CLVS), during the period between October 31, 2013 and November 13, 2015 inclusive. (the “Class Period”).
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, in addition to failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (i) the New Drug Application (“NDA”) that Clovis presented to the FDA for rociletinib contained immature data sets; (ii) Clovis’ Breakthrough Therapy designation submission contained immature data set based primarily on unconfirmed responses; (iii) Clovis presented interim data publicly and at medical meetings that comprised a data set based primarily on unconfirmed responses; (iv) as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than predictable; (v) as a result of the foregoing, Clovis’ NDA was likely to be delayed and/or rejected by the FDA; and (vi) Clovis was in possession of data during its third-quarter conference call held on November 5, 2015, which demonstrated that the confirmed rociletinib response rate is lower than what was formerly revealed..
Clovis Oncology, Inc., a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally. It is developing three product candidates which comprise Rociletinib, an oral epidermal growth factor receptor and mutant-selective covalent inhibitor that is in advanced clinical development for the treatment of non-small cell lung cancer; Rucaparib, an oral inhibitor of poly polymerase, which is in advanced clinical development for the treatment of ovarian cancer; and Lucitanib, an oral inhibitor of the tyrosine kinase that is in Phase II development for the treatment of breast and lung cancers.
Shares of Amgen, Inc. (NASDAQ:AMGN), declined -0.68% to $161.37, during its current trading session.
Amgen, declared that CVS Health will provide preferred access to Repatha® (evolocumab) through its CVS/caremark commercial formularies.
“Ensuring access to Repatha for appropriate patients is among Amgen’s highest priorities, and we are delighted that CVS Health has granted Repatha a preferred position on their commercial formularies,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “Value-based partnerships are a key area of focus for Amgen, and Repatha gave us a great opportunity to offer value-based contracts that address payers’ concerns by linking the net price of Repatha to predictable LDL cholesterol reductions and anticipated appropriate patient utilization. This is an important milestone for patients, and we will continue to engage constructively with other payers to enable patients to have access to Repatha.”
Repatha, approved by the U.S. Food and Drug Administration on Aug. 27, is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C); and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
Amgen Inc., a biotechnology company, discovers, develops, manufactures, and delivers human therapeutics worldwide. It focuses for the treatment of illness in the areas of oncology, hematology, inflammation, bone health, nephrology, cardiovascular, and general medicine.
Finally, Shares of Eli Lilly and Co (NYSE:LLY), lost -0.79%, and is now trading at $84.07.
Eli Lilly and Company, declared it will host a meeting for the investment community, counting institutional investors, sell-side analysts, ratings agency representatives, and financial and business media.
The meeting will take place Tuesday, December 8, 2015, from 9:00 a.m. (EST) until about 4:00 p.m., at the Four Seasons Hotel in Boston.
In the meeting, company leaders will provide an overview of Elanco, Lilly’s animal health business, and present a comprehensive survey of the company’s Alzheimer’s disease research program. There will be Q&A opportunities throughout the meeting.
“We look forward to providing details on two key areas of focus for our company, animal health and Alzheimer’s disease,” said John C. Lechleiter, Ph.D., Lilly’s chairman, president and chief executive officer. “We will review Elanco’s strategy and its growth prospects. Since the acquisition of Novartis Animal Health in January, Elanco has emerged as a top-tier animal health company. In addition, investors can expect to learn more about Lilly’s broad research efforts aimed at improving the diagnosis and treatment of Alzheimer’s disease.”
Eli Lilly and Company discovers, develops, manufactures, and sells pharmaceutical products worldwide. It operates through two segments, Human Pharmaceutical Products and Animal Health Products.