2015 News Releases

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Q1 2017 Clovis Oncology, Inc. Earnings Conference Call  (Replay)
05/03/17 at 2:30 p.m. MT
Q1 2017 Clovis Oncology, Inc. Earnings Conference Call
Wednesday, May 3, 2017 2:30 p.m. MT  
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12/15/15Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib
PDUFA goal date extended by three months to June 28, 2016 BOULDER, Colo.--(BUSINESS WIRE)--Dec. 15, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Clovis’ New Drug Application (NDA) for rociletinib by the standard extension period of three months with the new goal date of June 28, 2016. Rociletinib is an investigational ... 
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11/16/15Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing
Mid-Cycle Communication Meeting with FDA completed Additional clinical information for 500mg and 625mg BID dose groups to be provided by the Company today BOULDER, Colo.--(BUSINESS WIRE)--Nov. 16, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), the agency requested addition... 
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11/05/15Clovis Oncology Announces Third Quarter 2015 Operating Results
New Drug Application (NDA) for rociletinib for the treatment of advanced EGFR-mutant T790M+ non-small cell lung cancer (NSCLC) on file with U.S. FDA Marketing Authorization Application (MAA) for rociletinib on file in E.U.; action expected mid-2016 Raised $298 million in July equity offering Enrollment now complete in mutant BRCA population required for U.S. NDA submission for rucaparib... 
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11/03/15Clovis Oncology to Present at the 2015 Credit Suisse Healthcare Conference
BOULDER, Colo.--(BUSINESS WIRE)--Nov. 3, 2015-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that Erle T. Mast, the Company’s Executive Vice President and CFO, will present at the 2015 Credit Suisse Healthcare Conference on Tuesday, November 10, at 1:30pm MST. The conference is being held at the Phoenician in Scottsdale, Arizona. A live webcast of the corporate presentation at the conference will be accessible through the investor ... 
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10/22/15Clovis Oncology to Announce Third Quarter 2015 Financial Results and Host Webcast Conference Call on November 5
BOULDER, Colo.--(BUSINESS WIRE)--Oct. 22, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its third quarter 2015 financial results on Thursday, November 5, 2015, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET that day to discuss the company’s results in greater detail. The conference call is being webcast and can be accessed from the Clovis ... 
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09/29/15Clovis Oncology Announces U.S. and E.U. Regulatory Milestones for Rociletinib in the Treatment of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer
FDA Grants Priority Review Status to Rociletinib New Drug Application; Assigns Action Date of March 30, 2016 EMA Accepts Marketing Authorization Application for Rociletinib; Awards Accelerated Assessment BOULDER, Colo.--(BUSINESS WIRE)--Sep. 29, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced two major regulatory milestones for rociletinib, its investigational therapy for the treatment of patients with... 
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09/23/15Clovis Oncology Announces Data Presentations at 2015 European Cancer Congress
Three oral presentations and four scientific posters selected for presentation at the European Cancer Congress in Vienna, Austria Rucaparib oral presentation on Tuesday, September 29 to include final outcomes data from full ARIEL2 part 1 population of 206 women with advanced ovarian cancer Clinical updates on rociletinib in various patient subsets with advanced disease BOULDER, Colo.--(BUSINE... 
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09/10/15Clovis Oncology to Present at the Morgan Stanley Global Healthcare Conference 2015
BOULDER, Colo.--(BUSINESS WIRE)--Sep. 10, 2015-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that its Chief Executive Officer and President, Patrick J. Mahaffy, will present at the Morgan Stanley Global Healthcare Conference 2015 on Thursday, September 17, 2015 at 12:20 PM Eastern Time. The conference will be held at the Grand Hyatt Hotel in New York. A live webcast of the presentation can be accessed through the investor relation... 
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09/04/15Clovis Oncology Announces Data Presentations at 16th World Conference on Lung Cancer
Four rociletinib mini-oral presentations and two scientific posters debuting at World Conference on Lung Cancer in Denver BOULDER, Colo.--(BUSINESS WIRE)--Sep. 4, 2015-- Clovis Oncology (NASDAQ:CLVS) today announced that rociletinib, the company’s oral targeted covalent (irreversible) mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated, T790M positive non-small cell lung cancer ... 
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08/11/15Clovis Oncology Enters into Clinical Trial Collaboration
Study to evaluate the combination of rociletinib (CO-1686) with Genentech’s atezolizumab (MPDL3280A) for patients with advanced EGFR-mutant non-small cell lung cancer BOULDER, Colo.--(BUSINESS WIRE)--Aug. 11, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that they have entered into a clinical trial collaboration with Genentech, a member of the Roche Group to evaluate a novel combination therapy of Genentech’s investigational canc... 
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08/06/15Clovis Oncology Announces Second Quarter 2015 Operating Results
Completed rociletinib (CO-1686) U.S. NDA and E.U. MAA regulatory submissions in July for patients with EGFR-mutant non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the T790M mutation Preparing for potential Q4 2015 U.S. launch of rociletinib; establishing European commercial organization for potential 2016 launch of rociletinib Raised $298 million in Ju... 
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08/03/15Clovis Oncology Completes U.S. and E.U. Regulatory Submissions for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer
New Drug Application submitted to U.S. Food and Drug Administration and Marketing Authorization Application submitted to European Medicines Agency BOULDER, Colo.--(BUSINESS WIRE)--Aug. 3, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that it has submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor... 
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07/23/15Clovis Oncology to Announce Second Quarter 2015 Financial Results and Host Webcast Conference Call on August 6
BOULDER, Colo.--(BUSINESS WIRE)--Jul. 23, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its second quarter 2015 financial results on Thursday, August 6, 2015, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET that day to discuss the company’s results in greater detail. The conference call is being webcast and can be accessed from the Clovis ... 
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07/10/15Clovis Oncology Announces Exercise in Full of Underwriters’ Option to Purchase Additional Shares of Common Stock
BOULDER, Colo.--(BUSINESS WIRE)--Jul. 10, 2015-- Clovis Oncology (NASDAQ:CLVS) announced today that the underwriters of its recently announced public offering of its common stock have exercised in full their option to purchase an additional 528,846 shares. The offering, including the sale of the additional shares, is expected to close on July 14, 2015, subject to customary closing conditions. Clovis Oncology intends to use the net proceed... 
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07/08/15Clovis Oncology Announces Pricing of Public Offering of Common Stock
BOULDER, Colo.--(BUSINESS WIRE)--Jul. 8, 2015-- Clovis Oncology (NASDAQ:CLVS) announced today the pricing of an underwritten public offering of 3,525,641 shares of its common stock at $78.00 per share, before underwriting discounts and commissions. In addition, the underwriters have a 30-day option to purchase up to an additional 528,846 shares of common stock from Clovis Oncology on the same terms and conditions. The offering is expected ... 
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07/07/15Clovis Oncology Announces Proposed Offering of Common Stock
BOULDER, Colo.--(BUSINESS WIRE)--Jul. 7, 2015-- Clovis Oncology (NASDAQ:CLVS) announced today that it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of approximately $275 million. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology. Clovis Oncology intends to use the net proceeds of the offering for general corporate purposes, including commer... 
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07/01/15Clovis Oncology Initiates Rolling NDA Submission to the FDA for Rociletinib in the Treatment of Advanced EGFR-Mutant Non-small Cell Lung Cancer
NDA submission is expected to complete by late July BOULDER, Colo.--(BUSINESS WIRE)--Jul. 1, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously ... 
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06/22/15Clovis Oncology Appoints Dr. Lindsey Rolfe as Chief Medical Officer
Dr. Rolfe, currently Clovis’ Senior Vice President of Clinical Development, oversees the rociletinib and rucaparib development programs Dr. Andrew Allen stepping down after rociletinib NDA/MAA submissions to create a new biotech company and serve as its CEO BOULDER, Colo.--(BUSINESS WIRE)--Jun. 22, 2015-- Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that Dr. Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, has bee... 
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05/31/15Clovis Oncology’s Rociletinib (CO-1686) Phase 2 Study Results Demonstrate Consistent and Promising Clinical Activity and Disease Control in Very Advanced Patients with EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
60% overall response rate (ORR) and 90% disease control rate (DCR) in heavily pretreated centrally confirmed tissue T790M-positive patients Median progression free survival (PFS) of 10.3 months observed in patients without a history of CNS metastases; median PFS of 8 months observed in overall population of 270 heavily pretreated centrally confirmed tissue T790M-positive patients, including 40% of patients with a history of CN... 
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05/30/15Clovis Oncology’s Phase 2 Studies of Rucaparib in Ovarian Cancer Demonstrate Highly Compelling Clinical Activity, in Both BRCA-mutant and BRCA-like Patients, Together Comprising Approximately 60 Percent of Patients
Data from ARIEL2 in platinum-sensitive BRCA-mutant patients demonstrated an overall response rate (ORR) of 82%, a disease control rate (DCR) of 94% and a median progression-free survival (PFS) of 9.4 months Complete responses (CRs) observed in 10% of patients Data from ARIEL2 in patients with BRCA-like signature demonstrated ORR of 45% and DCR of 73% in and a median PFS of 7.1 ... 
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05/13/15Clovis Oncology Announces Data Presentations at 2015 ASCO Annual Meeting
Rociletinib oral presentation on Sunday, May 31 to update TIGER-X clinical data in heavily pretreated, advanced EGFR-mutant lung cancer patients, including in plasma-genotyped T790M-positive patients Rucaparib oral presentation on Monday, June 1 to include outcomes data from full ARIEL2 part one population of ~200 women with advanced ovarian cancer Rociletinib rolling NDA submission for EGFR-mutant lung cancer ... 
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05/06/15Clovis Oncology Announces First Quarter 2015 Operating Results
Rociletinib (CO-1686) rolling NDA submission for EGFR-mutant lung cancer expected to commence in June, and complete by July/August Launch planning underway for potential late 2015 U.S. launch of rociletinib Phase 1/2 rociletinib data published in April 30 issue of the New England Journal of Medicine Rucaparib granted Breakthrough Therapy designation in April NDA filing f... 
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04/23/15Clovis Oncology to Announce First Quarter 2015 Financial Results and Host Webcast Conference Call on May 6
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 23, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its first quarter 2015 financial results on Wednesday, May 6, 2015, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET that day to discuss the company’s results in greater detail. The conference call is being webcast and can be accessed from the Clovis O... 
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04/06/15Clovis Oncology Receives Breakthrough Therapy Designation for Rucaparib for Monotherapy Treatment of Advanced Ovarian Cancer in Patients with BRCA-mutated Tumors (Inclusive of both Germline and Somatic BRCA Mutations)
Only PARP inhibitor to receive Breakthrough Therapy designation Rucaparib NDA filing for treatment of advanced platinum-sensitive ovarian cancer planned for 2016 Second Breakthrough Designation granted to a Clovis Oncology drug candidate BOULDER, Colo.--(BUSINESS WIRE)--Apr. 6, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has granted... 
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02/25/15Clovis Oncology Announces 2014 Operating Results
Rociletinib (CO-1686) NDA and MAA submissions for EGFR-mutant lung cancer planned mid-2015 Rucaparib development program accelerated; filing now planned for treatment of platinum-sensitive ovarian cancer in 2016 BOULDER, Colo.--(BUSINESS WIRE)--Feb. 25, 2015-- Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter and year ended December 31, 2014, and provided an update on the Compan... 
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02/17/15Clovis Oncology to Announce Fourth Quarter/Year-End 2014 Financial Results and Host Webcast Conference Call on February 25
BOULDER, Colo.--(BUSINESS WIRE)--Feb. 17, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its fourth quarter/year-end 2014 financial results on Wednesday, February 25, 2015, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET that day to discuss the company’s results in greater detail. The conference call is being webcast and can be accessed from the... 
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02/04/15Clovis Oncology to Present at the 2015 Leerink Global Healthcare Conference
BOULDER, Colo.--(BUSINESS WIRE)--Feb. 4, 2015-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that Erle T. Mast, the Company’s executive vice president and CFO, will present at the 2015 Leerink Global Healthcare Conference on Thursday, February 12, at 1:25 p.m. EST. The conference is being held at the Waldorf Astoria in New York City. A live webcast of the corporate presentation at the conference will be accessible through the inves... 
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01/05/15Clovis Oncology to Present at the 33rd Annual J.P. Morgan Healthcare Conference
BOULDER, Colo.--(BUSINESS WIRE)--Jan. 5, 2015-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that its Chief Executive Officer and President, Patrick J. Mahaffy, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2015 at 1:30 PM Pacific Time. The conference will be held at the Westin St. Francis Hotel in San Francisco. A live webcast of the presentation can be accessed through the investor relat... 
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Investor Relations and Corporate Communications Contacts
Breanna Burkart
Phone: 303.625.5023
E-mail: bburkart@clovisoncology.com
Anna Sussman
Phone: 303.625.5022
E-mail: asussman@clovisoncology.com