2016 News Releases

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12/19/16ADDING MULTIMEDIA and CONFERENCE CALL DETAILS Clovis Oncology Announces FDA Accelerated Approval of RUBRACA™ (rucaparib) for the Monotherapy Treatment of Advanced Ovarian Cancer in Women with Deleterious Germline or Somatic BRCA Mutations...
First and only PARP inhibitor in the U.S. indicated to treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations Rubraca received approval under the FDA’s accelerated approval program based on objective response rate and duration of response Most common Grade 3-4 adverse reaction was anemia; most common Grade... 
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12/19/16Clovis Oncology Announces FDA Accelerated Approval of RUBRACA™ (rucaparib) for the Monotherapy Treatment of Advanced Ovarian Cancer in Women with Deleterious Germline or Somatic BRCA Mutations Treated with Two or More Chemotherapies
First and only PARP inhibitor in the U.S. indicated to treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations Rubraca received approval under the FDA’s accelerated approval program based on objective response rate and duration of response Most common Grade 3-4 adverse reaction was anemia; most common Grade... 
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11/03/16Clovis Oncology Announces Q3 2016 Operating Results and Corporate Update
Rucaparib New Drug Application (NDA) accepted for Priority Review in the treatment of advanced BRCA-mutant ovarian cancer; PDUFA date February 23, 2017 Rucaparib MAA submission submitted this week Clovis commercial and medical affairs organizations preparing for potential U.S. commercial launch of rucaparib ARIEL3 pivotal rucaparib maintenance study enrollment completed; data expected i... 
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10/31/16Clovis Oncology to Present at the 2016 Credit Suisse Healthcare Conference
BOULDER, Colo.--(BUSINESS WIRE)--Oct. 31, 2016-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that Patrick Mahaffy, the Company’s President and CEO, will present at the 2016 Credit Suisse Healthcare Conference on Tuesday, November 8, at 1:00pm 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 relations se... 
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10/27/16Clovis Oncology to Announce Third Quarter 2016 Financial Results and Host Webcast Conference Call on November 3
BOULDER, Colo.--(BUSINESS WIRE)--Oct. 27, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its third quarter 2016 financial results on Thursday, November 3, 2016, 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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10/07/16Clovis Oncology Presents Efficacy and Safety Data from New Drug Application (NDA) Population for Rucaparib in the Treatment of Advanced Mutant BRCA Ovarian Cancer at 2016 ESMO Congress
Rucaparib NDA Dataset to be presented in oral presentation today at ESMO Rucaparib NDA currently under priority review with FDA Prescription Drug User Fee Act (PDUFA) date is February 23, 2017 European Marketing Authorization Application (MAA) submission planned for Q4 2016 BOULDER, Colo.--(BUSINESS WIRE)--Oct. 7, 2016-- Clovis Oncology (NASDAQ:CLVS) announced today the oral pre... 
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09/28/16Clovis Oncology Announces Rucaparib Data Presentations at ESMO 2016 Congress
Data for rucaparib in the treatment of advanced ovarian cancer to be highlighted in oral presentation U.S. Food and Drug Administration (FDA) accepted accelerated approval application for review and granted priority review status Prescription Drug User Fee Act (PDUFA) date is February 23, 2017 European Marketing Authorization Application (MAA) planned in Q4 2016 BOULDER, Colo.... 
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08/23/16FDA Accepts Clovis Oncology’s New Drug Application for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer
Seeking approval for mutant BRCA patients treated with two or more prior therapies FDA Grants Priority Review Status Assigns PDUFA Date of February 23, 2017 BOULDER, Colo.--(BUSINESS WIRE)--Aug. 23, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and gra... 
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08/08/16Clovis Oncology Announces Q2 2016 Operating Results and Corporate Update
Rucaparib NDA submission completed in late June for treatment of patients with advanced ovarian cancer with deleterious BRCA mutated tumors FDA decision on filing and determination of PDUFA date is anticipated in late August Rucaparib MAA submission on track for Q4 2016 Rucaparib NDA dataset accepted for an oral presentation at ESMO 2016 Congress in October Clov... 
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07/26/16Clovis Oncology to Announce Second Quarter 2016 Financial Results and Host Webcast Conference Call on August 8
BOULDER, Colo.--(BUSINESS WIRE)--Jul. 26, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its second quarter 2016 financial results on Monday, August 8, 2016, 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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06/06/16Clovis Oncology Presents Data from Phase 2 Studies of Rucaparib in Advanced Ovarian Cancer and Pancreatic Cancer at 2016 ASCO Annual Meeting
BOULDER, Colo.--(BUSINESS WIRE)--Jun. 6, 2016-- Clovis Oncology (NASDAQ:CLVS) announced updated phase 2 results from Part 1 of the ongoing ARIEL2 study in patients with advanced ovarian cancer as well as the final results of the RUCAPANC study of rucaparib in pancreatic cancer at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1, PARP2 and PARP3 ... 
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05/19/16Clovis Oncology Announces Data Presentations at 2016 ASCO Annual Meeting
New rucaparib data to be highlighted in poster presentations Rolling New Drug Application (NDA) submission for rucaparib for the treatment of patients with advanced ovarian cancer expected to complete during Q2 2016 European Marketing Authorization Application (MAA) planned in Q4 2016 BOULDER, Colo.--(BUSINESS WIRE)--May 19, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced its presen... 
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05/05/16Clovis Oncology Announces Q1 2016 Operating Results and Corporate Update
Rucaparib rolling NDA submission initiated for treatment of patients with advanced ovarian cancer with deleterious BRCA mutated tumors and expected to complete Q2 2016 Rucaparib MAA submission planned Q4 2016 Clovis preparing for potential U.S. commercial launch of rucaparib with existing commercial infrastructure in Q4 2016 or Q1 2017 ARIEL3 pivotal rucaparib maintenance study target enrollment... 
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04/26/16Clovis Oncology to Announce First Quarter 2016 Financial Results and Host Webcast Conference Call on May 5
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 26, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its first quarter 2016 financial results on Thursday, May 5, 2016, 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 On... 
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04/12/16Trading of Clovis Oncology, Inc. Common Stock Halted
FDA’s Oncologic Drugs Advisory Committee to Review Rociletinib New Drug Application for the Treatment of Non-Small Cell Lung Cancer BOULDER, Colo.--(BUSINESS WIRE)--Apr. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that NASDAQ has halted trading of the Company’s common stock. The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting this morning to discuss the company’s New Drug Application ... 
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04/12/16Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib for Treatment of Advanced T790M-Positive Mutant Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-... 
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04/08/16FDA Posts Briefing Documents for Advisory Committee Meeting to Review Clovis Oncology’s Rociletinib for Treatment of Advanced T790M-Positive Mutant Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 8, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) posted briefing materials in advance of the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss accelerated approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung ca... 
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02/25/16Clovis Oncology Announces 2015 Operating Results
Rociletinib NDA scheduled for discussion at ODAC panel on April 12 with a June 28 PDUFA date Rucaparib NDA submission for treatment of advanced ovarian cancer expected to complete Q2 2016 BOULDER, Colo.--(BUSINESS WIRE)--Feb. 25, 2016-- Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter and year ended December 31, 2015, and provided an update on the Company’s clinical deve... 
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02/16/16Clovis Oncology to Announce Fourth Quarter/Year-End 2015 Financial Results and Host Webcast Conference Call on February 25
BOULDER, Colo.--(BUSINESS WIRE)--Feb. 16, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its fourth quarter/year-end 2015 financial results on Thursday, February 25, 2016, 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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02/12/16Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting
BOULDER, Colo.--(BUSINESS WIRE)--Feb. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who ... 
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01/27/16Clovis Oncology Initiates Immunotherapy Combination Trial
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)--Jan. 27, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that it initiated a clinical trial to evaluate a novel combination therapy of Genentech’s investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PD-L1) and rociletini... 
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01/25/16Clovis Oncology Appoints Dale Hooks as Chief Commercial Officer
Hooks, Clovis’ Vice President of Sales since 2014, has been instrumental in building out the Company’s commercial organization BOULDER, Colo.--(BUSINESS WIRE)--Jan. 25, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that Dale Hooks has been named Senior Vice President and Chief Commercial Officer. Mr. Hooks succeeds Steve Hoerter, the Company’s current Chief Commercial Officer and Executive Vice President, who is leaving to pursue other ... 
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01/06/16Clovis Oncology to Present at the 34th Annual J.P. Morgan Healthcare Conference
BOULDER, Colo.--(BUSINESS WIRE)--Jan. 6, 2016-- Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that its Chief Executive Officer and President, Patrick J. Mahaffy, will present at the 34th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2016 at 11:00 AM 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 r... 
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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