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Clovis Oncology Inc (CLVS.OQ)

CLVS.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Clovis Oncology reports Q3 adjusted shr loss of $1.24
Thursday, 2 Nov 2017 

Nov 1 (Reuters) - Clovis Oncology Inc -:CLOVIS ONCOLOGY ANNOUNCES THIRD QUARTER 2017 OPERATING RESULTS.Q3 ADJUSTED LOSS PER SHARE $1.24 EXCLUDING ITEMS.Q3 LOSS PER SHARE $1.24.Q3 EARNINGS PER SHARE VIEW $-1.22 -- THOMSON REUTERS I/B/E/S.  Full Article

Clovis oncology says entered into a manufacturing services agreement - sec filing
Wednesday, 5 Oct 2016 

Clovis Oncology Inc : Says Clovis Oncology and Lonza Ltd entered into a manufacturing services agreement - SEC filing .Deal provides Lonza will be non-exclusive manufacturer of Rucaparib Api during term of deal , which expires on December 31, 2025.  Full Article

Clovis Oncology announces Rucaparib data presentations at ESMO 2016 Congress
Wednesday, 28 Sep 2016 

Clovis Oncology Inc : Clovis Oncology announces Rucaparib data presentations at ESMO 2016 Congress . European Marketing Authorization Application (MAA) planned in Q4 2016 . ESMO will take place october 7-11, 2016 in Copenhagen, Denmark . Prescription Drug User Fee Act (PDUFA) date is February 23, 2017 . U.S. FDA accepted accelerated approval application for review and granted priority review status for Rucaparib .Data from ARIEL3 are expected in Q4 2017, which is expected to be followed by submission of a supplemental NDA.  Full Article

Clovis enters into first amendment to license agreement between Clovis and pfizer
Wednesday, 31 Aug 2016 

Clovis Oncology Inc : Entered into first amendment to license agreement between Clovis and Pfizer, Inc. . First amendment amends existing license agreement, between Clovis and Pfizer, dated June 2, 2011 . Amendment amends license agreement to permit co to defer milestone payments payable upon fda approval of an NDA for 1(st)indication in US .Amendment amends existing license agreement to permit co to defer milestone payments payable on EMA approval of MAA for 1(st)indication in EU.  Full Article

Clovis Oncology says FDA accepts co's new drug application for rucaparib for priority review
Wednesday, 24 Aug 2016 

Clovis Oncology Inc : FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer .FDA assigns PDUFA date of February 23, 2017.  Full Article

Clovis Oncology Q2 adjusted loss per share $2.07 excluding items
Tuesday, 9 Aug 2016 

Clovis Oncology Inc : Clovis oncology announces q2 2016 operating results and corporate update . Q2 adjusted loss per share $2.07 excluding items . Q2 earnings per share view $-2.10 -- Thomson Reuters I/B/E/S .Q2 loss per share $3.37.  Full Article

Clovis Oncology Inc files for mixed shelf of up to $200 mln
Friday, 10 Jun 2016 

Clovis Oncology Inc :Clovis Oncology Inc files for mixed shelf of up to $200 million.  Full Article

Clovis Oncology Announces Rociletinib New Drug Application meeting schedule
Friday, 12 Feb 2016 

Clovis Oncology Inc:Says U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee April 12.ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.  Full Article

Kessler Topaz Meltzer & Check, LLP Announces Shareholder Class Action Against Clovis Oncology Inc - ACSWIR
Thursday, 17 Dec 2015 

Clovis Oncology Inc:The law firm ofKessler Topaz Meltzer & Check, LLPannounces that a shareholder class action lawsuit has been filed against Clovis Oncology, Inc. on behalf of purchasers of the Company's securities between October 31, 2013 and Nov15, 2015, inclusive - ACSWIR.The shareholder complaint alleges that Clovis and certain of its executive officers made a series of false and/or misleading statements - ACSWIR.Specifically, the defendants are alleged to have made false and misleading statements and/or failed to disclose the following - ACSWIR.that the New Drug Application ("NDA") that Clovis submitted to the FDA for rociletinib contained immature data sets based on both unconfirmed response rates and confirmed response rates - ACSWIR.(2) that Clovis' Breakthrough Therapy designation submission contained immature data set based primarily on unconfirmed responses- ACSWIR.(3) that Clovis presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses - ACSWIR.(4) that as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected.that, as a result of the foregoing, Clovis' NDA was likely to be delayed and/or rejected by the FDA.that, as a result of the foregoing, the Defendants' statements about Clovis' business, operations, and prospects, were false and misleading and/or lacked a reasonable basis. - ACSWIR.  Full Article