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FDA Grants Priority Review Designation For Clovis Oncology's Rubraca Label Expansion
Wednesday, January 15, 2020 - 10:22am | 252Clovis Oncology Inc (NASDAQ: CLVS) shares are advancing strongly after the company clinched a regulatory milestone with respect to its oncology drug Rubraca. The Boulder, Colorado-based biopharma company that focuses on the development of anti-cancer agents said the FDA has accepted its sNDA for...
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A Biotech Binary Event Playbook: How To Play Clovis And Tesaro Ahead Of Label Decision
Tuesday, August 8, 2017 - 1:36pm | 641Morgan Stanley said in a note Tuesday it would be buyers of Clovis Oncology Inc (NASDAQ: CLVS) and TESARO Inc (NASDAQ: TSRO) ahead of the Lynparza label decision. AstraZeneca plc (ADR) (NYSE: AZN)'s Lynparza is a poly polymerase, or PARP, inhibitor indicated for use as a monotherapy in patients...
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Clovis Addresses Some Of The Company's Biggest Controversies
Tuesday, June 20, 2017 - 1:35pm | 469Analysts at Leerink maintain an Outperform rating on shares ofClovis Oncology Inc (NASDAQ: CLVS) with a price target boosted from $85 to $114 after the company hosted a conference call on Monday, which addressed some of the biggest controversies it faces. Clovis' conference calls came after the...
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Tesaro Gets Approval For Zejula, Expect U.S. Launch Late April
Tuesday, March 28, 2017 - 9:26am | 363TESARO Inc (NASDAQ: TSRO) announced the FDA approval of Zejula (niraparib) in recurrent ovarian cancer maintenance with a broad label. The approval came in three months ahead of schedule and the launch is expected in late April, Baird’s Michael E. Ulz said in a report. While reiterating a...
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Clovis Shares Reiterated As A Sell Following 10% Rally
Wednesday, March 15, 2017 - 7:08am | 290AstraZeneca plc (ADR) (NYSE: AZN) on Tuesday presented positive Lynparza results in ovarian cancer maintenance. This raises competitive risks for Clovis Oncology Inc’s (NASDAQ: CLVS) Rubraca, which is currently in the phase III ARIEL3 maintenance study, Chardan Capital Markets’ Madhu...
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Breaking Down The Crowded Novel Ovarian Cancer Treatment Space
Wednesday, December 21, 2016 - 9:19am | 621The incidence of ovarian cancer is supposed to be sporadic, with just about 3 percent of cancers among women said to originate from the ovaries. However, it is considered more lethal than any other cancer of female reproductive system. Clovis' Slice Of Luck So when the FDA granted accelerated...
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Unexpected FDA Approval May Spark Extended Clovis Short Squeeze
Monday, December 19, 2016 - 2:24pm | 297Shares of Clovis Oncology Inc (NASDAQ: CLVS) initially spiked more than 12 percent on Monday following surprise news from the FDA that is has approved advanced ovarian cancer drug Rubraca. The FDA ruling caught the market off-guard because a ruling wasn't expected until February, and Clovis...
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FDA Approves Clovis Oncology's Ovarian Cancer Treatment
Monday, December 19, 2016 - 11:53am | 381Shares of Clovis Oncology Inc (NASDAQ: CLVS) soared higher by more than 15 percent Monday after the U.S. Food and Drug Administration granted an accelerated approval for the company's PARP inhibitor rucaparib for the treatment of women with advanced ovarian cancer which will now be branded...