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News Breaks
April 3, 2014
06:33 EDTCLVS, FMIFoundation Medicine and Clovis Oncology partner for cancer diagnostic
Foundation Medicine (FMI) and Clovis Oncology (CLVS) are expanding their ongoing collaboration to incorporate a coordinated regulatory strategy for the development of a novel Premarket Approval companion diagnostic test. This test is designed for use by physicians to identify patients most likely to respond to rucaparib, Clovis’ poly polymerase inhibitor currently the subject of Phase 2 and Phase 3 clinical trials in patients with ovarian cancer. This companion diagnostic is being developed in parallel with the clinical development of rucaparib to facilitate an FDA submission of the PMA for the companion diagnostic concurrent with the New Drug Application for rucaparib.
News For FMI;CLVS From The Last 14 Days
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November 20, 2014
07:24 EDTFMIGoldman to hold a conference
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07:13 EDTFMICanaccord to hold a forum
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November 19, 2014
18:03 EDTCLVSClovis reports initial Phase 2 results from ARIEL2 study
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09:16 EDTCLVSOn The Fly: Pre-market Movers
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06:36 EDTCLVSClovis rociletinib data 'good news/bad news,' says Mizuho
Mizuho analyst Peter Lawson says his initial read of the new rociletinib data is "good news/bad news," which leaves his price target for Clovis unchanged. Lawson pegs the bad news as the drug losing its progression-free survival lead since the estimated PFS dropped from 12 months to 10.4 months, essentially in-line with AstraZeneca's (AZN) competing drug AZD9291. Lawson sees the good news as the "encouraging" PFS of 7.5 months in T790M-negative patients. He keeps a Buy rating on Clovis with a $100 price target.
November 18, 2014
18:38 EDTCLVSClovis announces positive data from Phase 2 clinical study of rociletinib
Clovis Oncology announced updated findings from its ongoing Phase 2 clinical study of rociletinib, or CO-1686, the Company’s novel, oral, targeted covalent mutant-selective inhibitor of the epidermal growth factor receptor, or EGFR, for the treatment of NSCLC in patients with initial activating EGFR mutations as well as the primary resistance mutation T790M. These data are being presented Friday, November 21 in an oral presentation at the 26th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. “These data demonstrate the very encouraging activity and tolerability observed with rociletinib at our go-forward dose of 625mg BID, and our step-down dose of 500mg BID,” said Clovis Oncology. “We are now expanding beyond our initial focus on T790M-positive patients and are very enthusiastic about our expansion into front-line patients with TIGER-1, and soon, into an all-comer population of patients with acquired TKI resistance, including both T790M-positive and T790M-negative patients with TIGER-3. We are actively preparing for the first of our planned regulatory filings, which include the U.S. NDA and E.U. MAA in mid-2015.”
07:20 EDTCLVSEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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November 17, 2014
17:02 EDTCLVSClovis in oncology clinical trial collaboration with GlaxoSmithKline
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07:20 EDTFMILeerink to hold a tour
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November 14, 2014
12:08 EDTCLVSClovis November volatility elevated into update
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November 12, 2014
17:30 EDTCLVSClovis announces first patient enrolled in TIGER-1 study
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10:07 EDTCLVSHigh option volume stocks: DDS FOSL ZTS CMA CLVS CZR
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