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July 25, 2014
07:25 EDTGILDGilead receives positive opinion from CHMP for Zydelig
Gilead Sciences announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application for Zydelig, a first-in-class treatment for patients with chronic lymphocytic leukemia and follicular lymphoma, the most common subtype of indolent non-Hodgkin lymphoma. The CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. The CHMP positive opinion for Zydelig is based on data from two clinical trials – Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of Zydelig in combination with rituximab in patients with previously treated CLL. The Phase 2 101-09 study assessed the efficacy and safety of Zydelig in patients with iNHL who are refractory to rituximab and alkylating agents. Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014.
News For GILD From The Last 14 Days
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June 29, 2015
16:30 EDTGILDFDA sued by advocacy groups for Gilead Hep-C drug trial data, Reuters says
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June 25, 2015
09:34 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB NFLX AMZN BAC CVX TWTR INTC GILD BBBY
June 23, 2015
14:10 EDTGILDGilead price target raised to $150 from $130 at Argus
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June 22, 2015
09:40 EDTGILDActive equity options trading on open
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June 19, 2015
16:00 EDTGILDOptions Update; June 19, 2015
iPath S&P 500 VIX Short-Term Futures up 11c to 18.21, Option volume leaders: AAPL TWTR BAC T FB GILD NFLX BABA AAL MU AMZN
06:40 EDTGILDPatent linked to Gilead's Solvadi rejected by China, Reuters reports
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June 18, 2015
07:36 EDTGILDReceptos remains an attractive takeover candidate, says Leerink
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June 16, 2015
14:23 EDTGILDReceptos price target raised to $348 at Wedbush on M&A potential
Wedbush analysts Liana Moussatos and Kelechi Chikere said they'd interpreted Receptos (RCPT) comments with its earnings report in May about its ability to commercialize ozanimod on its own as a message to potential buyers that their bids were too low. Following a recent report from Proactive Investors, which claimed that Receptos had turned down bids of $200 per share from AstraZeneca (AZN) and $280 per share from Teva (TEVA) and Gilead (GILD), the analysts said they have reconsidered their valuation assumptions, as they believe these bid values could be accurate. Wedbush raised its fair value estimate on Receptos to $348 from $211, citing a belief in increased industry interest in ozanimod and the rest of Receptos’ pipeline, and maintains an Outperform rating on the stock.

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