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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.
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July 28, 2015
16:05 EDTGILDGilead narrows FY15 adj product gross margin view to 88%-90% from 87%-90%
16:04 EDTGILDGilead reports Q2 antiviral product sales increased to $7.6B
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16:03 EDTGILDGilead reports Q1 total product sales $8.1B
Total product sales for the second quarter of were $8.1B compared to $6.4B for the second quarter of 2014. Product sales in the U.S. were $5.6B compared to $4.8B for the second quarter of 2014. In Europe, product sales were $2B compared to $1.3B for the same period in 2014.
16:02 EDTGILDGilead raises FY15 net product sales view to $29B-$30B from $28B-$29B
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16:01 EDTGILDGilead reports Q2 adjusted EPS $3.15, consensus $2.71
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15:47 EDTGILDGilead July weekly 112 straddle priced for 6% movement
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15:21 EDTGILDNotable companies reporting after market close
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13:39 EDTGILDGilead technical notes before results
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11:42 EDTGILDStocks with call strike movement; FB GILD
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July 27, 2015
11:57 EDTGILDStocks with call strike movement; FB GILD
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08:42 EDTGILDGilead July weekly volatility increases into Q2 and outlook
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05:56 EDTGILDStocks with implied volatility movement; CRM GILD
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July 24, 2015
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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July 23, 2015
12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
July 20, 2015
07:33 EDTGILDInternational AIDS Society to hold a conference
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July 17, 2015
10:21 EDTGILDCigna says 98.4% of customers treated with hep C drug Harvoni are cured
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09:03 EDTGILDGilead granted orphan status for gastric cancer treatment
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July 16, 2015
09:22 EDTGILDBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
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July 15, 2015
07:58 EDTGILDAnalysts break down impact of $7.2B Receptos buyout
After Celgene (CELG) announced last night that the company has agreed to acquire Receptos (RCPT) for $232 per share in cash, or a total of about $7.2B net of cash acquired, research firms have chimed in with their opinions on how the proposed deal may impact others in the biotech space. Receptos key asset is Ozanimod, which is being studied in Phase III trials for relapsing multiple sclerosis and ulcerative colitis. DERIVATIVE CALLS: Piper Jaffray analyst Edward Tenthoff told investors that he views Celgene's deal for Receptos as good for Arena Pharmaceuticals (ARNA). The analyst notes that Arena's APD334 is already showing dose-dependent decreases in circulating lymphocyte counts and that the company will initiate Phase II studies in ulcerative colitis and Crohn's disease this year. Tenthoff reiterates an Overweight rating and $7.50 price target on Arena, which has a market capitalization around $1B and closed yesterday up 8c to $4.47. In its own note to investors this morning, Nomura said Celgene's deal could put downward pressure on Biogen's (BIIB) long-term multiple sclerosis estimates. Nomura's M. Ian Somaiya contended that one-year Phase II efficacy data for Ozanimod looked as good as Novartis’s (NVS) Gilenya and Biogen's Tecfidera’s Phase III at year 2. Somaiya also wondered if rival Gilead (GILD) could be "looking for something bigger" than Receptos for its own deal, telling investors that the firm views Incyte (INCY) as Gilead's most likely takeout target. Incyte's shares closed up $4.46 at $117.46 yesterday, giving the company a market cap of about $20B. RIVAL BID?: Wedbush analyst Liana Moussatos believes another bidder may seek to acquire Receptos, noting that she previously estimated Receptos could be valued at $348 per share, or about $10.9B, in a buyout. Moussatos noted that Celgene said it expects annual peak sales for Ozanimod to reach about $4B-$6B for RMS and UC, making its acquisition price of $7.2BN only a bit more than about 1X peak sales without accounting for other possible indications or the rest of its pipeline. Moussatos told investors she sees "plenty" of potential upside to justify a rival bidder stepping in and reiterated the firm's Outperform rating on Receptos shares. PRICE ACTION: In pre-market trading, Receptos rose 10% to $228.61 while Gilead gained 1.4% to about $119 per share.
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