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News Breaks
August 20, 2014
08:02 EDTBMY, CELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
Bristol-Myers Squibb (BMY) and Celgene (CELG) announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, OPDIVO and Celgene’s nab technology-based chemotherapy ABRAXANE in a Phase I study. Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer. The proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval. The study, which is expected to begin in 4Q14, will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with ABRAXANE and OPDIVO, patients with NSCLC will be treated with the combination of ABRAXANE, carboplatin and OPDIVO, and patients with pancreatic adenocarcinoma will be treated with ABRAXANE, gemcitabine and OPDIVO. Additional details of the collaboration were not disclosed.
News For BMY;CELG From The Last 14 Days
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January 28, 2016
09:25 EDTBMYBristol-Myers reports Q4 non-GAAP EPS 38c, consensus 28c
Reports Q4 revenue $4.29B, consensus $4.15B.
08:09 EDTCELGAlliqua announces partnership with Human Longevity
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07:36 EDTCELGCelgene sees Q1 adjusted EPS $1.27-$1.30, consensus $1.30
07:36 EDTCELGCelgene sees FY16 adjusted EPS $5.50-$5.70, consensus $5.69
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07:31 EDTCELGCelgene reports Q4 adjusted EPS $1.18, consensus $1.22
Reports Q4 revenue $2.56B, consensus $2.54B.
07:11 EDTBMYBristol-Myers: DMC concluded that CheckMate Phase 3 study met primary endpoint
07:00 EDTBMYBristol-Myers says CheckMate-141 Opdivo Phase 3 trial stopped early
Bristol-Myers Squibb announced that a randomized Phase 3 study evaluating Opdivo versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon. "With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer." CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -141 data, and work with investigators on the future presentation and publication of the results.
January 27, 2016
14:34 EDTBMY, CELGNotable companies reporting before tomorrow's open
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14:29 EDTCELGCelgene technical remarks ahead of earnings news
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14:17 EDTBMYBristol-Myers technical comments before earnings news
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13:55 EDTBMYBristol-Myers volatility elevated into Q4 and outlook
Bristol-Myers Black & Decker January weekly call option implied volatility is at 49, February is at 30; compared to its 52-week range of 18 to 43, suggesting large near term price movement into the expected release of Q4 results on January 28.
12:19 EDTCELGPiper Jaffray biopharma analyst holds an analyst/industry conference call
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January 25, 2016
11:05 EDTCELGOncoMed price target lowered to $29 from $43 at Piper Jaffray
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10:57 EDTCELGCelgene management to meet with Evercore ISI
Meeting to be held in Canada on February 1 hosted by Evercore ISI.
10:00 EDTBMYOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: American Eagle (AEO) downgraded to Hold from Buy at BB&T... American Express (AXP) downgraded on weak revenue outlook at Argus... Bristol-Myers (BMY) downgraded to Market Perform from Outperform at BMO Capital... Caterpillar (CAT) downgraded to Sell from Neutral at Goldman... Crestwood Equity (CEQP) downgraded to Neutral on potential distribution cut at Baird... Cummins (CMI) downgraded to Neutral from Buy at Citi... Federal Realty (FRT) downgraded to Hold from Buy at Evercore ISI... GKN PLC (GKNLY) downgraded to Neutral from Outperform at Credit Suisse... Galapagos NV (GLPG) downgraded to Neutral from Buy at GoldmanvHortonworks (HDP) downgraded to Perform from Outperform at Oppenheimer... International Flavors (IFF) downgraded on headwinds at Stifel... International Paper (IP) downgraded to Neutral from Buy at Citi... JPMorgan (JPM) downgraded to Neutral from Buy at Nomura... KapStone (KS) downgraded to Underperform from Neutral at Macquarie... Mosaic (MOS) downgraded to Neutral from Overweight at JPMorgan... NetSuite (N) downgraded to Equal Weight from Overweight at Stephens... ONEOK Partners (OKS) downgraded to Neutral at Baird... OvaScience (OVAS) downgraded to Perform from Outperform at Oppenheimer... Packaging Corp. (PKG) downgraded to Neutral from Buy at Citi... Potash (POT) downgraded to Neutral from Overweight at JPMorgan... Power Solutions (PSIX) downgraded to Neutral from Overweight at Piper Jaffray... Raymond James (RJF) downgraded to Neutral from Buy at Nomura... Regeneron (REGN) downgraded to Sell from Neutral at Chardan... SanDisk (SNDK) downgraded to Underperform from Outperform at CLSA... Toll Brothers (TOL) downgraded to Market Perform from Outperform at JMP Securities... Twitter (TWTR) downgraded to Hold from Buy at Stifel... WPX Energy (WPX) downgraded to Sector Perform from Outperform at Iberia... WestRock (WRK) downgraded to Neutral from Buy at BofA/Merrill... Whole Foods (WFM) downgraded to Underperform from Market Perform at BMO Capital... Zurich Insurance (ZURVY) downgraded to Neutral from Outperform at Exane BNP Paribas.
08:27 EDTBMYBristol-Myers downgraded at BMO Capital
As noted earlier, BMO Capital downgraded Bristol-Myers to Market Perform from Outperform. The firm says that its positive thesis on clinical catalysts for the company's Opdivo drug has "mostly materialized." Target to $70 from $74.
08:04 EDTBMYAgilent's Dako announces FDA expanded approval of Dako PD-L1 IHC 28-8 pharmDx
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06:05 EDTBMYBristol-Myers downgraded to Market Perform from Outperform at BMO Capital
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05:36 EDTCELGStocks with implied volatility below IV index mean; CELG INTC
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January 24, 2016
13:50 EDTBMYBristol-Myers says FDA expands indication for Opdivo-Yervoy
Bristol-Myers Squibb announced that the FDA has approved Opdivo, or nivolumab, in combination with Yervoy, or ipilimumab, for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. "This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials," the company noted. The approval expands the original indication for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial. The FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients.
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