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News Breaks
June 24, 2014
16:47 EDTBMYBristol-Myers says Phase 3 study of nivolumab versus dacarbazine stopped early
Bristol-Myers Squibb announced that a randomized blinded comparative Phase 3 study evaluating nivolumab versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm. Patients in the trial will be unblinded and allowed to cross over to nivolumab. The company will share these data with health authorities. “The outcome of CheckMate -066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” said Michael Giordano, MD, Head of Oncology Development. “Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival.” CheckMate -066 investigators have been informed of the decision to stop the blinded comparative portion of the trial. Bristol-Myers Squibb will ensure that patients are informed of the opportunity to continue or start treatment with nivolumab in an open-label extension as part of the company’s commitment to characterize long-term survival. The study, which was designed in consultation with the Committee for Medicinal Products for Human Use, was primarily conducted in countries where DTIC is a commonly-used treatment in the first-line setting, including Canada, but not at U.S. trial sites. The company will complete a full evaluation of the final CheckMate -066 data and work with investigators on the future presentation and publication of the results.
News For BMY From The Last 14 Days
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April 17, 2015
09:41 EDTBMYBristol-Myers up after Phase III Opdivo study met endpoint, trial stopped early
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09:36 EDTBMYActive equity options trading on open
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09:08 EDTBMYBristol-Myers data should be positive, says SunTrust
SunTrust expects the AACR data for Bristol-Myers' CheckMate-069 Opdivo + Yervoy combo, a treatment for melanoma, to show a positive overall response rate and progressive free survival that exceeds its prior -0004 results. The firm notes that the data is due to be presented on April 20. It raised its 2020 Opdivo revenue estimate to $7.1B versus the Street's $6.9B and raised its price target o n he stock to $74 from $70 while keeping a Buy rating on the shares.
08:58 EDTBMYBristol-Myers jumps 4% after Opdivo study stopped early after meeting endpoint
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08:56 EDTBMYBristol-Myers says Phase III Opdivo study met endpoint, trial stopped early
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April 16, 2015
12:16 EDTBMYEli Lilly and Bristol-Myers restructure Erbitux collaboration in N. America
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
09:08 EDTBMYOn The Fly: Pre-market Movers
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07:41 EDTBMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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April 8, 2015
08:08 EDTBMYuniQure price target raised to $50 from $28 at Leerink
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08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
April 7, 2015
07:14 EDTBMYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
16:17 EDTBMYOn The Fly: Closing Wrap
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12:44 EDTBMYOn The Fly: Midday Wrap
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12:13 EDTBMYuniQure price target raised to $40 from $35 at Piper Jaffray
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08:13 EDTBMYCelldex announces initiation of Phase 1/2 study of Varlilumab combination
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07:33 EDTBMYBristol-Myers announces strategic collaboration with uniQure
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