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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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May 26, 2015
09:38 EDTBMYuniQure reports collaboration with Bristol-Myers closed, triggers $50M payment
uniQure (QURE) announced the closing of its strategic collaboration with Bristol-Myers Squibb (BMY) to develop gene therapies for cardiovascular disease. The transaction was previously announced on April 6. Under the terms of the agreement, Bristol-Myers Squibb will make near-term payments of approximately $100M, including an initial upfront payment of $50M upon closing of the transaction, a $15M payment upon selection of three collaboration targets, in addition to S100A1, to be made within three months of closing, and an initial equity investment in uniQure representing 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or approximately $37M in total. The initial equity investment is expected to close on June 12. Bristol-Myers-Squibb will acquire an additional 5.0% ownership before December 31, at a 10% premium, and has been granted two warrants, each to acquire up to an additional 5% equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration. uniQure will also be eligible to receive research, development and regulatory milestone payments, including up to $254M for the lead S1A001 therapeutic and up to $217M for each other gene therapy product potentially developed under the collaboration. Additionally, uniQure is eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales.
07:37 EDTBMYBristol-Myers opportunity in renal cell over $2B, says JPMorgan
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May 22, 2015
10:52 EDTBMYJPMorgan says Actavis shares cheap compared to peers
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07:33 EDTBMYBristol-Myers receives positive CHMP opinion for Nivolumab
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May 21, 2015
07:37 EDTBMYPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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07:21 EDTBMYUBS to hold a conference
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May 19, 2015
08:57 EDTBMYLeerink biotech analyst holds an analyst/industry conference call
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07:56 EDTBMYGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
May 14, 2015
11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:22 EDTBMYLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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May 13, 2015
13:12 EDTBMYSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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