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August 8, 2014
10:03 EDTBMYBristol-Myers Hodgkin lymphoma treatment granted orphan drug status
Bristol-Myers' nivolumab was designated for orphan drug status as a treatment of Hodgkin lymphoma, the FDA stated in a post to its site. Reference Link
News For BMY From The Last 14 Days
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March 4, 2015
14:28 EDTBMYBristol-Myers announces FDA approval of added Opdivo indication
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13:58 EDTBMYBristol-Myers jumps 4% to $64.23 after FDA approves Opdivo for lung cancer
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13:40 EDTBMYFDA expands use of Opdivo to treat lung cancer
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05:25 EDTBMYBristol-Myers signs exclusive agreement with Bavarian Nordic for Prostvac
Bavarian Nordic and Bristol-Myers Squibb announced an agreement that provides Bristol-Myers Squibb an exclusive option to license and commercialize Prostvac, Bavarian Nordic’s investigational Phase 3 prostate-specific antigen, or PSA,-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer, or mCRPC. Under terms of the agreement, Bavarian Nordic will receive an upfront payment of $60M. Bristol-Myers Squibb can exercise the option in its sole discretion within a designated time after data is available from the ongoing Phase 3 trial. Bavarian Nordic would be entitled to a payment of $80M upon exercise of the option plus additional incremental payments starting at $50M, but with a potential to exceed $230M should the median overall survival benefit of Prostvac exceed the efficacy seen in Phase 2 results. Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110M, up to $495M in sales milestones as well as tiered double-digit royalties on future sales of Prostvac. The parties have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of Prostvac. An investigator sponsored Phase 2 study is currently in the planning stages to investigate the combination of Bristol-Myers Squibb’s Yervoy and Prostvac. The companies have also entered into an agreement by which they may conduct one or more exploratory combination studies of Prostvac and agents from Bristol-Myers Squibb’s immuno-oncology portfolio.
March 3, 2015
11:46 EDTBMYLeerink biotech analyst holds an analyst/industry conference call
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07:16 EDTBMYCowen to hold a conference
35th Annual Health Care Conference is being held in Boston on March 2-4 with webcasted company presentations to begin on March 3 at 8 am; not all company presentations may be webcasted. Webcast Link
06:02 EDTBMYBristol-Myers reports hepatitis C cure rate of 97% in study
A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with HIV. This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection. Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks, 97% achieved cure. The ALLY-2 study met the primary endpoint, with 96% of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase. In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
March 2, 2015
09:28 EDTBMYBristol-Myers says FDA accepts Yervoy sBLA for review
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07:20 EDTBMYCowen to hold a conference
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February 27, 2015
13:35 EDTBMYBristol-Myers reports FDA accepts BLA for Opdivo
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08:29 EDTBMYBristol-Myers price target raised to $78 from $70 at Argus
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February 26, 2015
15:23 EDTBMYBristol-Myers reports ALLY trial demonstrates 97% hepatitis C cure rates
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08:35 EDTBMYBristol-Myers says BMS-966176 Phase IIa study met primary endpoint
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February 25, 2015
08:36 EDTBMYBristol-Myers announces data from Phase IIb BMS-663068 trial
Bristol-Myers Squibb Company announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor, virologic response rates and immunologic reconstitution were similar across the BMS-663068 and Reyataz/ritonavir arms of the trial through 48 weeks. Specifically, 61-82% of BMS-663068 patients had HIV-1 RNA levels <50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48. HIV-1 RNA levels <50 c/mL typically indicate virus replication is undetectable. Treatment with BMS-663068 resulted in no dose response safety signals, no treatment discontinuations related to adverse events, and no treatment-related serious adverse events over the course of the trial. The most common AEs were headache and abdominal pain. Due to the positive results seen thus far, a Phase III clinical trial of the attachment inhibitor among heavily treatment-experienced patients began on Monday, February 23, 2015. For the purposes of the Phase III trial, heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications. The Phase IIb study results, presented yesterday at the 22nd Conference on Retroviruses and Opportunistic Infections, highlight the novel mechanism of action of the investigational prodrug BMS-663068, which when converted into its active moiety BMS-626529, is designed to bind directly to the HIV gp120 protein, and prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
February 24, 2015
07:46 EDTBMYJacobs Engineering awarded contract from Bristol-Myers
Jacobs Engineering Group (JEC) announced that it received a contract from Bristol-Myers Squibb Company (BMY) to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. The facility is being designed 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.
February 23, 2015
12:21 EDTBMYOn The Fly: Midday Wrap
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08:15 EDTBMYRigel Pharmaceuticals and Bristol-Myers announces R&D collaboration agreement
Rigel Pharmaceuticals (RIGL) and Bristol-Myers (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel's extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system's activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb's Opdivo and Yervoy. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel's TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:06 EDTBMYBristol-Myers, Rigel enter R&D agreement for TGF beta receptor kinase inhibitors
Rigel Pharmaceuticals (RIGL) and Bristol-Myers Squibb (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb’s Opdivo, or nivolumab, and Yervoy, or ipilimumab. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel’s TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:01 EDTBMYBristol-Myers to acquire Flexus, potential total consideration may be $1.25B
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February 20, 2015
07:23 EDTBMYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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