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News Breaks
January 14, 2014
07:06 EDTBMY, AGENAgenus initiates Prophage Phase 2 trial
Agenus (AGEN) announced initiation of a randomized Phase 2 trial with Prophage for melanoma, and Bristol-Myers Squibb's (BMY) Yervoy for the treatment of Stage III and IV metastatic melanoma. The combination has the potential to trigger a more effective immune response against the tumor than Yervoy alone. The Phase 2, randomized, open label, single-center, investigator-sponsored trial is designed to evaluate the safety, feasibility and immunogenicity of the combination of Prophage vaccine and Yervoy with or without low dose cyclophosphamide in 25 patients with unresectable Stage III or IV metastatic melanoma. Jorge Quesada, principal investigator of the study said "The combination may improve the prospects for patients who do not respond to ipilimumab alone, which is approximately 70% of the metastatic melanoma patients."
News For AGEN;BMY From The Last 14 Days
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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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07:08 EDTAGENAgenus reports Q4 EPS (41c), consensus (16c)
Reports Q4 revenue $1.62M, consensus $620K. Target Milestones for 2015 include: Publication of the Phase 2 data for Prophage in newly diagnosed GBM in a peer reviewed journal. Explore options for the advancement of Prophage for newly diagnosed GBM to a Phase 3 trial. Full Phase 3 data for partner GlaxoSmithKline’s HZ/su shingles vaccine are expected to be presented at a scientific conference and submitted for publication in a peer-reviewed journal. The vaccine contains Agenus’ proprietary QS-21 Stimulon adjuvant. EMA regulatory decision on GlaxoSmithKline’s malaria vaccine candidate RTS,S, which contains Agenus’s QS-21 Stimulon adjuvant. File Investigational New Drug applications for two checkpoint modulator antibody programs as part of our global oncology alliance with Incyte.
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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