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March 17, 2014
07:00 EDTBMY, FPRXFive Prime and Bristol-Myers sign collaborative agreement
Five Prime (FPRX) and Bristol-Myers (BMY) announced that they have signed a collaboration agreement for the discovery, development and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime’s proprietary target discovery platform. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize products directed toward certain protein targets identified by Five Prime prior to and during the collaboration. Bristol-Myers Squibb will make an upfront payment of $20M to Five Prime and provide up to $9.5M in research funding over the course of the research term. Additionally, Bristol-Myers Squibb will make a payment of approximately $21M to acquire 4.9% of Five Prime’s outstanding common stock purchased at approximately a 30% premium. Five Prime will be eligible to receive up to $300M in future development, regulatory and sales based milestone payments per collaboration target and tiered mid-single-digit rising to low-double-digit royalty payments on net sales of each product commercialized by Bristol-Myers Squibb.
News For FPRX;BMY From The Last 14 Days
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November 26, 2014
13:25 EDTBMYAchillion to benefit from Bristol-Myers CRL, says FBR Capital
FBR Capital expects Achillion (ACHN) to benefit from the complete response letter that the FDA sent to Bristol-Myers (BMY) on its daclatasvir HCV drug. The firm thunks the letter increases the value of GT-3 HCV patients for Achillion. FBR says that GT-3 patients constitute 5% of HCV patients in the U.S. and significantly higher in Europe. It keeps an Outperform rating on Achillion.
11:38 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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11:36 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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November 24, 2014
09:00 EDTFPRX, BMYBristol-Myers, Five Prime announce clinical collaboration for Opdivo, FPA008
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November 19, 2014
07:52 EDTBMYInforma Business Information to hold a conference
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06:07 EDTBMYBristol-Myers' Opdivo for melanoma shows positive Phase 3 results
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November 17, 2014
16:54 EDTFPRXFive Prime initiates dosing of RA patients in FPA008 Phase 1 clinical trial
Five Prime Therapeutics discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that the company has initiated dosing of rheumatoid arthritis, or RA, patients in its Phase 1 clinical trial of FPA008, a monoclonal antibody that inhibits colony stimulating factor-1 receptor, or CSF1R. FPA008 is being developed as a potential treatment for RA and solid tumors. FPA008 has two modes of action in RA, blocking the production of multiple inflammatory cytokines and directly inhibiting the activity of osteoclasts, thus preventing bone erosion.
11:06 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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08:13 EDTBMYPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-naïve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
November 16, 2014
13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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November 14, 2014
14:53 EDTBMYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTBMYAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
06:05 EDTBMYBristol-Myers to construct biologics manufacturing facility in Ireland
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