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May 14, 2014
08:07 EDTBMY, CLDXCelldex to collaborate with Bristol-Myers on varlilumab/nivolumab combo therapy
Bristol-Myers Squibb (BMY) and Celldex Therapeutics (CLDX) announced that they have entered into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers' investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study. Multiple tumor types will be explored in the study, which could potentially include non-small cell lung cancer, metastatic melanoma, ovarian, colorectal and squamous cell head and neck cancers. Under the terms of this agreement, Bristol-Myers Squibb will make a one-time payment of $5M to Celldex and the parties will share development costs. Celldex will be responsible for conducting the Ph 1/2 study, which is expected to begin in the fourth quarter of 2014. Additionally, the parties have re-structured an existing agreement between Celldex and Medarex related to Celldex’s CD27 program, and waived certain future milestone payments and reduced future royalty rates that would have been due from Celldex to Medarex. Medarex was acquired by Bristol-Myers Squibb in September of 2009. The companies will work exclusively with each other to explore anti-PD-1 antagonist antibody and anti-CD27 agonist antibody combination regimens. Bristol-Myers Squibb will have a time-limited right of first negotiation if Celldex wishes to out-license varlilumab.
News For CLDX;BMY From The Last 14 Days
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November 24, 2015
07:01 EDTBMYBristol-Myers announces EC approved reconciliation of indications for nivolumab
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06:58 EDTBMYBristol-Myers announces FDA approval of Opdivo injection
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November 23, 2015
19:29 EDTBMYBristol-Myers receives FDA approval for Opdivo
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15:00 EDTBMYFDA approves Bristol-Myers drug to treat form of kidney cancer
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07:51 EDTCLDXCelldex should be bought on weakness, says Oppenheimer
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November 20, 2015
14:52 EDTCLDXCelldex up 17% to $16.98 after presenting long-term survival benefits of Rintega
14:38 EDTCLDXCelldex presents long-term survival benefits of Rintega
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November 18, 2015
12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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08:11 EDTBMYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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November 17, 2015
10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
November 11, 2015
05:40 EDTBMYFive Prime receives HSR clearance for collaboration agreement with Bristol-Myers
Five Prime (FPRX) announced that the FTC has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Acts of 1976 in connection with the exclusive worldwide license and collaboration agreement with Bristol-Myers (BMY) for the development and commercialization of Five Prime's colony stimulating factor 1 receptor antibody program, including FPA008. With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with BMS is effective as of November 10, 2015, and the related $350M upfront payment by BMS to Five Prime is due within 30 days of the effective date.

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