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News Breaks
May 27, 2014
07:02 EDTINCY, BMYBristol-Myers, Incyte enter collaboration agreement for nivolumab, INCB24360
Bristol-Myers Squibb (BMY) and Incyte (INCY) announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 inhibitor, INCB24360, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include melanoma, non-small cell lung, ovarian, colorectal, squamous cell carcinoma of the head and neck and diffuse large B-cell lymphoma. The study, which is expected to begin in 4Q, will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed.
News For BMY;INCY From The Last 14 Days
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September 2, 2015
17:20 EDTBMYBristol-Myers to hold a conference call
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08:04 EDTBMYBristol-Myers says FDA accaepts sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental Biologics License Application for Opdivo for the treatment of previously treated patients with non-squamous non-small cell lung cancer. This sBLA seeks to expand the current indication for Opdivo in patients with previously treated squamous NSCLC. The projected FDA action date is January 2, 2016. The agency has also granted this application priority review, and Opdivo Breakthrough Therapy Designation for this indication, underscoring the need for new treatments for this patient population, where currently a significant unmet medical need remains. According to the FDA, the criteria for Breakthrough Therapy Designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. The submission is based on CheckMate -057, a Phase 3 study that evaluated the survival of patients with NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The positive results of a separate study, Checkmate -017, formed the basis of the current lung cancer indication; study -017 evaluated the survival of patients with SQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. In both studies Opdivo demonstrated an overall survival benefit.
05:36 EDTINCYIncyte announces global license agreement with Jiangsu Henrui Medicine
Incyte announced a global license and collaboration agreement with Jiangsu Hengrui Medicine for the development and commercialization of SHR-1210, an investigational anti-PD-1 monoclonal antibody. Under the agreement, Incyte will have the exclusive development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan. SHR-1210 is expected to enter proof-of-concept studies for the treatment of patients with advanced solid tumors in the coming months. Under the terms of the agreement, Incyte will acquire development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan, in exchange for an upfront payment of $25M. The terms also include potential milestone payments of up to $770 million to Hengrui, consisting of $90M for regulatory approval milestones, $530M for commercial performance milestones, and $150M based on clinical superiority. The terms also include tiered royalties to Hengrui on net sales of SHR-1210 in Incyte territories. Under the Agreement, Incyte and Hengrui will assume all financial obligations associated with the development and commercialization of SHR-1210 in their respective territories.
September 1, 2015
07:31 EDTBMYBristol-Myers, AbbVie say FDA accepts BLA for Empliciti for priority review
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07:07 EDTBMYHeat Biologics announces clinical trial combining HS-110, PD-1 in NSCLC
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August 31, 2015
09:11 EDTBMYEuropean Society of Cardiology
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08:32 EDTBMYBristol-Myers reports agreement providing exclusive right to acquire Promedior
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August 30, 2015
19:07 EDTBMYBristol-Myers partners with QIMR Berghofer for immuno-oncology research
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August 28, 2015
07:59 EDTBMYBristol-Myers management to meet with Leerink
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August 27, 2015
10:35 EDTBMYBristol-Myers calls active
Bristol-Myers August weekly 61 and 61.5 calls are active on total call volume of 7K contracts (4K puts). August weekly call option implied volatility is at 35, September is at 34, October is at 28; compared to its 52-week range of 14 to 36. Active call volume suggests traders taking positions for price movement.
07:51 EDTBMYRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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05:28 EDTBMYAllied-Bristol Life Sciences announces licensing agreement with Yale University
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August 24, 2015
09:45 EDTBMYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
08:16 EDTBMYBristol-Myers, Pfizer to present new data on Eliquis at ESC Congress 2015
Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) announced that 22 abstracts will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance's commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation and venous thromboembolism patient populations. In addition, data from the AEGEAN study evaluating adherence among NVAF patients further extends the Alliance's commitment to patient care.
07:08 EDTBMYBristol-Myers upgraded to Neutral from Underweight at Piper Jaffray
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August 23, 2015
12:35 EDTINCY, BMYBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
08:55 EDTINCYIncyte management to meet with JPMorgan
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