New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
May 27, 2014
07:09 EDTBMY, INCY, MRKIncyte, Bristol-Myers enter agreement to evaluate two Immunotherapies
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 Q4 will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed. INCB24360 is currently in Phase I/II development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer. Incyte has also established a clinical agreement with Merck (MRK) to combine INCB24360 with Merck’s (MRK) anti-PD-1 immunotherapy checkpoint inhibitor in a non-small cell lung cancer study.
News For INCY;BMY;MRK From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent news | >>
July 24, 2015
11:02 EDTBMYBristol-Myers selects Jones Lang LaSalle for facility management
Subscribe for More Information
July 23, 2015
18:21 EDTBMYOn The Fly: Top stock stories for Thursday
Stocks began the session mixed on the heels of weak earnings reports from both Caterpillar (CAT) and 3M (MMM). The Nasdaq managed to spend most of the day in positive territory but joined the other averages in negative territory by mid-afternoon. Selling picked up momentum towards late afternoon, and by day’s end each of the averages were lower by more than 0.4%, with the Dow losing nearly 0.7%. ECONOMIC EVENTS: In the U.S., initial jobless claims fell to 255,000 in the week ended July 18, below the 278,000 first-time claims that were expected. The Leading Economic Indicators advanced 0.6% in June, exceeding expectations for a 0.3% increase. In Asia, the Shanghai Composite index advanced for a sixth straight session, adding another 2.4%. In Europe, the Greek Parliament voted to accept creditor terms for a new bailout, though a decision on when to reopen Greek financial markets was deferred to next week. COMPANY NEWS: Shares of General Motors (GM) finished the session up 3.96% to $31.50 after reporting earnings per share above analyst expectations. Other notable names rising following earnings reports include SanDisk (SNDK), Under Armour (UA), Southwest (LUV)... Caterpillar, meanwhile, dropped $2.86, or 3.59%, to $76.90 after cutting its yearly guidance during this morning's earnings report, with the company noting a "relatively stagnant" global economy. Also lower following earnings were Comcast (CMCSA, CMCSK), Bristol-Myers Squibb (BMY), Dunkin Brands (DNKN), and Boston Scientific (BSX). MAJOR MOVERS: Among the notable gainers was Cigna (CI), which rose $3.29, or 2.18%, to $154.36 after the Wall Street Journal reported last night that Anthem (ANTM) is nearing a deal to acquire the company for roughly $187, representing a total transaction value of over $48B. Adding to that report, CNBC's David Faber said on Thursday morning that Anthem will announce an agreement Friday to purchase Cigna for $188 per share, at a 45% equity, 55% cash split. Also higher were shares of numerous IT security companies, with FireEye (FEYE) advancing 4.53% and Palo Alto Networks (PANW) adding 2.33% after earnings reports from security firms Fortinet (FTNT) and F5 Networks (FFIV) beat on both top and bottom lines. Fortinet and F5, meanwhile, finished Thursday's session up 10.71% and 7.75% to $46.83 and $127.68, respectively. Among the noteworthy losers following earnings was McDonald's (MCD), which edged down 0.52% to $97.10 after noting that Q2 global comparable sales fell 0.7% for the quarter, including a 2% decline in U.S. same-store sales. Also lower was Hertz (HTZ), which declined 8.53% to $16.45 following a downgrade to Underweight at Morgan Stanley, with the research firm citing increased competition from Uber and similar mobility services. INDEXES: The Dow fell 119.12, or 0.67%, to 17,731.92, the Nasdaq lost 25.36, or 0.49%, to 5,146.41, and the S&P 500 declined 12.00, or 0.57%, to 2,102.15.
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
Subscribe for More Information
07:34 EDTBMYBristol-Myers raises FY15 adjusted EPS view to $1.70-$1.80 from $1.60-$1.70
Subscribe for More Information
07:31 EDTBMYBristol-Myers reports Q2 EPS 53c, consensus 36c
Subscribe for More Information
06:38 EDTBMYBristol-Myers' two Opdivo applications validated by European Medicines Agency
Subscribe for More Information
July 22, 2015
15:26 EDTBMYNotable companies reporting before tomorrow's open
Subscribe for More Information
07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
Subscribe for More Information
July 21, 2015
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
July 20, 2015
12:09 EDTBMYBristol-Myers says Nivolumab BMS approved in EU for SQ NSCLC
Subscribe for More Information
12:08 EDTBMYOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday in the first trading day of a week that will be light on domestic economic data but heavy on earnings reports. Investors will be receiving profit reports from about 25% of the companies on the S&P 500 this week, making this the highest volume earnings week of this season. ECONOMIC EVENTS: In the U.S., no major data was released. In Europe, Greece reopened its banks three weeks after closing as the country worked out another bailout agreement. The country announced it has started the process of paying off its creditors, including the European Central Bank and the International Monetary Fund, with a bridge loan it just received. COMPANY NEWS: Lockheed Martin (LMT) agreed to buy the Sikorsky Aircraft business from United Technologies (UTX) for $9B, noting the price is "effectively reduced" to $7.1B after taking into account tax benefits resulting from the transaction. Shares of Lockheed, which also reported better than expected second quarter results and increased its fiscal year guidance, gained nearly 2% after the Sikorsky announcement and saying it will conduct a strategic review of its government IT infrastructure services business and technical services business... Shares of Morgan Stanley (MS) shares were little changed near noon after the bank reported earnings and revenue, excluding certain adjustments, that topped analysts' consensus forecasts... SunEdison (SUNE) announced a deal to acquire Vivint Solar (VSLR) for approximately $2.2B, payable in a combination of cash, shares of SunEdison common stock and SunEdison convertible notes. In connection with the proposed acquisition of Vivint Solar, SunEdison has entered into a definitive purchase agreement with a subsidiary of TerraForm Power (TERP) which, concurrently with the completion of SunEdison's acquisition of Vivint, will acquire Vivint Solar's rooftop solar portfolio, consisting of 523 MW expected to be installed by year-end 2015, for $922M in cash. Shares of Vivint rose 44% following the announcement, while SunEdison's stock gained 4% and TerraForm dropped 3%. Fellow residential solar installer SolarCity (SCTY), which is backed by Tesla's (TSLA) Elon Musk, rose 7% following the deal in the space. MAJOR MOVERS: Among the notable gainers was Exelixis (EXEL), which rallied 43% after the company reported that a study of cabozantinib in metastatic renal cell carcinoma met its primary endpoint of significant improvement in progression-free survival. The shares were indicated to rise even more in early pre-market trading, but lost some of their gains after Bristol-Myers (BMY) announced that its Opdivo study was stopped early after showing superior overall survival in a Phase 3 study of previously treated patients with advanced or metastatic renal cell carcinoma. Bristol-Myers rose a bit less than 1% to trade near $70 per share after its own announcement. Also higher was PayPal (PYPL), which gained more than 5.5% in its first day of trading after being spun out of eBay (EBAY). Meanwhile, eBay shares rose over 2%. Cal-Maine Foods (CALM) dropped 8% after posting lower than expected sales and profits in its fourth quarter and warning that while it should have an adequate supply of its primary feed ingredients, the company expects that prices will be "volatile" in the year ahead. Also lower were shares of several gold miners, including Barrick Gold (ABX) and Newmont Mining (NEM), which each fell about 11%, as gold prices declined about 2% near midday. INDEXES: Near midday, the Dow was up 31.66, or 0.18%, to 18,118.11, the Nasdaq was up 9.81, or 0.19%, to 5,219.96, and the S&P 500 was up 2.82, or 0.13%, to 2,129.46.
08:28 EDTBMYExelixis off highs, but still up 34% after Bristol-Myers data
Subscribe for More Information
08:05 EDTBMYBristol-Myers says Phase III study evaluating Opdivo stopped early
Subscribe for More Information
07:33 EDTBMYInternational AIDS Society to hold a conference
Subscribe for More Information
July 16, 2015
09:22 EDTBMYBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
Subscribe for More Information
09:01 EDTBMYuniQure has reached compelling entry point, says Roth Capital
Subscribe for More Information
July 15, 2015
08:32 EDTBMYBristol-Myers Squibb, MUSC announce translational research collaboration
The Medical University of South Carolina, or MUSC, and Bristol-Myers Squibb (BMY) announced that they have entered into a translational research collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis. The agreement includes studies designed to improve the mechanistic understanding of fibrosis, explore patient segmentation based on disease characteristics and/or biomarker approaches and predictors of disease progression.
07:58 EDTINCYAnalysts break down impact of $7.2B Receptos buyout
After Celgene (CELG) announced last night that the company has agreed to acquire Receptos (RCPT) for $232 per share in cash, or a total of about $7.2B net of cash acquired, research firms have chimed in with their opinions on how the proposed deal may impact others in the biotech space. Receptos key asset is Ozanimod, which is being studied in Phase III trials for relapsing multiple sclerosis and ulcerative colitis. DERIVATIVE CALLS: Piper Jaffray analyst Edward Tenthoff told investors that he views Celgene's deal for Receptos as good for Arena Pharmaceuticals (ARNA). The analyst notes that Arena's APD334 is already showing dose-dependent decreases in circulating lymphocyte counts and that the company will initiate Phase II studies in ulcerative colitis and Crohn's disease this year. Tenthoff reiterates an Overweight rating and $7.50 price target on Arena, which has a market capitalization around $1B and closed yesterday up 8c to $4.47. In its own note to investors this morning, Nomura said Celgene's deal could put downward pressure on Biogen's (BIIB) long-term multiple sclerosis estimates. Nomura's M. Ian Somaiya contended that one-year Phase II efficacy data for Ozanimod looked as good as Novartis’s (NVS) Gilenya and Biogen's Tecfidera’s Phase III at year 2. Somaiya also wondered if rival Gilead (GILD) could be "looking for something bigger" than Receptos for its own deal, telling investors that the firm views Incyte (INCY) as Gilead's most likely takeout target. Incyte's shares closed up $4.46 at $117.46 yesterday, giving the company a market cap of about $20B. RIVAL BID?: Wedbush analyst Liana Moussatos believes another bidder may seek to acquire Receptos, noting that she previously estimated Receptos could be valued at $348 per share, or about $10.9B, in a buyout. Moussatos noted that Celgene said it expects annual peak sales for Ozanimod to reach about $4B-$6B for RMS and UC, making its acquisition price of $7.2BN only a bit more than about 1X peak sales without accounting for other possible indications or the rest of its pipeline. Moussatos told investors she sees "plenty" of potential upside to justify a rival bidder stepping in and reiterated the firm's Outperform rating on Receptos shares. PRICE ACTION: In pre-market trading, Receptos rose 10% to $228.61 while Gilead gained 1.4% to about $119 per share.
1 | 2 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use