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August 18, 2014
04:55 EDTAGN, AGN, AGN, AGN, AGN, SHPG, SHPG, SHPG, SHPG, SHPG, REGN, REGN, REGN, REGN, REGN, PFE, PFE, PFE, PFE, PFE, ALXN, ALXN, ALXN, ALXN, ALXN, MRK, MRK, MRK, MRK, MRK, AZN, AZN, AZN, AZN, AZN, BMY, BMY, BMY, BMY, BMYCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
News For AGN;SHPG;REGN;PFE;ALXN;MRK;AZN;BMY From The Last 14 Days
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July 22, 2015
08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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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
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
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.
12:47 EDTREGNPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
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.
08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
07:05 EDTALXNOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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July 20, 2015
12:09 EDTBMYBristol-Myers says Nivolumab BMS approved in EU for SQ NSCLC
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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
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08:05 EDTBMYBristol-Myers says Phase III study evaluating Opdivo stopped early
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07:33 EDTBMYInternational AIDS Society to hold a conference
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07:05 EDTAGNAllergan Q2 to alleviate competitive concerns, says JPMorgan
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July 17, 2015
10:05 EDTAGNOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Accretive Health (ACHI) downgraded to Market Perform from Outperform at Cowen... Allergan (AGN) downgraded to Outperform from Top Pick at RBC Capital... Best Buy (BBY) downgraded to Underperform from Buy at BofA/Merrill... Cablevision (CVC) downgraded to Hold from Buy at Jefferies... Credit Suisse (CS) downgraded to Hold from Buy at Deutsche Bank... Domino's Pizza (DPZ) downgraded to Sector Weight from Overweight at KeyBanc... First Quantum Minerals (FQVLF) downgraded to Neutral from Outperform at Credit Suisse... First Republic (FRC) downgraded to Market Perform from Outperform at FBR Capital... Fresenius SE (FSNUY) downgraded to Neutral from Buy at Goldman... Golden Minerals (AUMN) downgraded to Neutral from Buy at Roth Capital... JD Wetherspoon (JDWPY) downgraded to Reduce from Neutral at Nomura... NV5 Holdings (NVEE) downgraded to Neutral from Accumulate at Global Hunter... National Oilwell (NOV) downgraded to Sell from Neutral at UBS... Natural Gas Services (NGS) downgraded to Neutral from Buy at Global Hunter... Primoris (PRIM) downgraded to Neutral from Accumulate at Global Hunter... Receptos (RCPT) downgraded to Hold from Buy at Evercore ISI... SKF AB (SKFRY) downgraded to Hold from Buy at Deutsche Bank... STAG Industrial (STAG) downgraded to Sell from Neutral at UBS... SolarWinds (SWI) downgraded to Hold from Buy at Deutsche Bank... Syntel (SYNT) downgraded to Market Perform from Outperform at William Blair... TECO Energy (TE) downgraded to Neutral from Buy at UBS... Tangoe (TNGO) downgraded to Underweight from Equal Weight at Barclays... Tegna (TGNA) downgraded to Hold from Buy at Evercore ISI.
06:39 EDTAGNAllergan downgraded to Outperform from Top Pick at RBC Capital
RBC Capital downgraded Allergan to Outperform and maintained its $361 price target. The firm sees few catalysts and is less confident near-term in P&L upside, but has left estimates unchanged. RBC Capital said there are several important products subject to competitive threats that could pressure sentiment but said valuation remains attractive against solid mid-teens multi-year earnings growth.
July 16, 2015
16:00 EDTPFEOptions Update; July 16, 2015
iPath S&P 500 VIX Short-Term Futures down 1.17 to 16.52 Option volume leaders: NFLX AAPL BAC FB F INTC C EBAY AMZN GM JPM MU PFE BABA JD X
09:22 EDTBMYBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
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09:01 EDTBMYuniQure has reached compelling entry point, says Roth Capital
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