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News Breaks
May 19, 2014
08:04 EDTBMY, ABBVBristol-Myers, AbbVie granted breakthrough therapy designation for elotuzumab
Bristol-Myers Squibb (BMY) and AbbVie (ABBV) announced that the U.S. Food and Drug Administration has granted elotuzumab breakthrough therapy designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. The designation is based on findings from a randomized Phase 2, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials. Data from the Phase 2 trial were most recently presented at the 18th Annual Congress of the European Hematology Association in 2013.
News For BMY;ABBV From The Last 14 Days
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January 28, 2016
14:29 EDTABBVNotable companies reporting before tomorrow's open
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13:05 EDTABBVAbbVie volatility elevated into Q4 and outlook
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12:42 EDTBMYBristol-Myers says EU approves Daklinza for treatment of chronic hepatitis C
Bristol-Myers Squibb announced that the European Commission has approved Daklinza for the treatment of chronic hepatitis C in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. Daklinza is already approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza + sofosbuvir regimen is the only approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis. The new indications are based on data from the ALLY-1 clinical trial and ALLY-2 clinical trial. The recommended treatment regimens and durations are as follows:
09:27 EDTBMYBristol-Myers reports Q4 US revenue $2.3B
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09:27 EDTBMYBristol-Myers sees FY16 non-GAAP EPS $2.30-$2.40, consensus $2.29
Sees FY16 revenue up in mid-single digit range, consensus $17.4B. Sees FY16 gross margin as percentage of revenue ot be approximately 75%-76%. Sees FY16 marketing, sales and administrative expenses decreasing in mid-single digit range. Sees FY16 R&D expenses increasing in high-single digit range. Sees FY16 effective tax rate between 21%-22%.
09:25 EDTBMYBristol-Myers reports Q4 non-GAAP EPS 38c, consensus 28c
Reports Q4 revenue $4.29B, consensus $4.15B.
07:12 EDTABBVAbbVie intiates enrollment in Phase 3 clinical program for Elagolix
AbbVie (ABBV), in cooperation with Neurocrine Biosciences (NBIX), announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo. These studies are designed to assess the change in menstrual blood loss utilizing the alkaline hematin method, comparing baseline to month six of treatment. Additional secondary efficacy endpoints are being evaluated; including assessing changes in fibroid volume, monthly blood loss and hemoglobin levels. Bone mineral density will also be assessed.
07:11 EDTBMYBristol-Myers: DMC concluded that CheckMate Phase 3 study met primary endpoint
07:00 EDTBMYBristol-Myers says CheckMate-141 Opdivo Phase 3 trial stopped early
Bristol-Myers Squibb announced that a randomized Phase 3 study evaluating Opdivo versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon. "With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer." CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -141 data, and work with investigators on the future presentation and publication of the results.
05:54 EDTABBVStocks with implied volatility movement; EMR ABBV
Stocks with implied volatility movement; Emerson (EMR) 38, AbbVie (ABBV) 42 according to iVolatility.
05:37 EDTABBVAbbVie announces venetoclax granted Breakthrough Therapy Designation by FDA
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January 27, 2016
14:34 EDTBMYNotable companies reporting before tomorrow's open
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14:17 EDTBMYBristol-Myers technical comments before earnings news
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13:55 EDTBMYBristol-Myers volatility elevated into Q4 and outlook
Bristol-Myers Black & Decker January weekly call option implied volatility is at 49, February is at 30; compared to its 52-week range of 18 to 43, suggesting large near term price movement into the expected release of Q4 results on January 28.
12:19 EDTABBVPiper Jaffray biopharma analyst holds an analyst/industry conference call
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11:07 EDTABBVGilead sinks as Attorney General probes pricing strategy
Shares of drugmaker Gilead (GILD) are underperforming after Massachusetts Attorney General Maura Healey warned that her office may bring an unfair commercial conduct complaint against it related to the pricing for its Hepatitis C virus treatments Sovaldi and Harvoni. UNFAIR PRICING: Healey, in a letter addressed to Gilead CEO John Martin dated January 22 that has just been made public, said that her office is considering whether Gilead's pricing strategy for Sovaldi and Harvoni may constitute an "unfair trade practice" in violation of Massachusetts law. "Because Gilead's drugs offer a cure for a serious and life-threatening infectious disease, pricing the treatment in a manner that effectively allows HCV to continue spreading through vulnerable populations, as opposed to eradicating the disease altogether, results in massive public harm," Healey stated in her letter to Martin. Healey, who urged Gilead to adjust its pricing strategy, noted that the company has invoked the high cost and risk associated with research and development as a justification for its prices, but she said that Gilead quickly recouped its outlay to acquire Pharmasset by selling "$12.4B worth of HCV medication in the first year alone" after its deal. The AG, who said that Sovaldi costs $1,000 per pill in the U.S. but only $10 per pill in Egypt and about $4 per pill in India, contends that American taxpayers "have been footing the bill for Gilead's record profits." FREQUENT TARGET: The pricing of Gilead's hep C treatments have been the focus of significant criticism and political rhetoric in the past. In December, Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley released the results of an 18-month investigation into the pricing and marketing of Sovaldi and Harvoni. The company "pursued a marketing strategy and final wholesale price of Sovaldi - $1,000 per pill, or $84,000 for a single course of treatment - that it believed would maximize revenue," and "fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices," the senators wrote. Members of the Affordable Drug Pricing Task Force, who held a press conference last November to announce "meaningful action" to combat the "skyrocketing" costs of pharmaceuticals, specifically took aim at Sovaldi. During her campaigning efforts, presidential candidate Hillary Clinton has repeatedly decried the "outrageous" prices of specialty drugs. OTHERS TO WATCH: AbbVie (ABBV), Merck (MRK) and Johnson & Johnson (JNJ) also market or are at work on therapies for hepatitis C. PRICE ACTION: In morning trading, Gilead slid 2% to $90.35.
January 25, 2016
10:00 EDTBMYOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: American Eagle (AEO) downgraded to Hold from Buy at BB&T... American Express (AXP) downgraded on weak revenue outlook at Argus... Bristol-Myers (BMY) downgraded to Market Perform from Outperform at BMO Capital... Caterpillar (CAT) downgraded to Sell from Neutral at Goldman... Crestwood Equity (CEQP) downgraded to Neutral on potential distribution cut at Baird... Cummins (CMI) downgraded to Neutral from Buy at Citi... Federal Realty (FRT) downgraded to Hold from Buy at Evercore ISI... GKN PLC (GKNLY) downgraded to Neutral from Outperform at Credit Suisse... Galapagos NV (GLPG) downgraded to Neutral from Buy at GoldmanvHortonworks (HDP) downgraded to Perform from Outperform at Oppenheimer... International Flavors (IFF) downgraded on headwinds at Stifel... International Paper (IP) downgraded to Neutral from Buy at Citi... JPMorgan (JPM) downgraded to Neutral from Buy at Nomura... KapStone (KS) downgraded to Underperform from Neutral at Macquarie... Mosaic (MOS) downgraded to Neutral from Overweight at JPMorgan... NetSuite (N) downgraded to Equal Weight from Overweight at Stephens... ONEOK Partners (OKS) downgraded to Neutral at Baird... OvaScience (OVAS) downgraded to Perform from Outperform at Oppenheimer... Packaging Corp. (PKG) downgraded to Neutral from Buy at Citi... Potash (POT) downgraded to Neutral from Overweight at JPMorgan... Power Solutions (PSIX) downgraded to Neutral from Overweight at Piper Jaffray... Raymond James (RJF) downgraded to Neutral from Buy at Nomura... Regeneron (REGN) downgraded to Sell from Neutral at Chardan... SanDisk (SNDK) downgraded to Underperform from Outperform at CLSA... Toll Brothers (TOL) downgraded to Market Perform from Outperform at JMP Securities... Twitter (TWTR) downgraded to Hold from Buy at Stifel... WPX Energy (WPX) downgraded to Sector Perform from Outperform at Iberia... WestRock (WRK) downgraded to Neutral from Buy at BofA/Merrill... Whole Foods (WFM) downgraded to Underperform from Market Perform at BMO Capital... Zurich Insurance (ZURVY) downgraded to Neutral from Outperform at Exane BNP Paribas.
08:27 EDTBMYBristol-Myers downgraded at BMO Capital
As noted earlier, BMO Capital downgraded Bristol-Myers to Market Perform from Outperform. The firm says that its positive thesis on clinical catalysts for the company's Opdivo drug has "mostly materialized." Target to $70 from $74.
08:04 EDTBMYAgilent's Dako announces FDA expanded approval of Dako PD-L1 IHC 28-8 pharmDx
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06:05 EDTBMYBristol-Myers downgraded to Market Perform from Outperform at BMO Capital
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