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News Breaks
February 1, 2014
16:51 EDTABBV, LLYFDA probes risk of cardiovascular events from testosterone product use
FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA said, "We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete." The Fly notes that products in this category include AndroGel from AbbVie (ABBV) and Axiron from Eli Lilly (LLY). Reference Link
News For ABBV;LLY From The Last 14 Days
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January 29, 2016
09:21 EDTABBVOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Gigamon (GIMO), up 17.7%... Fortinet (FTNT), up 10%... Flextronics (FLEX), up 10%... Skyworks (SWKS), up 5.7%... Seagate Technology (STX), up 4.9%.. Microsoft (MSFT), up 4.6%. ALSO HIGHER: Inovio Pharmaceuticals (INO), up 8.1% after CEO says Zika vaccine could enter human testing this year... J.C. Penney (JCP), up 2.1% after being upgraded to Neutral from Underperform at Credit Suisse... BRF S.A. (BRFS), up 3.1% after being upgraded to Buy from Hold at Deutsche Bank... Axiall (AXLL), up 83.4% after rejecting $20 per share acquisition proposal from Westlake Chemical (WLK)... Energous (WATT), up 12% after Bloomberg reported that Apple (AAPL) is working with partners in the U.S. and Asia to develop new wireless charging technology. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 10.1%... Electronic Arts (EA), down 6.2%... AbbVie (ABBV), down 4%... American Airlines (AAL), down 1.3%. ALSO LOWER: Gilead Sciences (GILD), down 5.5% after CEO John Martin to assume role of executive chairman and COO John Milligan will be promoted to CEO.
07:54 EDTABBVAbbVie backs FY16 adjusted EPS $4.90-$5.10, consensus $5.03
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07:54 EDTABBVAbbVie reports Q4 adjusted net revenue $6.36B, consensus $6.39B
Global HUMIRA sales increased 16% on an operational basis to $3.72B, excluding the impact of foreign exchange. Exceptional U.S. HUMIRA growth of 20.7% was driven by continued momentum across all three major market categories - rheumatology, dermatology and gastroenterology. International HUMIRA sales growth was also strong in the fourth quarter, up 9.7 percent on an operational basis. Reported international HUMIRA sales growth in the quarter was reduced by 13.1 percent due to unfavorable foreign exchange. Fourth-quarter global IMBRUVICA net revenue was $343 million, with U.S. sales of $295 million and international profit sharing of $48 million for the quarter.
07:52 EDTABBVAbbVie reports Q4 adjusted EPS $1.13, consensus $1.12
Reports Q4 revenue $6.40B, consensus $6.39B.
07:49 EDTABBVBristol-Myers, AbbVie receive 'positive' CHMP opinion for Empliciti
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05:20 EDTLLYEli Lilly, Adocia initiate Phase 1b study of BioChaperone Lispro U100
Adocia and Eli Lilly announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia's proprietary technology, BioChaperone, which is designed to enable the acceleration of insulin absorption. The study, under the Adocia-Lilly partnership, aims to compare the pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro to that of Humalog in 15 healthy Japanese subjects placed under euglycemic clamp.
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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09:55 EDTLLYEli Lilly nears test of key support at $80 area
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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.
06:29 EDTLLYEli Lilly backs FY16 adjusted EPS view of $3.45-$3.55, consensus $3.54
Backs FY16 revenue guidance of $20.2B-$20.7B, consensus $20.83B.
06:27 EDTLLYEli Lilly reports Q4 EPS 78c, consensus 78c
Reports Q4 revenue $5.38B, consensus $5.32B.
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
14:44 EDTLLYEli Lilly volatility elevated into Q4 and outlook
Eli Lilly January weekly call option implied volatility is at 54, February is at 29; compared to its 52-week range of 15 to 41, suggesting large near term price movement into the expected release of Q4 results on January 28.
14:34 EDTLLYNotable companies reporting before tomorrow's open
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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.
09:02 EDTLLYEli Lilly and Roche to collaborate on Alzheimer's diagnostic tool
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January 25, 2016
08:36 EDTLLYFDA accepts supplemental NDA for Eli Lilly and Boehringer's Jardiance
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