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News Breaks
May 21, 2014
11:09 EDTMRK, GILD, BMY, ABBVGilead sees new pushback over price of hepatitis C drug
An insurance trade group harshly criticized Gilead (GILD) for charging too much for its hepatits C drug, while Florida has reportedly restricted the ability of Medicaid recipients to receive the drug. WHAT'S NEW: The price that Gilead is charging for its HCV treatment Sovaldi is "astronomical," America's Health Insurance Plans stated on its blog yesterday. The drug has shown "tremendous results" and is the "kind of medical innovation we need to sustain," but the price is not sustainable for consumers or society and is the result of Gilead taking "advantage of a lack of competition," according to the group, which represents the health insurance industry. Meanwhile, Florida has restricted the ability of Medicaid patients in the state to access Sovaldi, Bank of America Merrill Lynch reported in a note to investors earlier today. The firm wrote that Florida's decision supports its thesis that payers will increasingly limit access to expensive drugs. WHAT'S NOTABLE: In late March, shares of Gilead fell after three Democratic members of the House Committee on Energy and Commerce said they were concerned about the price the company is charging for Sovaldi. In a letter to Gilead's CEO, the House members stated that reports have indicated that Gilead plans to charge $84,000 per treatment for Sovaldi and that they were concerned that the drug would not be able to cure patients if it cannot be afforded. Sovaldi's costs are likely to be too high for many patients, including those with both public and private insurance, the lawmakers contended, adding that the FDA's decision to speed the approval of Sovaldi makes the high price of the drug even more problematic. They requested that the company provide more information about its methodology for determining Sovaldi's prices and they sought information about any discounts the company is providing to low income patients. Other companies that are developing HCV drugs include AbbVie (ABBV), Bristol-Myers Squibb (BMY), and Merck (MRK). PRICE ACTION: In mid-morning trading, Gilead rose 24c, or 0.3%, to $81.38. Over the last three months, Gilead shares are down about 1.5%.
News For GILD;ABBV;BMY;MRK From The Last 14 Days
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January 28, 2016
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
07:08 EDTMRKFDA PDUFA Date for Merck's Grazoprevir/Elbasvir is January 28, 2016
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 EDTABBV, MRKPiper Jaffray biopharma analyst holds an analyst/industry conference call
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11:07 EDTGILD, ABBV, MRKGilead 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.
10:38 EDTGILDGilead trades near session lows
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10:00 EDTMRKOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: BG Group (BRGYY) downgraded to Neutral from Outperform at Credit Suisse... Bed Bath & Beyond (BBBY) downgraded to Sell from Neutral at Citi... Bill Barrett (BBG) downgraded to Neutral from Buy at Ladenburg... Brown & Brown (BRO) downgraded to Underweight at Morgan Stanley... Buffalo Wild Wings (BWLD) downgraded to Neutral from Buy at BTIG... Canadian National (CNI) downgraded to Market Perform from Outperform at Raymond James... DreamWorks (DWA) downgraded to Sell from Hold at Topeka... FirstMerit (FMER) downgraded at RBC Capital... Gentex (GNTX) downgraded to Neutral from Outperform at Baird... Haverty Furniture (HVT) downgraded to Sector Weight from Overweight at KeyBanc... Hercules Technology (HTGC) downgraded to Neutral from Buy at Compass Point... Horizon Technology (HRZN) downgraded to Market Perform from Outperform at Raymond James... Installed Building downgraded to Sector Weight from Overweight at KeyBanc... Jarden (JAH) downgraded to Neutral from Buy at Citi... K+S (KPLUF) downgraded to Sell from Hold at Berenberg... La-Z-Boy (LZB) downgraded at BB&T... Legacy Reserves (LGCY) downgraded to Market Perform from Outperform at FBR Capital... Medivation (MDVN) downgraded to Hold from Buy at Canaccord... Merck (MRK) downgraded to Neutral from Buy at BofA/Merrill... Metaldyne Performance (MPG) downgraded to Neutral from Outperform at Baird... Pier 1 Imports (PIR) downgraded to Sector Weight from Overweight at KeyBanc... Priceline (PCLN) downgraded to Neutral from Buy at Goldman... Profire Energy (PFIE) downgraded to Neutral from Buy at Chardan... Regeneron (REGN) downgraded to Hold at Canaccord... Starwood (HOT) downgraded to Underperform from Outperform at CLSA... Swiss Re (SSREY) downgraded to Equal Weight from Overweight at Morgan Stanley... TSYS (TSS) downgraded to Equal-Weight from Overweight at First Analysis... Talmer Bancorp (TLMR) downgraded to Sector Perform from Outperform at RBC Capital... TopBuild (BLD) downgraded to Sector Weight from Overweight at KeyBanc... TripAdvisor (TRIP) downgraded to Sell from Neutral at Goldman... VMware (VMW) downgraded to Hold from Buy at Summit Research... W.R. Grace (GRA) downgraded to Buy from Conviction Buy at Goldman... WEC Energy (WEC) downgraded to Neutral from Conviction Buy at Goldman... Welltower (HCN) downgraded to Underperform from Market Perform at BMO Capital... Yamana Gold (AUY) downgraded to Neutral from Overweight at JPMorgan.
09:32 EDTMRKActive equity options trading on open
Active equity options trading on open: AAPL FB AMZN AAL BAC PCLN NFLX MRK GOOG
08:52 EDTGILDMassachusetts AG warns Gilead hep C drug prices may be unfair, Boston Globe says
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08:36 EDTMRKMerck downgraded to Neutral on lack of catalysts at BofA/Merrill
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08:31 EDTMRKMerck says FDA accepts for review BLA for investigational antitoxin
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08:29 EDTMRKMerck downgraded to Neutral from Buy at BofA/Merrill
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