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News Breaks
March 31, 2014
13:41 EDTNVS, MRKNovartis rises after committee recommends early closure of study
Shares of drug maker Novartis (NVS) are climbing after the Data Monitoring Committee of its PARADIGM-HF study, which tested LCZ696 in comparison to patients who received standard care with enalapril, unanimously recommended early closure of the trial due to the drug's efficacy. WHAT'S NEW: Novartis announced that the committee unanimously recommended early closure of the study, indicating patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial was closed early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. One of the two principal investigators, Dr. Milton Packer, said, "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure." The company said the results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing. WHAT'S NOTABLE: Novartis said that the PARADIGM-HF study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken. LCZ696 is a medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 for acute heart failure. The standard ACE-inhibitor enalapril has been marketed as VASOTEC in the U.S. by Merck (MRK). Several companies sell generic enalapril under the name enalapril maleate tablets. PRICE ACTION: During afternoon trading, shares of Novartis were up by $3.31 or 4%, to $84.90.
News For NVS;MRK From The Last 14 Days
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January 29, 2016
07:53 EDTNVSNovartis management to meet with JPMorgan
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07:37 EDTNVSRadius Health should be bought aggressively at current prices, says Canaccord
Canaccord said they would be aggressive buyers of Radius Health (RDUS) especially at current share prices. The firm cited its partnership with Novartis (NVS), its drug pipeline, and expectations for an FDA filing of abaloparatide in the first quarter of 2016. Canaccord reiterated its Buy rating and $85 price target on Radius Health shares.
05:33 EDTMRKStocks with implied volatility movement; VRX MRK
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January 28, 2016
19:02 EDTMRKMerck receives FDA approval of Zepatier
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18:37 EDTMRKFDA approves Merck's Zepatier for chronic hepatitis C
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12:09 EDTNVSRadius Health to hold a conference call
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09:38 EDTNVSNovartis downgraded to Neutral from Outperform at Exane BNP Paribas
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07:08 EDTMRKFDA PDUFA Date for Merck's Grazoprevir/Elbasvir is January 28, 2016
January 27, 2016
16:33 EDTNVSRadius Health announces clinical collaboration with Novartis
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12:19 EDTNVS, MRKPiper Jaffray biopharma analyst holds an analyst/industry conference call
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11:07 EDTMRKGilead 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.
10:00 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
08:36 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
05:22 EDTNVSNovartis sees FY16 revenue, core operating income in line with FY15
Group net sales and core operating income in 2016 are expected to be broadly in line with the prior year, after absorbing the impact of generic competition. Generic competition impact on sales is expected to be as much as $3.2B compared to $2.2B in 2015.
05:20 EDTNVSNovartis reports Q4 core EPS $1.14, consensus $1.18
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January 26, 2016
14:32 EDTNVSNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include Novartis (NVS), consensus $1.18... Boeing (BA), consensus $1.26... United Technologies (UTX), consensus $1.52... Biogen (BIIB), consensus $4.08... EMC (EMC), consensus 65c... General Dynamics (GD), consensus $2.38... Anthem (ANTM), consensus $1.22... Illinois Tool Works (ITW), consensus $1.21... State Street (STT), consensus $1.18... Norfolk Southern (NSC), consensus $1.24... Progressive (PGR), consensus 47c... St. Jude Medical (STJ), consensus $1.01... Rockwell Automation (ROK), consensus $1.33... Textron (TXT), consensus 83c... Hess (HES), consensus ($1.47)... Cliffs Natural (CLF), consensus (26c).
11:34 EDTNVSJuno, Kite valuations at risk following study, TheStreet's Feuerstein says
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