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News Breaks
November 13, 2012
15:32 EDTEW, MDTMedtronic says appeals court ruling has no impact on CoreValve trials
Medtronic (MDT) confirmed that the Federal Circuit Court of Appeals affirmed the April 2010 jury verdict from the Federal District Court of Delaware that the CoreValve System infringed a single Andersen patent held by Edwards Lifesciences (EW). The Court of Appeals also remanded the case back to the District Court to consider a potential injunction. Medtronic said, "While Medtronic respects the court's ruling, we respectfully disagree with this conclusion and we are evaluating next steps...While Edwards has applied for a patent extension, there is no assurance an extension will be issued or what the impact or duration of that extension would be. These applications involve a review by two government agencies, and the process often can take between 2 and 5 years." Medtronic said the legal actions have no impact on the Medtronic CoreValve U.S. Pivotal Trial, the Medtronic CoreValve SURTAVI Trial, or any other clinical studies evaluating the CoreValve System. Due to its global manufacturing capabilities, Medtronic does not anticipate any interruption to the global supply of the Medtronic CoreValve System, the company added.
News For MDT;EW From The Last 14 Days
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March 25, 2015
16:05 EDTMDTMedtronic highlights data on patients undergoing laparoscopic colon resections
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March 24, 2015
10:08 EDTEWSenate Health, Education, Labor & Pensions Committee to hold a hearing
The Committee holds a hearing entitled, "Continuing America’s Leadership: Advancing Research and Development for Patients" with Chairman & CEO Mussallem of Edwards Lifesciences on March 24 at 10 am. Webcast Link
March 20, 2015
16:33 EDTEWStocks end week higher after market reads Fed statement as dovish
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March 18, 2015
05:39 EDTMDTSt. Jude Medical downgraded to Market Perform from Outperform at Wells Fargo
Wells Fargo downgraded St. Jude Medical (STJ) to Market Perform saying competitive pressures will drive 2015 market share losses in the company's cardiac rhythm management business, which represents 50% of total sales. Wells believes the launch of CardioMEMS will not be strong enough to offset the headwinds in CRM unit. The firm thinks Boston Scientific's (BSX) earlier than expected approval for its next generation subcutaneous implantable cardioverter-defibrillator called Emblem will drive share gains against St. Jude and Medtronic (MDT) in the single chamber ICD market. Wells cut its price target range for St. Jude shares to $69-$70 from $73-$74. The medical technology company closed yesterday down $2.01 to $65.45.
March 16, 2015
16:28 EDTEWOn The Fly: Closing Wrap
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13:16 EDTMDT, EWAnalysts upbeat on results of Edwards' Sapien 3 data
The shares of Edwards Lifesciences (EW) are rising after the company released data on its Sapien 3 transcathter aortic valve over the weekend. In notes to investors today, a number of analysts were upbeat on the data. BACKGROUND: Edwards yesterday announced that high- and intermediate-risk patients treated with Sapien 3 demonstrated lower mortality rates than patients treated with previous transcathter aortic valves, or TAVR, made by the company. The patients also had excellent clinical outcomes in the other primary endpoints of stroke and paravalvular regurgitation, the company stated. Meanwhile, a five year study of patients treated with the first generation SAPIEN device showed that the patients had equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention, the company stated. ANALYST REACTION: Edwards' Sapien 3 data was impressive, as the device showed one of the lowest stroke and mortality rates of any major TAVR study so far, Bernstein analyst Derrick Sung wrote in a note to investors earlier today. Data presented by Edwards and other companies at the American College of Cardiology, or ACC, conference this weekend caused investors and the medical community to become more optimistic about the potential for TAVR devices to replace surgical valves, Sung stated. The analyst wrote that he continues to believe that investors are underestimating the potential size of the TAVR market. Also upbeat on Edwards' data was Wells Fargo, which wrote that the data exceeded high expectations and could pressure the FDA to approve Sapien 3 for intermediate risk patients earlier than Edwards' guidance of late 2016. WHAT'S NOTABLE: Analysts were also upbeat on data reported by other companies at the ACC conference. Medtronic's (MDT) data suggested that its CoreValve Evolut-R product may be as effective as Edwards' Sapien 3, Bernstein's Sung stated. The FDA appears to have allowed Boston Scientific's (BSX) left atrial appendage closure, Watchman, to be provided to more patients than expected, research firm Stifel believes. Meanwhile, St. Jude's (STJ) CardioMEMS device yielded "impressive" mortality data, the firm added. Stifel kept Buy ratings on both Medtronic and St. Jude. PRICE ACTION: In early afternoon trading, Edwards Lifesciences climbed 9% to $147.64, Boston Scientific advanced 4% to $17.27, St. Jude added 2% to $67.55, and Medtronic rose 1.3% to $77.50.
12:43 EDTEWOn The Fly: Midday Wrap
Stocks on Wall Street were higher at midday after stimulus talk out of China and a rally in European stock markets lifted the U.S. market at the open. There was little reaction to the day’s domestic economic reports, which included the Empire manufacturing index, industrial production data, and a homebuilder confidence index. The week's big economic news, however, is yet to come, as investors look forward to the conclusion of the Federal Reserve's latest rate setting meeting on Wednesday. ECONOMIC EVENTS: In the U.S., the Empire State manufacturing index dipped to 6.9 in March, versus the consensus forecast for a reading of 8.0. Industrial production edged up 0.1% in February, versus expectations for an increase of 0.2%, and capacity utilization fell to 78.9%, versus the 79.5% consensus forecast. The NAHB homebuilder sentiment index dropped to 53 in March from 55 in February, missing expectation for the index to rise to 56. Oil prices continued to tumble, with U.S. crude dropping to a six-year low below $44 per barrel earlier in the session. In Asia, Chinese Premier Li Keqiang said Sunday that his government has room and the tools to take action should growth falter, without detailing specific remedies the government might pursue. COMPANY NEWS: Valeant (VRX), which not long ago lost out to Actavis (ACT) in the race to buy Allergan (AGN), increased its chances of making sure its latest buyout deal gets done by increasing its takeover offer to Salix Pharmaceuticals (SLXP) by about $1B. Rival bidder Endo Health (ENDP) confirmed that it is withdrawing its cash and stock proposal to acquire Salix after Valeant raised its all-cash bid for Salix to $173 per share from $158 per share. Shares of Valeant and Salix both rose about 2%, while Endo shares gained 2.5% following the announcements. MAJOR MOVERS: Among the notable gainers was Life Time Fitness (LTM), which rose 5% after entering into a definitive agreement to be acquired by private equity firms Leonard Green & Partners and TPG in a transaction valued at more than $4B, or $72.10 per share, in cash. Also higher was Edwards Lifesciences (EW), which rose 8% after the company reported data at this weekend's American College of Cardiology conference. Among the noteworthy losers was iDreamSky (DSKY), which dropped more than 25% after the company lowered its guidance because the launch of a popular casual game was delayed on one of the company distribution platforms and the monetization of another popular casual game was less than expected. Also lower were shares of Enzo Biochem (ENZ), which fell 17% after an appeals court reversed-in-part and vacated-in-part the judgment in Enzo’s favor that Life Technologies' (LIFE) Applera Corp. infringed certain Enzo patents. INDEXES: Near midday, the Dow was up 174.81, or 0.98%, to 17,924.12, the Nasdaq was up 39.80, or 0.82%, to 4,911.55, and the S&P 500 was up 20.07, or 0.98%, to 2,073.47.
10:07 EDTEWHigh option volume stocks
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07:30 EDTEW, MDTAmerican College of Cardiology to hold an expo
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07:22 EDTMDT, EWMedtronic Edwards Lifesciences data 'impressive,' says Bernstein
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