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News Breaks
July 28, 2014
14:25 EDTABT, ABT, ATRC, ATRC, BSX, BSX, EW, EW, MDT, MDT, STJ, STJ, VOLC, VOLCLeerink medical devices analyst holds an analyst/industry conference call
Medical Devices Analyst Antalffy, along with MEDACorp Specialist Arie Pieter Kappetein, MD, PhD and Bernhard Meier, MD, assess EU cardiology trends on an Analyst/Industry conference call to be held on July 31 at 3 pm.
News For ABT;ATRC;BSX;EW;MDT;STJ;VOLC From The Last 14 Days
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March 20, 2015
06:44 EDTBSXBoston Scientific initiated with an Outperform at Raymond James
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March 18, 2015
10:00 EDTSTJOn The Fly: Analyst Downgrade Summary
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05:39 EDTBSX, STJ, MDTSt. 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 17, 2015
16:13 EDTBSXBoston Scientific announces FDA, CE Mark approval of EMBLEM S-ICD system
Boston Scientific has received FDA and CE Mark approval of the EMBLEM Subcutaneous Implantable Defibrillator, or S-ICD, system. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest, yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May and subsequent U.S. launch planned for the third quarter of 2015.
March 16, 2015
16:28 EDTEWOn The Fly: Closing Wrap
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13:16 EDTMDT, STJ, BSX, 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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09:22 EDTBSXOn The Fly: Pre-market Movers
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08:05 EDTSTJSt. Jude Medical data 'impressive,' says BMO Capital
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07:30 EDTEW, MDTAmerican College of Cardiology to hold an expo
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07:25 EDTBSXBoston Scientific Watchman indication 'very favorable,' says Bernstein
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07:22 EDTEW, MDTMedtronic Edwards Lifesciences data 'impressive,' says Bernstein
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March 15, 2015
15:27 EDTMDTMedtronic unveils data from high risk study of the CoreValve U.S. pivotal trial
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15:23 EDTMDTMedtronic unveils preclinical outcomes of its novel Drug-Filled Stent
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15:20 EDTMDTMedtronic announces outcomes for its next-generation CoreValve Evolut R System
Medtronic announced initial clinical outcomes for its next-generation CoreValve Evolut R System. At 30-days, the new recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population. Data from the Evolut R Study, which enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand, were unveiled today at the 64th Annual Scientific Session of the American College of Cardiology. The CoreValve Evolut R System is not approved for commercial use in the United States where it is currently undergoing clinical trials. "Initial clinical experience with the Evolut R system is remarkable and ushers in a new era of TAVR technology that provides increased confidence with recapturability, excellent procedural results, and impressive clinical outcomes," said Ian Meredith, M.D., of Monash Heart - Monash Health, Melbourne, Australia, who is one of the investigators of the study. "The 14 French equivalent delivery system allowed transfemoral access for most patients and the recapturable technology enabled implanters to optimize valve placement for improved annular sealing and reduced conduction disturbances without compromise on mortality or stroke."
14:16 EDTABTAbbott announces 'favorable' data from MitraClip study
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14:10 EDTEWEdwards Lifesciences announces data on Sapien 3 transcatheter aortic valve
Edwards Lifesciences announced that 30-day outcomes for high- and intermediate-risk patients treated with the Sapien 3 transcatheter aortic valve demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation. This first report of Sapien 3 data in the United States, and first report on intermediate risk transcatheter aortic valve replacement, TAVR, patients, was presented as part of the late-breaking clinical trials at the American College of Cardiology's 64th Annual Scientific Session in San Diego.
14:04 EDTEWEdwards Lifesciences announces clinical data for high-risk Sapien patients
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12:47 EDTSTJSt. Jude Medical announces new data analysis from CHAMPION trial
St. Jude Medical announced a new data analysis from the CHAMPION trial showing that heart failure, HF, patients with reduced ejection fraction on optimal doses of guideline directed medical therapy, GDMT, managed by pulmonary artery, PA, pressure monitoring with the CardioMEMS HF System had a 57% reduction in mortality and a 43% reduction in HF hospitalizations compared with patients on GDMT managed by the standard of care, SOC. These data show a strong improvement for patients managed by optimal GDMT and the CardioMEMS HF System in both mortality and hospitalizations over currently defined best practices.
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