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Stock Market & Financial Investment News

News Breaks
June 16, 2014
16:27 EDTKPTI, FIO, DWA, MDT, BLUE, SNDK, COVOn The Fly: Closing Wrap
Stocks on Wall Street were slightly higher as M&A news competed with Iraq for headlines. There was little reaction to the day’s economic data, including industrial production in May and the Empire State manufacturing report for June. The averages moved in a narrow range near the flat-line throughout the session, with each of the major averages managing to notch small gains. ECONOMIC EVENTS: In the U.S., industrial production increased 0.6% in May, versus an expected increase of 0.5%, while capacity utilization rose slightly to 79.1%. The NY Fed Empire state survey for June ticked up to a four-year high of 19.3, which was higher than expected. The NAHB homebuilder survey index climbed to 49 in June, beating expectations for it to rise from its previous reading of 45 to 47. COMPANY NEWS: A number of merger and acquisition deals were announced, headlined by a another pharmaceutical industry mega-merger. Medtronic (MDT) agreed to acquire Ireland's Covidien (COV) in a cash-and-stock transaction valued at $93.22 per Covidien share, or a total of approximately $42.9B based on Medtronic's closing stock price on June 13. Following the deal announcement, Covidien shares trading in New York rose $14.73, or 20.45%, to $86.75. Medtronic, which also raised its dividend by 9% this morning, was upgraded at both William Blair and JPMorgan, though its shares declined 67c, or 1.1%, to $60.03. MAJOR MOVERS: Among the notable gainers was Bluebird bio (BLUE), which surged $8.37, or 32.08%, to $34.46 after reporting data that Piper Jaffray believes solidifies LentiGlobin prospects in one indication and positions it attractively for another indication that is also being pursued for the drug. Also higher was Fusion-io (FIO), which jumped $2.08, or 22.41%, to $11.36, which was above the $11.25 per share in cash that SanDisk (SNDK) agreed to pay to acquire the company. Among the noteworthy losers was Karyopharm Therapeutics (KPTI), which fell $5.90, or 12.52%, to $41.22 after announcing that the FDA Center for Veterinary Medicine has found the effectiveness and safety technical sections complete to support conditional approval under a New Animal Drug Application for Karyopharm's compound Verdinexor for the treatment of canine lymphoma. As part of conditional marketing approval, the sponsor is required to conduct a full, often randomized, study, to confirm the activity of the conditionally approved agent within five years, Karyopharm noted. Also lower were shares of DreamWorks Animation (DWA), which dropped $3.00, or 10.97%, to $24.35 after its latest film, "How to Train Your Dragon 2," didn't do as well as analysts had expected in its box-office debut. INDEXES: The Dow was up 5.27, or 0.03%, to 16,781.01, the Nasdaq was up 10.45, or 0.24%, to 4,321.11, and the S&P 500 was up 1.62, or 0.08%, to 1,937.78.
News For COV;MDT;FIO;SNDK;DWA;KPTI;BLUE From The Last 14 Days
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May 6, 2015
16:11 EDTBLUEbluebird bio reports Q1 EPS (76c), consensus (61c)
Reports Q1 revenue $6.34M, consensus $6.16M.
May 5, 2015
09:32 EDTMDTMedtronic announces FDA clearance, US launch of Euphora coronary balloon
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May 4, 2015
14:03 EDTMDTMedtronic announces launch of Divergence Stand Alone Interbody Cage
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10:02 EDTMDTMedtronic receives FDA clearance for ZEVO anterior cervical plate system
Medtronic announced it has received 510(k) clearance from the FDA to market the ZEVO Anterior Cervical Plate System. This system is now commercially available for the treatment of cervical degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions.
07:23 EDTCOVAmerican Association of Neurological Surgeons to hold annual meeting
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07:12 EDTCOVAmerican Congress of Obstetrics and Gynecology
2015 ACOG Annual Clinical & Scientific Meeting is being held in San Francisco on May 2-6.
May 3, 2015
18:11 EDTMDTSiemens investigated by Chinese regulator last year, Reuters says
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April 30, 2015
16:17 EDTDWADreamWorks reports Q1 adjusted EPS (25c), consensus (45c)
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09:22 EDTMDTMedtronic initiates study of AF treatment with ablation procedures combination
Medtronic announced the start of a clinical study using Medtronic technologies to determine whether paroxysmal and persistent atrial fibrillation, or AF, can be treated with a combination of two ablation procedures targeting different anatomical locations - specifically, the pulmonary veins and the renal arteries. Study patients will also receive an implantable cardiac monitor to track their heart rhythm on an automatic and continuous basis. Patients in both arms of the trial also will receive a Reveal LINQ Insertable Cardiac Monitor to automatically and continuously detect and record the net recurrence of abnormal heart rhythms after therapy randomization. This more comprehensive method of cardiac monitoring will provide greater detail and accuracy about the treatment effect of combination therapy with PVI and renal denervation versus PVI alone. SYMPLICITY AF will enroll up to 245 patients in up to 12 centers throughout the United States. Seventy of these patients meeting all inclusion but no exclusion criteria and thus determined to be eligible for the trial will then be randomized to either PVI and RDN or PVI alone; all randomized subjects will receive a Reveal LINQ ICM. The primary safety endpoint is comprised of events related to both the PVI and RDN procedures. The primary efficacy endpoint will measure freedom of chronic treatment failure, defined as AF lasting 30 seconds or longer or the requirement for an intervention for atrial fibrillation through a minimum of six months. Heart rhythm data from the Reveal LINQ ICM will be reviewed monthly.
April 29, 2015
06:49 EDTMDTMedtronic's stent graft system shows positive results
Medtronic's Endurant AAA stent graft system delivered positive results for endovascular repair of abdominal aortic aneurysmsin patients with short and standard neck lengths who were enrolled in the global ENGAGE registry. Delivery and deployment was successful in 99.4% of the patients with a standard neck and in 100% of the patients with a short neck. Through four years, the two groups showed similar results in terms of secondary endovascular procedures, ruptures or conversions to open repair, and no main body migrations were reported in any of the patients.
06:49 EDTBLUEbluebird bio price target raised to $186 from $119 at Piper Jaffray
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April 28, 2015
10:11 EDTBLUEPiper Jaffray biotech analysts hold an analyst/industry conference call
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April 27, 2015
15:35 EDTMDTMedtronic announces consent decree with FDA for Synchromed system
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15:31 EDTMDTFDA enters consent decree with Medtronic
The FDA announced the filing of a consent decree against Medtronic and two of the company’s officers—S. Omar Ishrak and Thomas Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured. The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment. The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
11:02 EDTMDTMedtronic begins clinical study of Endurant Evo AAA strent graft system
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09:22 EDTBLUEOn The Fly: Pre-market Movers
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08:17 EDTBLUEbluebird bio, uniQure slide after Celladon trial misses endpoints
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April 23, 2015
11:11 EDTKPTIKaryopharm management to meet with Maxim
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10:00 EDTBLUEOn The Fly: Analyst Initiation Summary
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06:01 EDTSNDKStocks with implied volatility below IV index mean; SNDK NFLX
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