Stockwinners Market Radar for September 23, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

CMCSA...

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19:30 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Comcast (CMCSA; CMCSK) announced that it has prevailed with the highest offer price in the auction to acquire the entire issued and to be issued share capital of Sky (SKYAY) with an offer price of GBP17.28 per Sky share. This implies a value of $40B for the fully diluted share capital of Sky. The announcement ends the competitive bidding process for Sky. 21st Century Fox (FOXA) was the other bidder. 2. Regal Beloit (RBC) announced that Mark Gliebe, Chairman and CEO, will retire from the company after the completion of calendar year 2018. Regal's Board of Directors has begun a process to identify Gliebe's successor, who has agreed to lead the company until a successor has been named and to resign from the Board effective as of his retirement date as CEO. Additionally, the company confirmed 2018 adjusted diluted EPS guidance of $5.70-$6.00 and said it forecasts 2018 GAAP diluted EPS of $4.55-$4.85, which now includes an estimate of currently known and anticipated CEO transition costs of 23c per share. 3. Led by Tilray (TLRY), the U.S.-listed grower that went public in July, the shares of Canada's pot producers skyrocketed by Wednesday and then gave most of their gains back, raising comparisons between marijuana stocks and the Bitcoin bubble, Bill Alpert wrote in this week's edition of Barron's. Canada's licensed marijuana producers begin recreational sales on October 17 and they have acres of greenhouses in bloom, but their stock prices have been weakly tethered to business fundamentals for months now, and last week's blow-off was all the proof needed that the trading has become irrational, Alpert contended. 4. Comcast subsidiary Universal's "The House With a Clock in its Walls" debuted to a better than expected $26.9M from 3,592 theaters, topping the chart. Overseas, the pre-Halloween offering that follows a young orphan who goes to live in his uncle's spooky house launched to $8.7M for a global start of $35.6M. The movie earned a B+ CinemaScore and sports a 68% Rotten Tomatoes score. 5. Boston Scientific (BSX), Intuitive Surgical (ISRG), Caterpillar (CAT), Applied Materials (AMAT), BorgWarner (BWA), KeyCorp (KEY), Parker-Hannifin (PH), Apple (AAPL), Cisco Systems (CSCO), Intel (INTC), IBM (IBM), Microsoft (MSFT), Oracle (ORCL), and Berkshire Hathaway (BRK.A, BRK.B) saw positive mentions in Barron's.
RBC

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19:04 EDT Regal Beloit announces planned CEO retirement - Regal Beloit announced that Mark Gliebe, Chairman and CEO, will retire from Regal after the completion of calendar year 2018. Regal's Board of Directors has begun a process to identify Gliebe's successor. Gliebe has agreed to lead the company until a successor has been named and to resign from the Board effective as of his retirement date as CEO.
TRXC

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18:14 EDT TransEnterix acquires assets, intellectual property from MST Medical Surgery - TransEnterix announced that it has acquired substantially all of the assets of MST Medical Surgery Technologies. The addition of MST's technology, IP portfolio, and R&D team supports and accelerates TransEnterix's vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability. TransEnterix acquired from MST substantially all of its assets, which includes technology and intellectual property, and will transfer MST's Israeli-based R&D team to a newly formed subsidiary, TransEnterix Israel. The transaction will be financed with a combination of cash and stock, delivered in two separate tranches. At the closing of the transaction, MST will receive approximately $5.8M in cash and 3,150,000 shares of TransEnterix common stock. The second tranche of $6.6M, payable in cash or stock, is to be paid within one year of closing. The timing and form of payment of the second tranche is at TransEnterix's sole discretion.
T...

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17:24 EDT Box Office Battle: 'The House With a Clock in Its Walls' opens to $26.9M in U.S. - Comcast (CMCSA) subsidiary Universal's "The House With a Clock in its Walls" debuted to a better than expected $26.9M from 3,592 theaters, topping the chart. Overseas, the pre-Halloween offering that follows a young orphan who goes to live in his uncle's spooky house launched to $8.7M for a global start of $35.6M. The movie earned a B+ CinemaScore and sports a 68% Rotten Tomatoes score. BOX OFFICE RUNNERS-UP: Lionsgate's (LGF.A, LGF.B) "A Simple Favor" held nicely in its sophomore outing, grossing $10.4M to place number two and finish the weekend with a domestic total of $32.6M. Behind it was AT&T (T) subsidiary Warner Bros' "The Nun," ending its third weekend with $10.3M and crossing the $100M mark domestically. 21st Century Fox's (FOX, FOXA) "The Predator" placed number four, falling 65% in its sophomore session for a domestic total of $40.4M after earning another $8.7M. Rounding out the top five, "Crazy Rich Asians," another Warner Bros. movie, grossed an estimated $6.5M from 2,802 theaters. Other publicly traded companies in filmmaking include Sony (SNE), Viacom (VIAB) and Disney's (DIS).
ABT

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16:15 EDT Abbott announces positive clinical study results from MitraClip trial - Abbott announced positive clinical study results from a randomized controlled trial comparing treatment with the MitraClip device to guideline-directed medical therapy in select patients with secondary mitral regurgitation, or a leaky heart valve, as a result of advanced heart failure. The landmark COAPT study met both the primary safety and efficacy endpoints and all secondary endpoints, and showed treatment with MitraClip plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years. This therapeutic mitral valve intervention is the first and only to demonstrate positive outcomes in a clinical trial for ailing heart failure patients with clinically significant secondary mitral regurgitation. The COAPT study data will be submitted to the U.S. Food and Drug Administration to support consideration of an expanded indication for Abbott's MitraClip to treat secondary mitral regurgitation. Treatment with MitraClip plus medical therapy resulted in a statistically significant reduction in heart failure hospitalization through two years compared to medical therapy alone. MitraClip treatment reduced all-cause mortality through two years, from 46.1% of patients in the control group to 29.1% in the device group at two years of follow-up. At one year, freedom from device-related complications was 96.6%, exceeding the performance goal for the primary safety endpoint. Patients in the device group experienced significant reduction in MR severity and NYHA class. Treatment with MitraClip provided a substantial improvement in patients' perception of their health status, measured by the KCCQ quality-of-life score, and functional capacity at one year. MitraClip treatment resulted in a reduction in the composite of death or first heart failure hospitalization by 43.0%. The results were consistent across numerous subgroups, including patients with ischemic and non-ischemic cardiomyopathy - a disease of the heart muscle that weakens the ability of the heart to pump blood to the rest of the body - and those at high and low surgical risk.
MDT

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12:37 EDT Medtronic presents IN.PACT global study three-year data - Medtronic announced data that continues to reinforce the safety, durability, and consistency of the IN.PACT Admiral drug-coated balloon in real-world patients with peripheral arterial disease. Three-year real-world results from the full clinical cohort of the IN.PACT Global Study and one-year data from the Total IN.PACT pooled imaging and propensity analyses were presented at the Cardiovascular and Interventional Radiological Society of Europe annual meeting and the 30th Transcatheter Cardiovascular Therapeutics conference, the annual scientific symposium of the Cardiovascular Research Foundation, respectively. The freedom from clinically-driven target lesion revascularization rate calculated using Kaplan Meier survival estimates was 76.9% in a real-world patient cohort with a mean lesion length of 12.09 +/- 9.54 cm, 18.0% in-stent restenosis, 35.5% occluded lesions, and 39.9% diabetic subjects. Additionally, the proportion of patients undergoing repeat procedures were low through three years. Total IN.PACT combined independently adjudicated data from a total of 1,837 patients treated with IN.PACT Admiral DCB from all IN.PACT Admiral randomized clinical trials and real-world studies from 147 sites across 28 countries. The analyses presented today at TCT specifically looked at two different groups - a core laboratory-adjudicated imaging cohort and a propensity matched imaging cohort. The data showed that IN.PACT Admiral DCB demonstrated consistently superior patency and freedom from clinically-driven target lesion revascularization compared to standard PTA alone. The propensity analysis matched one PTA subject with up to four IN.PACT Admiral DCB subjects based on baseline variables. The propensity-matched analysis showed a patency rate of 90.5% for the IN.PACT Admiral DCB as compared to 53.8% for PTA and a freedom from CD-TLR rate of 96.9% compared to 80.7% for PTA. Additional safety and effectiveness outcomes from the DCB arm also included low rates of thrombosis and CD-TLR, and no occurrences of major target limb amputation at one year.
CMCSA...

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12:29 EDT Comcast prevails with highest offer price in auction for Sky - Comcast (CMCSA) published an announcement that Comcast has prevailed with the highest offer price in the auction to acquire the entire issued and to be issued share capital of Sky (SKYAY) with an offer price of GBP17.28 per Sky share. This implies a value of $40B for the fully diluted share capital of Sky. The announcement ends the competitive bidding process for Sky.
MDT

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12:26 EDT Clinical study shows safety, efficacy outcomes for Medtronic Resolute Onyx DES - Investigators unveiled new clinical data from the physician-initiated BIONYX study, representing the first all-comers analysis in nearly 2,500 patients comparing the safety and efficacy of the durable polymer Resolute Onyx drug-eluting stent from Medtronic to the Orsiro biodegradable polymer stent. At one year, the study showed patients with coronary artery disease who were treated with Orsiro BP-DES received no clinical advantage compared to patients treated with the Resolute Onyx DP-DES, and Orsiro BP-DES demonstrated a higher rate of stent thrombosis. Enrolling approximately 2,500 real-world patients, the BIONYX study had a primary composite endpoint of target vessel failure at one-year and showed no statistically significant difference in outcomes for the Resolute Onyx DP-DES treated group at 4.5% compared to 4.7% with the Orsiro BP-DES. However, notable differences were observed in significantly lower rates of definite or probable stent thrombosis at one year. The Resolute Onyx DES is coated with the proprietary BioLinx polymer, a bio-compatible and non-thrombogenic coating specifically designed for use on DES. Low rates of stent thrombosis have been observed in more than 70,000 real-world clinical study patients, with additional studies underway, including the global Medtronic Onyx ONE Month DAPT Program comprised of two studies designed to investigate safety following one-month of dual anti-platelet therapy discontinuation post-PCI. The Resolute Onyx DES offers the broadest size matrix available and is the first-and-only DES to feature Core Wire Technology which enables thinner struts and greater deliverability while maintaining structural strength and enhanced visibility.
BSX

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12:20 EDT Boston Scientific announced positive 12-month data from IMPERIAL trial - Boston Scientific announced positive 12-month data from the IMPERIAL trial, the first head-to-head drug-eluting stent trial in the superficial femoral artery. The IMPERIAL trial evaluated the Eluvia Drug-Eluting Vascular Stent System versus the Zilver PTX Drug-Eluting Peripheral Stent in patients with symptomatic peripheral artery disease. PAD occurs when fatty or calcified atherosclerotic material, called plaque, builds up on the walls of the arteries of the legs, restricting blood flow and causing pain, swelling, ulceration and in some cases, the need for amputation of the affected limb. Stents are commonly used to restore and maintain blood flow, reducing symptoms and improving quality of life. In the IMPERIAL trial, the Eluvia stent, which utilizes a drug-polymer combination to offer sustained release of the drug paclitaxel, exhibited superior rates of primary patency, a measure of the target vessel remaining unobstructed at 12 months, and thus able to provide sufficient blood flow to the lower limbs.1 Patients in the Eluvia arm of the study also experienced higher rates of freedom from target lesion revascularization, thus reducing their need for repeat procedures at one year, when compared to those treated with the drug-coated Zilver PTX.
NITE

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12:16 EDT Nightstar reports proof of concept data from dose escalation in XIRIUS trial - Nightstar Therapeutics announced that positive preliminary safety and efficacy data of NSR-RPGR from the dose escalation study in the Phase 1/2 XIRIUS trial were presented at the EURETINA 2018 Congress. XIRIUS is a Phase 1/2, open-label, dose-ranging, single-eye clinical trial consisting of a dose escalation study and an expansion study with sites in both the U.S. and the U.K. The XIRIUS trial is intended to evaluate the safety, tolerability and efficacy of NSR-RPGR for the treatment of XLRP in patients with the RPGR mutation. Available safety data from the 15 treated patients in cohorts 1-5 indicates that NSR-RPGR was well-tolerated. The safety profile in the dose escalation study is generally consistent with that of surgical vitrectomy procedures and what has been observed in clinical trials of other ocular gene therapies. No serious adverse events related to treatment were reported and no early discontinuations or dose limiting toxicity were observed. Mild drug-related inflammation that potentially dampened efficacy was seen in the treated eyes of cohorts 4-5, with treatment efficacy observed to have been rescued in patients who received additional steroid treatment. Adverse events of varying severity and duration related to the vitrectomy procedure or drug have been observed in the dose escalation study such as retinal changes, intraocular inflammation and visual disturbances. The Data Monitoring Committee reviewed preliminary safety data for cohorts 1-5 and recommended escalation to cohort 6. The DMC also has not restricted pediatric enrollment in either the dose escalation study or expansion study. Based on the totality of results to date, Nightstar expects to initiate enrollment of the expansion study in the XIRIUS trial in the fourth quarter of 2018. The expansion study is intended to enroll approximately 30 adult and pediatric patients at a therapeutic dose informed by the dose escalation study and a low-dose control group of approximately 15 patients. Preliminary efficacy data from the expansion study is expected to be available in mid-2019, with one-year follow-up data expected to be available in 2020.