Stockwinners Market Radar for April 15, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

TWX...

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19:24 EDT On The Fly: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Sir Martin Sorrell has stepped down as CEO of WPP (WPP) with immediate effect. Roberto Quarta, Chairman of WPP, becomes Executive Chairman until the appointment of a new CEO. Mark Read, CEO of Wunderman and WPP Digital, and Andrew Scott, WPP Corporate Development Director and Chief Operating Officer, Europe, have been appointed as joint Chief Operating Officers of WPP. 2. Caesars (CZR) announced it has signed an agreement to manage two luxury hotels and a beach club in Dubai, the casino operator's first non-gaming resorts. 3. U.S. Bancorp (USB) looks appealing after lagging behind most big banks during the past year, Andrew Bary wrote in this week's edition of Barron's. It generates some of the industry's highest returns and a modest price/earnings ratio of 12.6, the report added. 4. Warner Bros.' (TWX) New Line movie "Rampage" opened to $34.5M from $4,101 theaters, one of the best showings ever for a video game adaptation and enough to win the weekend ahead of Paramount's (VIAB) horror sensation "A Quiet Place." The movie stars Dwayne Johnson as a primatologist whose beloved pal, an albino gorilla, is transformed into a giant menace as the result of genetic experiment. 5. Cummins (CMI), Alcoa (AA), Century Aluminum (CENX) saw positive mentions in Barron's.
AZN MRK

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19:14 EDT Merck, AstraZeneca present data from Phase II OlympiAD trial - AstraZeneca (AZN) and Merck (MRK) presented data from the Phase III OlympiAD trial, showing the final overall survival results for LYNPARZA in metastatic breast cancer at the American Association for Cancer Research Annual Meeting in Chicago, April 14-18, 2018. The trial compared LYNPARZA with chemotherapy for patients with germline BRCA-mutated HER2-negative metastatic breast cancer and met its primary endpoint of progression-free survival. Results at AACR include updated findings from the secondary endpoint of overall survival. While the trial was not powered to demonstrate a statistically-significant difference, the median OS was 19.3 months in patients treated with LYNPARZA and 17.1 months for patients treated with chemotherapy. At the final OS data cut-off, nearly 13% of patients remained on LYNPARZA and no patients remained on chemotherapy.
TWX...

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19:03 EDT Box Office Battle: 'A Quiet Place' falls to second as 'Rampage' wins weekend - Warner Bros.' (TWX) New Line movie "Rampage" opened to $34.5M from $4,101 theaters, one of the best showings ever for a video game adaptation and enough to win the weekend ahead of horror sensation "A Quiet Place." The movie stars Dwayne Johnson as a primatologist whose beloved pal, an albino gorilla, is transformed into a giant menace as the result of genetic experiment. BOX OFFICE RUNNERS-UP: Paramount's (VIAB) high-concept horror-thriller "A Quiet Place" came in second, earning $32.6M for a domestic total just shy of $100M at $99.6M. Behind it was another newcomer. Comcast (CMCSA, CMCSK) subsidiary Universal's "Truth or Dare" opened to a strong $19.2M in the U.S. Warner Bros. "Ready Player One" placed number four, falling 54.5% over the weekend to $11.2M for a domestic tally of $114.6M. Rounding out the top five, Universal's "Blockers" earned an estimated $10.3M from 3,418 theaters. Other publicly traded companies in filmmaking include Disney (DIS), 21st Century Fox's (FOXA), Lionsgate's (LGF.A), Viacom (VIA, VIAB) and Sony's (SNE).
GS

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18:54 EDT Marcus by Goldman Sachs announces acquisition of Clarity Money - Goldman Sachs has completed the acquisition of Clarity Money and is delighted to welcome its over one million customers to Marcus. Clarity Money is a leading app that helps consumers better manage their personal finances by harnessing the power of machine learning and intuitive design to provide actionable insights. The acquisition expands Marcus' products and services to help consumers make smarter financial decisions. Clarity Money is free to use and over time will be branded Marcus by Goldman Sachs.
BDRBF

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17:23 EDT Bombardier announces range of 7,700 nautical miles for Global 7000 Aircraft - Bombardier announced that its marquee Global 7000 business jet, having completed multiple long-range flights around the world, now boasts an outstanding range of 7,700 nautical miles, connecting more city pairs than any other business aircraft. Global 7000 flight test vehicles have completed several long-haul flights to destinations including Sydney, Dubai and Hawaii. This rigorous flight test program has demonstrated the aircraft's incredible reach, and Bombardier's ability to surpass its commitments. The new 7,700-nautical-mile baseline range will be a feature on the Global 7000 aircraft for all existing and future customers. This enhanced performance will come at no additional cost to customers.
MRK AZN

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17:13 EDT Merck, AstraZeneca present data from Phase II PlympiAD trial - AstraZeneca (AZN) and Merck (MRK) presented data from the Phase III OlympiAD trial, showing the final overall survival results for LYNPARZA in metastatic breast cancer at the American Association for Cancer Research Annual Meeting in Chicago, April 14-18, 2018. The trial compared LYNPARZA with chemotherapy for patients with germline BRCA-mutated HER2-negative metastatic breast cancer and met its primary endpoint of progression-free survival. Results at AACR include updated findings from the secondary endpoint of overall survival. While the trial was not powered to demonstrate a statistically-significant difference, the median OS was 19.3 months in patients treated with LYNPARZA and 17.1 months for patients treated with chemotherapy. At the final OS data cut-off, nearly 13% of patients remained on LYNPARZA and no patients remained on chemotherapy.
NLNK

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17:10 EDT NewLink announces data from Phase 1 study of Indoximod in combo therapies - NewLink Genetics reported initial data from NLG2105, a Phase 1 study evaluating indoximod, its IDO pathway inhibitor, in combination with radiation and chemotherapy for the treatment of pediatric patients with progressive brain tumors. Initially, 29 heavily pretreated patients were enrolled in a dose-escalation protocol with initial data presented at the Society for Neuro-Oncology Conference, November 2017. Seventeen of the 29 patients were appropriate candidates for re-irradiation of their tumors and were treated with a combination therapy including indoximod plus conformational radiotherapy followed by maintenance indoximod combined with temozolomide chemotherapy. The other 12 patients were treated with immuno-chemotherapy consisting of indoximod and temozolomide. In aggregate, with further follow-up, the 29 subjects in the dose-escalation phase of the study had a median progression-free survival of 6.2 months and median time on study of 11.7 months. The treatment continued to be well tolerated with minimal toxicity attributed to indoximod. Once initial safety data were generated, an additional pilot cohort of newly-diagnosed patients with diffuse intrinsic pontine glioma was opened using indoximod during front-line radiotherapy followed by maintenance indoximod plus temozolomide. Six newly diagnosed DIPG patients initiated treatment, with all 6 having completed induction radioimmunotherapy. Treatment was well tolerated with symptomatic improvement in all 6 patients. Site-reported radiographic review indicated near resolution of tumor in one patient at the end of radiotherapy and observable improvement in 5 out of 6 patients overall. A seventh patient with progressive DIPG received re-RT combined with indoximod, which was well tolerated with symptomatic improvement and objective tumor reduction per site-reported assessment on post-RT MRI. Separately, the company has determined that it will not initiate the randomization portion of Indigo301, its study of indoximod in combination with pembrolizumab or nivolumab for patients with advanced melanoma. NewLink's clinical team will evaluate the design, trial size and feasibility of an alternative randomized evaluation of indoximod in melanoma in the context of the failure of a competitor's trial of its enzymatic IDO inhibitor in a similar clinical setting. The evaluation will include analysis of the full data set from the Company's single-arm Phase 2 melanoma study, the differentiated mechanism of action of indoximod, and the opinions of experts in the field. The company will present final results from its Phase 2 trial in melanoma and its single-arm Phase 2 trial in pancreatic cancer at an upcoming medical conference in the first half of 2018.
FPRX

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17:03 EDT Five Prime presents on novel B7-H4 therapeutic antibody - Five Prime Therapeutics announced that an oral presentation featuring FPA150, Five Prime's first-in-class B7-H4 antibody, was given today at the 2018 AACR Annual Meeting in Chicago. FPA150 is a novel B7-H4 antibody that possesses both T cell immune checkpoint blockade and antibody-dependent cellular cytotoxicity activities. FPA150 demonstrates dose-dependent anti-tumor activity in vivo as a monotherapy and elicits complete tumor regressions in preclinical tumor models when given in combination with PD-1 blockade. Five Prime is currently studying FPA150 in a Phase 1 monotherapy trial in patients with solid tumors that overexpress B7-H4. In Investigational New Drug-enabling pharmacokinetics and toxicity studies, FPA150 demonstrated a suitable PK profile and was generally well tolerated. A B7-H4 immunohistochemistry assay is in development for clinical use as a companion diagnostic to help identify the patients who might benefit most from this treatment. Five Prime is studying FPA150 in a Phase 1 monotherapy trial with a dose-escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and bladder cancers.
BPMC

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16:58 EDT Blueprint announces proof-of-concept data from Phase 1 ARROW trial of BLU-667 - Blueprint Medicines announced proof-of-concept data from the ongoing Phase 1 ARROW clinical trial of BLU-667 in patients with RET-altered solid tumors. Designed and developed by Blueprint Medicines, BLU-667 is a potent and highly selective inhibitor targeting oncogenic RET fusions and mutations, which are key drivers across multiple cancers, including subsets of patients with non-small cell lung cancer and medullary thyroid cancer. The data from the dose escalation portion of the ARROW trial showed broad and robust clinical activity for once-daily dosing of BLU-667 across multiple tumor types and RET genotypes, including in patients whose disease had progressed on prior multi-kinase inhibitor therapy. As of the data cutoff date of April 6, 2018, the data showed radiographic tumor reductions in 84% of patients with RET-altered solid tumors with measurable target lesions. In patients evaluable for response, preliminary overall response rates were 50% in patients with NSCLC and 40% in patients with MTC. As of the data cutoff date, QD dosing of BLU-667 was well-tolerated, and most adverse events reported by investigators were Grade 1 or 2.
MRK

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16:51 EDT Merck Keytruda shows recurrence-free survival benefit across state III melanoma - Merck announced findings from the Phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma. Study results showed KEYTRUDA significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 43% compared to placebo in the overall study population. For the primary endpoint of RFS in the overall study population, the one-year RFS rate was 75.4% for KEYTRUDA compared to 61% for placebo. For the co-primary endpoint of RFS in patients whose tumors were considered PD-L1 positive, KEYTRUDA demonstrated significantly prolonged RFS compared to placebo. The safety profile of KEYTRUDA was consistent with what has been seen in previous trials among patients with advanced melanoma. KEYTRUDA is the first anti-PD-1 therapy to show RFS benefit across stage IIIA, IIIB and IIIC melanoma. The RFS benefit was also seen regardless of BRAF mutation status. As previously announced, Merck is working to submit data from EORTC1325/KEYNOTE-054 to regulatory agencies in the U.S. and around the world.
CZR

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16:44 EDT Caesars, Meraas plan to open two Caesars Hotels & Beach Club in Dubai - Caesars and Meraas Holdings have announced that they have entered into a non-binding letter of intent for Caesars Entertainment to manage two luxury hotels and a beach club at Meraas' Dubai-based Bluewaters Island development. In late 2018, Bluewaters Island is expected to become home to Caesars Palace Bluewaters Dubai and Caesars Bluewaters Dubai, both of which will represent Caesars Entertainment's first non-gaming resorts.
AMZN PTNR

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16:42 EDT Partner Communications announces collaboration with Amazon Prime Video in Israel - Partner Communications (PTNR) announced a first of its kind collaboration agreement in Israel between Amazon Prime Video (AMZN) and Partner TV. Partner TV customers now have direct access to the Amazon Prime Video service on Partner TV set top box, which offers access to view a broad selection of global content and Amazon Prime original content, including TV series and movies. Partner TV is the first and only television service in Israel to offer Amazon Prime Video application on a set top box and the first OTT service in the world to support this application on an Android TV set top box.
GKOS

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16:39 EDT Glaukos iStent data demonstrate primary, secondary effectiveness endpoints - Glaukos announced that two-year U.S. Investigational Device Exemption pivotal trial data showed that its iStent inject Trabecular Micro-Bypass System achieved a statistically significant reduction in unmedicated diurnal intraocular pressure in patients undergoing cataract surgery. Results of the iStent inject prospective, randomized, multicenter clinical trial, which included 41 investigational sites and 505 open-angle glaucoma subjects, were presented at the American Society of Cataract and Refractive Surgery Annual Meeting. In the study, 387 subjects were randomized to iStent inject in combination with cataract surgery and 118 subjects were randomized to cataract surgery only. Subjects were followed through 24 months with annual medication washouts. The iStent inject met the study's primary and secondary effectiveness endpoints. The iStent inject is designed to improve aqueous humor outflow into Schlemm's canal and reduce IOP in mild-to-moderate OAG patients undergoing cataract surgery. The iStent inject is not approved for use in the U.S. Glaukos submitted a pre-market approval application for the iStent inject to the FDA in December 2017. The iStent inject is commercially available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa. In addition to the iStent inject, the company is currently pursuing FDA approval for four additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the U.S.
ALBO

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15:58 EDT Albireo reports data on Pharmacodynamic Marker for A4250 in children with CLD - Albireo Pharma announced that data on a pharmacodynamic marker measured in its completed Phase 2 clinical trial evaluating lead product candidate A4250 in children with cholestatic liver disease and pruritus were presented during a poster session at the European Association for the Study of the Liver The International Liver Congress 2018 in Paris. The lysophospholipase autotaxin and its product, lysophosphatic acid, have been shown to be increased in patients with pruritus due to cholestasis. In this study, treatment with A4250 decreased ATX levels in most patients, and there was a statistically significant correlation with a reduction in serum bile acids. Pruritus intensity at baseline was significantly correlated with baseline levels of ATX. Correlations between reduction in ATX and reduction in pruritus did not reach statistical significance. As previously reported, A4250 also reduced sBA and improved pruritus, a common and debilitating manifestation of cholestatic liver disease, in most patients during a 4-week treatment period. A statistically significant correlation between reduction in sBA levels and improvement in pruritus scores was observed, as well as improvement in sleep disturbance. Pharmacodynamic markers measured in addition to autotaxin were: ALP, GT, AST, ALT, conjugated and total bilirubin, FGF19 and C4. A4250 exhibited a favorable overall tolerability profile in the study, with all patients completing the 4-week treatment period and no reports of diarrhea associated with multiple dose therapy. There were no serious adverse events reported in the study that were considered to be drug related. Most adverse events, including some increased transaminases, were mild, transient and assessed as either unrelated to study drug or the relationship was unclear.
GKOS

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15:33 EDT Glaukos files patent infringement lawsuit against Ivantis - Glaukos announced that it has filed a patent infringement lawsuit against Ivantis in the U.S. District Court for the Central District of California, Southern Division. The lawsuit alleges that Ivantis' Hydrus Microstent device infringes Glaukos patents relating to certain of Glaukos' core glaucoma technologies. "Since our founding in 1998, Glaukos has invested considerable time and resources to develop novel technologies that create entirely new treatment options for glaucoma surgeons and their patients," said Thomas Burns, Glaukos president and chief executive officer. "This lawsuit reflects our unwavering commitment to protect our proprietary inventions for the benefit of patients, customers, shareholders, employees and others who rely on us."
ALNY

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15:31 EDT Alnylam presents new positive results for Givosiran in Acute Hepatic Porphyrias - Alnylam Pharmaceuticals announced new results from the Phase 1 and Phase 1/2 open-label extension studies of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyrias, or AHPs. New data from the ongoing EXPLORE natural history study were also presented. "We view these new results with givosiran as very encouraging, since they demonstrate robust and what we believe to be clinically meaningful reductions in urinary ALA, porphyria attack rate, and hemin administration with continued dosing for up to nearly two years. We also believe our new data support use of a monthly dosing regimen for sustained reductions in ALAS1 mRNA and urinary ALA, with improved clinical activity. In sum, we believe the clinical activity and overall safety profile for givosiran continue to support an accelerated Phase 3 development plan," said Akin Akinc, Vice President and General Manager, Givosiran Program at Alnylam. "In the meanwhile, we continue to enroll patients in the ENVISION Phase 3 pivotal study, which was initiated at the end of 2017. Further, we are pleased to announce today that we expect to enroll the thirtieth patient into ENVISION in the coming weeks in support of the planned interim analysis in mid-2018, which, if positive, would support a potential NDA filing for givosiran by end of this year."
WPP

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09:56 EDT Sir Martin Sorrell steps down as CEO from WPP - Sir Martin Sorrell has stepped down as Chief Executive Officer of WPP (WPP) with immediate effect. Roberto Quarta, Chairman of WPP, becomes Executive Chairman until the appointment of a new CEO. Mark Read, Chief Executive Officer of Wunderman and WPP Digital, and Andrew Scott, WPP Corporate Development Director and Chief Operating Officer, Europe, have been appointed as joint Chief Operating Officers of WPP. Sir Martin will be available to assist with the transition, the company said in a statement yesterday. It added, "The previously announced investigation into an allegation of misconduct against Sir Martin has concluded. The allegation did not involve amounts that are material. In accordance with his at-will employment agreement, Sir Martin will be treated as having retired on leaving WPP, as detailed in the Directors' Compensation Policy. His share awards will be pro-rated in line with the plan rules and will vest over the next five years, to the extent Group performance targets are achieved." Sir Martin Sorrell said in the statement: "Obviously I am sad to leave WPP after 33 years. It has been a passion, focus and source of energy for so long. However, I believe it is in the best interests of the business if I step down now. I leave the Company in very good hands, as the Board knows. Mark and Andrew and the management team at all levels have the knowledge and abilities to take WPP to even greater heights and capitalise on the geographic and functional opportunities. I will particularly miss the daily interactions with everyone across the world and want to thank them and their families for all they have done, and will do, for WPP."