Stockwinners Market Radar for May 05, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
BA... | Hot Stocks19:19 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. In a tweet, President Trump said that, "For 10 months, China has been paying Tariffs to the USA of 25% on 50 Billion Dollars of High Tech, and 10% on 200 Billion Dollars of other goods. These payments are partially responsible for our great economic results. The 10% will go up to 25% on Friday. 325 Billions Dollars [...] of additional goods sent to us by China remain untaxed, but will be shortly, at a rate of 25%. The Tariffs paid to the USA have had little impact on product cost, mostly borne by China. The Trade Deal with China continues, but too slowly, as they attempt to renegotiate. No!" 2. Boeing (BA) did not share information about a problem with a cockpit safety alert for about a year before the issue drew attention with the October crash of a 737 Max jet in Indonesia, and then gave some airlines and pilots partial and inconsistent explanations, The Wall Street Journal's Andy Pasztor, Andrew Tangel and Alison Sider reported, citing industry and government officials. It was only after a second Max accident in Ethiopia nearly five months later that Boeing became more forthcoming with airlines about the problem, these officials said. Nonetheless, the company has since said that the missing display alerting pilots to a mismatch of flight data represented no safety risk, according to a report by Reuters' Tracy Rucinski and David Shepardson. 3. Alphabet (GOOG; GOOGL) is facing a sudden growth slowdown in its core advertising business, with the stock plunging 7.5% the day after earnings, Tae Kim wrote in this week's edition of Barron's. The author noted that the company is "too stingy" with its shareholders and executives may need to employ a similar tactic to Apple (AAPL) and its share repurchases. The good news is that Alphabet can afford to pay back shareholders - in a big way, the report added. 4. Disney (DIS) and Marvel's "Avengers: Endgame" crossed $2B in ticket sales and its now the second-highest-grossing film of all time with $2.189B. The super hero movie surpassed James Cameron "Titanic," which earned $2.187B. Domestically, "Endgame" collected another $145.8M in its second weekend. The top-grossing film of all time is Cameron's "Avatar," with $2.8B at the global box office. The super hero pic sports an A+ CinemaScore and a 96% Rotten Tomatoes. 5. Farfetch (FTCH), Home Depot (HD), Lovesac (LOVE), Nike (NKE), Zuora (ZUO), Burlington Stores (BURL), and Facebook (FB) saw positive mentions in this week's edition of Barron's.
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OXY APC | Hot Stocks19:11 EDT Occidental delivers revised proposal to acquire Anadarko for $76 per share - Occidental Petroleum (OXY) delivered a letter to the Board of Directors of Anadarko Petroleum (APC) setting forth the terms of a revised and significantly enhanced superior proposal to acquire Anadarko for $76 per share comprised of $59.00 in cash and 0.2934 shares of Occidental common stock per share of Anadarko common stock. The revised proposal, which has been unanimously approved by the Occidental Board of Directors, represents a premium of approximately 23.3% to the $61.62 per share value of Chevron's pending offer as of market close on May 3, 2019. On April 29, 2019, Anadarko announced its Board of Directors had determined that Occidental's prior proposal, made on April 24, could reasonably be expected to result in a "Superior Proposal", and the two companies have engaged since that determination. "We firmly believe that Occidental is uniquely positioned to drive significant value and growth from Anadarko's highly complementary asset portfolio," said Occidental President and CEO, Vicki Hollub. "The financial support of Berkshire Hathaway [BRK.A, BRK.B] as well as the agreement we announced with Total [TOT] allows us to delever our balance sheet while focusing our integration efforts on the assets that will provide the most value for us," she continued.
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ESPR | Hot Stocks18:10 EDT Esperion announces FDA acceptance of NDAs for Bempedoic Acid, combo tablet - Esperion announced that the U.S. Food and Drug Administration has accepted both New Drug Applications for bempedoic acid and the bempedoic acid/ezetimibe combination tablet for filing and regulatory review. Bempedoic acid and the bempedoic acid/ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol who need additional LDL-C lowering despite the use of currently accessible therapies. The PDUFA goal date for the completion of the bempedoic acid NDA review is set for February 21, 2020, and the PDUFA goal date for completion of the bempedoic acid/ezetimibe combination tablet NDA review is set for February 26, 2020. The FDA has communicated that there is no current plan to hold an advisory committee meeting to discuss the applications.
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URGN | Hot Stocks16:57 EDT UroGen delivers updated CR, durability data from UGN-101 Phase 3 OLYMPUS trial - UroGen Pharma announced findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which showed that UGN-101 for instillation, an investigational mitomycin formulation, demonstrated a 59% complete response rate in a subset of patients with endoscopically unresectable low-grade upper tract urothelial cancer. The analysis showed that in the OLYMPUS intent-to-treat population, 71 patients had undergone PDE at the time of the analysis and 42 of the 71 patients achieved a CR. 41 patients entered follow-up. Of the evaluated complete responses to date, 27 patients have undergone a six-month evaluation, and 24 out of 27 patients have remained disease free at six months. Overall, 5 of 41 patients who achieved a CR have relapsed at any time during the study. Of these 71 patients, 34 were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline, and 20 of 34 of these patients achieved a CR at the PDE. The most common adverse events observed were urinary tract infection, ureteral narrowing and stricture formation. The majority of ureteral events were reported as mild to moderate and have resolved. The company initiated its rolling submission of the UGN-101 New Drug Application to the U.S. Food and Drug Administration in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
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TWTR FB | Hot Stocks15:30 EDT Trump criticizes social media companies after bans - In a tweet, President Donald Trump said that, "How can it be possible that James Woods (and many others), a strong but responsible Conservative Voice, is banned from Twitter [TWTR]? Social Media & Fake News Media, together with their partner, the Democrat Party, have no idea the problems they are causing for themselves. VERY UNFAIR!" This followed a previous tweet stating that, "So surprised to see Conservative thinkers like James Woods banned from Twitter, and Paul Watson banned from Facebook [FB]!" Reference Link
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OXY... | Hot Stocks15:23 EDT Occidental agrees to $8.8B contingent sale of Anadarko African assets to Total - Occidental Petroleum (OXY) announced that, in connection with Occidental's proposal to acquire Anadarko Petroleum (APC), it has entered into a binding agreement to sell Anadarko's Algeria, Ghana, Mozambique and South Africa assets to Total S.A. (TOT) for $8.8B. The sale is contingent upon Occidental entering into and completing its proposal to acquire Anadarko, and would be expected to close simultaneously or as soon as reasonably practicable afterwards. The assets to be sold to Total represent approximately 6% of the expected net production and approximately 7% of the cash flow after capital expenditures of Occidental in 2020 pro forma for the acquisition of Anadarko. The proceeds of the sale of the assets covers a portion of the cash consideration to fund the proposed acquisition of Anadarko. The sale fast-tracks the divestiture plan previously described by Occidental, delivering on the majority of the $10B-$15B of planned asset sales. It also reduces the overall integration demands of the acquisition. After giving effect to the asset sale, Occidental continues to expect to deliver $2B of annual cost synergies and $1.5B of annual capital reductions from the proposed acquisition of Anadarko.
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CYTK | Hot Stocks15:20 EDT Cytokinetics announces results of FORTITUDE-ALS - Cytokinetics announced that results of FORTITUDE-ALS - Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints - in ALS - were presented at a podium presentation at the American Academy of Neurology Annual Meeting in Philadelphia. FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity after 12 weeks of dosing. Similar analyses of ALSFRS-R and slope of the Muscle Strength Mega-Score yielded p-values of 0.09 and 0.31, respectively. However, patients on all dose groups of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, patients who received reldesemtiv in FORTITUDE-ALS declined less than patients who received placebo. The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints. The differences between reldesemtiv and placebo in SVC and ALSFRS-R total score observed after 12 weeks of treatment were still evident at follow-up, four weeks after the last dose of study drug. The incidence of early treatment discontinuations, serious adverse events and clinical adverse events in FORTITUDE-ALS were similar between placebo and active treatment arms. The most common clinical adverse effects in the trial included fatigue, nausea and headache. The leading cause for early termination from FORTITUDE-ALS for patients who received placebo was progressive disease; the leading cause for early termination for patients who received reldesemtiv was a decline in cystatin C based estimated glomerular filtration rate, a measure of renal function. Elevations in transaminases and declines in cystatin C eGFR were dose-related. In collaboration with Astellas, Cytokinetics is developing reldesemtiv, a next-generation fast skeletal muscle troponin activator, as a potential treatment for people living with debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.
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NBIX VYGR | Hot Stocks12:52 EDT Neurocrine Biosciences, Voyager Therapeutics announce Phase I data for VY-AADC - Neurocrine Biosciences (NBIX) and Voyager Therapeutics (VYGR) announced Phase I trial results for VY-AADC from eight patients with Parkinson's disease who participated in the open-label trial to evaluate the safety and efficacy of VY-AADC and to further assess the posterior surgical delivery approach. Treatment with VY-AADC improved good ON time by 1.7 hours from baseline and reduced OFF time by 2.2 hours at 12 months from baseline in patients with Parkinson's disease. Exploratory analyses in four of the eight patients with low or no dyskinesia or absence of impulse control disorder at baseline demonstrated a greater improvement in motor function including a 3.2-hour improvement in good ON time from baseline to 12 months. Infusions of VY-AADC were well tolerated with no serious adverse events reported. These Phase I results show that the posterior trajectory is an additional surgical delivery route in patients with Parkinson's disease. The PD-1102 trial includes eight patients with advanced Parkinson's disease. On average, patients' baseline characteristics in PD-1102 were consistent with patients' baseline from a separate, ongoing Phase Ib trial employing a frontal surgical delivery approach. Two patients in PD-1102 were identified as having impulse control disorder while no patients were identified as having impulse control disorder in PD-1101. At baseline, patients' mean good ON time was 9.1 hours and mean OFF time was 6.8 hours. Administration of VY-AADC with the posterior trajectory resulted in a mean coverage of the putamen of 54% and reduced the infusion time by approximately two hours compared to PD-1101. In PD-1102, treatment with VY-AADC increased AADC enzyme activity in the putamen as measured by positron emission tomography using fluorodopa by 85%. AADC enzyme activity in the putamen as measured by PET using 18F-DOPA reflects the capacity of neurons in the brain to convert levodopa to dopamine. Treatment with VY-AADC improved patients' motor function from baseline to twelve months across multiple assessments. These assessments include patient self-reported diary entries of ON and OFF times, Unified Parkinson's Disease Rating Scales, and activities of daily living measures. In addition, patients' reported an ability to maintain motor function with less Parkinson's disease medication, as patients' reported a mean 28% reduction in the dosage of Parkinson's disease medication at six months and at 12 months from a baseline mean of 1,500 mg/day. Treatment with VY-AADC improved patients' good ON time by 1.7 hours from baseline and reduced OFF time by 2.2 hours from baseline to 12 months. Exploratory analyses in PD-1101 suggested that patients with high dyskinesia or an ICD at baseline may show different outcomes, especially in patient-reported diary measures. A clinical assessment of the subgroup of patients with no or low baseline dyskinesia as measured by the Unified Dyskinesia Rating Scale score and absence of ICD at baseline as determined by the investigator, indicated that VY-AADC improved good ON time from baseline by 3.2 hours and reduced OFF time by 3.2 hours in patients at 12 months. In addition to motor function, VY-AADC improved patients' quality of life as measured by the patient-reported 39-item Parkinson's Disease Questionnaire. For PDQ-39, VY-AADC improved (reduced) patients' score by a mean change from baseline to 12 months of -7.6. Infusions of VY-AADC have been well tolerated in the eight patients treated in PD-1102 with no serious adverse events reported. Based on the results from PD-1101 and PD-1102, Voyager initiated RESTORE-1, a Phase II, randomized, placebo-surgery controlled, double-blinded, multi-center, clinical trial to evaluate the safety and efficacy of VY-AADC in patients who have been diagnosed with Parkinson's disease for at least four years, are not responding adequately to oral medications, and have at least three hours of OFF time during the day as measured by a validated self-reported patient diary.
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NBIX | Hot Stocks12:48 EDT Neurocrine presents data analysis from two Phase III studies of opicapone - Neurocrine Biosciences announced the presentation of a data analysis from two Phase III studies of opicapone, a novel, once-daily, oral, selective, peripherally-acting catechol-O-methyltransferase inhibitor for the treatment of Parkinson's disease. The analysis found that treatment with opicapone 50 mg, added to levodopa, resulted in a significant and sustained increase in ON time without troublesome dyskinesia, in Parkinson's disease patients with motor fluctuations. In addition, more than 60% of patients treated with once-daily opicapone 50 mg achieved greater than or equal to a one-hour increase from baseline in total ON time at week 14/15. The analysis, which included data from more than 900 patients in the double-blind, placebo-controlled Phase III BIPARK-1 and BIPARK-2 studies, was highlighted as an oral session at the 2019 American Academy of Neurology Annual Meeting in Philadelphia. The data presentation highlighted statistically significant increases in absolute ON time without troublesome dyskinesia from baseline to the week 14/15 endpoint in both the BIPARK-1 and BIPARK-2 studies. The improvements in ON time without troublesome dyskinesia were sustained in all patients treated with opicapone in the one-year long-term open-label extension studies, with an average increase from baseline of 2.0+/-2.6 hours in BIPARK-1 and 1.8+/-3.2 hours for BIPARK-2. In addition, a significantly higher percentage of patients treated with opicapone 50 mg had an increase in total ON time of an hour or longer at week 14/15 in both BIPARK-1 and BIPARK-2. Pooled safety data from the double-blind opicapone-treated population showed that 17.4% patients treated with opicapone reported dyskinesia as a treatment-emergent adverse event versus 6.2% in placebo-treated patients. Only 1.9% of opicapone-treated patients discontinued treatment due to a TEAE of dyskinesia and only 0.3% experienced dyskinesia as a serious TEAE. Other TEAEs included constipation, insomnia and dry mouth in opicapone- and placebo-treated patients, respectively.
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CHDN | Hot Stocks12:44 EDT 145th Kentucky Derby sets all-time wagering record - Derby fans weathered a steady late-afternoon rain as Country House captured the 145th Kentucky Derby Presented by Woodford Reserve over a sloppy track. Wagering from all-sources was the highest all-time on both the Kentucky Derby Day program and on the Kentucky Derby race. Wagering from all-sources on the Kentucky Derby Day program totaled $250.9M, an 11% increase over the 2018 total and previous record of $225.7M. Wagering from all-sources on the Kentucky Derby race increased 10% to $165.5M from the previous record of $149.9M set last year. This year's wagering record includes $4.1M of handle wagered in Japan with this being the first year the Kentucky Derby has ever been offered for wagering in the country. Attendance of 150,729 decreased 4% compared to last year, as the threat of an all-day rain forecast kept many fans away. This year's Derby purse was elevated $1M to a guaranteed $3M making it the richest in history for America's greatest race and first leg of horse racing's Triple Crown.
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EPIX | Hot Stocks12:41 EDT Essa Pharma presents new preclinical data for EPI-7386 - ESSA Pharma presented new preclinical data on ESSA's lead Investigational New Drug candidate at the 2019 American Urological Association Annual Meeting. The studies demonstrate that, pre-clinically, EPI-7386: Displays similar in vitro IC50 potency compared to the 'lutamide class of antiandrogens in an in vitro androgen receptor inhibition assay; Shows in vitro activity in several enzalutamide-resistant prostate cancer cell models in which enzalutamide is resistant; Exhibits a favorable metabolic profile across three preclinical animal species, which suggests that EPI-7386 will have high exposure and a long half-life in humans; Provides similar antitumor activity to enzalutamide in the enzalutamide-sensitive LNCaP prostate cancer xenograft model; Provides superior antitumor activity to enzalutamide, as a single agent or in combination with enzalutamide, in the enzalutamide-resistant VCaP prostate cancer xenograft model; AR inhibition with both an N-terminal domain inhibitor and a ligand binding domain inhibitor, induces deeper and more consistent anti-tumor responses in the enzalutamide-resistant VCaP xenograft model.
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ASML | Hot Stocks12:38 EDT U.S. court issues final judgment in favor of ASML against XTAL - ASML announced that the Santa Clara County Superior Court entered its final judgment in favor of ASML against XTAL and awarded ASML the amount of $845M as well as an injunction. The judgment finalizes the verdict returned by the jury on 28 November 2018. The jury found that XTAL's conduct as to all counts was malicious, entitling ASML to an award of punitive damages on all five counts pleaded against XTAL. According to ASML, the primary driver behind the jury's verdict and the $845M final judgment were saved research and development costs by XTAL, due to XTAL's theft of trade secrets, inducing former employees to breach their contracts with ASML, aiding and abetting former employees to breach their fiduciary duty of loyalty to ASML, and multiple violations of California's Computer Data Access and Fraud Act. ASML did not claim much in the way of out-of-pocket damages which were a minor element of the award. The judgment will be uncollectable as XTAL is in bankruptcy, but under a settlement arrangement ASML will end up owning most, if not all, of XTAL's intellectual property through the bankruptcy process. In addition to the $845M judgment, the trial court issued an injunction. The injunction orders XTAL not to conduct any software development activities on its software products that ASML alleged are contaminated with ASML's IP, grants ASML explicit permission to reach out to actual or potential customers of XTAL and inform them of the jury's verdict and result of the lawsuit, and bars XTAL from continued work in the same field of business as Brion for a certain period of time. ASML has been meanwhile working to ensure that the customers of ASML Brion that XTAL initially lured away, or tried to lure away, continue to be supported with computational lithography products from ASML, despite the disruption caused by XTAL.
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TSN | Hot Stocks12:32 EDT Tyson Foods expands recall of ready-to-eat chicken breast strips - Tyson Foods said it has decided to expand a voluntary recall originally issued on March 21, 2019 of frozen, ready-to-eat chicken strip products made at one location between October 1, 2018 and March 8, 2019. In recent days additional consumers reported finding fragments of metal in a small number of products. The company is expanding the recall in the interest of public health even though the vast majority of the products have already been consumed without any reported incidents.
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