Stockwinners Market Radar for January 07, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
CELG... | Hot Stocks20:03 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. Celgene (CELG) and Impact Biomedicines announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1B upfront and up to $1.25B in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible. 2. Pfizer (PFE) will stop trying to discover new drugs for Alzheimer's disease and Parkinson's disease, according to The Wall Street Journal. The move will result in layoffs of 300 employees over several months, the report added. 3. U.S. postal rates look likely to rise, pinching Amazon (AMZN) and benefiting FedEx (FDX) and UPS (UPS), Jack Hough wrote in this week's edition of Barron's. While for now UPS enjoys higher profit margins, investors should favor FedEx as years-long investment in automating and expanding its hubs has given the company a speed and efficiency advantage over the former, he added. Earnings per share growth for FedEx should more than triple next year as tax cuts kick in, the report noted. 4. Sony's (SNE) "Jumanji: Welcome to the Jungle" has topped the charts after three weekends in theaters, earning $36M from 3,801 theaters and bringing its total to $244.4M. The Dwayne Johnson and Kevin Hart-led remake has received an A- CinemaScore and got a 77% from Rotten Tomatoes. 5. Kohl's (KSS), Charles Schwab (SCHW), Home Depot (HD), Valero Energy (VLO), NextEra Energy (NEE), Allstate (ALL), Cisco Systems (CSCO), Las Vegas Sands (LVS), Wynn Resorts (WYNN), and Melco Resorts & Entertainment (MLCO), saw positive mentions in Barron's, while Caterpillar (CAT) was mentioned cautiously.
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LX | Hot Stocks19:39 EDT LexinFintech announces full exercise of underwriters' over-allotment option - LexinFintech announced that the underwriters of the company's initial public offering have exercised their over-allotment option in full to purchase an additional 1,800,000 American depositary shares from the company for the IPO price of $9.00 per ADS, less an underwriting discount and commission of 63c per ADS, or a net price of $8.37 per ADS. Total proceeds to the company from ADSs sold in the IPO, including the 12,000,000 ADSs sold initially and the 1,800,000 ADSs sold pursuant to the over-allotment option, were approximately $115.5B, after deducting underwriting discounts and commissions but before deducting offering expenses payable by the company.
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ZYME | Hot Stocks19:03 EDT Zymeworks announces 2018 priorities - Building on its 2017 accomplishments, over the next 12 months, Zymeworks expects to complete enrollment and report additional data from its adaptive Phase 1 clinical study of ZW25, refine the regulatory strategy and accelerate the development of ZW25, file an Investigational New Drug Application for one of its wholly-owned product candidates, present preclinical data showcasing its maturing candidate pipeline and evolving therapeutic platforms, and establish new strategic drug development partnerships. Additionally, Zymeworks expects its partners' Azymetric programs to begin entering the clinic in 2018.
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TWX... | Hot Stocks18:35 EDT Box Office Battle: 'Jumanji' topples 'Star Wars: The Last Jedi' - Sony's (SNE) "Jumanji: Welcome to the Jungle" has topped the charts after three weekends in theaters, earning $36M from 3,801 theaters and bringing its total to $244.4M. The Dwayne Johnson and Kevin Hart-led remake has received an A- CinemaScore and got a 77% from Rotten Tomatoes. BOX OFFICE RUNNERS-UP: Comcast's (CMCSA; CMCSK) newcomer "Insidious: The Last Key" opened in second with $29.6M helped by young audiences. Behind it was Disney (DIS) and Lucasfilm's "Star Wars: The Last Jedi," earning $23.6M in its fourth weekend in theaters. 21st Century Fox's (FOXA) "The Greatest Showman" placed number four, earning $13.8M from 3,342 theaters. Rounding out the top five, Comcast's "Pitch Perfect 3" should end the weekend with $10.2M from 3,458 theaters. Other publicly traded companies in filmmaking include Viacom (VIAB), Lionsgate (LGF.A), and Warner Bros. (TWX).
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CELG | Hot Stocks18:03 EDT Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline - Celgene and Impact Biomedicines announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1B upfront and up to $1.25B in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible. Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials. In a randomized, placebo-controlled, phase III pivotal trial for patients with treatment-naive myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively. In an exploratory subgroup analysis, these improvements were observed regardless of a patient's baseline platelet count. A multi-center, single-arm phase II trial evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib, a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score. JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration after potential cases of Wernicke's encephalopathy were reported in eight out of 877 patients receiving one or more doses. The FDA removed the clinical hold in August 2017. Based on the reported benefit risk profile of fedratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in myelofibrosis are planned beginning in the middle of 2018.
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GLPG | Hot Stocks17:26 EDT Galapagos NV announces positive topline results with GLPG1972 in osteoarthritis - Galapagos NV reported positive preliminary topline results with a Phase 1b study in osteoarthritis patients in the U.S. Galapagos evaluated GLPG1972 in a randomized, placebo-controlled, double-blind Phase 1b study in 30 patients aged 50 to 75 years with diagnosis of knee and/or hip osteoarthritis, in the U.S. Patients were given one of three doses of GLPG1972 or placebo for a total of 4 weeks, with a 3 week follow-up period. Primary objectives were to evaluate safety, tolerability, and pharmacokinetics of GLPG1972 in patients. A secondary objective was to measure the reduction of ARGS neoepitope, an important cartilage breakdown biomarker. The mechanism of action of GLPG1972, which targets a cartilage degrading enzyme called ADAMTS-5, was confirmed in two animal models. An earlier Phase 1 study in healthy volunteers met all its safety and pharmacokinetic targets and also demonstrated that GLPG1972 reduced the blood level of ARGS neoepitope by up to more than 50% within two weeks. In this Phase 1b study in patients, GLPG1972 was well tolerated. There was one treatment discontinuation with reversible abnormal liver function test on Day 15 in the highest dose cohort. The pharmacokinetics of GLPG1972 in a population of elderly individuals with OA were similar to those in healthy volunteers, potentially supporting once-daily oral treatment. Patients on treatment achieved a dose-dependent, reduction of ARGS neoepitope versus placebo.
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ALNY SNY | Hot Stocks17:10 EDT Alnylam expects Patisiran to be first commercially available RNAi in mid-2018 - Alnylam (ALNY) announced 2018 corporate goals, namely that it expects Patisiran to be first commercially available RNAi therapeutic in mid-2018, restructured Sanofi (SNY) Alliance to provide Alnylam with global commercial footprint for ATTR Amyloidosis, Givosiran Interim Phase 3 data in mid-2018 and U.S. New Drug Application filing in late 2018. The company also plans to advance three additional Phase 3 programs: Fitusiran, Inclisiran, and ALN-TTRsc02.
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ALNY SNY | Hot Stocks17:03 EDT Alnylam, Sanofi announce strategic restructuring of RNAi therapeutics alliance - Alnylam Pharmaceuticals (ALNY) and Sanofi (SNY) announced a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases. Specifically, Alnylam will obtain global development and commercialization rights to its investigational RNAi therapeutics programs for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will receive royalties based on net sales of these ATTR amyloidosis products. Sanofi will obtain global development and commercialization rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with hemophilia A and B. Global commercialization of fitusiran, upon approval, will be done by Sanofi Genzyme, the specialty care global business unit of Sanofi. Alnylam will receive royalties based on net sales of fitusiran products. With respect to other products falling under the RNAi therapeutics alliance, the material terms of the 2014 Alnylam-Sanofi Genzyme alliance remain unchanged.
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MDXG | Hot Stocks15:59 EDT MiMedx provides update to share repurchase program - MiMedx provided an update to its share repurchase program that was initiated in May 2014. The company reported that since inception, its Board of Directors has authorized $130M in share repurchases. To date, the number of shares purchased through the share repurchase program is $124.2M, and these repurchased shares represent in excess of 10% of the company's total diluted shares outstanding.
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NBIX | Hot Stocks15:47 EDT Neurocrine announces Christopher O'Brien retirement, Eiry Roberts as CMO - Neurocrine Biosciences announced that Christopher O'Brien, Chief Medical Officer, has notified the company he plans to retire in February 2018, after a transition period with his successor. Eiry Roberts will join the company as Chief Medical Officer, effective January 8, 2018. Neurocrine also announced the grant of an inducement award to Roberts pursuant to NASDAQ Listing Rules. In connection with her employment by Neurocrine, Roberts will be granted an inducement award consisting of a stock option to purchase 70,000 shares of Neurocrine common stock. The stock option will vest over a period of four years, with 25% vesting on the first anniversary of its grant date and the balance vesting each month over the remaining three years. Roberts also received 20,000 restricted stock units which vest in equal increments over four years, with 25% vesting each year. These awards are subject to the terms and conditions of Neurocrine's Inducement Plan, and will be effective on January 8, 2018. The stock option grant will have an exercise price equal to the closing price of Neurocrine's common stock on the NASDAQ Global Select Market on that date.
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RARE | Hot Stocks15:35 EDT Ultragenyx announces positive interim results from DTX301 study - Ultragenyx Pharmaceutical announced positive interim safety and efficacy data from the first dose cohort of the Phase 1/2 study of DTX301, an adeno-associated virus gene therapy for the treatment of ornithine transcarbamylase deficiency. "We are encouraged by these initial data showing activity with our AAV8 vector in patients in the first, lowest-dose cohort. Patient 1 showed a normalization of ureagenesis that was maintained through 12 weeks, and we view this initial efficacy data as clinically meaningful and a promising indication of the potential of DTX301," said Emil Kakkis, CEO and President of Ultragenyx. "Based on the data to date, we expect to be able to move to the higher-dose second cohort pending the data monitoring committee's review of the 12-week safety data for all three patients in this cohort, and data from this second cohort should be available in the second half of 2018."
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BGNE | Hot Stocks09:30 EDT Harbour BioMed announces licensing agreement with BeiGene - Harbour BioMed announced that it has licensed its patented H2L2 transgenic mouse platform for generating fully human therapeutic monoclonal antibodies to BeiGene. The license was issued through Harbour BioMed's wholly owned subsidiary, Harbour Antibodies BV. Harbour BioMed's transgenic H2L2 platform enables biotechnology and pharmaceutical companies and academia to accelerate new drug development by generating fully human monoclonal antibodies. Under the licensing agreement, BeiGene has rights to use the H2L2 platform for multiple programs over a multi-year period. Financial details were not disclosed.
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