Stockwinners Market Radar for December 06, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:37 EST Fifth Third issues statement on temporary network outage - Fifth Third Bank (FITB) issued the following statement related to a temporary network outage this afternoon: "Earlier today we experienced a temporary outage with our network connectivity. The issue involved a simultaneous failure in both the primary system and a backup which impacted our ability to provide normal levels of service to customers. We worked closely with Cisco Systems (CSCO) to identify the issue and restore service. We are deeply sorry for the inconvenience and will make every effort to make things right for our customers who were affected."

18:31 EST Gol Linhas announces preliminary traffic figures for November - GOL's domestic supply increased 8.9% and demand increased by 6.3%. GOL's domestic load factor was 81.7%. The slight decrease in load factor was mainly due to GOL's discipline in yield management and some spill caused by a temporary suspension of sales on flights impacted by unscheduled aircraft maintenance. The volume of departures increased by 8.5% and seats increased by 11.6% over November 2018. GOL's international supply and demand decreased by 9.3% and 13.2% respectively, and international load factor was 72.8%. The decrease in load factor was mainly due to lower demand in Argentina and Chile. GOL's total supply was 6.4% higher due to a 11.0% increase in seats and a 7.9% increase in departures. GOL's total demand increased by 3.8% in comparison to November 2018 and consolidated load factor was 80.7%.

18:22 EST Boot Barn CEO: More than 80% of our business is in the store - In an interview on CNBC's Mad Money, Boot Barn CEO Jim Conroy said: Most of our product is still for functional use, but we've picked up in the fashionable space... We have diversified quite a bit... We are now in 33 states... We think we can double the store count... Our exclusive brands now make up about 25% of sales... We've been able to mitigate the impact of the China tariffs.

17:55 EST SPDR Gold Shares holdings fall to 886.23MT from 888.57MT - This is the lowest level of holdings since September 19th.

17:31 EST Quorum Health receives NYSE continued listing standard notice - Quorum Health Corporation announced that it was notified on December 3, 2019 by the New York Stock Exchange that it was not in compliance with the NYSE's continued listing standards as a result of the average closing price of the company's common stock being less than $1.00 per share over a consecutive 30 trading-day period. As set forth in the December Notice, as of December 3, 2019, the 30 trading-day average closing share price of the company's common stock was 90c. In accordance with the NYSE rules, the company has a period of six months following the receipt of the December Notice to regain compliance with the minimum share price requirement. The company plans to notify the NYSE within 10 business days of its intent to cure the deficiency. The company can regain compliance with the minimum share price requirement at any time during the six month cure period if, on the last trading day of any calendar month during the cure period or on the last day of the cure period, the company has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on such date.

17:25 EST Lockheed Martin awarded $153.39M Navy contract modification - Lockheed Martin was awarded a $153.39M cost-plus-fixed-fee modification to a previously-awarded contract. This modification procures special tooling and special test equipment required to meet current and future F-35 Lightning II low-rate initial production as well as full-rate production rates. Work is expected to be completed in December 2023. FY18, FY19 and FY20 aircraft procurement funds in the amount of $153.39M will be obligated at time of award, $39.89M of which will expire at the end of the current fiscal year. This modification combines purchases for the Air Force; Navy; Marine Corps; non-U.S DoD international partners and FMS customers. The Naval Air Systems Command is the contracting activity.

17:03 EST Support.com announces special distribution of $1.00 per share - The record date for the special distribution is December 17, and the payment date for the distribution is December 26. This is a part of the ongoing capital allocation review being conducted by the Board.

16:32 EST Alector reports Phase 1 safety, biomaker data on AL002 - Alector reported safety and biomarker data from the single ascending dose phase of the INVOKE Phase1 study of its product candidate, AL002, in healthy volunteers. AL002 is a monoclonal antibody intended to enhance the activity of TREM2 and is being developed by Alector for the treatment of Alzheimer's disease in collaboration with its partner AbbVie. The data were presented today at the 12th Clinical Trials on Alzheimer's Disease meeting being held December 4-6 in San Diego, California. The AL002 presentation at CTAD showcases the first data in humans showing that a TREM2 activating antibody engages its target and demonstrates downstream activity in the CNS. Robert Paul, M.D., Ph.D., chief medical officer of Alector, presented an abstract entitled, A Phase 1 Study of AL002 in Healthy Volunteers and Patients With Mild-To-Moderate Alzheimer's Disease during an oral communications session. The INVOKE clinical study is a first-in-human study in healthy adults and in patients with mild to moderate Alzheimer's disease, designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of AL002. The data reported today are from the study's SAD phase in 56 healthy adults, who were enrolled into nine escalating dose cohorts. Summary of the clinical data of the SAD portion of the Phase 1 INVOKE clinical study presented at CTAD: 56 healthy volunteers were treated with nine escalating doses of AL002; AL002 was found to be generally safe and well-tolerated; AL002 reduced cerebrospinal fluid soluble TREM2 in a dose-dependent manner, demonstrating proof-of-target engagement in the brain; AL002 elevated a biomarker for microglia activity in the CSF, indicating proof-of-mechanism; the Phase 1b portion of the study in Alzheimer's disease patients is on-going. Alector expects to initiate the AL002 Phase 2, proof-of-concept study in 2020. "Loss of TREM2 activity has been shown through human genetics to be one of the major risk factors of developing Alzheimer's disease," said Robert Paul, M.D., Ph.D., chief medical officer of Alector. "AL002 is the first TREM2 agonistic antibody in clinical development for Alzheimer's disease, and we are pleased to see safety and tolerability in healthy volunteers and that AL002 is showing proof-of-target engagement and proof-of-mechanism at this early stage in development. These results together will help guide our dose selection for the Phase 2 study in Alzheimer's patients."

16:29 EST PNM Resources raises quarterly dividend 6% to 30.75c per share - The Board of Directors of PNM Resources unanimously voted to increase the company's annual dividend payment by 7c, a 6% increase, to an indicated annual rate of $1.23 per share of common stock. This is consistent with the company's target to pay out 50%-60% of annual ongoing earnings. The board has declared the resulting quarterly stock dividend of 30.75c per share, payable February 14, 2020, to shareholders of record at the close of business February 3, 2020.

16:22 EST Crescent Park Management reports 6.4% passive stake in Accell - In a regulatory filing, Crescent Park Management disclosed a 6.4% stake in Accell Entertainment, which represents over 5M shares. The filing does not allow for activism.

16:16 EST Lilis Energy discloses notice of NYSE listing deficiency - Lilis Energ received a deficiency letter from the NYSE stating that the company is below compliance with the continued listing standards as set forth in Section 1003(f)(v) of the NYSE American Company Guide because the company's common stock has been selling for a low price per share for a substantial period of time. The Letter states that the company must effect a reverse stock split of its common stock or otherwise demonstrate sustained price improvement no later than June 3, 2020. As previously announced, the Board of Directors of the company has formed a Special Committee and engaged a financial advisor tasked with reviewing and evaluating strategic alternatives that may enhance the value of the company, however there is no assurance that any alternative will materialize.

16:13 EST Ra Medical Systems receives noncompliance notice from NYSE - Ra Medical Systems announced that on December 4, it received a notice from the NYSE that it is not in compliance with a NYSE continued listing requirement for maintaining an average total market capitalization of not less than $50M over a period of 30 consecutive trading days and having stockholders' equity of not less than $50M. The company intends to submit a plan within 45 days of the notice to the NYSE advising how the company plans to regain compliance with the continued listing standards within 18 months of the receipt of the notice. If NYSE does not accept the plan or the company is not in compliance with the continued listing standards at the end of such 18 month cure period, or does not make progress consistent with the plan, NYSE may initiate delisting procedures. The NYSE notification does not affect the company's business operations or its Securities and Exchange Commission reporting requirements. During this period, the company's common stock will continue to be traded on the NYSE, subject to compliance with other continued NYSE listing requirements.

16:03 EST Cohen & Steers announces approval of Global Income Builder reorganization - Cohen & Steers Global Income Builder announced the results of the special meeting where stockholders approved the reorganization of INB with and into Cohen & Steers Infrastructure Fund, Inc. The Reorganization is expected to occur after the close of business on December 20, 2019, subject to the satisfaction of customary closing conditions. After the Reorganization, the investment strategies, policies and restrictions of the combined Fund will be those of UTF. The Fund seeks to deliver total return, with an emphasis on income, through investments in securities issued by infrastructure companies that own and operate assets such as utilities, cell towers, pipelines, toll roads, airports, railroads and marine ports. Until the Closing Date, INB is expected to deviate from its principal investment strategies and INB's current investment restrictions will not apply as INB's portfolio will be managed in anticipation of the Reorganization.

15:30 EST Exxon Mobil Treasurer sells 8K shares of common stock - In a regulatory filing, Exxon Mobil disclosed that its Treasurer Robert Schleckser sold 8.0K shares of common stock on December 4th. The total transaction size was $548K.

14:35 EST Amgen confirms FDA approval of Avsola for same indications as Remicade - Amgen announced that the U.S. Food and Drug Administration has approved Avsola for all approved indications of the reference product, Remicade: for the treatment of moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn's Disease in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

14:20 EST Grifols higher after new data show reduction in Alzheimer's progression - Grifols shares moved higher after the company presented its latest Alzheimer's clinical trial data at the Clinical Trials on Alzheimer's Disease Conference. New neuroimaging data results from the Ambar clinical trial show the reduction in the progression of the disease in patients with mild-to-moderate Alzheimer's disease, Grifols announced. The neuroimaging, which was measured by the FDG-PET1 technique, shows "positive" results particularly in patients receiving both albumin and immunoglobulin, according the company. In comparison with the placebo group, these patients had less reduction of brain glucose metabolism over the 14 months of the clinical trial. "This suggests that neuronal damage was reduced in these patients," Grifols said. The company added that it will soon meet with the FDA to discuss the Ambar clinical development program and the design of a successive Ambar II trial "that will deepen and complement the just-concluded one." Shares of Grifols are up 74c to $23.12 in afternoon trading.

13:36 EST Baidu reports filing total of 5,712 AI-related patent applications - Baidu (BIDU) announced in a press release that it has "filed the most AI-related patent applications in China," according to a recent study from the research unit of China's Ministry of Industry and Information Technology. Baidu filed a total of 5,712 AI-related patent applications as of October 2019, "ranking No.1 in China for the second consecutive year," the company announced. Baidu said its patent applications were followed by Tencent (TCEHY) with 4,115, Microsoft (MSFT) with 3,978, Inspur with 3,755, and Huawei with 3,656, according to the report issued by the China Industrial Control Systems Cyber Emergency Response Team, a research unit under the MIIT.

12:53 EST FDA approves Amgen's Avsola - The U.S. Food and Drug Administration has approved Avsola, Amgen's (AMGN) biosimilar copy of Johnson & Johnson's (JNJ) rheumatoid arthritis treatment Remicade.

12:49 EST Leidos among team awarded DOE contract for Hanford site services - The U.S. Department of Energy announced that it has awarded a contract to provide a variety of services at the Hanford Site, called the Hanford Mission Essential Services Contract, to Hanford Mission Integration Solutions in Richland, Washington. The HMIS LLC members are Leidos Integrated Technology; Centerra Group; and Parsons Government Services. The total award value is $4,002,348,330 with a base period of performance of five years, including a 120-day transition period. The contract also has a potential option period of three years, and a second option period of two years. Reference Link

12:04 EST Momenta granted orphan status for hemolytic anemia treatment - The FDA granted Momenta Pharmaceuticals orphan status for its treatment of autoimmune hemolytic anemia. Reference Link

12:00 EST Weidai falls -8.3% - Weidai is down -8.3%, or -37c to $4.09.

12:00 EST Yext falls -15.4% - Yext is down -15.4%, or -$2.56 to $14.04.

12:00 EST Big Lots rises 26.5% - Big Lots is up 26.5%, or $5.08 to $24.23.

11:58 EST Ford issues two safety recalls in North America - Ford Motor Company is issuing two safety recalls in North America. The company said, "Ford is issuing a safety recall for select 2017-19 Ford F-250, F-350 and F-450 Super Duty vehicles for unintended tailgate opening. In affected vehicles with an electric tailgate latch-release switch mounted in the tailgate handle, water entering the electrical wiring system may cause a short circuit, resulting in unintended switch activation and release of the tailgate latches. This could cause the tailgate to open unintentionally, whether the vehicle is in motion or stationary. This condition may result in the loss of unrestrained cargo, increasing the risk of a crash. Vehicles with a mechanical tailgate release handle are not affected. Ford is not aware of any reports of accident or injury related to this condition. This action affects 231,664 vehicles in the U.S. and federal territories and 29,953 in Canada...Dealers will modify the tailgate frame wiring harnesses by adding jumper pigtails to isolate the tailgate release control circuits and install a new tailgate handle release switch...Ford is issuing a safety recall for select 2020 Ford Explorer and 2020 Lincoln Aviator vehicles. In some affected vehicles, the convolute protective sleeve on the liquid fuel line is not long enough, which may allow for potential hard contact with the convolute-protected vapor fuel line. Over time, with vibration and engine roll, hard contact between the two fuel lines could cause the convolute on the vapor fuel line to rub through the plastic liquid fuel line. A fuel leak in the presence of an ignition source increases the risk of a fire. Ford is not aware of any reports of accident, injury or fire related to this condition. This action affects 3,858 vehicles in the U.S. and federal territories, 35 in Canada, and seven in Mexico...Dealers will inspect vehicles for a full-length yellow-colored protective convolute on the liquid fuel line. If the convolute does not cover the full length of the liquid fuel line, dealers will remove the existing convolute, replace it with one that has the correct length and secure it with a tie strap."

10:34 EST 3M higher after Bloomberg says running auction for drug delivery unit - 3M is exploring a sale of its drug delivery systems unit, which could be worth about $1B, Bloomberg reports, citing people with knowledge of the matter. Sources told Bloomberg that the company working with an adviser to run an auction process for the business that makes asthma inhalers and skin patches. The unit, which had $300M in sales in the first nine months of 2019, is likely to draw interest from private equity firms, the sources add. Shares of 3M are up 4%, or $6.87, to $171.24 in morning trading.

10:00 EST PagerDuty falls -14.5% - PagerDuty is down -14.5%, or -$3.63 to $21.36.

10:00 EST Chemours rises 9.2% - Chemours is up 9.2%, or $1.38 to $16.44.

10:00 EST Big Lots rises 22.3% - Big Lots is up 22.3%, or $4.27 to $23.43.

09:47 EST PagerDuty falls -15.4% - PagerDuty is down -15.4%, or -$3.84 to $21.15.

09:47 EST Medallia rises 9.2% - Medallia is up 9.2%, or $2.74 to $32.60.

09:47 EST Big Lots rises 22.8% - Big Lots is up 22.8%, or $4.37 to $23.53.

09:19 EST Trinity Industries raises quarterly dividend to 19c per share from 17c per share - Trinity Industries has declared an increase in its quarterly dividend to 19c per share on its 1c par value common stock. The new dividend reflects an increase of 12% compared to the most recent quarterly dividend of 17c per share. The quarterly cash dividend, representing Trinity's 223rd consecutively paid dividend, is payable January 31, 2020 to stockholders of record on January 15, 2020.

09:08 EST Apple Hospitality REIT CFO Rachael Rothman resigns, Bryan Peery succeeds - Apple Hospitality REIT announced Rachael Rothman, executive VP and CFO, has resigned from the company effective immediately. The company also announced that its board appointed Bryan Peery, the company's executive VP and chief accounting officer, to fill the position. Peery previously served as the company's executive VP and CFO from the company's inception in 2007 until June 30. In March, Peery informed the company of his intention to retire from his positions with the company in Q1 of 2020; however, Peery has agreed to remain with the company, as necessary, beyond March 2020 to provide for a transition of his responsibilities. The company said Rothman's resignation is not due to any disagreement with the company on any matter relating to the company's operations, policies or practices.

09:05 EST Shineco announces completion of first board meeting for 2019 - Shineco announced that it completed its first board meeting for fiscal year 2019 held on November 26, 2019 in Beijing, China and pursuant to which the Company's directors: Re-elected Mr. Yuying Zhang as the Chairman of the Board of Company to hold office until the next annual general meeting. Elected Mr. Baolin Li as the Vice Chairman of the Board of Company to hold office until the next annual general meeting. Elected Mr. Harry Edelson as an independent director of the Board of Company.

09:02 EST Aptevo Therapeutics receives Orphan Drug Designation for APVO436 - Aptevo Therapeutics announced that the United States Food and Drug Administration has granted Orphan Drug Designation to APVO436, a bispecific antibody candidate intended for the treatment of acute myelogenous leukemia. APVO436 is currently being evaluated in a Phase 1/1b clinical trial in patients with AML and myelodysplastic syndrome.

09:00 EST Orgenesis, Theracell to launch cell therapy platform in HYGEIA Group's network - Orgenesis announced a strategic partnership agreement between the HYGEIA Group and the Theracell-Orgenesis joint venture. Under the Agreement, the JV will implement Orgenesis' POCare cell therapy platform for clinical development and commercialization of cell and gene therapies within HYGEIA Group's network of three hospitals in Greece. As previously announced, Orgenesis and TheraCell Advanced Biotechnology formed a JV to advance Orgenesis' POCare platform in Greece, Cyprus, the Balkan region and selected Middle Eastern countries. The POCare platform is designed to collect, process and supply cells within the patient care setting for various therapeutic treatments. The goal of the platform is to reduce the cost and complexity of supplying cell and gene therapies, as well as elevate quality standards by integrating automated processing units and proprietary technologies. HYGEIA is the first hospital network in this region to implement Orgenesis' POCare cell therapy platform. The Partnership is intended to provide HYGEIA Group with resources to advance clinical development and deliver personalized, advanced therapies across its network for a wide range of diseases in oncology, hematology, orthopedics, nephrology, dermatology and diabetes.

08:49 EST Xenon provides updates on proprietary neurology pipeline programs - Xenon Pharmaceuticals announced that it will provide updates on its proprietary, neurology programs at the American Epilepsy Society Annual Meeting held in Baltimore, MD. Xenon is presenting updates on both of its proprietary, clinical-stage programs, XEN1101 and XEN496 - as well as presenting promising pre-clinical data - in a number of poster sessions at AES: XEN496 is a Kv7 potassium channel modulator being developed by Xenon. A poster entitled "Development of a Pediatric Immediate-Release Formulation of the Potassium Channel Opener XEN496" will be presented in a scientific poster session, as well as the BioMarin exhibit, on Sunday, December 8, 2019. After examining multiple formulations with different properties, Xenon has developed XEN496 as a pediatric-specific, granule formulation to be packaged as single-dose sprinkle capsules that has excellent properties supported by both in vitro and in vivo data. A planned pharmacokinetic study will test XEN496 in healthy adult volunteers, with data expected in the first quarter of 2020. Xenon will also present a poster in the BioMarin exhibit entitled, "An Online Survey of Caregivers of Patients with KCNQ2 Developmental & Epileptic Encephalopathy." Xenon recently performed a caregiver survey to obtain additional phenotypic information regarding the seizure history of the disease as well as Anti-Seizure Medication use, with a focus on ezogabine. Importantly, all seven respondents who had access to ezogabine responded that they saw improvements in their child's seizures, behavior or development while they were taking ezogabine. In addition, ezogabine was reported to be well-tolerated. Information from this survey, as well as input from key opinion leaders, will help inform the proposed Phase 3 clinical trial design and protocol. Xenon expects to file an Investigational New Drug application in the first quarter of 2020 to discuss with the FDA the design of a Phase 3 clinical trial in KCNQ2-DEE. The FDA has indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. A poster entitled "Use of Transcranial Magnetic Stimulation Data in the Design of a Dose Range Finding Efficacy, Safety, Tolerability, and Pharmacokinetics Study of XEN1101 in Patients with Focal Epilepsy" will be presented on Monday, December 9, 2019. This poster outlines the XEN1101 Phase 2 study design and concludes that incorporating TMS evidence of CNS activity in healthy volunteers may be a useful adjunct in refining dose selection for Phase 2 epilepsy studies. A Phase 2b double-blind, placebo-controlled, multicenter clinical trial, which is currently underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient enrollment for this XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. Long term six and nine-month toxicology studies have now been completed, providing support to the planned 12-month open label extension for patients enrolled in the Phase 2b clinical trial. Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020. Xenon also continues to conduct pre-clinical work on other promising molecules to address neurological disorders. A poster entitled, "Small Molecule Potentiators of Nav1.1 Increase Action Potential Firing in Fast Spiking Cortical Inhibitory Interneurons from a Mouse Model of Dravet Syndrome" - which will be presented on Monday, December 9, 2019 - outlines promising work on highly selective small molecule potentiators of Nav1.1 that could address the underlying cause of Dravet Syndrome using a precision medicine approach. Selectively potentiating Nav1.1, the dominant sodium channel isoform expressed in inhibitory interneurons, restores the capability of Scn1a+/- interneurons to fire action potentials at high frequency. In brain slices from Scn1a+/- mice, the tested compound increased the firing rate of inhibitory neurons. A small molecule pharmaceutical with this profile could enable reversal of the fundamental defect in Dravet Syndrome and may have utility in other neurologic indications where interneuron excitability is impaired. Xenon intends to build upon this promising work and continue to advance potential Nav1.1 potentiators in pre-clinical development.

08:44 EST Capstone Turbine appoints Eric Hencken as CFO - Capstone Turbine announced the appointment of Eric Hencken III, the company's current Interim CFO, to the position of CFO, effective as of January 1, 2020. Hencken will continue to serve as the company's Chief Accounting Officer, and principal financial officer and principal accounting officer of the company. Hencken was appointed to Interim CFO of Capstone effective October 1. Hencken has served as the company's Chief Accounting Officer since April and served as the company's Controller from October 2017 to April 2019.

08:41 EST Turkcell signs MoU with China Development Bank - Turkcell has signed a Memorandum of Understanding in relation to an 8-year term loan of EUR 500M with China Development Bank. "Supported by growing demand from corporate and retail customers, the new loan will be used to finance the procurement of hardware and equipment from Chinese vendors. The door-to-door tenor of the loan facility will be 8 years, of which the first 3 years will be an availability (and grace) period. The parties have already begun work on the structuring and execution of the loan agreement."

08:33 EST South Jersey Industries announces sale of Marina Thermal Facility for $100M - SJI (SJI) announced it has entered into an agreement through its wholly-owned subsidiary, Marina Energy, LLC, to sell its Marina Thermal Facility to DTE Energy Services (DTE) for $100M in cash. Located in Atlantic City, New Jersey, the Marina Thermal Facility is an eight-megawatt combined heat and power generation facility that provides electricity and hot and chilled water to both Borgata Hotel Casino & Spa and The Water Club. The transaction is expected to close within 60 days, subject to satisfying customary closing conditions. Consistent with SJI's stated goal of maintaining a strong balance sheet, the company intends to use proceeds from the sale to repay debt.

08:17 EST Canopy Growth provides update on Cannabis 2.0 portfolio roll-out - Canopy Growth officially revealed its Cannabis 2.0 portfolio of products last week, set to come to market as part of the second wave of Canadian cannabis commercialization. With December 16 being the first date new product formats can be sold into distribution channels, the company expects that in most markets new products will not be seen on shelves until early in January 2020. Leveraging learnings from Cannabis 1.0, the company will stagger its launch of various products and formats to ensure a smooth roll-out. As such, availability will vary by province based on their individual ordering and distribution activities. While the company is providing this update in advance of the launch of Cannabis 2.0 products, for competitive reasons, it will not provide ongoing updates during the actual roll-out period.

08:08 EST PriceSmart opens new warehouse club in Guatemala City, Guatemala - PriceSmart announced that on November 13, the company opened a new warehouse club in Guatemala City, Guatemala bringing to 45 the total number of warehouse clubs in operation by the company. This warehouse club is located within the San Cristobal development, in the southwestern side of Guatemala City, Guatemala. The San Cristobal club is PriceSmart's fourth warehouse club in Guatemala and the first to utilize the company's smaller warehouse club format in that country.

08:06 EST Kratos awarded $39M sole-source contract for RF signal communication services - Kratos Defense & Security Solutions announced that it had been awarded a $39M sole-source contract for Geolocation Global Support Services. The award is a five year contract that includes a base year and four one-year options, for a total value of up to $39M. Work on the initial $7.7M base year contract began on December 1, 2019. Kratos will provide continuous RF monitoring services for government leased bandwidth on commercial satellites and bandwidth on military satellite communications; including bandwidth identified by the Combined Space Operations Center, or CSpOC.

08:03 EST Yahsat and Hughes launch satellite services joint venture in Brazil - Hughes Network Systems and Al Yah Satellite Communications Company, a leading global satellite operator based in the United Arab Emirates and wholly owned by Mubadala Investment Company, announced the commencement of a joint venture to provide satellite broadband services in Brazil. Now operational under the established Hughes do Brasil name, the new venture combines Hughes decades of experience delivering satellite networks and services in Brazil with Yahsat's strong position and capabilities in the region. The agreement to form the joint venture was announced in May 2019, during the SATELLITE 2019 conference held in Washington, D.C., and was subject to regulatory and other approvals which have now been obtained. Resulting ownership of Hughes do Brasil is now 80% by Hughes and 20% by Yahsat.

08:01 EST Post Holdings announces new $400M share repurchase authorization - Post Holdings announced its Board of Directors has approved a new $400M share repurchase authorization, with share repurchases under the new authorization beginning on December 6, 2019. As of December 5, 2019, Post had repurchased approximately $252M under its previous $400M stock repurchase authorization, which was approved on September 4, 2019 and was cancelled effective December 5, 2019.

07:47 EST RADA Electronic announces new orders totaling $12.5M - RADA Electronic Industries announced that it has received a total of $12.5M in new orders during the months of October and November of 2019. This level of over $53M new orders received so far in 2019, is an all-time record for the Company and demonstrates the market acceptance of our radar growth engine. Over 90% of the new orders are for RADA's growth engine: multi-mission, software-defined tactical radar systems. Applications for these radar systems are mainly for C-UAV solutions, for V-SHORAD and APS solutions. Half of the orders were growing follow-on orders from customers that have become a RADA customer in the past two years, and half were from altogether new customers.

07:34 EST SL Green Realty increases quarterly dividend 4.1% to 88.5c per share - SL Green Realty reported that its board of directors has increased the company's quarterly dividend by 4.1%, to 88.5c per share on its common stock and OP units, resulting in a new annual dividend of $3.54 per share. The Q4 dividend is payable on January 15, 2020 to shareholders of record at the close of business on January 2, 2020.

07:32 EST Onconova, Inceptua announce Pre-approval Access collaboration for rigosertib - Onconova Therapeutics and Inceptua Medicines Access announced that they have entered into a collaboration to make available intravenous rigosertib via a Pre-approval Access Program in selected countries around the world. Pre-approval Access Programs are regulatory-compliant processes permitting experimental agents in development to be made available upon the request of a physician or a patient for appropriate patients for whom no alternative treatment option exists in their country. Rigosertib is a small molecule that inhibits cellular signaling in cancer cells by acting as a RAS mimetic. Current clinical development of rigosertib is centered upon the therapeutic management of MDS, a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis that often develop into acute myeloid leukemia. Rigosertib, in its intravenous formulation, is currently in Phase 3 clinical development for the treatment of higher-risk MDS. The rigosertib Pre-approval Access Program is expected to launch in first half of 2020 and will allow Inceptua to supply intravenous rigosertib within designated countries, primarily and initially concentrated in selected countries in Europe, in response to physician requests for patients with higher-risk MDS who have exhausted all available treatment options, and are not eligible for or have no access to the INSPIRE study. Under the terms of this agreement, Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially into a number of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain, and the UK.

07:29 EST Curis provides updated results from Phase 1 dose escalation study of CA-4948 - Curis announced updated preliminary data from its ongoing Phase 1 dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, including patients with diffuse large B-cell lymphoma, Waldenstrom's macroglobulinemia and oncogenic MYD88 mutations. "We are very encouraged by the anti-cancer activity that we have observed to date from CA-4948 during dose escalation in our Phase 1 study," said Robert Martell, MD, PhD, Head of R&D at Curis. "Notably, five of the six patients evaluable for anti-cancer activity at the two highest dose levels of CA-4948 have experienced reduced tumor burden. Additionally, treatment for three of these five patients is ongoing after 33 to 51 weeks. These findings illustrate dose dependent activity compared to earlier dose levels." Dr. Martell continued: "We believe these results achieve the desired activity outcome for a targeted single agent treating malignancies with complex molecular genetics. Unlike the minority of cancers with a single driver mutation, these genetically complex malignancies have aberrant signaling through multiple signaling pathways. One such pathway is the oncogenic TLR pathway, which depends on IRAK4. Such complex cancers represent the bulk of actual medical need in oncology today, and we believe the most effective therapeutic approaches in these situations is to target multiple such mechanisms. Indeed, synergy was observed preclinically when combining CA-4948 with either BTK inhibitors or a BCL2 inhibitor, and we intend to explore combinations in the clinic." "We believe these updated clinical data further support the potential of CA-4948 to become a safe, effective therapeutic option for patients with NHL," said James Dentzer, President and CEO of Curis. "CA-4948 is currently the most advanced molecule targeting IRAK4 in clinical development for cancer and given these exciting results, we intend to move aggressively to advance CA-4948 with the goal of bringing this promising new therapy to patients in need. We look forward to expanding the development of CA-4948 with two new clinical trials in 2020 that will study CA-4948 in AML/MDS and in combination therapy in NHL."

07:05 EST UCB: Phase 3 BE SURE results met co-primary, ranked secondary endpoints - UCB announced positive results from the Phase 3 active-controlled BE SURE study. BE SURE compared the investigational IL-17A and IL-17F inhibitor bimekizumab to the TNF inhibitor adalimumab in the treatment of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-primary endpoints at week 16, demonstrating superiority of bimekizumab to adalimumab in achieving at least a 90% improvement in the Psoriasis Area and Severity Index and Investigator Global Assessment response of clear or almost clear. The BE SURE study also met all of its ranked secondary endpoints with statistical significance, including superior total skin clearance at weeks 16 and 24, as measured by PASI 100, compared to adalimumab. Furthermore, bimekizumab was statistically superior to adalimumab in achieving rapid response, defined as PASI 75 at week 4. During the dose-blind maintenance period, high levels of skin clearance were maintained with bimekizumab through week 56. The continued data assessment indicates that the safety profile of bimekizumab was consistent with earlier clinical studies. The full BE SURE results will be presented at a scientific congress in 2020.

07:02 EST Applied Therapeutics to present pre-clinical data highlighting AT-001 - Applied Therapeutics announced the presentation of data at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles on AT-001, a novel, potent and selective aldose reductase inhibitor in Phase 3 clinical development for Diabetic Cardiomyopathy. Overcoming the Safety Challenges of Aldose Reductase Inhibition: Development of AT-001 for Diabetic Cardiomyopathy: AT-001 is logarithmically more potent than zopolrestat in inhibiting Aldose Reductase; The unique structure and activity of AT-001 provide selectivity for Aldose Reductase and avoid off-target inhibition of Aldehyde Reductase; The in vitro safety of this agent together with the positive safety data from the phase 1/2 program, support the ongoing pivotal study in DbCM.

07:02 EST Curis reports 'positive' data from Phase 1 study of fimepinostat - Curis announced preliminary tolerability and PK data from its ongoing Phase 1 dose-finding study of fimepinostat, a small molecule dual inhibitor of PI3K/HDAC and suppressor of MYC, in combination with venetoclax, a BCL-2 inhibitor, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, including patients with double-hit/double-expressor lymphoma. "We are very pleased with the progress in our ongoing Phase 1 study, with the combination of fimepinostat and venetoclax demonstrating a favorable tolerability profile thus far," said James Dentzer, President and CEO of Curis. "We believe demonstrating that this combination is generally well-tolerated for patients is a significant milestone, as both drugs have shown activity as monotherapies in this patient population and we believe activity will be improved by combining the two agents. Based on these data, we plan to initiate an expansion of the current study in 2020."

06:51 EST Hi-Crush Inc. CFO Laura Fulton to resign, Phil McCormick to succeed - Hi-Crush Inc. announced that Laura Fulton, CFO, will resign as CFO and principal financial and accounting officer of the company effective December 31 to pursue another career opportunity. Phil McCormick, Vice President of Finance has been appointed by the Board of Directors to the role of CFO and principal financial and accounting officer effective January 1, 2020. Fulton's departure was not related to any disputes or disagreements regarding financial disclosures, accounting or legal matters. Prior to joining Hi-Crush, McCormick served in various senior level positions at KBR, Inc. from 2009 to 2018, including Vice President of Finance and Treasurer.

06:47 EST Cassava Sciences saw Alzheimer's disease biomarker improvements in Ph2 PTI-125 - Cassava Sciences announced additional clinical data from a Phase 2a study of PTI-125, its investigational drug candidate for Alzheimer's disease. Company scientists presented the new data during a late-breaking oral presentation at the 12th International Conference on Clinical Trials on Alzheimer's Disease, or CTAD, in San Diego, CA. Consistent with over 10 years of basic research and pre-clinical data, the new data show clinical evidence of PTI-125's mechanism of action and drug-target engagement, including: Improvements in biomarkers of Alzheimer's disease in plasma and lymphocytes; Consistency across biomarker improvements in CSF, plasma, and lymphocytes; Significant reductions (pless than0.01) in both nitrated and phosphorylated forms of tau protein; Evidence that each individual patient showed biomarker responses to PTI-125; Evidence that PTI-125 reversed the shape of altered filamin A in lymphocytes; Early clinical validation of the drug target - altered filamin A - as a facilitator protein between amyloid beta and both neuroinflammation and tau pathology. Cassava Sciences expects to publish a manuscript of these new clinical data in a peer-reviewed medical journal.

06:08 EST Centogene names Philip Lambert, PhD as Chief Scientific Officer - Centogene announced the expansion of its executive leadership team with the appointment of Philip Lambert, PhD in Cambridge, MA as Chief Scientific Officer. With more than two decades of experience in the global drug discovery and pre-clinical development sectors, Philip will have the overall responsibility of driving scientific programs to align with the needs of pharmaceutical partners. In parallel to this appointment, Prof. Peter Bauer, MD will take on the role of Chief Genomic Officer, directing Centogene's genomic programs.

06:05 EST Hooker Furniture raises quarterly dividend to 16c from 15c per share - Payable on December 30 to shareholders of record at December 16.

06:02 EST Baker Hughes announces November international rig count of 1,096, down 34 - Baker Hughes announced that the Baker Hughes international rig count for November 2019 was 1,096, down 34 from the 1,130 counted in October 2019, and up 105 from the 991 counted in November 2018. The international offshore rig count for November 2019 was 247, up 5 from the 242 counted in October 2019, and up 41 from the 206 counted in November 2018. The average U.S. rig count for November 2019 was 810, down 38 from the 848 counted in October 2019, and down 267 from the 1,077 counted in November 2018. The average Canadian rig count for November 2019 was 136, down 9 from the 145 counted in October 2019, and down 62 from the 198 counted in November 2018. The worldwide rig count for November 2019 was 2,042, down 81 from the 2,123 counted in October 2019, and down 224 from the 2,266 counted in November 2018.

05:15 EST Dr. Reddy's announces launch of Deferasirox Film-Coated Tablets in U.S. market - Dr. Reddy's announced the launch of Deferasirox Film-Coated Tablets, 90 mg and 360 mg, a therapeutically equivalent generic version of Jadenu Film-Coated Tablets, 90 mg, 180 mg, and 360 mg, approved by the FDA.