Stockwinners Market Radar for December 13, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:49 EST Weatherford completes financial restructuring, emerges from Chapter 11 - Weatherford announced that it has completed its financial restructuring and emerged from chapter 11 protection. The company emerges with a stronger financial foundation having reduced approximately $6.2B of outstanding funded debt, secured $2.6B in exit financing facilities, including a $450M revolving credit facility, secured a $195M letter of credit facility, and secured over $900M of liquidity. Weatherford expects its newly issued ordinary shares will initially resume trading on the OTC Markets with the company ultimately planning to transition trading to the New York Stock Exchange, subject to the receipt of applicable approvals. The transition to the New York Stock Exchange is expected to occur after the company reports results for its fourth quarter ending December 31, holds an investor call, and completes the fresh-start accounting process, which are expected to be completed by early March.

18:29 EST S&P announces changes to S&P 400, 500, 600 indices - S&P Dow Jones Indices will make the following index adjustments to the S&P 500, S&P MidCap 400 and S&P SmallCap 600 to ensure each index more appropriately represents its market capitalization range. The changes will be effective prior to the open of trading on Monday, December 23 to coincide with the December re-balance. Live Nation Entertainment (LYV), Zebra Technologies (ZBRA), and Steris (STE) will move to the S&P 500, switching places with Affiliated Managers Group (AMG), TripAdvisor (TRIP), and The Macerich Co. (MAC), respectively. All companies moving to the S&P 500 have market capitalizations above $12B, and all companies moving to the S&P MidCap 400 have market capitalizations below $4.5B. Grand Canyon Education (LOPE) and Lear (LEA) will replace Oasis Petroleum (OAS) and Southwestern Energy (SWN) in the S&P MidCap 400 respectively. Oasis Petroleum and Southwestern Energy will replace Unit Corp. (UNT) and Frontier Communications (FTR) in the S&P SmallCap 600. Oasis Petroleum and Southwestern Energy are more representative of the small-cap market space, while Unit and Frontier Communications are no longer representative of the small-cap market space. Arrowhead Pharmaceuticals (ARWR) will switch places with Granite Construction (GVA) in the S&P MidCap 400. Arrowhead Pharmaceuticals has a market capitalization more representative of the mid-cap market space, and Granite Construction has a market capitalization more representative of the small-cap market space.

17:47 EST Harmonic CFO sells 28K shares of common stock - In a regulatory filing, Harmonic disclosed that its CFO Sanjay Kalra sold 28K shares of common stock on December 11th. The total transaction size was $229K.

17:33 EST Amarin rises 1.4% to $24.46 after resuming trading

17:27 EST Arrowhead to replace Granite Construction in S&P 400 at open on 12/23

17:24 EST Amarin raises guidance after FDA approves Vascepa - Amarin (AMRN) shares rallied almost 5% in intraday trading on Friday before they were halted, news pending. After the market closed, the FDA announced it approved the use of Vascepa as an adjunctive therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 milligrams per deciliter or higher. The statement added that Vascepa was the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Shortly afterward, Amarin confirmed the FDA announcement, raised its FY19 revenue guidance, and gave FY20 revenue guidance. The company raised its FY19 revenue view to $410M-$425M from $380M-$420M, against a consensus of $410.25M, and gave FY20 revenue guidance of $650M-$700M, against a consensus of $654.55M. The company said, "Amarin is providing this projected revenue guidance for 2020 and has based its projection on a number of factors, including, but not limited to, expectations on market acceptance of the newly expanded label for Vascepa and current plans for expanded promotion. Vascepa revenues are anticipated to continue to increase in 2020, accompanied by quarterly industry variability, including recurring seasonal factors, particularly in the first quarter... Beyond 2020, Amarin believes that Vascepa total net revenue will grow to reach multiple billions of dollars. "

17:20 EST Raytheon awarded $123.53M Navy contract modification - Raytheon was awarded a $123.53M firm-fixed-price and cost-plus-fixed-fee modification to previously awarded contract to exercise options for FY20 production of AEGIS weapon system fire control system, or FCS, MK 99 equipment, AEGIS modernization production requirements and associated engineering services. These services are in support of DDG 51 Class Flight III destroyers and the Spanish navy's F-110 program. This modification also covers the production of the AEGIS BMD kill assessment ordnance alteration kits and solid state switch assembly special test equipment. The AMOD program fields combat system upgrades that will enhance the anti-air warfare and ballistic missile defense capabilities of AEGIS equipped DDG 51 Arleigh Burke-class destroyers. Work is expected to be completed by April 2023. Foreign Military Sales; FY20 shipbuilding and conversion;FY20 other procurement and FY20 defense wide procurement funding in the amount of $123.53M will be obligated at the time of award and will not expire at the end of the current fiscal year. The Naval Sea Systems Command is the contracting activity.

17:15 EST BAE Systems awarded $249.15M Army contract modification - BAE Systems was awarded a $249.15M modification to a contract for the self-propelled Howitzer and carrier, ammunition, tracked vehicles and their associated support under the production contract to build and deliver M109A7s and M992A3s. Work will be performed in York, Pennsylvania, with an estimated completion date of January 31, 2023. FY18 and FY19 other procurement, Army funds in the amount of $249.15M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:01 EST iBio receives NYSE noncompliance notice - iBio, Inc. announced that on December 9, 2019, the company received a letter from NYSE American LLC indicating the company's securities have been selling for a low price per share for a substantial period of time and pursuant to Section 1003fv of the NYSE American Company Guide, the company's continued listing on the Exchange is predicated on the company effecting a reverse stock split or otherwise demonstrating sustained improvement in its share price within a reasonable period of time, which the Exchange has determined to be no later than June 9, 2020. Additionally, the company does not currently meet certain other NYSE American continued listing standards as set forth in Part 10, Section 1003(a)(i), (ii) and (iii) of the Company Guide, due to the fact the company had reported stockholders' equity of less than $6.0M, as of September 30, 2019, and net losses in its five most recent fiscal years.

16:50 EST Amarin confirms FDA approval of Vascepa - Amarin announced that the FDA has approved a new indication and label expansion for Vascepa capsules. After more than a decade of development and testing, Vascepa is now the first and only drug approved by the FDA "as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease." It is estimated that millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy.

16:34 EST CME Group CEO Duffy sells 39,309 class A common shares - In a regulatory filing, CME Group chairman and CEO Terrence A. Duffy disclosed the sale of 39,309 class A common shares of the company at a price of $202.38 per share on December 12.

16:30 EST Horizon Pharma trading resumes

16:18 EST Erie Indemnity increases quarterly dividend - The board of Erie Indemnity Company set the management fee rate charged to Erie Insurance Exchange, approved an increase in shareholder dividends and declared the quarterly dividend. The board agreed to maintain the current management fee rate paid to Erie Indemnity Company by Erie Insurance Exchange at 25%, effective January 1, 2020. The management fee rate was 25% for the period January 1 through December 31, 2019. The board also agreed to increase the regular quarterly cash dividend to 96.5c from 90c on each Class A share and to $144.75 from $135.00 on each Class B share. This represents a 7.2% increase in the payout per share over the current dividend rate. The next quarterly dividend is payable January 22, 2020, to shareholders of record as of January 7, 2020, with a dividend ex-date of January 6, 2020.

16:17 EST Host Hotels declares special dividend of 5c per share - Host Hotels & Resorts maintained its regular quarterly cash dividend of 20c per share and declared a special dividend of 5c per share, bringing the total dividends declared for the year to 85c per share. The dividend is payable on January 15, 2020, to stockholders of record on December 31, 2019.

16:13 EST Owens Corning exec chairman Thaman sells 30,000 common shares - In a regulatory filing, Owens Corning executive chairman Michael H. Thaman disclosed the sale of 30,000 common shares of the company at a price of $65.646 per share on December 12.

16:07 EST Chesapeake receives continued listing notice from NYSE - Chesapeake Energy announced that on December 10, 2019 it received written notice from the New York Stock Exchange of its noncompliance with the standard set forth in Rule 802.01C of the NYSE Listed Company Manual that requires listed companies to maintain an average closing share price of at least $1.00 over a consecutive 30 trading-day period. The company intends to regain compliance with the NYSE listing standards by pursuing measures that are in the best interests of the company and its shareholders, including: executing on its current capital and operating program, which includes a planned 30% reduction in 2020 capital expenditures and ongoing implementation of operating cost efficiencies; continued debt reduction through capital market transactions and asset sales; and potentially consummation of a potential reverse stock split, subject to shareholder approval at the May 2020 Annual Meeting of Shareholders. As required by the NYSE, the company intends to respond to the NYSE within ten business days with respect to its intent to cure the deficiency. The company has six months following the receipt of the noncompliance notice to cure the deficiency and regain compliance.

16:05 EST 22nd Century CEO Cliff Fleet to step down - 22nd Century announced changes to the company's management. Chairman James Cornell states: "Today we are announcing several management changes. First, Cliff Fleet has decided to step away from the role of CEO of 22nd Century while continuing to remain actively engaged in the Company's leadership as a member of our Board. Cliff has been called to service to lead The Colonial Williamsburg Foundation, which is charged with the stewardship of Colonial Williamsburg, a national, historical treasure. We are happy for Cliff and quite gratified that he will continue as a Director and leader in our organization. In conjunction with this move, we are forming an Executive Committee of our board, on which Cliff and I will serve, to help guide the company's leadership, and Michael Zercher, the company's Chief Operating Officer, has been appointed to serve as the company's President, effective immediately."

16:00 EST Piper Jaffray announces ticker symbol change to PIPR - Piper Jaffray Companies announced that following the completion of its merger with Sandler O'Neill + Partners, L.P. it will trade on the NYSE under the ticker symbol "PIPR". As previously announced, to reflect the combination of the two companies, Piper Jaffray Companies will be renamed Piper Sandler Companies. The change in name to Piper Sandler Companies and the new ticker symbol will both become effective following the merger, which is expected to close on January 3, 2020.

14:46 EST Muddy Waters' Block says still short Burford Capital - Muddy Waters' Carson Block, speaking on CNBC, pushed back against Burford Capital CEO Christopher Bogart's prior statements that the firm is no longer short the stock. Block said Muddy Waters is still short, but its position has been trimmed due to various factors, including concerns about the uncertainty of the Brexit vote and the firm's capital needs. Block, during the interview on CNBC, added that he believes Bogart is a "dishonest person."

14:01 EST Tandem Diabetes up 5% upon resumption following FDA approval news - After resuming trading, Tandem Diabetes shares are up $2.85, or 4.9%, to $60.53.

13:57 EST Vertex expands long-term CF medicines reimbursement agreement with Ireland - Vertex Pharmaceuticals confirmed that, following recent collaborative discussions, it has negotiated an agreement with the Health Service Executive in the Republic of Ireland to expand the existing long-term cystic fibrosis reimbursement agreement to include the triple combination regimen, which is under review and pending approval by the European Medicines Agency, for all eligible patients ages 12 and older in line with the potential future licensed indication. Triple combination treatment is not currently licensed for use in the European Union. Vertex submitted a Marketing Authorization Application to the European Medicines Agency on October 31, 2019. Ludovic Fenaux, Senior Vice President, Vertex International, said, "With this expanded agreement, even more patients in the Republic of Ireland will be among the first in Europe to benefit from the triple combination treatment once the medicine is licensed."

13:45 EST Tandem Diabetes to resume trading at 2 pm ET - Tandem Diabetes shares are scheduled to resume trading at 2 pm ET, with quotation to resume at 1:55 pm ET, according to Nasdaq.

13:41 EST AT&T raises quarterly dividend 2% - AT&T's board approved a 2% increase in the company's quarterly dividend. The dividend is payable on February 3, 2020, to stockholders of record at the close of business on January 10, 2020. AT&T's quarterly dividend will increase to 52c per share from 51c per share. On an annualized basis, this equates to a full year dividend of $2.08, up from $2.04. The increase is consistent with AT&T's capital allocation strategy announced in October calling for continued modest annual increases in the dividend.

13:33 EST Boston Scientific announces FDA clearance of single-use duodenoscope - Boston Scientific announced Food and Drug Administration 510(k) clearance of the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography procedures. The EXALT Model D Duodenoscope is the first and only FDA cleared single-use duodenoscope on the market, the company said in a statement. The company plans to commence a limited market release of the device in the U.S. during Q1 of 2020.

13:17 EST Accenture to acquire Clarity Insights, terms not disclosed - Accenture announced that it has entered into an agreement to acquire Clarity Insights, a U.S.-based data consultancy with deep data science, artificial intelligence and machine learning expertise. The acquisition will add nearly 350 employees, along with a portfolio of accelerators, to Accenture's Applied Intelligence business. These additions will further equip clients with leading capabilities to meet the growing demand for enterprise-scale AI, analytics and automation solutions. Completion of the acquisition is subject to customary closing conditions, including antitrust clearance. Financial terms of the acquisition were not disclosed.

13:11 EST Amarin halted for news pending after rallying 5% to $24.12 - Shares of Amarin halted for news pending with the stock up 5% today, or $1.13, to $24.12.

13:04 EST Live Nation acquires DG Medios, terms not disclosed - Live Nation announced that it has acquired a majority stake in DG Medios, a Chilean concert promoter. Live Nation's extensive resources combined with DG's broad reach and regional expertise will help continue to grow live entertainment offerings throughout Chile. The deal follows several recently announced acquisitions in Latin America that have expanded Live Nation's reach in the region including OCESA in Mexico, DF Entertainment in Argentina and Brazil's Rock in Rio. DG Medios was founded and is owned by Carlos Geniso. Following the acquisition, Geniso will continue to oversee all operations of DG Medios.

13:02 EST Baker Hughes reports U.S. rig count flat at 799 rigs

12:03 EST Eagle granted orphan status for organophosphate exposure treatment - The FDA granted Eagle Pharmaceuticals orphan status for dantrolene, its treatment of organophosphate exposure. Reference Link

12:00 EST Phreesia falls -10.2% - Phreesia is down -10.2%, or -$2.92 to $25.75.

12:00 EST Vince Holding falls -14.7% - Vince Holding is down -14.7%, or -$3.66 to $21.24.

12:00 EST RBS rises 9.4% - RBS is up 9.4%, or 58c to $6.74.

11:56 EST FDA grants marketing of Tandem Diabetes Care Control-IQ Technology - The Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. "This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery," the FDA said in a statement. It added, "This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system." The FDA granted marketing authorization of the Control-IQ Technology controller to Tandem Diabetes Care.

11:49 EST Linux Foundation unveils networking OS Dent, Amazon one of six premier members - The Linux Foundation, the nonprofit organization enabling mass innovation through open source, announced the launch of DENT, a project to enable the creation of Network OS for Disaggregated Network Switches in campus and remote enterprise locations. Under the Linux Foundation, DENT hopes to unify and grow the community of Silicon Vendors, Original Design Manufacturers (ODM), System Integrators, Original Equipment Manufacturers and end users to create an ecosystem of contributors around a full-featured network operating system. The initial use case will focus on the retail industry with premier members including Amazon (AMZN), Cumulus Networks, Delta Electronics Inc, Marvell (MRVL), Mellanox, Wistron NeWeb. "The Linux Foundation will establish a neutral home from the start for DENT - vital for community infrastructure, meetings, events and collaborative discussions," said Arpit Joshipura, GM of Networking at The Linux Foundation. "Our goal is to create an open source, open participation technical community to benefit the ecosystem of solution providers and users focused on network operating system, control plane and management plane use cases across a variety of industry solutions." Reference Link

11:13 EST Computer Services names Brian K. Brown as permament CFO - Computer Services announced that Brian K. Brown has been appointed the company's CFO, effective immediately. Brown previously served as interim CFO. As CFO, he will provide leadership for CSI's financial reporting, accounting, tax, budgeting, planning and analysis, treasury management, and investor relations. Brown will also serve as a strategic member of the executive leadership team.

10:40 EST Abbott raises quarterly dividend 12.5% to 36c per share - The board of directors of Abbott announced an increase in the company's quarterly common dividend to 36c per share - a 12.5% increase. The cash dividend is payable Feb. 14, 2020, to shareholders of record at the close of business on Jan. 15, 2020.

10:25 EST Microsoft unveils Xbox Series X, available Holiday 2020 - Microsoft announced that the next gaming console in its Xbox line will be called the Xbox Series X. "Xbox Series X will be our fastest, most powerful console ever and set a new bar for performance, speed and compatibility, allowing you to bring your gaming legacy, thousands of games from three generations and more forward with you," the company said. "Its industrial design enables us to deliver four times the processing power of Xbox One X in the most quiet and efficient way, something that is critically important in delivering truly immersive gameplay. We also designed Xbox Series X to support both vertical and horizontal orientation. It's bold and unique, very much like our fans around the world and the team of collaborators and innovators who built it." Alongside the new system, the company also unveiled the new Xbox Wirless Controller, which will be compatible with Xbox One and Windows 10 PCs and will be included with every Xbox Series X. "One of the things we're most proud of with Xbox Series X is the promise we're delivering to our fans who have and continue to invest with Xbox," Microsoft added. "Thanks to backward compatibility, you can expect your gaming legacy, thousands of your favorite games across four generations of gaming, all your Xbox One gaming accessories, and industry-leading services like Xbox Game Pass to be available when you power on your Xbox Series X in Holiday 2020. Building on our compatibility promise, with Xbox Series X we're also investing in consumer-friendly pathways to game ownership across generations. Leading the way with our first-party titles including Halo Infinite in 2020, we're committed to ensuring that games from Xbox Game Studios support cross-generation entitlements and that your Achievements and game saves are shared across devices. As we branch out and extend gaming to more players around the world, console gaming will remain at the heart of our Xbox offering. Game creators around the globe are already hard at work building content for Xbox Series X and our 15 Xbox Game Studios are developing the largest and most creatively diverse lineup of Xbox exclusive games in our history. On behalf of Team Xbox, we're excited to enter the future of console gaming with you and can't wait to share more in 2020." Reference Link

10:00 EST Lloyds Banking rises 7.2% - Lloyds Banking is up 7.2%, or 23c to $3.43.

10:00 EST Barclays rises 8.0% - Barclays is up 8.0%, or 73c to $9.81.

09:50 EST Ford issues safety recall for 2017-2019 Ford Super Duty SuperCrew vehicles - Ford Motor Company is issuing a safety recall for select 2017-19 Ford Super Duty SuperCrew vehicles with carpet flooring due to the risk of a post-crash interior fire. In affected vehicles, a front seat belt pretensioner that deploys during a crash can generate excessive sparks. In some cases, this could ignite the carpet or carpet insulation in the area of the B-pillar. A fire in the B-pillar area may spread within the vehicle and increase the risk of injury. Ford is aware of one report in the U.S. of a fire related to this condition. The company is not aware of any accidents or injuries related to this condition. The action affects 490,574 vehicles in the U.S. and federal territories, 56,112 in Canada, and 852 in Mexico. Affected vehicles were built at Kentucky Truck Plant from Oct. 8, 2015, to Oct. 29, 2019.

09:47 EST Universal Technical falls -5.2% - Universal Technical is down -5.2%, or -36c to $6.60.

09:47 EST Comstock Resources rises 8.2% - Comstock Resources is up 8.2%, or 53c to $7.03.

09:47 EST RBS rises 11.5% - RBS is up 11.5%, or 71c to $6.87.

09:33 EST PAVmed expects to 'be ready' to resubmit CarpX 510(k) application in January - PAVmed provided an update on its CarpX first-in-human 510(k) clinical safety study. This week, senior PAVmed personnel met with the local investigators in New Zealand and completed an on-site review of the study data. Full 90-day follow-up is now 90% complete and 90-day clinical follow-up is 95% complete- with one patient completing clinical follow-up but not yet completing electrodiagnostic testing. The research team continues to pursue the two incomplete follow-up patients. The study has, however, already exceeded the minimum 80% follow-up rate requested by the U.S. Food and Drug Administration with no device-related adverse events. The team has concluded that the device appears to have met the study's primary effectiveness and safety endpoints. PAVmed is now proceeding with finalization of the clinical reports, including customary overreads of the diagnostic test results by a U.S. physician. The 510(k) application has been drafted by the Company's regulatory consultants pending the final reports and is expected to be ready for resubmission in January as anticipated.

09:27 EST Aspen Group decides not to proceed with proposed public offering of common stock - Aspen Group announced that it has determined not to proceed with the proposed public offering of its common stock previously announced on December 12, 2019. The determination results from an assessment by the Company's management that current equity market conditions are not conducive for an offering on terms that would be in the best interests of the Company's stockholders. The offering was being made pursuant to a shelf registration statement that was declared effective by the Securities and Exchange Commission on April 18, 2018.

09:23 EST SI-Bone says Cigna establishes positive coverage for MIS SI joint fusion - SI-BONE (SIBN) announced that CIGNA (CI) has established a positive coverage policy for minimally invasive SI joint fusion. The new policy specifies that coverage will be exclusive for FDA cleared implants that are placed across the SI joint and intended to promote bone fusion. This decision follows an extensive amount of published clinical evidence demonstrating the safety and effectiveness of the iFuse Implant System, including a recent publication of 5-year results from a long-term prospective study called LOIS.

09:09 EST Wrap Technologies receives international order and deposit of $162,000 - Wrap Technologies announced that the company has received a signed purchase order this week with a $162,000 deposit for 2020 deliveries of BolaWrap product and accessories.

09:05 EST IEC Electronics to begin trading on Nasdaq Stock Exchange - IEC Electronics announced that it has been approved for listing on the Nasdaq Global Market under the symbol "IEC". Trading on the Nasdaq Global Market is expected to commence on Thursday, January 2, 2020. The Company's shares of common stock will continue to trade on the NYSE American until the close of the market on Tuesday, December 31, 2019.

09:02 EST Cerner board of directors authorizes additional $1.5B share repurchase - Cerner announced that its Board has approved an amendment to its stock repurchase program, authorizing the repurchase of an additional $1.5B of its common stock. Cerner has repurchased $1.3B of its shares in 2019 and had $0.2B of available authorization remaining prior to the increase. The total authorized amount available for repurchase is now $1.7B.

09:01 EST Fly Intel: Pre-market Movers - UP AFTER EARNINGS: Adobe (ADBE), up 2%. ALSO HIGHER: Snap (SNAP), up 2% after JMP Securities analyst Ronald Josey upgraded the stock to Outperform from Market Perform with a $20 price target. The analyst is "incrementally confident" in Snap's ability to grow its user base, increase engagement, and improve overall monetization as the service attracts more advertisers and share of advertising budgets... Xperi (XPER), up 2% after raising Q4 and FY19 billings outlook... Exelixis (EXEL), up 4% after Genentech announced the Phase III IMspire150 study met its primary endpoint of progression-free survival. In late 2006, Exelixis entered into a worldwide collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND... Sarepta (SRPT), up 32% after announcing that the FDA has approved VYONDYS 53, an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping. DOWN AFTER EARNINGS: Oracle (ORCL), down 2%... Broadcom (AVGO), down 1%. ALSO LOWER: Patterson-UTI (PTEN), down 2% after JPMorgan analyst Sean Meakim downgraded shares to Underweight from Neutral with a price target of $6, down from $7... Anixa Biosciences (ANIX), down 2% after announcing optimization work for its CAR-T therapy may take an additional year, resulting in the filing of the IND in late 2020, with clinical trials to commence in 2021... Aquestive Therapeutics (AQST), down 18% after its 7M share secondary priced at $5.00 per share.

08:34 EST OncoSec reports interim results from KEYNOTE-890 study - OncoSec announced interim results from KEYNOTE-890, an ongoing Phase 2 study of TAVO in combination with KEYTRUDA in patients with metastatic, chemotherapy-refractory triple negative breast cancer. Patients who previously had progressed after an average of three prior lines of chemotherapy were enrolled in the KEYNOTE-890 study to evaluate if the addition of TAVO could provide meaningful clinical activity when combined with KEYTRUDA. The interim analysis, presented on December 12 at the San Antonio Breast Cancer Symposium, included more than half of the patients (14 out of 25) enrolled in the KEYNOTE-890 study evaluating tumor responses, related immunological responses and safety. Four of the 14 patients showed a rapid tumor reduction and had a confirmed partial response by RECIST v1.1, including a deep partial response in a patient with multiple liver, bone, skin and nodal metastases and a short disease-free interval following neoadjuvant chemotherapy. All responses are ongoing and a median duration of response has not yet been reached. Three of the four patients with a partial response experienced deepening tumor shrinkage over six months. These interim findings compare favorably to the response rate observed with KEYTRUDA as a monotherapy in mTNBC patients. Stable disease was observed in three patients (21.4%), with two stable disease patients reporting 20% or greater tumor shrinkage. Of the seven patients who progressed following treatment, two received only one cycle of combination treatment prior to rapid clinical deterioration. Regression of both TAVO treated and untreated lesions were observed. Regression of distal visceral lesions were also observed. Additionally, 3 of the 4 responding patients' lesions were PD-L1 negative by IHC analysis before treatment (1 patient was undetermined). "Metastatic TNBC is a heterogeneous disease with a poor prognosis where very few pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint inhibitor therapy," said Melinda Telli, MD, Stanford University School of Medicine. "These preliminary data suggest that TAVO may enhance sensitivity to pembrolizumab in mTNBC patients with a 28.5% ORR reported. I'm encouraged by the tumor responses observed in PD-L1 negative patients and the overall safety profile." Importantly, TAVO and pembrolizumab were well tolerated, with only 3 of 16 patients experiencing grade 3 treatment-related adverse events with combination treatment. Patients demonstrated encouraging immunological responses in tumor and blood consistent with an IL-12-associated mechanism of action, including significantly increased on-treatment proliferating T cell subsets in the periphery and increased gene expression signatures associated with productive immunological responses in the tumor. Biomarker analysis of patient tumor and blood samples are ongoing. To date, the KEYNOTE-890 study has enrolled 24 of the planned 25 patients. OncoSec expects to report the full data results in 2020.

08:32 EST Athenex announces results from Phase III trial of oral paclitaxel - Athenex announced results from a pivotal Phase III clinical trial showed oral paclitaxel and encequidar had superior response and survival with much lower incidence and severity of neuropathy compared to IV paclitaxel in the treatment of metastatic breast cancer. CMO Rudolf Kwan commented, "Oral paclitaxel and encequidar is the first oral taxane to demonstrate in a Phase III study statistically significant improvement in response rate and median overall survival compared to IV paclitaxel, in the treatment of metastatic breast cancer while associated with a much lower incidence and severity of neuropathy. We believe these data suggest the potential for oral paclitaxel and encequidar to provide an important advance in the management of patients with metastatic breast cancer." These results will be presented in an oral presentation today at the 2019 San Antonio Breast Cancer Symposium at 3:15 p.m. CT in General Session 6 in Hall 3 of the Henry B. Gonzalez Convention Center in San Antonio, Texas, and were selected for the official SABCS press program at 7:30 a.m. CT. The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

08:18 EST Norwood Financial raises quarterly cash dividend 4.2% to 25c per share - Norwood Financial announced that the Board of Directors declared a 25c per share quarterly dividend payable February 3, 2020 to shareholders of record as of January 15, 2020. The 25c per share represents an increase of 4.2% over the cash dividend declared in the prior quarter of this year and the fourth quarter of last year. During 2019, total cash dividends declared were 97c per share, compared to the 90c declared in 2018.

08:10 EST AMERI Holdings regains compliance with Nasdaq listing rule - AMERI Holdings announced that it had received written notice from the Nasdaq Stock Market Listing Qualifications Staff on December 10, 2019, indicating that the Company has regained compliance with the minimum bid price requirement as set forth in Nasdaq Listing Rule 5550(a)(2). Nasdaq considers the matter closed.

08:08 EST Nokia signs contract with TIM Brazil to launch IoT services - Nokia (NOK) has signed a contract with TIM (TIAOF) to provide Internet of Things services to its enterprise customers in Brazil. Using the fully virtualized Nokia Worldwide IoT Network Grid managed service offer, TIM and its enterprise customers across industries,such as automotive and agriculture, will be able to capture IoT opportunities faster and more securely. Nokia's first WING deal in Latin America enables TIM to leverage new business models to tap this opportunity and generate additional revenue streams. Additionally, incremental services, such as device management and analytics, will help TIM extend SIM management capabilities to create value added opportunities. WING will enable local and multinational companies to benefit from global IoT services. It features a distributed architecture that maintains all user data in-country, such as in Brazil, to remain compliant with data sovereignty and privacy laws.

08:04 EST Eastside Distilling partners with Publix to offer Redneck Riviera Whiskey - Eastside Distilling announced Florida grocery giant Publix will sell Redneck Riviera Whiskey in 273 stores throughout the Sunshine State. Select stores will begin carrying Redneck Riviera American blended whiskey immediately, with all 273 locations expected to have the product on the shelves by the end of January.

08:04 EST Rio Tinto receives aluminum certifications for several facilities - Rio Tinto is now offering independently certified, responsibly produced aluminium from its smelters in Australia and New Zealand that predominantly use hydro-powered electricity. Aluminium Stewardship Initiative, or ASI, has granted its Performance Standard and Chain of Custody certifications to Rio Tinto's Amrun and Weipa bauxite mines, Yarwun alumina refinery, and the Bell Bay and NZAS aluminium smelters. This enhances Rio Tinto's ability to offer ASI Aluminium throughout its global supply chain, building on the certifications in place for its Canadian operations.

08:02 EST Intercept submits MAA for OCA for treatment of fibrosis due to NASH - Intercept Pharmaceuticals announced that it has submitted its Marketing Authorization Application to the European Medicines Agency for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis. The MAA submission is supported by the positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH. Intercept also announced that the U.S. Food and Drug Administration has notified the company of the tentative date for the previously announced advisory committee meeting related to Intercept's New Drug Application for OCA in liver fibrosis due to NASH. The FDA has tentatively scheduled the AdCom for April 22, 2020. Intercept anticipates that the FDA accordingly will extend the recently announced March 26, 2020 Prescription Drug User Fee Act target action date for Intercept's NDA. Intercept previously announced the FDA's acceptance of the NDA and granting of priority review.

07:36 EST Theratechnologies reports results from in vitro, in vivo experiments on TH-1902 - Theratechnologies reported on new data presented at the San Antonio Breast Cancer Symposium. Results from in vitro and in vivo experiments demonstrated that TH-1902, currently being developed for the treatment of triple-negative breast cancer, improves efficacy and tolerability compared to docetaxel alone. Data presented at the SABCS demonstrated: Stronger and sustained inhibition of TNBC tumor growth in mice treated with TH-1902 when using equimolar doses of TH-1902 and docetaxel; Significantly improved efficacy over full dose of docetaxel even with conjugate administered at a quarter of the dose of docetaxel; A very low level of docetaxel found in the blood when conjugated to TH19P01; No significant side effects, weight loss or neutropenia observed in vivo; Absence of neutropenia after six consecutive treatments with TH-1902 while neutrophil counts decreased after only one treatment with non-conjugated docetaxel. Based on the positive feedback received from the U.S. Food and Drug Administration, Theratechnologies is moving forward with its oncology programs and is aiming to initiate a phase I trial using TH-1902 for the treatment of TNBC before the end of 2020.

07:32 EST Biogen: Primary endpoint not statistically significant in Phase 2 PASSPORT study - Biogen announced topline results from the Phase 2 PASSPORT study of gosuranemab for progressive supranuclear palsy. The primary endpoint, as measured by the PSP rating scale at week 52, was not statistically significant. In addition, the study did not demonstrate efficacy on key clinical secondary endpoints. Based on these results, Biogen will discontinue development of gosuranemab for PSP and other primary tauopathies. "We are disappointed with the efficacy results of the Phase 2 PASSPORT study," said Alfred Sandrock Jr., M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer at Biogen. "We remain unwavering in our commitment to advancing therapies that have the potential to address the significant unmet medical needs of people with neurodegenerative diseases who are faced with limited to no treatment options." Safety results of the PASSPORT study were generally consistent with previous studies of gosuranemab. Detailed results of this study will be made available in a future scientific forum. Biogen will continue its ongoing Phase 2 TANGO study of gosuranemab for mild cognitive impairment due to Alzheimer's disease or mild AD, given differences in disease pathology.

07:14 EST BeiGene announces clinical data on tislelizumab in combination with sitravatinib - BeiGene (BGNE) and Mirati Therapeutics (MRTX) announced preliminary data from an ongoing Phase 1b trial of investigational anti-PD-1 antibody tislelizumab in combination with investigational tyrosine kinase inhibitor sitravatinib in patients with platinum-resistant ovarian cancer, which demonstrated antitumor activity and was generally well tolerated. Results from the Phase 1b clinical trial were presented at the 2019 European Society for Medical Oncology Immuno-Oncology Congress on December 13, 2019 in Geneva, Switzerland. This open-label, multi-center Phase 1b trial of tislelizumab in combination with sitravatinib consists of nine disease-specific cohorts in patients with advanced solid tumors. The results presented at ESMO I-O were from cohort E in 20 patients with recurrent platinum-resistant ovarian cancer who did not have prior exposure to anti-PD-1/PD-L1 agents. Patients were treated with tislelizumab at 200 mg IV every three weeks and sitravatinib at 120mg orally once daily. At the data cutoff of July 17, 2019, 17 patients were evaluable and preliminary results included: Seven patients achieved a partial response, including four confirmed PRs; the overall response rate was 23.5%; eight patients achieved stable disease; The median duration of response was not reached; The median progression-free response was 18 weeks, and the PFS rate at 3 months and 6 months was 88.2% and 35.3%, respectively; All 20 patients in this cohort experienced treatment-emergent adverse events of any grade; Fifteen patients experienced at least one grade greater than or equal to 3 TEAE, with the most common being hypertension and fatigue; Immune-related TEAEs were hypothyroidism, diarrhea, and rash; Six patients discontinued the study treatment due to TEAEs; and Two patients experienced TEAEs leading to death, abdominal pain and respiratory failure, both of which were considered unrelated to treatment by the study investigator. BeiGene and Mirati entered into an exclusive license agreement for the development, manufacturing and commercialization of Mirati's sitravatinib in Asia, Australia, and New Zealand in January 2018. Clinical trials for tislelizumab and sitravatinib are ongoing in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, hepatocellular cancer and gastric cancer.

07:08 EST BioLineRx CEO 'very excited' about data from Phase 2a COMBAT/KEYNOTE-202 study - "Metastatic pancreatic cancer has a very poor response to chemotherapy, and immunotherapy treatments have failed to show any effect as single agents," said Manuel Hidalgo, MD, PhD, Chief of the Division of Hematology and Medical Oncology and a Senior Member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study. "These promising initial results presented today show an overall response rate almost double the current chemotherapy standard-of-care treatment in second-line patients. The results are even stronger when taking into account the extended durability of clinical benefit seen to date in this study (median of 7.8 months), compared to approximately three months of response duration with other treatments for second-line pancreatic cancer. I look forward to the survival data expected in mid-2020." "We are very excited by the positive data accumulating from this triple combination arm of our Phase 2a pancreatic study under our collaboration with Merck (MRK)," stated Philip Serlin, CEO of BioLineRx (BLRX). "These data continue to confirm our hypothesis relating to the synergistic effect of cytotoxic chemotherapy, along with the trafficking, tumor microenvironment modulation and T-cell infiltration effects seen in PDAC patients from previous dual combination trials of BL-8040 with checkpoint inhibitors. It is therefore very encouraging to see robust and durable responses to the triple combination treatment, especially as we continue to see a trend of patients receiving treatment for an extended period that move from stable disease to partial response. We hope to see these results translate into an extended survival benefit for these patients, which we expect to announce in mid-2020, and we hope will pave the way for use of immunotherapy in pancreatic cancer and in other cold tumors."

07:07 EST Medipharm Labs receives GMP certification from Australian TGA - MediPharm Labs Corp. announced that the Australian Therapeutic Goods Administration has notified the Company that its Canadian manufacturing facility meets the requirements for Good Manufacturing Practice for Medicinal Products, a key business breakthrough that increases MediPharm Labs' global manufacturing capabilities. During an intensive audit under the TGA's clearance program for the overseas manufacture of medicine and Active Pharmaceutical Ingredients for supply to Australia, MediPharm Labs demonstrated that its state-of-the-art Canadian facility met the PIC/S GMP requirements as a Medicines Manufacturer of both Cannabis as a Medicine in accordance with Part I of the PIC/S GMP guide and Cannabis as an API in accordance with Part II of the PIC/S GMP. The site was also successfully audited for chemical testing and analysis of cannabis as a medicine. MediPharm Labs received its certification less than 60 days from its TGA inspection, which was completed between October 14-16, 2019. While the certificate was issued by Australia's TGA to permit MediPharm Labs' Canadian facility to deliver APIs and final medicinal products to the Australian medical cannabis market, upon MediPharm Labs' Australian production facility receiving its GMP certificate, the Company will be positioned to leverage a global supply chain to sell cannabis APIs and finished products to countries across the EU, including Germany, due to a Mutual Recognition Agreement between Australia and the EU.

07:05 EST Enthusiast Gaming starts trading in the U.S. on OTCQB Venture Market - Enthusiast Gaming Holdings announced that the Company's common shares will commence trading on the OTCQB Venture Market, under the symbol "ENGMF". The Law Firm of Burns Figa & Will PC acted as the Company's sponsor. Enthusiast Gaming's common shares continue to trade on the TSX Venture Exchange under the symbol "EGLX" and on the Frankfurt stock exchange under the symbol "2AV".

07:03 EST Xperi raises Q4 billings view to $124M-$126M from $111M-$115M - Raises FY19 billings view to $411M-$413M from $398M-$402M. The increase is primarily driven by a one-time payment in connection with the resolution of an IP licensing matter.

07:01 EST DHI Group names Kevin Bostick as CFO, effective December 16 - DHI Group announced Kevin Bostick has joined as CFO. Effective Monday, December 16th, Bostick will have overall responsibility for the financial organization, including financial planning, accounting, financial reporting, investor relations, treasury, internal audit and tax. Bostick most recently served as partner and CFO of Level 5 Capital Partners, accelerating the acquisition strategy and raising capital for the owner and operator of fitness franchises throughout Denver and Michigan.

06:55 EST Horizon Pharma trading halted, news pending

06:53 EST SandRidge Energy CEO Paul McKinney resigns, John Suter named interim CEO - SandRidge Energy announced it has initiated a series of actions designed to improve shareholder value. The company will be focusing on actions to maximize value to shareholders, which will include evaluation of the 2020 capital expenditure program in light of market conditions with a focus on maximizing free cash flow. Management and the board will undertake a comprehensive review of the company with the aim to improve operational efficiencies and cost controls. In connection with this initiative, Paul McKinney has resigned as president and CEO and as a board member and John Suter, who currently serves as the company's COO, has agreed to serve as interim president and CEO. Suter has senior management, operational and technical experience in the exploration and production industry as well as knowledge of the company through his service as the company's COO for the past three years. Having overseen Suter and the management team since June 2018, the board is confident in his ability to perform as SandRidge's interim president and CEO. Suter joined SandRidge in April 2015 as senior VP of mid-continent operations, bringing with him experience in the exploration and production sector.

06:08 EST Airbus acquires industrial automation company MTM Robotics - Airbus has acquired industrial automation company, MTM Robotics, for an undisclosed sum. The move deepens Airbus' commitment to expanding advanced robotics capabilities within its manufacturing processes, the company said in a statement. The MTM business will retain its current leadership and 40-person staff, as well as its facility in Mukilteo, Washington, near Seattle. "The competitiveness of tomorrow will be determined by both designing the best aircraft and by building the most efficient manufacturing system, in parallel," said Michael Schoellhorn, Airbus COO." Automation & robotics are central to our industrial strategy. We are very happy to welcome MTM Robotics as a family member and take a step forward on this exciting endeavor together." Reference Link

06:03 EST Regis enters franchise arrangement with Bushell Investment Group - Regis announced that it entered into a franchise arrangement with the Bushell Investment Group, which has acquired over 100 Supercuts and Regis salons in the United Kingdom from The Beautiful Group. The Bushell Investment Group is a UK based private family office focused on investing in small and medium enterprise businesses within the U.K., Europe and North America. As part of the arrangement, BIG is retaining longtime portfolio manager, Jackie Lang. The remaining TBG salons not acquired by BIG will likely be closed as part of TBG's insolvency proceeding in the United Kingdom. Regis did not have and does not incur any financial obligations related to the closure of those salons.

05:36 EST Volvo appoints Scott Rafkin as Chief Digital Officer - Scott Rafkin, currently President of Volvo Financial Services, has been appointed to the new position of Executive Vice President and Chief Digital Officer for the Volvo Group, effective January 1, 2020. In this role he will be a member of the Executive Board and report to the Volvo Group President and CEO Martin Lundstedt. Scott Rafkin has served as President of Volvo Financial Services since 2014.

05:22 EST Genentech says Phase III IMspire150 study met primary endpoint of PFS - Genentech, a member of the Roche Group, announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival, or PFS. The study showed adding Tecentriq to Cotellic and Zelboraf helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf. A significant and clinically meaningful improvement in PFS was demonstrated in the study. The safety profile observed in IMspire150 was consistent with the known safety profiles of the individual medicines. Results from the study will be presented at an upcoming medical meeting and discussed with health authorities, including the FDA and European Medicines Agency. Genentech has an extensive clinical trial development program for Tecentriq, with more than 50 ongoing studies, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. Studies are evaluating Tecentriq alone and in combination with other medicines.