Stockwinners Market Radar for June 14, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:45 EDT Centene CEO: Medicare for all will not work - In an interview on CNBC's Mad Money, Centene (CNC) CEO Michael Neidorff said: If we can move WellCare (WCG) to our systems, it will be very good for them... We're using the marketplace to teach people how to use insurance... Medicare for all will not work as services would be drastically cut.

18:22 EDT RH CEO: We think our stock is massively undervalued - In an interview on CNBC's Mad Money, RH CEO Gary Friedman said: We think our stock should be worth $200 per share... People misunderstand our business model... We don't want to be over-reactive to tariffs... We have to stick to the long-term narrative... The global view for our business is just beginning... Long term we think RH could be a $10B-$20B company... We comfortably think we can be $4B-$5B in North America.

17:14 EDT FTE Networks granted financial viability exception by NYSE regulation - FTE Networks announced that the NYSE American LLC has granted the company's request for a financial distress exception to the shareholder approval requirements otherwise applicable to the issuance of shares of preferred stock to the holders of its Series A convertible notes and Series B promissory notes and additional equity to the company's lenders under its credit agreement in connection with the contemplated debt restructuring, by and among the company, the Benchmark Sellers and several lenders, pursuant to which the Benchmark Sellers and the company's senior lenders have agreed, among other things, to extend the maturity of the company's senior debt.

17:11 EDT Chatterjee Fund Management reports 5.6% passive stake in McDermott - In a regulatory filing, Chatterjee Fund Management disclosed a 5.6% stake in McDermott, which represents over 10M shares. The filing does not allow for activism.

16:46 EDT Foresight Energy discloses NYSE listing standard notice - Foresight Energy is announcing that it has been notified by the New York Stock Exchange that its common units did not satisfy one of the NYSE's standards for continued listing. The NYSE requires that the average closing price per unit of a listed partnership be in excess of $1.00 for a consecutive 30-trading-day period. Foresight plans to notify the NYSE that it anticipates that this deficiency will be cured and that it will return to compliance with the NYSE continued listing standard.

16:32 EDT Best Inc CAO Guo resigns - Best Inc announced that Alice Guo, Chief Accounting Officer, Senior Vice President of Finance and General Manager of Best Capital, has resigned and will leave the company on June 30, 2019. Guo is leaving for personal reasons and her departure is not related to any policy or control issues or any disagreements on the company's accounting or financial reporting matters.

16:30 EDT Hibbett Sports to delay filing 10-Q, cites accounting update - Hibbett Sports has determined that it is unable to file its Quarterly Report on Form 10-Q for the quarter ended May 4 within the prescribed time period due to the company's need to further review its recent adoption of the Financial Accounting Standards Board's Accounting Standards Update 2016-02, Topic 842, Leases, as of February 3. ASU 2016-02 replaced previous lease accounting guidance in GAAP and requires, among other things, lessees to recognize right-of-use assets and corresponding lease liabilities on the balance sheet for certain leases with a term of greater than 12 months. The company intends to file the Form 10-Q as soon as practicable following completion of its review.

16:19 EDT MicroVision receives noncompliance notice from Nasdaq - MicroVision announced that it received a notice from Nasdaq advising the company that for 30 consecutive business days preceding the date of the notice, the bid price of the company's common stock had closed below the $1.00 per share minimum required for continued listing on Nasdaq pursuant to Nasdaq's listing requirements. In accordance with Nasdaq's listing rules, the company has 180 calendar days, or until December 10, to regain compliance with this requirement. This notification is a notice of deficiency, not of imminent delisting, and has no current effect on the listing or trading of MicroVision's common stock on Nasdaq. During the 180-day compliance period, MicroVision can regain compliance if the bid price of its common stock closes at $1.00 or higher for a minimum of ten consecutive business days. If the company does not regain compliance by December 10, Nasdaq will notify the company that its securities are subject to delisting. The company is monitoring the bid price for its common stock. The company continues to execute its business plan and will consider other actions that it may take in order to regain compliance with the listing requirements.

16:06 EDT Shoe Carnival raises quarterly dividend 6% to 8.5c per share - The quarterly cash dividend will be paid on July 22 to shareholders of record as of the close of business on July 8.

16:02 EDT Revolution Lighting names Joan Nano as CFO, effective June 14 - Revolution Lighting announced that Joan Nano has agreed to serve as the company's CFO, effective as of June 14. Nano has served as a financial consultant to the company since March 27. Prior to joining the company, Nano served as Managing Director of Finance Solutions, a financial consulting firm, since 2008.

15:37 EDT Frontline rules out mechanical, human error in Front Altair explosion - Frontline provided an update on the LR2 tanker Front Altair, stating: "On the morning of June 13, an explosion occurred on the Front Altair shortly after the vessel had passed through the Strait of Hormuz in the Persian Gulf. Frontline was able to deploy emergency responders in a timely manner, who extinguished fire on the vessel within hours of the incident and ensured no pollution resulted. Contrary to media reports, the vessel remains afloat and is being attended to by a salvage vessel. The cause of the explosion remains unknown to the company, although we have ruled out the possibility that it was caused by mechanical or human error. The incident will be thoroughly investigated by the company along with third parties, including governmental officials, to determine the cause. As geopolitical tensions rise in the Persian Gulf, the company is intensely focused on the safety in this region. Until further information is received regarding the cause of the explosion and the security of this important shipping lane is secured, Frontline will exercise extreme caution when considering new contracts in the region."

15:15 EDT Sprint up 3% after NY Times says DOJ nearing approval of merger - T-Mobile (TMUS) shares are up 1% following the report.

14:48 EDT Amgen, others sue to prevent rule over televising drug price in commercials - Amgen (AMGN), along with Merck (MRK), Eli Lilly (LLY), and the Association of National Advertisers, filed suit in the U.S. District Court for the District of Columbia. The lawsuit seeks to prevent the Department of Health and Human Services' new rule, which goes into effect July 9, that will require direct-to-consumer television advertisements for certain pharmaceuticals and biologics to state the list price of the medicine being advertised. The statement reads, "Amgen agrees with the Administration that patients need clear and relevant information to understand what they can expect to pay for their medicines. In fact, we have already taken proactive steps in our direct-to-consumer (DTC) television advertising and related product websites to enhance pricing transparency (these can be viewed by visiting www.Amgen.com, including links to the list price for all of our products advertised on television). What Amgen doesn't agree with is a government-prescribed approach as required in the new DTC rule. Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments, and patients themselves, by requiring disclosure of list price. Most importantly, it does not answer the fundamental question patients are asking: "What will I have to pay for my medicine?" Reference Link

14:41 EDT MiMedx former CEO sees 'flaws' in revenue recognition allegations - Former Chairman and CEO Pete Petit of Mimedx issued a statement to fellow shareholders, stating in part: "All the revenue recognition allegations against MiMedx purposefully ignore the stark reality that the company collected basically all of its booked revenue over the years. In addition, the company bought over $130M of its stock back without incurring debt or affecting revenue and profit growth. Channel stuffing results in reduced cash collections and the aging of accounts receivable. MiMedx suffered neither of these problems for the wrong reasons for any extended period of time. Their accounts receivable did age in 2015 right after Petit informed Avkare that they were going to cancel their contract because the company had received their own federal supply contract. Avkare became upset and slowed down their payments to MiMedx. That situation corrected itself when executive management called Avkare out, and MiMedx accounts receivable came down into the 70 day and then 60 day range... It is very disappointing to see the extent of misinformation and actual lies contained in the MiMedx press release and 8K dated May 23rd and their press release of June 10th. Executive management has never been given a meaningful opportunity to review ANY of these specific allegations or been able to respond until now, except for the recommended revenue recognition changes for 2012-2016, which management totally disagreed with in June of 2018. The nine bullet points of allegations in the company's communications are twisted and knowingly incorrect conclusions from thousands of emails. It is Mr. Petit's contention that he and his staff conducted MiMedx business with honesty and integrity without knowingly violating regulations, laws or GAAP accounting."

14:01 EDT Bluebird Bio CEO says Zynteglo 'nowhere near' most expensive drug in world - Bluebird Bio (BLUE) CEO Nick Leschly said much has been made of the headline price tag for gene therapies being offered by his company and Novartis (NVS), but he pushes back against the contention that his company's Zynteglo and Novartis' Zolgensma are the most expensive drugs in the world. He said during an interview on CNBC that Zynteglo is "nowhere near" the most expensive drug in the world and that one-time curative gene therapies should be thought about differently.

13:03 EDT Amgen acute myeloid leukemia treatment granted FDA orphan status - Amgen's treatment of acute myeloid leukemia was granted orphan designation by the FDA, according to a post to the agency's website. Reference Link

12:37 EDT Meet Group announces new $30M share repurchase authorization - The Meet Group announced that its Board of Directors has approved a share repurchase program that enables the company to purchase up to $30M of its shares of common stock from time to time in the open market or through negotiated transactions through 2021. The company expects to fund purchases with cash from operations. "The new stock repurchase program underscores our belief in the livestreaming video opportunity and our positive long-term outlook for our business," said Geoff Cook, CEO of The Meet Group. "We expect to continue to generate meaningful cash flow, enabling us to buy back shares as we execute on our commitment to drive value for our shareholders." The Meet Group had approximately 75.6 million shares of common stock outstanding as of May 31, 2019.

12:01 EDT pdvWireless announces rebranding as Anterix - pdvWireless announced its new operating name and brand, Anterix. "Anterix aims to deliver the dedicated broadband so desperately needed to modernize our nation's critical infrastructure. Enabling connectivity for the devices that can power and protect the crucial services we all rely on, we are poised and ready to transform the way utilities and enterprise operate through the use of broadband technology," said Anterix CEO, Morgan O'Brien. In addition to the new corporate name, the company will be changing its ticker symbol on the Nasdaq Stock Market to ATEX effective June 17. Until that date, the company's stock will continue to trade under the existing PDVW ticker symbol.

11:51 EDT Dish opposed Sprint, T-Mobile merger in meeting with FTC, filing shows

10:35 EDT Ashford Hospitality falls 16% after cutting its dividend to 6c per share - Earlier today, Ashford Hospitality Trust announced that its board declared a quarterly cash dividend of 6c per diluted share for the company's common stock for the second quarter ending June 30. The prior dividend was 12c per share. The dividend, which equates to an annual rate of 24c per share, will be distributed on July 15, to shareholders of record as of June 28. Our Board of Directors set the quarterly common dividend at a level that it believes is competitive with our lodging REIT peers," said Douglas A. Kessler, Ashford Trust's President and Chief Executive Officer. "For some time, our dividend has significantly exceeded what we would have needed to distribute from a taxable income standpoint. This adjustment effectively preserves capital for more advantageous purposes including strengthening our balance sheet and enhancing our ability to pursue more opportunistic growth such as acquisitions that qualify for our Enhanced Return Funding Program. One of the intended purposes of the ERFP is to make good deals, great deals. We believe we are having success in achieving that goal. To date, we have been pleased with the strong performance and attractive initial results from our recent ERFP acquisitions, namely the Hilton Alexandria Old Town, La Posada de Santa Fe, Embassy Suites New York Midtown Manhattan, and Hilton Santa Cruz/Scotts Valley." Shares of Ashford Hospitality are down 16% or 68c per share to $3.61 per share in morning trading.

10:14 EDT Athene unit Athene Life Re Ltd CEO to retire - Athene Holding announced that Frank "Chip" Gillis, CEO of Athene Life Re and Co-Founder of Athene Holding, will retire at the end of 2019. Mr. Gillis will continue his involvement with the company as Executive Chairman of the ALRe board and will serve as a board member of the newly announced Athene Co-Invest Reinsurance Affiliate (ACRA). As co-founder of Athene, Mr. Gillis worked for two years to raise capital leading up to July 2009, when Athene was officially formed and licensed. His deep knowledge of the reinsurance industry and strong business relationships led to Athene's first reinsurance deal. Since then, Mr. Gillis has been responsible for leading the growth of Athene's reinsurance channel, which has completed agreements with nearly two dozen third-party cedents since inception.

10:00 EDT PPDAI Group falls -9.5% - PPDAI Group is down -9.5%, or -42c to $4.02.

10:00 EDT Norbord rises 7.4% - Norbord is up 7.4%, or $1.60 to $23.15.

10:00 EDT Bluegreen Vacations rises 31.0% - Bluegreen Vacations is up 31.0%, or $2.48 to $10.48.

09:47 EDT STMicroelectronics falls -4.7% - STMicroelectronics is down -4.7%, or -78c to $15.76.

09:47 EDT Norbord rises 6.6% - Norbord is up 6.6%, or $1.43 to $22.98.

09:47 EDT Bluegreen Vacations rises 35.0% - Bluegreen Vacations is up 35.0%, or $2.80 to $10.80.

09:11 EDT Caledonia Mining CEO purchases 3,500 depositary interests - Caledonia Mining Corporation announces that it received notice that Steve Curtis, a director and the CEO, has purchased a total of 3,500 depositary interests representing the same number of common shares of no par value each in the Company at a price per depositary interest of GBP4.10 each. Following this transaction, Mr Curtis has an interest in 164,882 shares in the Company representing approximately 1.53% of the issued share capital of Caledonia.

09:04 EDT Alaska Communications CEO to leave June 30, COO William Bishop named interim CEO - Alaska Communications announced CEO Anand Vadapalli will depart the company on June 30. Effective July 1, COO William Bishop will serve as interim CEO while the board conducts a candidate search for a permanent CEO. Vadapalli will serve as an advisor for board and management during this transition period through the end of 2019.

09:03 EDT Baxter to lead hemodialysis research consortium for German program - Baxter announced receipt of a major research and development grant from the German Federal Ministry of Education and Research program to lead a consortium investigating an anticoagulation-free hemodialysis, or HD, option for end-stage renal disease, or ESRD, patients. The grant provides EUR1.5M in funding over three years to Baxter's research team in Hechingen, Germany, and the consortium partners to find a solution that will improve health-related, quality-of-life outcomes for the millions of patients receiving HD therapy globally. Anticoagulant use is a necessary component of HD that helps prevent blood clotting during therapy sessions, which are typically performed three days a week for an average of four hours per session. HD patients can experience short-term side effects from the anticoagulants, such as increased bleeding time at the end of a dialysis session. The consortium is taking a novel approach to its research by analyzing modifications of dialysis membranes to minimize the interaction between blood and membrane surfaces, which is the main cause of blood clotting.

09:01 EDT MGM Growth raises annual dividend to $1.87 per share - MGM Growth announced that its board of directors declared a quarterly cash dividend of 46.75c per Class A common share for the second quarter. On an annualized basis, the dividend of $1.87 represents an increase of 1c per share. This is the eigth dividend increase since MGP's initial public offering in April 2016. The dividend will be payable on July 15 to shareholders of record as of the close of business on June 28.

08:58 EDT Synchrony, Suzuki extend partnership - Synchrony announced it has renewed a multi-year financing agreement with Suzuki Motor of America, a leading manufacturer and distributor of motorcycles, ATVs, scooters, and outboard motors.

08:53 EDT Diana Shipping commences self tender offer to purchase up to 2M shares - Diana Shipping announced the commencement of a tender offer to purchase up to 2,000,000 shares, or about 2.0%, of its outstanding common stock using funds available from cash and cash equivalents at a price of $3.25 per share. The tender offer will expire at the end of the day, 5:00 P.M., Eastern Time, on July 16, 2019, unless extended or withdrawn. The Board of Directors determined that it is in the Company's best interest to repurchase shares at this time given Diana Shipping's cash position and stock price. The tender offer is not conditioned upon any minimum number of shares being tendered; however, the tender offer is subject to a number of other terms and conditions. Specific instructions and an explanation of the terms and conditions of the tender offer are contained in the Offer to Purchase and related materials that are being mailed to shareholders.

08:51 EDT Iteris to acquire Albeck Gerken for $10.7M in cash, stock - Iteris announced that it has entered into a definitive agreement to acquire Albeck Gerken, a privately held traffic operations engineering services provider headquartered in Tampa, Florida. Under the terms of the agreement, Iteris will acquire Albeck Gerken for a total purchase price of $10.7M to be paid in cash and stock, with the ability for key principals to realize an additional $2.3M in other incentives over three years from the date of close. The proposed acquisition is expected to close on July 2. For FY18, Albeck Gerken's audited GAAP revenue was $8.1M and EBITDA was $2M. The combined total value of Albeck Gerken's current contracts across all geographic markets is approximately $16M.

08:46 EDT Blueprint Medicines submits NDA to FDA for avapritinib - Blueprint Medicines announced it has submitted a New Drug Application to the U.S. FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors, regardless of prior therapy, and fourth-line GIST. Currently, no effective therapy exists for either population. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST. Blueprint Medicines has requested priority review for the application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

08:33 EDT Digital Ally enters into multi-year agreement with the Kansas City Chiefs - Digital Ally announces a multi-year agreement with the Kansas City Chiefs Football Club to provide the Chiefs' security personnel with its body-worn video cameras and cloud based storage software to document interactions between security personnel and guests.

08:31 EDT Taseko Mines announces senior management appointments - Taseko Mines announced the voting results from its 2019 Annual General Meeting held Thursday, June 13, in Vancouver, British Columbia. Additionally, the company announces the following executive management appointments, which are effective immediately. Stuart McDonald, currently Taseko's CFO, will become President of the company and Russell Hallbauer will remain as CEO. Bryce Hamming, currently Director of Corporate Finance, has been appointed CFO and Richard Tremblay, currently the VP and General Manager of Taseko's Gibraltar Mine will become Vice President, Operations.

08:07 EDT Theravance Biopharma, Mylan expand YUPELRI development agreement - Theravance Biopharma (TBPH) and Mylan (MYL) announced the expansion of the companies' current development and commercialization agreement for nebulized revefenacin to include China and certain adjacent territories. Revefenacin, marketed as YUPELRI in the U.S., is a long-acting muscarinic antagonist, which is the first and only once-daily, nebulized bronchodilator approved for the treatment of chronic obstructive pulmonary disease in the U.S.

08:06 EDT Roan Resources sees Q2 production over 50,000 mboepd - Sees Q2 capital expenditures below $155M. The company anticipates 14 gross operated wells to be turned to first sales during June and July. These wells are spaced and being completed in accordance with the company's improved development program of 2019 and anticipates strong performance results from the Mad Play unit, along with the Mayes wells .

08:05 EDT Clinical researchers to present results from studies evaluating Bionano's Saphyr - Bionano Genomics announces presentations of initial results of two key clinical studies at the European Human Genetics Conference, the annual conference of the European Society of Human Genetics. In a workshop on June 16, speakers from leading clinical research hospitals in Europe who are evaluating Bionano optical mapping with the Saphyr system against traditional cytogenetics workflows, will present initial results that demonstrate Saphyr's ability to modernize existing workflows. Dr. Alexander Hoischen, PhD, from Radboud University Medical Center in the Netherlands, will provide an update on their study comparing Bionano optical mapping with Saphyr to the current clinical testing workflows for Chronic Myelogenous Leukemia and Acute Lymphoblastic Leukemia among other hematologic malignancies and some genetic disorders. In a second presentation, Dr. Laila El-Khattabi, PharmD, PhD, from Hopital Cochin - Paris Descartes University, will present results where the Saphyr system has been used to detect a wide variety of balanced and unbalanced chromosomal abnormalities that occur in reproductive disorders, such as those causing recurrent pregnancy loss. The workflow based on the Saphyr system has the potential to dramatically simplify patient testing by consolidating the traditional approach into a single workflow compared to current practice, which relies on multiple platforms and can be cumbersome, slow and costly. In addition, compared to existing methods like karyotyping, Bionano optical mapping with Saphyr has significantly higher resolution of the breakpoints of the chromosomal rearrangements that are detected, which makes it possible to more definitively identify the genes affected by the mutation and could improve patient management and therapy selection.

08:02 EDT Krystal Biotech submits IND application for KB105 - Krystal Biotech announces that it has submitted an Investigational New Drug application with the U.S. Food and Drug Administration to initiate a Phase 1/2, first in-human trial of KB105, an HSV-1 based gene therapy engineered to deliver a human transglutaminase-1 gene to patients with TGM1-deficient autosomal recessive congenital ichthyosis. TGM1-deficient ARCI is a debilitating rare skin disease characterized by excessive, thick scaling of the skin and causing multiple chronic health conditions. Leveraging its Skin Targeted Delivery platform technology, Krystal's approach is to use a non-replicating, non-integrating engineered HSV-1 virus, to deliver the TGM1 gene to dividing and non-dividing skin cells, causing them to produce the TGM1 protein that is lacking in this patient population. KB105 is designed to be an off-the-shelf treatment for TGM1-deficient ARCI that can be applied topically, directly to a patient's skin.

07:32 EDT Ampio receives FDA approval of special protocol assesment - Ampio announced that it received FDA approval of the company's special protocol assessment of a clinical protocol titled "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee." The FDA response noted, "We have completed our review, and based on the information submitted, agree that the design and planned analysis of your study adequately address the objectives necessary to support a regulatory submission." The FDA continued, "However, final determinations for marketing application approval are made after a complete review of the marking application and are based on the entire data in the application."

07:21 EDT Revolution Lighting announces resignation of accounting firm - Revolution Lighting Technologies announced that on June 13, 2019, RSM US informed the Company's Audit Committee that it has resigned from the engagement as the Company's independent registered public accounting firm, effective immediately. Additional information about RSM's resignation will be included in a Form 8-K due to be filed with the Securities and Exchange Commission no later than June 19, 2019.

07:18 EDT Kura Oncology says primary endpoint achieved in Phase 2 trial of tipifarnib - Kura Oncology announced updated interim data from the ongoing Phase 2 clinical trial of its lead drug candidate, tipifarnib, in patients with relapsed or refractory peripheral T-cell lymphoma. The results, which will be presented during an oral session at 16:45 CET / 10:45 am ET tomorrow at the European Hematology Association Annual Congress in Amsterdam, demonstrate ongoing anti-tumor activity and a manageable safety profile in advanced patients with angioimmunoblastic T-cell lymphoma as well as non-AITL PTCL. The multi-center, single-arm, open-label Phase 2 trial was designed to determine the efficacy, safety and biomarkers of activity of tipifarnib in patients with relapsed or refractory PTCL. Initially, patients were enrolled without selection in the Phase 2 trial. Based upon molecular characterization of the initial patients, the Phase 2 trial was amended to include two expansion cohorts: 1) patients with AITL, an aggressive form of T-cell lymphoma often characterized by high levels of CXCL12 expression, and 2) patients with PTCL who lack a single nucleotide variation in the 3'-untranslated region of the CXCL12 gene. As of the May 24, 2019 data cutoff, a total of 50 relapsed/refractory PTCL patients with a median number of three prior regimens have been enrolled in all stages of the Phase 2 trial. Key preliminary findings include: The primary efficacy endpoint was achieved in each of the AITL and CXCL12+ expansion cohorts. Sixteen patients were treated in the AITL cohort and 15 in the CXCL12 SNP+ cohort. Among the 11 evaluable patients in the AITL extension cohort, three achieved a complete response and two achieved a partial response, for an objective response rate of 45%. Among the 12 evaluable patients in the CXCL12+ expansion cohort, three achieved a CR and two achieved a PR, for an ORR of 42%. Two of the five responders in the CXCL12+ expansion cohort were AITL patients. When all AITL patients and all PTCL not otherwise specified with available rs2839695 data and absence of this 3'UTR variant enrolled in all portions were taken into account, ORR were 53%/39% for AITL and 20%/18% for CXCL12 SNP+ PTCL-NOS. Thirty-four patients had available gene expression data. Patients with a high ratio of CXCL12 expression to its receptor CXCR4 experienced an ORR of 47% and a clinical benefit rate of 82% with tipifarnib. Next-generation sequencing of 16 AITL patients revealed a high rate of mutation/variation of the killer cell immunoglobulin-like receptors, including KIR3DL2. KIR3DL2 mutation at C336R was concurrent with Q386E and was associated with outcome from tipifarnib therapy. Four of the eight KIR3DL2 C336R/Q386E patients achieved a CR, two achieved a PR and two achieved stable disease for a CR rate of 50%, an ORR of 75% and a clinical benefit rate of 100%. Furthermore, high KIR3DL2 mutant variant allele frequency KIR3DL2 was predictive of complete response to tipifarnib in AITL. Tumors with KIR3DL2 mutations expressed low levels of CXCL5 and its receptor CXCR1 and CXCR2, a potential mechanism of resistance to tipifarnib. Tipifarnib was generally well-tolerated in this Phase 2 trial, with adverse events consistent with its known safety profile. The most frequently observed treatment-related adverse events were hematology-related, including thrombocytopenia, neutropenia, leukopenia, anemia, febrile neutropenia and lymphopenia. Separately, Kura has been evaluating the potential to use CXCL12 pathway biomarkers to enrich for clinical activity in other hematologic malignancies. In addition to AITL, high CXCL12 expression was observed in tumors from other lymphoma patients, including patients with PTCL-NOS, diffuse large B-cell lymphoma and mycosis fungoides, the most common form of cutaneous T-cell lymphoma. Lymphoma patients with CXCL12 reference sequences also appeared to have a higher chance of clinical benefit from tipifarnib treatment. The identification of these CXCL12 reference sequences in responders to tipifarnib across multiple hematologic malignancies will be presented in a poster presentation at 17:30 CET / 11:30 am ET tomorrow at the EHA Annual Congress in Amsterdam.

07:13 EDT Karyopharm to present new data on pomalyst, SPd arm in Phase 1b/2 STOMP study - Karyopharm Therapeutics announced three presentations highlighting new and updated data from the Phase 1b/2 STOMP study evaluating selinexor, the company's first-in-class, oral Selective Inhibitor of Nuclear Export compound, and dexamethasone in combination with standard approved multiple myeloma therapies, Kyprolis Darzalex, or Pomalyst, in patients with previously treated multiple myeloma. Selinexor plus Pomalyst and Low-dose Dexamethasone: In this arm of the Phase 1b/2 STOMP study, oral selinexor is being evaluated in combination with Pomalyst and low dose dex in patients with relapsed or refractory MM who received at least two prior lines of therapy, including a PI and an IMiD, or patients with MM refractory to both a PI and an IMiD. Among the 45 patients evaluated for safety as of the data cutoff date, the most common treatment-related AEs were cytopenias, along with gastrointestinal and constitutional symptoms; most manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea, fatigue and anorexia and mostly Grade 1 and 2 events. As expected, the most common treatment-related Grade 3 and 4 AEs were hematologic AEs and included neutropenia, thrombocytopenia, anemia and leukopenia. There were three Grade 5 treatment-related events. Determination of the RP2D is still ongoing.

07:07 EDT Karyopharm to present new data on Phase 1b/2 STOMP study - Karyopharm Therapeutics announced three presentations highlighting new and updated data from the Phase 1b/2 STOMP study evaluating selinexor, the company's first-in-class, oral Selective Inhibitor of Nuclear Export compound, and dexamethasone in combination with standard approved multiple myeloma therapies, Kyprolis Darzalex, or Pomalyst, in patients with previously treated multiple myeloma. The data will be featured in oral and poster presentations at the European Hematology Association 2019 Annual Meeting. In this arm of the Phase 1b/2 STOMP study, oral selinexor is being evaluated in combination with Kyprolis and low dose dex in patients with relapsed refractory MM who have received at least two prior therapies, which can include previous treatment with a proteasome inhibitor , one or more immunomodulatory drugs Darzalex. All patients on the study had previously received both PIs and IMiDs. Among the 9 patients evaluated for safety as of the data cutoff date, the most common treatment-related AEs were cytopenias, along with gastrointestinal and constitutional symptoms; most were manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea, fatigue, hyperglycemia, anorexia and vomiting, and were mostly Grade 1 and 2 events. As expected, the most common treatment-related Grade 3 and 4 AEs were hematologic AEs and included thrombocytopenia, leukopenia, anemia and neutropenia. Dose limiting toxicities, including Grades 3 and 4 thrombocytopenia, Grade 3 pneumonia and Grade 3 vomiting, were observed in patients receiving selinexor 80mg and Kyprolis 70mg/m2 and selinexor 100mg and Kyprolis 56mg/m2. No DLTs were reported in the selinexor 80mg and Kyprolis 56mg/m2 cohort, and therefore, confirmation of the recommended Phase 2 dose is ongoing with this dosing regimen.

07:02 EDT Regeneron announces 'positive early-stage data' for REGN1979 - Regeneron announced positive early-stage data for REGN1979 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The emerging data, which includes patients with R/R diffuse large B-cell lymphoma who had progressed after CAR-T therapy, will be presented tomorrow at the 24th Congress of the European Hematology Association. REGN1979 is an investigational bispecific monoclonal antibody and is designed to trigger tumor killing by binding to both a B-cell tumor protein and an immune system T-cell receptor. "We are very encouraged by the continued high response rates observed with REGN1979 in both relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, cancers with typically poor outcomes," said Israel Lowy, M.D., Ph.D., Senior Vice President and Head of Clinical and Translational Sciences, Oncology at Regeneron. "In this trial, two patients who failed CAR-T therapy and received REGN1979 80 mg achieved complete responses; there is currently no approved therapy for patients who progress on CAR-Ts. Our potentially registrational Phase 2 program is initiating this month and will proactively evaluate active REGN1979 doses in indolent and aggressive non-Hodgkin lymphoma."

06:43 EDT Toronto-Dominion receives regulatory approval for 20M share repurchase plan - The Toronto-Dominion Bank announced that the Toronto Stock Exchange and the Office of the Superintendent of Financial Institutions Canada have approved TD's previously announced normal course issuer bid. As previously announced, TD intends to repurchase for cancellation up to 20M of its common shares pursuant to its bid which will commence on June 18, 2019 and end on June 17, 2020, such earlier date as TD may determine or such earlier date as TD may complete its purchases pursuant to the notice of intention filed with the TSX.

06:40 EDT Allete subsidiary announces power sales agreement with Smithfield Foods - ALLETE Clean Energy, a wholly owned subsidiary of ALLETE (ALE), announced a power sales agreement with Smithfield Foods for the remaining output of the Diamond Spring wind site ALLETE Clean Energy will build, own and operate in Oklahoma. The Smithfield agreement follows an earlier announcement of power sale agreements with Walmart (WMT) and Starbucks (SBUX). Walmart has agreed to purchase 175 megawatts for 15 years, Smithfield will purchase 75 megawatts for 12 years, and Starbucks will purchase 50 megawatts for 15 years. The approximately 300-megawatt Diamond Spring site, which is ALLETE Clean Energy's first project to sell wind power to corporate customers, is now fully contracted with the Smithfield agreement.

06:31 EDT Alexion announces positive Phase 3 extension data for ULTOMIRIS - Alexion announced the presentation of new data demonstrating that ULTOMIRIS, the first and only long-acting C5 complement inhibitor administered every eight weeks, provided consistent efficacy and safety through 52 weeks in the extension1 of the Phase 3 study of ULTOMIRIS and SOLIRIS in complement inhibitor-naive, adult patients with paroxysmal nocturnal hemoglobinuria. Sustained efficacy of ULTOMIRIS was observed on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase levels and the secondary endpoints of LDH level reduction and breakthrough hemolysis. In an additional sub-study, nearly all patients preferred ULTOMIRIS over SOLIRIS.3 The data will be presented at the Annual Congress of the European Hematology Association, taking place June 13-19 in Amsterdam, Netherlands.

06:10 EDT Expedia settles alleged violations of U.S. sanctions on Cuba, Treasury says - Expedia Group has agreed to pay more than $325,000 to settle allegations that it violated U.S. sanctions on Cuba, the Treasury Department said. The Office of Foreign Assets Control said: " Expedia, headquartered in Bellevue, Washington, on behalf of itself and its subsidiaries and affiliates worldwide, has agreed to pay $325,406 to settle its potential civil liability for providing Cuba-related travel services in apparent violation of the Cuban Assets Control Regulations, 31 C.F.R. part 515. Specifically, between on or about April 22, 2011 and on or about October 16, 2014, Expedia dealt in property or interests in property of Cuba or Cuban nationals by assisting 2,221 persons - some of whom were Cuban nationals - with travel or travel-related services for travel within Cuba or between Cuba and locations outside the United States. These transactions appear to have violated Section 515.201(b) of the CACR. OFAC determined that the apparent violations were voluntarily self-disclosed to OFAC and occurred prior to agency notice." Reference Link

06:06 EDT ArQule announces preliminary results from phase 1 ARQ 531 study at EHA - ArQule announced preliminary results from the company's phase 1 dose escalation study for ARQ 531, an orally bioavailable, dual inhibitor of both wild type and C481S-mutant Bruton's tyrosine kinase, or BTK, in patients with relapsed or refractory hematologic malignancies at the European Hematology Association, or EHA. The reported data are from the ongoing phase 1, open label, single arm dose escalation study and include the first eight cohorts at dose levels of 5, 10, 15, 20, 30, 45, 65 and 75 mg once a day in patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, small lymphocytic leukemia, or SLL, Richter's Transformation, Waldenstrom macroglobulinemia and other B-cell Non-Hodgkin lymphomas. Cohort 8 enrollment is ongoing. ARQ 531 is well-tolerated through 65 mg QD. Pharmacokinetic data demonstrate a steady-state mean Cmin of above 1 microM in patients receiving 45 mg QD. The plasma half-life ranges from 20-30 hours. Pharmacodynamic data at doses above 20-30 mg QD is associated with complete pBTK inhibition and substantial CCL3 suppression. Robust, dose-dependent, anti-tumor activity was observed. ORR of 66% was observed in heavily pretreated R/R CLL patients, all with the BTK-C481S mutation, from cohort 7. A partial response was observed in the first patient with Richter's Transformation, who had progressed on ibrutinib and R-CHOP, suggesting that ARQ 531's distinct MOA is amenable to target this unmet medical need. A Follicular Lymphoma patient remains a confirmed PR and has been on therapy approximately two years, providing initial insights into long- term safety as well as durability of response.

06:05 EDT Great Elm DME unit acquires respiratory assets of Midwest Respiratory Care - Great Elm Capital announced that on June 12, Focus Respiratory, a wholly owned subsidiary of Great Elm DME, acquired the respiratory assets of Omaha, Nebraska-based Midwest Respiratory Care in an all-cash transaction valued at approximately $6.25M or 4.6x MRC's EBITDA less capital expenditures for the twelve months ended April 30. The acquisition expands the company's geographic reach in the Midwestern U.S. beyond its existing Omaha presence by adding respiratory operations in Lincoln, NE, Fort Madison, IA and Lenexa, KS, significantly increasing the pool of potential patients who may be serviced by the company. The acquisition also presents potential cost synergies, including combining corporate offices in Omaha, implementing best practices with respect to billing and collection and purchasing rental equipment. The acquired assets represent approximately $3.5M of trailing twelve-month revenue, including approximately $2.8M of recurring rental revenue, and are estimated to increase the company's unleveraged free cash flow by approximately $1.7M per annum. The acquisition was funded through $3.4M of additional debt under the company's existing term loan facility, $2.7M of equity from Great Elm Capital Group and the remainder from pro rata equity contributions by the company's other shareholders. Upon the closing of the acquisition, MRC's non-hospice patients became customers of Focus, while MRC focuses its operations on its durable medical equipment business servicing hospice customers.

06:03 EDT Bayer to invest EUR5B in alternative weedkillers over next decade - While glyphosate will continue to play an important role in agriculture and in Bayer's portfolio, the company said in a statement that it is committed to offering more choices for growers and will invest approximately 5 billion euros in additional methods to combat weeds over the next decade. This R&D investment will go towards improving the understanding of resistance mechanisms, discovering and developing new modes of actions, further developing tailored Integrated Weed Management solutions and developing more precise recommendations through digital farming tools. In addition, partnerships with weed scientists around the world will be enhanced to help develop customized solutions for farmers at a local level.

06:00 EDT CGI Group makes 254.15 pence per share offer to acquire SCISYS - CGI announced a cash offer of 254.15 pence per share to acquire the entire issued and to be issued ordinary share capital of SCISYS through its wholly owned indirect subsidiary CGI Group Holdings Europe Limited. The offer is unanimously recommended by the SCISYS board and CGI has received irrevocable undertakings to vote in favour of the transaction from SCISYS directors representing approximately 25.0% of the existing issued share capital of SCISYS. The offer represents a premium of 43.7% to SCISYS' volume weighted average closing price over the last 6 months, 47.0% to its volume weighted average closing price over the last 12 months and 24.6% to its closing price on June 13. The offer values the entire issued and to be issued ordinary share capital of SCISYS at approximately GBP 78.9M. The transaction is expected to close during the second half of 2019.

05:56 EDT Novartis: follow-up data from ENESTfreedom, ENESTop trials show sustained TFR - Long-term follow-up data from the ongoing, pivotal open-label ENESTfreedom and ENESTop trials showed sustained treatment-free remission, or TFR, after stopping frontline and second-line Tasigna therapy in eligible adult patients with Philadelphia chromosome-positive, or Ph+, chronic myeloid leukemia, or CML, in the chronic phase, or CP. Separate data demonstrate promising results for asciminib, an investigational allosteric BCR-ABL inhibitor, in combination with three different tyrosine kinase inhibitors, or TKIs, in heavily pre-treated Ph+ CML-CP patients.

05:36 EDT Align Technology, Straumann Group end talks concerning possible agreement - Align Technology and Straumann Group announced that they have terminated discussions regarding a possible development and distribution agreement that was disclosed as part of the patent settlement agreement announced by the two companies in March. As a result, Straumann will pay Align an additional $16M in lieu of the development and distribution agreement. This settlement between Align and Straumann brought an end to outstanding patent disputes in the U.S., the U.K. and Brazil, including those involving ClearCorrect, a subsidiary of Straumann. As part of this settlement, Align and Straumann signed a non-binding letter of intent for a 5-year global development and distribution agreement whereby Straumann would distribute 5,000 iTero Element scanners which would be fully integrated into the Straumann/Dental Wings CARES/DWOS workflow. Additionally, the parties considered exploring the possibility of offering existing iTero users access to Straumann's prosthetic and surgical planning workflows.

05:19 EDT Agnico Eagle offers to acquire Alexandria Minerals for C$26M - Agnico Eagle announced that it has delivered a definitive offer to the board of directors of Alexandria Minerals pursuant to which Agnico Eagle would acquire 100% of Alexandria's issued and outstanding common shares, including common shares issuable under outstanding options and warrants, by way of a plan of arrangement under the Canada Business Corporations Act. Total consideration required to effect the acquisition is expected to be approximately C$26M. The Proposal is not subject to any financing or due diligence condition. Agnico Eagle has been informed that Alexandria's board of directors has determined that the Proposal constitutes a "Superior Proposal" as defined in the arrangement agreement dated May 14 between Alexandria and Chantrell Ventures Corp. The acquisition of Alexandria will allow Agnico Eagle to consolidate an additional 14,819 hectares of mining claims that cover approximately 35 kilometres of strike length along the Cadillac-Larder Lake break in the prospective Val d'Or gold camp. Three of Alexandria's properties collectively contain historical inferred mineral resources of 526,702 ounces of gold and indicated mineral resources of 448,654 ounces of gold, each as estimated by Alexandria.