Stockwinners Market Radar for December 04, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:53 EST Acadia's Pimavanserin met endpoints in Ph 3 trial for dementia-related psychosis - Acadia presented positive top-line results from its Phase 3 HARMONY study at the 12th Clinical Trials on Alzheimer's Disease Meeting, December 4 -7, in San Diego, California. HARMONY was a double-blind, placebo-controlled, relapse prevention study in 392 patients evaluating pimavanserin for the treatment of dementia-related psychosis. Pimavanserin met the primary endpoint of the study and was stopped at the pre-planned interim analysis by significantly reducing risk of relapse of psychosis by 2.8 fold compared to placebo. In addition, pimavanserin met the key secondary endpoint by significantly reducing risk of discontinuation for any reason by 2.2 fold. The Phase 3 HARMONY study included a 12-week open-label pimavanserin treatment period prior to the randomization period of the study. In this open-label treatment period, 61.8% of eligible patients met pre-specified criteria for pimavanserin treatment response at both week 8 and week 12 and were subsequently randomized into the double-blind period of the study. For patients in the open-label treatment period, change from baseline to week 8 and week 12 on the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions score improved by 63.0% and 75.2% respectively. Pimavanserin was well-tolerated over the entire 9-month study duration. Patients receiving pimavanserin treatment had no worsening in cognition and no worsening of motor symptoms from baseline. In the double-blind period, low rates of adverse events were observed, 41.0% of patients on pimavanserin and 36.6% on placebo. Discontinuations due to adverse events were low, 2.9% for pimavanserin and 3.6% for placebo. Serious adverse events were also low, 4.8% in the pimavanserin group and 3.6% in the placebo group. One death was reported in the open-label period and one death was reported in the pimavanserin group during the double-blind period. Investigators determined neither death was related to the study drug. Additionally, pimavanserin did not result in clinically significant differences in vital signs, weight, or daytime sedation compared to placebo. ACADIA is planning to meet with the FDA in the first half of 2020 regarding a supplemental NDA submission.

20:17 EST Trade Desk director sells 2.9K shares of common stock - In a regulatory filing, Trade Desk disclosed that its director Eric Paley sold 2.9K shares of common stock on December 2nd-4th. The total transaction size was over $610K.

19:01 EST LGI Homes reports 748 home closings in November - LGI Homes announced 748 homes closed in November 2019, up from 500 home closings in November 2018, representing year-over-year growth of 49.6%. In addition, the company ended the first eleven months of 2019 with 6,638 home closings, a 18.0% increase over 5,628 home closings during the first eleven months of 2018. As of the end of November 2019, the company had 103 active selling communities.

18:48 EST Telus to acquire Competence Call Center for approximately C$1.3B - Telus, through Telus International, announced that it has agreed to acquire privately-owned Competence Call Center, a leading provider of higher-value-added business services with a focus on customer relationship management and content moderation, for approximately approximately C$1.3B consisting of debt and equity, subject to customary closing adjustments. The acquisition is expected to add significant scale to TELUS International, an important and differentiated growth driver for TELUS, and will support TELUS' consolidated financial and operating results including revenue, EBITDA and free cash flow growth. In fiscal 2019, CCC is expected to report revenue of approximately C$450M. On a pro-forma basis, TELUS International's 2019 combined annualized revenue will surpass C$1.75B and EBITDA will increase to approximately C$400M. The acquisition of CCC will be immediately revenue and EBITDA accretive to TELUS and TELUS International, as well as EBITDA margin accretive to TELUS International. Additionally, given the low capital intensity of the combined business, the transaction is also expected to support immediate free cash flow expansion. The acquisition of CCC will be financed from TELUS International non-recourse credit facilities and additional equity from TELUS Corporation and Baring Private Equity Asia. As part of the transaction, CCC's senior management will reinvest a significant portion of their equity ownership in CCC into TELUS International. TELUS Corporation's and BPEA's equity capital contributions are expected to be approximately C$165M and approximately C$90M, respectively. Following the close of the acquisition, TELUS Corporation will retain an approximate 62% interest in TELUS International. The acquisition is subject to customary closing conditions and regulatory approvals. Closing is expected to occur in the early part of the first quarter of 2020.

18:41 EST Baytex Energy names Mark Bly chairman - Baytex Energy announced the appointment of Mark Bly as Chairman. Bly joined the board in 2017 and in March 2019 was appointed Lead Independent Director and Chair of the Human Resources and Compensation Committee.

18:23 EST Mattel CEO: We are in the process of reducing our manufacturing footprint - In an interview on CNBC's Mad Money, Mattel CEO Ynon Kreiz said: We have been executing exactly as planned... Barbie is doing great, we've had eight consecutive quarters of growth... We've announced eight movie projects, including some with Warner Brothers, MGM and Paramount... We are in a better market position than average due to our product mix... We are seeing strong momentum in both the top and bottom lines.

18:05 EST MediciNova discloses additional analysis from MN-166 clinical trial in ALS - MediciNova announced that additional analyses of MediciNova's completed clinical trial of MN-166, or ibudilast, in ALS, or amyotrophic lateral sclerosis, which was conducted at Carolinas HealthCare System's Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute, will be presented on December 5th at the 30th International Symposium on ALS/MND in Perth, Australia. Highlights of the presentation, entitled "Interaction of ALS Progression and the Efficacy of MN-166" include the following: We evaluated the potential background factors of patients' characteristics that could reasonably predict both ALS disease progression and treatment efficacy. Regression Tree Analysis and Stepwise Regression Analysis were performed to determine which potential factors have an impact on the treatment effect of MN-166 as assessed by the ALSFRS-R score. The regression analyses determined that ALS history was a statistically significant factor affecting treatment effect. Correlational Analysis was conducted to analyze the correlation between ALS history and baseline ALSFRS-R score, and ALS history and disease progression, measured as change in ALSFRS-R score from baseline to end of treatment. A significant negative correlation was observed between ALS history and baseline ALSFRS-R scores in patients with ALS onset less than600 days prior to enrollment, but not in patients with ALS onset greater than600 days prior to enrollment. A significant positive correlation was observed between ALS history and ALS disease progression in the placebo group. With riluzole treatment only, greater disease progression was observed in short ALS history patients. No correlation was observed between ALS history and ALS disease progression in the MN-166 group, which was attributed to the treatment effect in short ALS history patients. The results of these analyses indicate that the efficacy of MN-166 is expected to be more robust in patients with a short ALS history.

17:56 EST Pershing Square raises Howard Hughes stake to 14.8% from 12.6% - In a regulatory filing, Pershing Square Capital Management raised its stake in Howard Hughes Corp. to 14.8%, which represents 6,384,239 shares. The firm previously reported an economic interest of 12.6% in Howard Hughes. According to the filing, Pershing Square said that Bill Ackman may engage in discussions with the company and its management and board of directors, other stodkholders and other interested parties that relate to the business, management, operations, assets, capitalization, financial condition, strategic plans, governance and board composition and the future of the company.

17:46 EST SPDR Gold Shares holdings fall to 888.57MT from 889.16MT - This is the lowest level of holdings since September 19th.

17:38 EST Planet Fitness enters into $300M accelerated share repurchase program - Planet Fitness (PLNT) has entered into a $300M accelerated share repurchase agreement with JPMorgan (JPM) Chase Bank, National Association. The company will acquire shares under the ASR Agreement as part of its $500M share repurchase authorization. As of December 4, before giving effect to the ASR Agreement, $500M remained available for share repurchases pursuant to the Share Repurchase Authorization. Pursuant to the terms of the ASR Agreement, the company will pay JP Morgan Chase $300M in cash and will initially receive approximately 3.3 million shares of the company's Class A common stock, which is approximately 80% of the shares of the company's Class A common stock it expects to repurchase under the ASR Agreement. The final settlement of the transaction under the ASR is expected to occur no later than 2Q20.

17:28 EST Allergan announces 'positive' Phase 3 trial results for Ubrogepant - Allergan announced that positive results from ACHIEVE I, a robust Phase 3 clinical trial evaluating the efficacy, safety and tolerability of ubrogepant, have been published in the December 5 issue of The New England Journal of Medicine, or NEJM. The data from this second published pivotal trial reinforced that the acute treatment of migraine with ubrogepant, compared with placebo, led to significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours with both the 50 mg and 100 mg doses. If FDA-approved, ubrogepant would be the first available and approved small molecule, oral calcitonin gene-related peptide receptor antagonist for the acute treatment of migraine.

17:01 EST Allena plans to re-engage with FDA over streamlining URIROX-2 - Allena Pharmaceuticals announced updates on its clinical development programs for reloxaliase, a potential first-in-class, non-absorbed, orally administered enzyme for the treatment of severe hyperoxaluria, and several initiatives to realign resources to support the continued development of reloxaliase for patients with enteric hyperoxaluria. Following positive topline results from URIROX-1 and further analysis of the data from the trial, Allena plans to re-engage with the FDA, with the request to discuss measures to potentially streamline its ongoing URIROX program through modifications to the adaptive URIROX-2 trial design. These enhancements could potentially include reducing the target enrollment in URIROX-2, conducting an earlier interim analysis of the data from URIROX-2, and modifying the requirements for filing for accelerated approval of the initial reloxaliase Biologics Licensing Application. The company expects to meet with the FDA in early 2020 and to provide an update on the final design and timing of the URIROX-2 study as it evolves. "We continue to be encouraged by the pivotal Phase 3 URIROX-1 results and are committed to advancing reloxaliase as the first potential approved treatment for patients with EH," said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. "Reloxaliase achieved its primary endpoint in URIROX-1, demonstrating a statistically significant and clinically meaningful reduction in urinary oxalate (UOx). Based on the positive feedback that we continue to receive from key opinion leaders and clinicians and the severity of the condition in our trial population, we are confident that reloxaliase has the potential to alter the treatment landscape for patients with EH, and offer treating physicians an important new tool for combating the toxic accumulation of excess oxalate in patients with gastrointestinal (GI) disorders. We look forward to initiating discussions with the FDA in the near-term, as we consider opportunities to streamline the URIROX-2 program and expeditiously deliver reloxaliase to patients."

16:37 EST ViacomCBS announces completion of merger of CBS, Viacom - ViacomCBS (VIACA, VIAC) announced the completion of the merger between CBS Corporation and Viacom. ViacomCBS Class A and Class B shares will begin trading on the Nasdaq Global Select Market on December 5 under the ticker symbols "VIACA" and "VIAC", respectively. ViacomCBS said it "will have an attractive growth outlook, be positioned to deliver beneficial cost and revenue synergies and generate substantial free cash flow. This will sustain significant investment in programming and innovation, as well as support ViacomCBS's commitment to a modest dividend payment. ViacomCBS will also benefit from a strong balance sheet, solid investment grade rating and a board and management team that are focused on creating shareholder value."

16:35 EST Verint trading resumes

16:34 EST Universal Health Realty increases quarterly dividend to 68.5c per share - Universal Health Realty announced that its board of trustees voted to increase the quarterly dividend by .5c and pay a dividend of 68.5c per share on December 31 to shareholders of record as of December 18.

16:30 EST Ecolab raises quarterly cash dividend 2% to 47c per share - The board of directors of Ecolab Inc. declared a 2% increase in the company's quarterly cash dividend to 47c per common share, to be paid January 15, 2020, to shareholders of record at the close of business on December 17, 2019. This increase results in a new indicated annual cash dividend of $1.88 per share in 2020 and represents Ecolab's 28th consecutive annual dividend rate increase.

16:26 EST Slack falls 4.2% after reporting Q3 results

16:23 EST Air Industries receives new contract awards totaling $18.2M - Air Industries Group announced that it has received major new contract awards totaling $18.2M, and potential follow-on orders for an additional $13.7M. Air Industries Machining Corporation, a unit of its Complex Machining Sector, received firm orders totaling approximately $11.9 million, including: An award of approximately $3.0 million for F-35 Joint Strike Fighter landing gear components, with deliveries beginning next year and continuing through 2021; An award of approximately $8.9 million for complete landing gear for the E2-D Hawkeye with deliveries beginning in 2021. The company has also been awarded exclusivity for an additional three years (2023 to 2025), covering additional product that may be ordered by our customer, worth an estimated $13.7 million. Sterling Engineering Corporation, its Turbine & Engine Sector, received firm orders during October and November totaling $6.3 million, these orders extend to 2023. Jet engine components totaled $2.4 million. Rotorcraft components totaled $3.9 million. These orders increase the company's eighteen-month firm and funded backlog to approximately $110 million dollars.

16:18 EST Elastic reports Q2 billings up 125.3M, up 41% from last year - Reports Q3 SaaS: revenue $20.6M, an increase of 106% year-over-year, or 114% on a constant currency basis. Calculated billings was $125.3M, an increase of 41% year-over-year, or 45% on a constant currency basis. Deferred revenue was $201.3M, an increase of 58% year-over-year.

16:18 EST Verint to repurchase up to $300M of common stock - Verint announced that its board of directors has authorized a new share repurchase program whereby we may repurchase up to $300 million of common stock over the period ending on February 1, 2021 (on or shortly before the planned business separation). Repurchases are expected to be financed with the proceeds of the first tranche of the Apax Funds investment and available cash, including possible borrowings under our revolving credit facility. We may utilize a number of different methods to effect the repurchases, including but not limited to, open market purchases and accelerated share repurchases, and some of the repurchases may be made through Rule 10b5-1 plans. The specific timing, price, and size of purchases will depend on prevailing stock prices, general market and economic conditions, and other considerations, including the amount of cash available in the U.S. and other potential uses of cash. The program may be extended, suspended or discontinued at any time without prior notice and does not obligate us to acquire any particular amount of common stock.

16:17 EST Verint to separate into two independent publicly traded companies - Verint Systems announced that its board of directors has unanimously approved proceeding with a plan to separate Verint into two independent companies: one of which will consist of its customer engagement business, and one of which will consist of its cyber intelligence business. Verint expects to complete the separation shortly after the end of Verint's next fiscal year ending January 31, 2021. Verint intends to implement the separation through a pro-rata distribution of common stock of a new entity that will hold the cyber intelligence business and expects the distribution to qualify as tax free to Verint shareholders for U.S. federal income tax purposes. The completion of the transaction is subject to certain customary conditions, including final approval of the Verint Board of Directors, receipt of tax opinions from counsel as well as rulings from the Internal Revenue Service and the Israeli Tax Authority with respect to tax treatment to Verint and its shareholders, and effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission. The separation is not expected to require a shareholder vote. The separation structure is subject to change based upon various tax and regulatory factors and there can be no assurance that any separation transaction will ultimately occur or, if one does occur, of its terms or timing. Funds advised by Apax Partners (the "Apax Funds"), a global private equity advisory firm, have agreed to invest up to $400 million in Verint, subject to customary closing conditions including the receipt of required regulatory clearances. The Apax Funds have significant experience in the software sector, including through previous investments in TriZetto, Plex Systems, RealPage, Sophos, Epicor and Exact Software. The investment will be made in the form of convertible preferred stock in two tranches of $200 million each. The first tranche is targeted to close in our first quarter ending April 30, 2020. The second tranche, conditioned on and expected to close shortly following the separation (expected shortly after the end of Verint's next fiscal year ending January 31, 2021), will be made into Verint, the entity holding the customer engagement business. Under the investment agreement, the Apax Funds will initially purchase $200 million of Series A convertible preferred stock with an initial conversion price of $53.50, representing a conversion premium of 17% percent over the volume-weighted average price of the Company's common stock over the 45 day period prior to the signing date. The Series A convertible preferred stock will not participate in the spin-off of the cyber intelligence business but will have its conversion price adjusted and will remain invested in the entity holding the customer engagement business. Shortly following the separation, the Apax Funds will purchase, subject to certain conditions, up to $200 million of Series B convertible preferred stock with an initial conversion price based on the volume-weighted average price of the Company's common stock over a 20 day period following the separation, subject to a collar on the minimum and maximum enterprise value of the company post separation. Both the Series A and Series B will have an initial dividend rate of 5.2% dropping to 4.0% over time. Assuming both the Series A and the Series B are issued on the expected timeframe and remain outstanding for 8.5 years from their respective dates of issuance, the average dividend rate on the combined investment will be approximately 4.5%. Following the closing of the Series A investment, the Apax Funds' ownership in Verint on an as-converted basis will be approximately 5%. Assuming completion of the Series B investment and the separation, the Apax Funds' ownership on an as-converted basis will be between 11.5% and 15.0%.

16:13 EST Principal Financial names Chris Littlefield as new General Counsel - Principal Financial Group Christopher Littlefield, former president and CEO of Fidelity & Guaranty Life Insurance Holdings, will join Principal as its new general counsel effective January 13, 2020. After 38 years with the Principal(R)=, current executive vice president, general counsel and secretary Karen Shaff, announced her intentions to retire on July 1, 2020.

16:10 EST Smartsheet reports Q3 dollar based net retention rate of 134% - The company: "Ended the quarter with 83,139 domain-based customers ; The number of all customers with annualized contract values of $5,000 or more grew to 8,421, an increase of 51% year over year; The number of all customers with ACV of $50,000 or more grew to 770, an increase of 114% year over year; The number of all customers with ACV of $100,000 or more grew to 279, an increase of 120% year over year; Average ACV per domain-based customer increased to $3,286, an increase of 48% year over year."

16:09 EST Brookline Bancorp announces $10M stock repurchase program - Brookline Bancorp announced that the Board of Directors has approved a stock repurchase program for the Company. The program authorizes the repurchase by the Company of up to $10M of its total outstanding shares of common stock over a period of twelve months commencing on January 1, 2020 and ending on December 31, 2020. The shares may be repurchased from time to time in the open market or negotiated transactions at prevailing market rates in accordance with federal securities laws.

16:08 EST Synopsys sees FY20 operating cash flow $800M-$825M

16:06 EST SemGroup shareholders approve merger with Energy Transfer LP - SemGroup Corporation (SEMG) announced its shareholders voted to approve the previously announced merger agreement whereby SemGroup will be acquired by Energy Transfer (ET) in a unit and cash transaction. At completion of the merger, SemGroup shareholders will receive $6.80 per share in cash and 0.7275 of an ET common unit for each SemGroup share, or approximately 40% cash and 60% equity. The merger was announced on September 16. The transaction is expected to close December 5.

16:02 EST NetApp gets California data center modernization contract, terms not stated - NetApp announced that Enterprise Networking Solutions, Inc which develops and deploys solutions to help organizations maximize their IT investments, has been awarded an exclusive three-year contract by the State of California Department of General Services to deliver NetApp's data center modernization and hybrid cloud infrastructure solutions to the State of California. For this contract, ENS-Inc serves as the sole provider of a complete catalog of all NetApp enterprise technology to the State of California, including data center equipment and associated data center hardware.

16:00 EST Aurinia Pharmaceuticals trading halted, news pending

15:25 EST Commission-free stock trading start-up Robinhood exceeds 10M accounts - In an earlier blog posting, the company said: "We're delighted to share that more than 10 million people have accounts on Robinhood. We believe participation is power. We founded this company to break down barriers to our financial system. To do that, we spent our earliest days holding customer research sessions, so we could better understand how to serve a new generation of investors. Rooted in this customer focus, we pioneered commission-free stock and ETF trading with no account minimums. And since then, we've added commission-free options trading, commission-free crypto trading through Robinhood Crypto, our premium offering Robinhood Gold, the Robinhood Snacks newsletter and podcast, and soon, a competitive interest rate on uninvested cash through your brokerage account." Publicly traded companies that may be impacted by this information include Interactive Brokers (IBKR), TD Ameritrade (AMTD), E-Trade (ETFC) and Charles Schwab (SCHW). Reference Link

15:23 EST Altisource Residential trading resumes

15:11 EST Herbalife Nutrition announces four new training centers throughout China - Earlier on Wednesday, Herbalife Nutrition announced the opening of its new training facility in Chengdu, China. Created as a venue for Company leaders to train and educate customers and distributors on nutrition and healthy meal preparation, the facility is the first of four opening across China by the end of 2020. The centers will also feature a glimpse into Herbalife Nutrition's history and evolution. "These centers are another example of the many ways Herbalife Nutrition positively impacts the community through good nutrition and education," said John DeSimone, co-president and Chief Strategic Officer, Herbalife Nutrition. "They offer a state-of-the-art training facility through a truly immersive experience helping people learn more about the Company's past, present and how they can be a part of our future." In China, Herbalife Nutrition opened its first factory in 1998. Since then, the Company has grown its presence and now has the Product Innovation Center in Shanghai, the first training center in Chengdu, the botanical ingredients center in Changsha and two production technology centers in Nanjing and Suzhou.

15:01 EST Stryker raises quarterly dividend 11% to 57.5c per share - Payable on January 31, 2020 to shareholders of record at the close of business on December 31, 2019.

14:37 EST Allakos trading resumes

14:28 EST Allakos halted for volatility after jumping 10% to $105.66

14:12 EST Classes 5-8 truck orders soften in November amid trade and tariff worries - ACT Research said in an earlier report: "Preliminary November data show that Classes 5-8 net order volumes were uniformly soft. Combined NA Classes 5-8 intake fell 15% m/m and 38% y/y in November on a nominal basis. Preliminary North America Class 8 net order data show the industry booked 17,500 units in November, down 20% from October, while Classes 5-7 orders fell 8% m/m, to 15,300 units. Complete industry data for November, including final order numbers, will be published by ACT Research in mid-December. ACT's State of the Industry: Classes 5-8 report provides a monthly look at the current production, sales, and general state of the on-road heavy and medium duty commercial vehicle markets in North America. It differentiates market indicators by Class 5, Classes 6-7 chassis and Class 8 trucks and tractors, detailing measures such as backlog, build, inventory, new orders, cancellations, net orders, and retail sales. Additionally, Class 5 and Classes 6-7 are segmented by trucks, buses, RVs, and step van configurations, while Class 8 is segmented by trucks and tractors with and without sleeper cabs. This report includes a six-month industry build plan, backlog timing analysis, historical data from 1996 to the present in spreadsheet format, and a ready-to-use graph package. A first-look at preliminary net orders is also published in conjunction with this report. "Preliminary November data show that Class 8 net orders failed to sustain October's encouraging start to the order season," said Tim Denoyer, ACT's Vice President and Senior Analyst. He continued, "The freight market downturn worsened in the past month and uncertainty surrounding trade and tariffs continue to weigh on truck buyers' psyches. With rising pressure on carrier profits from the combined impact of lower rates and the recent, rather sudden jump in insurance premia, recent events have not developed in the industry's favor." Denoyer concluded, "While private fleets continue to add capacity on the retail end, the market is increasingly heeding for-hire price signals and the stage is being set to right-size the fleet, bringing it closer to equilibrium with the work to be done." Publicly traded companies in the space include ArcBest (ARCB), J.B. Hunt (JBHT), Knight-Swift (KNX), Old Dominion (ODFL), Swift Transportation (SWFT), Werner (WERN), Paccar (PCAR), Navistar (NAV)and Cummins (CMI). Reference Link

13:57 EST FCC Chairman Pai announces plan to launch $9B 5G fund for rural America - Federal Communications Commission Chairman Ajit Pai announced that he intends to establish the 5G Fund, which would make up to $9B in Universal Service Fund support available to carriers to deploy advanced 5G mobile wireless services in rural America. This major investment in rural America would be allocated through a reverse auction and would target hard-to-serve areas with sparse populations and/or rugged terrain. The $9B Fund also would set aside at least $1B specifically for deployments facilitating precision agriculture needs. "5G has the potential to bring many benefits to American consumers and businesses, including wireless networks that are more responsive, more secure, and up to 100 times faster than today's 4G LTE networks. We want to make sure that rural Americans enjoy these benefits, just as residents of large urban areas will. In order to do that, the Universal Service Fund must be forward-looking and support the networks of tomorrow. Moreover, America's farms and ranches have unique wireless connectivity needs, as I've seen across the country. That's why I will move forward as quickly as possible to establish a 5G Fund that would bring next-generation 5G services to rural areas and would reserve some of that funding for 5G networks that promote precision agriculture. We must ensure that 5G narrows rather than widens the digital divide and that rural Americans receive the benefits that come from wireless innovation," said Chairman Pai. Mobile service providers working on building out 5G networks include Verizon (VZ), AT&T (T) and T-Mobile (TMUS), which is in the process of merging with Sprint (S). Suppliers of 5G networking gear include Nokia (NOK) and Ericsson (ERIC). Reference Link

13:39 EST Warren says Alphabet's Page still expected to testify before Congress - Senator Elizabeth Warren tweeted: "Congrats on the move, Larry Page! Quick reminder: We do still expect you to testify before Congress. And changing your title while staying on the board and retaining effective control of it will not exempt you from accountability." The presidential candidate included a link to a Bloomberg article about Google's co-founders Larry Page and Sergey Brin stepping down at Alphabet at the end of her tweet. Reference Link

13:30 EST Valaris calls Luminus' proposals 'value destructive' - Valaris confirmed that Luminus Management has stated that it intends to call an ordinary meeting of shareholders and nominate individuals to stand for election to the company's board of directors. Commenting on the announcement, the company stated in part: "The Valaris Board of Directors is committed to best-in-class corporate governance practices and the continued successful execution of our long-term strategy, reflecting the input received through our broad-based shareholder engagement program and underscoring our focus on enhancing value for all shareholders. As previously announced, the Board has implemented a refreshment and corporate governance action plan, which included evaluating the skills and experience of the directors on the Valaris Board. As a result of this evaluation, we recently announced: (1) the addition of Georges Lambert, former Partner and Senior Vice President of The Capital Group, and Frederick Arnold, the former Chief Financial Officer of Convergex Group, LLC, as new independent directors; (2) three directors stepping down; (3) a commitment to appoint an independent Chairman in 2020 at the end of the current Chairman's term; and (4) the formation of a Finance Committee of the Board of Directors to assist in the Board's oversight of the Company's capital structure and financial strategies. These actions have received universally positive feedback from our broader shareholder base...We have engaged extensively with Luminus over the past several months. As our conversations with Luminus progressed, it became clear that Luminus' proposals would significantly harm Valaris' financial profile and destroy shareholder value...We will continue to take actions to maintain our position as the leading offshore driller while implementing best-in-class corporate governance practices that align with the execution of our long-term strategy to enhance shareholder value."

13:05 EST Nintendo reports 'best week ever' in U.S. for Switch with over 830,000 sold - Over Thanksgiving week from Nov. 24 to Nov. 30, the Nintendo Switch and Nintendo Switch Lite systems sold a combined total of more than 830,000 units in the U.S., reported Nintendo, citing internal data. "This ranks as the single best week of U.S. sales in Nintendo Switch history. These results were bolstered in part by the recently introduced Nintendo Switch Lite system and a variety of Black Friday offers," the company stated in its press release reporting the sales figures.

13:01 EST Dr. Reddy's launches generic Velcade in U.S. - Earlier today, Dr. Reddy's Laboratorie announced the launch of Bortezomib for Injection 3.5 mg/vial, approved by the U.S. Food and Drug Administration, USFDA, via a 505(b)(2) new drug application, NDA, pathway for intravenous use only. "We're pleased to bring this product to market for the customers and patients who will benefit from this cost-efficient alternative in the marketplace," explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy's Laboratories. "This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio of products in the Hospital segment." Dr. Reddy's Bortezomib for Injection 3.5 mg/vial is for intravenous use only and is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

12:43 EST Wrap Technologies jumps after LAPD tests device - Wrap Technologies (WRTC) reported an article by the Los Angeles Times this morning highlighting the Los Angeles Police Department's, LAPD, decision to train its officers on the BolaWrap and deploy 200 devices in the field for 90 day pilot program beginning in January 2020. "LAPD is a forward-thinking agency known to be on the cutting edge of new technology," said Mike Rothans, Chief Operating Officer at Wrap Technologies and retired Assistant Sheriff from the Los Angeles County Sheriff's Department. "We are excited that after testing the BolaWrap for more than a year, they have decided to train several hundred officers in preparation of field deployment.""Considering the growing concern over police use of force and the issues police officers face in their encounters with individuals in a mental health crisis, police agencies across the U.S. and the world are seeing the value the BolaWrap brings. This device addresses those concerns in ways that create trust by dealing with people differently. It's a real paradigm shift of trying to restrain someone without hurting them." The fly notes that Axon Enterprise (AAXN) may be impacted by this news. Axon develops, manufactures, and sells conducted energy weapons, CEWs, worldwide. Shares of Wrap Technologies are up 6% or 30c to $5.35 per share in afternoon trading on Wednesday.

12:31 EST Chesapeake surges after arrangement of $1.5B term loan facility - Shares of oil and natural gas developer Chesapeake are surging on Wednesday after the company announced that it has consulted with JPMorgan and Morgan Stanley, among other firms, to assist with the arrangement of a $1.5B secured 4 1/2-year term loan facility. Chesapeake expects these transactions to improve its financial flexibility, as they will allow Brazos Valley and its subsidiaries to support Chesapeake's current and future debt. Shares of Chesapeake Energy are up 17% or 11c to 74c per share in afternoon trading on Wednesday.

12:17 EST Eldorado Resorts announces Missouri Gaming Commission approval for Caesars deal - Eldorado Resorts (ERI) announced that the company received approval from the Missouri Gaming Commission in connection with its pending acquisition of Caesars Entertainment (CZR), subject to customary conditions. The transaction is expected to be consummated in the first half of 2020 and remains subject to the receipt of all required regulatory approvals, and other closing conditions. On November 15, shareholders of both Eldorado and Caesars separately voted to approve certain actions in connection with the proposed merger, with over 99% of all votes cast in favor of the transaction, the company noted.

12:04 EST Tenable secures cloud workloads with Golden Amazon Machine Images pipeline - AWS re:Invent - Tenable, the Cyber Exposure company, announced the availability of a new, integrated offering to secure cloud workloads with Tenable.io and Golden Amazon Machine Images, AMIs, pipeline. This collaboration represents a critical step in ensuring that organizations of all sizes can build cybersecurity best practices directly into their cloud migration strategies. The Golden AMI pipeline provides users with an efficient way to mature their cloud strategies with standardized and consistent processes for validating the software configuration, hardening and security posture of machine images. Tenable.io assesses AMIs for vulnerabilities and exposures which are then deemed "golden," validating that they are verified and secured images which can be pushed to production and re-used by teams across the enterprise, ultimately helping customers by increasing the speed and security of development cycles. In addition, by using the existing AWS connector for Tenable.io, customers can automatically and continuously discover and track production assets to ensure all instances are known and assessed for exposures with every change. Customers can also leverage Tenable's Professional Services offering to optimize and streamline the creation and deployment of Golden AMIs. This ensures the process, from scripting to assessments, is fully, properly and quickly spun up in the cloud by Tenable security experts. "As a cloud-first company, we understand both the business benefits of operating in the cloud and the importance of building a solid cybersecurity foundation," said Renaud Deraison, co-founder and chief technology officer, Tenable. "AWS customers can now leverage Tenable.io, the number one SaaS platform in the industry for vulnerability and security configuration, to ensure their cloud instances are secure and ready to be deployed, ultimately reducing their cyber risk across dynamic cloud environments."

12:03 EST Peloton erases gains, shares now down 3% to $32.53

12:00 EST Britannia Bulk falls -10.7% - Britannia Bulk is down -10.7%, or -49c to $4.12.

12:00 EST Barnes & Noble Education falls -17.9% - Barnes & Noble Education is down -17.9%, or -86c to $3.94.

12:00 EST Valaris rises 13.5% - Valaris is up 13.5%, or 54c to $4.55.

11:59 EST Plex launches a free movie and TV streaming service - Plex, a client-server media player system and software suite, announced that, it started "streaming thousands of free movies, TV shows, extreme sports films, music documentaries, Bollywood musicals, and more. Some super familiar stuff (Hey there, Nic Cage! Looking good, Tom Cruise! You're totally Overboard, Goldie Hawn!) and super obscure stuff too (welcome to Plex, Squid Man!). All of this goodness is ready to go as soon as you open Plex. While there might be, oh, one or two other streaming services already out there , we're building on our decade of extreme passion for media to deliver the best experience possible, while also giving you the control and customization to stream it your way. So dip your toes in and give it a whirl! As with all the Plex content offerings, you can move the free movie source up and down your sidebar or even hide it forever-you're always in control of your own destiny, or at least your own interface," said the company earlier on Wednesday. Plex lets its users stream the content they create it over the web, and a choice of many devices. Plex supports all Apple products, Android devices, Roku devices, Amazon Fire devices, and some smarty televisions. Other publicly traded companies that may be impacted by this development include:Netflix (NFLX), Amazon (AMZN), Dish (DISH), Disney (DIS), Roku (ROKU), AT&T (T) and Apple (AAPL). Reference Link

11:01 EST BlackRock achieves $1B first close for GRP III fund - BlackRock Real Assets has achieved a $1B first close for its Global Renewable Power III fund with commitments from over 35 institutional investors in North America, Europe and Asia. BlackRock said in a statement that the record first close reflects strong investor demand for renewable power assets that can potentially generate attractive risk adjusted returns with low correlation to the economic cycle, and that align with their long-term sustainability goals.

10:53 EST Papa John's has made no changes to its pizza, new CEO says - Papa John's new CEO does not agree with its prior one. Last week, Papa John's ex-CEO and founder John Schnatter told a local news station, "I've had over 40 pizzas in the last 30 days, and it's not the same pizza. It's not the same product. It just doesn't taste as good. The way they're making the pizza is just not fundamental to what makes a Papa John's pizza." However, when appearing in an interview today on CNBC, the company's new CEO Rob Lynch said there have been no changes to the way Papa John's pizza is made. The company's shares are up 37c to $60.52 in morning trading.

10:38 EST Papa John's CEO says nothing has changed with way pizza is made - Rob Lynch is speaking on CNBC.

10:00 EST Britannia Bulk falls -8.2% - Britannia Bulk is down -8.2%, or -38c to $4.23.

10:00 EST Barnes & Noble Education falls -19.0% - Barnes & Noble Education is down -19.0%, or -91c to $3.89.

10:00 EST JetBlue up 2% in early trading to $19.17 - Contacts tell The Fly that conjecture is being circulated among traders that JetBlue cancelled from the Buckingham Airlines conference next week. The Fly has reached out to the company for comment on that rumor.

10:00 EST CooTek rises 14.3% - CooTek is up 14.3%, or 65c to $5.20.

09:51 EST Urovant Sciences Ltd trading halted, volatility trading pause

09:47 EST Instructure falls -9.4% - Instructure is down -9.4%, or -$4.98 to $47.98.

09:47 EST VelocityShares 3x Inv Natural Gas ETN rises 6.1% - VelocityShares 3x Inv Natural Gas ETN is up 6.1%, or $8.46 to $148.26.

09:47 EST Tata Motors rises 8.0% - Tata Motors is up 8.0%, or 88c to $11.82.

09:32 EST Bombardier announces agreement with GTAA to relocate Global final assembly - Bombardier announced that it has signed a long-term lease agreement with the Greater Toronto Airports Authority, or GTAA, to build its new Global Manufacturing Centre located at Toronto Pearson International Airport. With preliminary site work underway in Mississauga and first production activities set to begin in 2023, the facility will optimize final assembly operations for all Global business jets, including the industry flagship Global 7500 business jet, the company stated. Bombardier also confirmed it will continue to support the Downsview site with a multi-million-dollar contribution to the Downsview Aerospace Innovation and Research Consortium to develop a visionary aerospace hub for academic research and training activities.

09:32 EST SEI Investments renews strategic partnership with AGB - SEI announced the renewal of its strategic partnership with the Association of Governing Boards of Universities and Colleges, an organization centered on governance in higher education. AGB's membership boasts 1,300 boards, representing nearly 2,000 universities and institutionally-related foundations. Through this strategic partnership, SEI also maintains involvement in various educational forums throughout the year, including participation at AGB's Annual Foundation Leadership Forum.

09:16 EST Network-1 Technologies receives new U.S. patent - Network-1 Technologies announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,498,530. The claims in the newly issued patent are generally directed towards methods of communication between Machine-to-Machine modules and servers. The newly issued patent arises from a patent application contained in the M2M/IoT patent portfolio acquired by Network-1 in December 2017. The M2M/IoT Patent Portfolio relates to, among other things, the enabling technology for authenticating and using embedded SIM cards in next generation IoT, Machine-to-Machine, and other mobile devices, including smartphones, tablets and computers as well as automobiles. With this latest issuance, the M2M/IoT Patent Portfolio now includes twenty-four issued U.S. patents and six pending U.S. patent applications, plus seven additional pending non-U.S. patent applications. Network-1 anticipates further issuances of additional claims for the M2M/IoT Patent Portfolio.

09:09 EST Shineco enters preliminary processing sales framework contract with Shanxi Oasis - Shineco announced that the company, through its subsidiary SCHT, has entered into an approximately 82,348 acre hemp fiber preliminary processing sales framework contract with Shanxi Oasis Textile. SCHT is a biotechnology enterprise focusing on industrial hemp comprehensive utilization with RMB200M registered capital. The company holds 60% of the shares of SCHT and is the controlling shareholder of SCHT. SCHT is located in the Jinzhong Development Zone of Shanxi's Transition. The company plans to build an industrial chain of industrial hemp by applying the traditional local craftmanship. The total scale of the project is estimated to reach approximately 82,348 acres.The harvest of industrial hemp has been completed this year and the construction of the project is expected to be gradually completed in the next three years.

09:08 EST Expedia up 4% to $103.69 after resignation of CEO, CFO

09:05 EST Philips announces collaboration with Humana for Medicare Advantage members - Philips (PHG) announced a collaboration with Humana (HUM) to help improve care and health outcomes for select high-risk Medicare Advantage members. Through an integrated approach, Humana has implemented two programs that leverage Philips' medical alert services and remote member monitoring solutions to actively monitor at-risk Medicare Advantage members, encourage more timely interventions and improve care delivery. Philips connected care solutions will help Humana provide a seamless care experience by connecting services, analytics and devices to help increase patient engagement and access to care. Leveraging Philips' established solutions, Humana's care teams can have line-of-sight into members' wellbeing to help proactively deliver appropriate interventions.

09:04 EST MoneyGram expands P2P service with Visa Direct to Spain and Philippines - MoneyGram (MGI) announced the expansion of its debit card deposit service internationally which it launched in collaboration with Visa (V) through Visa's real-time push payments platform, Visa Direct. This service is now available to Spain and the Philippines. As a result of the launch, MoneyGram is the first company in the industry to enable cross-border transfers from the U.S. using Visa Direct. The company expects to launch the service to additional countries in the coming months. With Visa Direct, customers have the ability to send money in real time.

09:01 EST Zealand Pharma initiates Phase 3 dasiglucagon trial - Zealand Pharma announced that the second Phase 3 trial to evaluate dasiglucagon as a potential treatment option for children with congenital hyperinsulinism, or CHI, has been initiated. This Phase 3 trial will enroll up to 12 CHI children from the ages of seven days to one year who are dependent upon intravenous glucose infusions to maintain their plasma glucose levels. The aim of the trial is to evaluate the safety and efficacy of dasiglucagon treatment to reduce the intravenous glucose infusion rate, number of hypoglycemic events, and total amount of carbohydrate administered. An ongoing Phase 3 trial is evaluating the safety and efficacy of dasiglucagon versus current standard treatments to reduce the number of hypoglycemic events in up to 32 children with CHI age three months to 12 years. This trial has included 16 children so far, of which nine have finished and entered the long-term Phase 3 extension trial.

08:49 EST Campbell Soup management says FY20 will be 'year of stabilization'

08:41 EST Instructure trading resumes

08:39 EST WellCare selected by Kentucky's Medicaid managed care program - WellCare of Kentucky has been selected by the Kentucky Cabinet for Health and Family Services to continue serving the Commonwealth's Medicaid managed care program in all eight program regions. The new five-year contract is anticipated to begin on July 1, 2020. Under the new contract, WellCare will continue to coordinate medical, behavioral and dental health for eligible Medicaid recipients in the Temporary Assistance for Needy Families; State Children's Health Insurance Program; and Aged, Blind and Disabled programs. WellCare was also selected as the sole contractor for the Kentucky Supporting Kentucky Youth program. Under the program, WellCare will serve all children in Kentucky's foster care system, including former foster care youth, some children who have been adopted from foster care, as well as children dually committed to the Department of Juvenile Justice system, benefitting approximately 24,000 enrollees.

08:33 EST Instructure to be acquired by Thoma Bravo for $47.60 per share in cash, or $2B - Instructure announced that it has agreed to be acquired by Thoma Bravo, a leading private equity investment firm, in an all-cash transaction that values Instructure at an aggregate equity value of approximately $2B. As part of the terms of the agreement, Instructure stockholders will receive $47.60 in cash per share. The price per share represents an 18% premium to the company's 3-month volume-weighted average price as of October 27, the day prior to the company's third quarter earnings call at which it announced a strategic review for its Bridge business. The Instructure management team, led by CEO Dan Goldsmith, will continue to lead the company in their current roles. Thoma Bravo will support Instructure as it increases investment in education technology innovation and expands internationally. The members of Instructure's Board of Directors have unanimously approved the transaction and recommended that its stockholders approve the merger. A special meeting of Instructure's stockholders will be held as soon as practicable following the filing of a definitive proxy statement with the U.S. SEC and subsequent mailing to its stockholders. Instructure's headquarters will remain in Salt Lake City, Utah, with regional offices across the United States and abroad. Closing of the transaction is subject to approval by Instructure stockholders and certain regulatory and antitrust authorities and the satisfaction of customary closing conditions. The transaction is expected to close in the first quarter of 2020 and is not subject to a financing condition. Upon completion of the acquisition, Instructure will become wholly-owned by Thoma Bravo. The agreement includes a 35-day "go-shop" period expiring on January 8, 2020, which permits Instructure's Board of Directors and advisors to solicit alternative acquisition proposals from third parties. Instructure will have the right to terminate the merger agreement to enter into a superior proposal subject to the terms and conditions of the merger agreement. There can be no assurance that this "go-shop" will result in a superior proposal, and Instructure does not intend to disclose developments with respect to the solicitation process unless and until it determines such disclosure is appropriate or is otherwise required.

08:24 EST Cambrex trading halted, news dissemination

08:22 EST Anavex announces ANAVEX2-73 data at CTAD conference - Anavex announced late breaking oral communication at Clinical Trials On Alzheimer's Diseas, or CTAD. Interim two-year data from the Phase 2a ANAVEX2-73 extension study, with Alzheimer's disease patients followed for up to five years, will be presented at CTAD. FDA's Framework for Real World Evidence document released in December 2018 demonstrates how real world evidence can be incorporated into regulatory decision-making. This framework was applied to the study of ANAVEX2-73, a selective sigma-1 receptor agonist that was investigated in an open-label 57-week Phase 2a study of Alzheimer's Disease, or AD, patients showing a favourable safety profile and was further extended by 208 weeks. A hypothesis free data-driven analysis using Formal Concept Analysis Machine Learning as implemented in knowledge extraction and management software platform was used to identify exploratory efficacy and patient selection biomarkers including SIGMAR1 p.Q2P. The goal of this study was to evaluate the efficacy of ANAVEX2-73, measured by Mini Mental State Examination, or MMSE, and comparing treated patients with an external control AD cohort of patients from the Alzheimer's Disease Neuroimaging Initiative, or ADNI, database over a 104-week period. Individual patient-level data was obtained from the ADNI and DOD ADNI. ADNI is a longitudinal multicenter study designed to develop clinical, imaging, genetic, and biochemical biomarkers for the early detection and tracking of AD. A total of 1891 patients were followed in this study including 345 AD patients with available MMSE scores. Propensity score matching was applied using Linear Mixed Effects models including descriptors of age, sex, SIGMAR1 p.Q2P carrier status, APOE4 allele and MMSE at baseline to select patients with similar baseline characteristics and any confounding factors between AD patients in the Phase 2a ANAVEX2-73 cohort and AD patients from the ADNI control cohort. Change in MMSE score from baseline at week 104 of matched cohorts was assessed. It showed that ANAVEX2-73 high dose cohort had a significantly lower MMSE decline compared to the ADNI control cohort at week 104.

08:11 EST Sirius XM announces new creative partnership with U2 - SiriusXM announced a new creative partnership with U2 to launch U2X RADIO, which will include a dedicated SiriusXM channel and exclusive content available only to SiriusXM subscribers and Pandora listeners. The announcement was made by U2, live from The Joshua Tree Tour stage at the Saitama Super Arena in Tokyo, Japan, with a cut-in from frontman Bono to Howard Stern on his SiriusXM channel "Howard 100," which saw the tour's massive 200x40 ft screen light up with a video tribute to radio ahead of a live performance of the band's hit 'Elevation'. A simultaneous stream by U2 on Facebook Live allowed fans around the world to hear the news of U2X RADIO as it happened.

08:05 EST Trovagene reports data on onvansertib in Acute Myeloid LeukemiaAbbVie - Trovagene (TROV) announced new in-vitro and in-vivo data suggesting that onvansertib may provide a new therapeutic option for patients who develop resistance to frontline treatment with venetoclax. The data show that onvansertib, as a single agent, inhibits tumor growth in venetoclax - Abbvie's (ABV) Venclexta - resistant in-vitro and in-vivo models. Additionally, the data also demonstrate synergy with the combination of onvansertib and venetoclax, providing further support for the ability of onvansertib to rescue patients once they show signs of resistance to venetoclax. Currently, there are no viable treatment options for patients once they develop resistance to venetoclax. Onvansertib may represent a new therapeutic option to treat venetoclax-resistant AML and potentially increase progression-free and overall survival for these patients.

08:04 EST Ashford Hospitality sells Springhill Suites Jacksonville for $11.2M - Ashford Hospitality announced the sale of the 102-room SpringHill Suites Jacksonville in Jacksonville, Florida for $11.2M. The sales price, inclusive of buyer's estimated anticipated capex of $2.5M, represents a trailing twelve-month cap rate of 5.9% on net operating income and a 14.3x Hotel EBITDA multiple as of October 31. The hotel was unencumbered by debt, and the net proceeds of approximately $10.8M from the sale will be used for general corporate purposes. Based upon the 12-month period ended October 31, the hotel achieved an occupancy rate of 81% and Average Daily Rate of $118 resulting in a $95 RevPAR. This compares to the company's trailing 12-month RevPAR of $128 as of October 31.

08:03 EST McDonald's launches online merchandise shop called 'Golden Arches Unlimited' - McDonald's is launching "Golden Arches Unlimited," an online shop full of merchandise specifically designed for the McDonald's lover. For the first time, U.S. customers can access fun and functional items year-round that aren't available anywhere else. The lineup includes a rotating seasonal selection, starting with the winter collection which includes a warm beanie, festive ornaments and fun holiday sweater. There are more than 20 items available, from casual apparel to festive accessories.

07:39 EST Amarantus Bioscience subsidiary receives eltoprazine notice of allowance - Amarantus Bioscience announced that subsidiary Elto Pharma has received a notice of allowance from the European Patent Office, or EPO, covering the use of eltoprazine and eltoprazine in combination with a number of chemical compounds, including cannabidiol, or CBD, in the treatment of Parkinson's disease and Parkinson's disease levodopa-induced dyskinesia, or PD-LID. Once issued, the patent will protect the use of eltoprazine in the treatment of Parkinson's and PD-LID through 2034. Elto Pharma is focused on the development of eltoprazine as an oral formulation for the treatment of PD-LID, Adult ADHD and Agitation in Alzheimer's disease.

07:34 EST Aptose Biosciences appoints Rafael Bejar as CMO - Aptose Biosciences announced the appointment of Rafael Bejar to the position of senior VP, chief medical officer, or CMO, effective January 1, 2020. In his role as a member of the executive leadership team, Bejar will oversee global clinical development and regulatory initiatives for Aptose, as well as other research activities. Bejar is trained in internal medicine and board certified in oncology and hematology, with a special interest in hematologic malignancies and myelodysplastic syndrome, or MDS. Prior to joining Aptose, he served as associate professor of Clinical Medicine in the Division of Hematology and Oncology at University of California San Diego in the Moores Cancer Center, where he established an MDS Center of Excellence, which provides care, clinical trials and medical expertise in one center.

07:14 EST Gilat Satellite subsidiary awarded over $6M from DoD for GaN BUCs - Gilat Satellite announced that its subsidiary Wavestream received orders for over $6M from the U.S. Department of Defense, or DoD, for its GaN BUCs, to be supplied as the first award of a five-year base-period of potentially over $10M of deliveries to the DoD.

07:11 EST Omeros announces data from narsoplimab pivotal trial - Omeros announced positive data from its pivotal clinical trial of the company's novel investigational complement inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA, a frequently lethal complication of HSCT. These preliminary data were recently provided to FDA as part of the company's ongoing interactions with the Agency on the narsoplimab Biologics License Application, or BLA. All safety and efficacy endpoints - including the composite primary endpoint and the secondary endpoints - are agreed with FDA. The reported data support a strongly positive benefit-risk balance. The primary efficacy endpoint in this single-arm open-label trial of HSCT-TMA patients is the proportion of patients who achieve a highly rigorous set of response criteria that requires both improvement in HSCT-TMA laboratory markers and improvement in clinical status. Patients who did not fully meet these criteria were considered non-responders. The secondary endpoints include survival rates and change from baseline in HSCT-TMA laboratory markers. Consistent with the pre-specified statistical analysis plan for the trial, the primary and secondary endpoints are assessed for all patients who received at least one dose of narsoplimab and patients who received at least 4 weeks of narsoplimab dosing. Patients enrolled in this trial had a high expected mortality rate. In severe cases of HSCT-TMA, mortality can exceed 90 percent.

07:05 EST Akcea Therapeutics appoints Alex Howarth as COO - Akcea Therapeutics announced that Alex Howarth has joined the company as COO. In this role, Howarth will oversee a broad range of operational areas including corporate strategy, business development, management of stakeholder alliances, legal and compliance, as well as product supply chain. Howarth has more than 25 years of experience in healthcare and financial advisory roles at various companies. Prior to Akcea, Howarth served as president at Lycera Corp., a private biotechnology company developing small molecule medicines for autoimmune diseases and cancer.

07:02 EST Accelerate Diagnostics CEO Lawrence Mehren retiring, COO Jack Phillips succeeds - Accelerate Diagnostics CEO Lawrence Mehren will retire from the company. Jack Phillips, the company's COO, has been unanimously appointed by the board to the position, effective February 1, 2020. Mehren will support the transition process, remaining as a key advisor to the company through 2021. This move is the culmination of a succession plan initiated in 2018 by Mehren and the board to prepare the company for the next phase of commercial growth. Phillips has been COO since September 1. Prior to joining Accelerate Diagnostics, he was the President and CEO of Roche Diagnostics, North America, for nearly a decade. Mehren has been Accelerate Diagnostics' CEO since its restructuring in 2012.

07:00 EST Bristol-Myers receives FDA FDA Breakthrough Therapy Designation for ORENCIA - Bristol-Myers announced that the U.S. FDA has granted Breakthrough Therapy Designation for ORENCIA for the prevention of moderate to severe acute graft-versus-host disease in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of acute GvHD, a potentially life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and hematologic cancers.

06:54 EST Patterson-UTI reports an average of 119 drilling rigs operating in November

06:47 EST International Game extends private management agreement with Barbados Lottery - International Game announced that its subsidiary, IGT Global Services, has signed a 10-year extension to its existing agreement to provide its Private Management Lottery services to the four license holders and beneficiaries of The Barbados Lottery. The extension enables IGT to continue to provide its current private management lottery services.

06:31 EST 21Vianet announces $20M share repurchase program - 21Vianet announced that its board of directors has approved a share repurchase program to repurchase up to $20M worth of its American Depositary Shares, representing its Class A ordinary shares, during a 13-month period ending on December 31, 2020.

06:06 EST Tesla says Model X earned 'exact same overall score' as Model 3 from Euro NCAP - Tesla said in a blog post: "Model X made history when it became the first and only SUV to ever receive a 5-star safety rating in every category and sub-category from the U.S. National Highway Traffic Safety Administration. Today, we're excited to build on that legacy with the addition of a 5-star safety rating from the European New Car Assessment Programme, which evaluates a car's safety assistance features as well as its ability to protect adults, children and vulnerable road users. Model X's top performance and score in Euro NCAP testing is notable for several reasons: It earned the highest overall rating to date in the 2018/2019 protocol for the Large Off-Road class. It earned the exact same overall score as Model 3 - showing that our large SUV is just as safe as our smallest and most affordable sedan. Model X achieved the exact same Safety Assist score that Model 3 got earlier this year, which is the highest ever recorded Safety Assist score under Euro NCAP's current and most stringent protocol to date. And, these Model X tests were the first time an official safety rating organization has tested our new full self-driving computer. Model X achieved a near-perfect score in the Adult Occupant Protection category, scoring a full 8 out of 8 points on the Frontal Offset Deformable Barrier test, and 16 out of 16 possible points on the Side Impact tests." Reference Link

06:02 EST Canadian National and Teck Resources sign long-term rail shipping agreement - Canadian National (CNI) and Teck Resources (TECK) announced a long-term rail agreement for shipping of steelmaking coal from Teck's four B.C. operations between Kamloops and Neptune Terminals, and other west coast ports. The agreement runs from April 2021 to December 2026, and will enable Teck to significantly increase shipment volumes through an expanded Neptune Terminals. The agreement also provides for investments by CN of more than $125M to enhance rail infrastructure and support increased shipment volumes to Neptune. The terms of this agreement are confidential.

05:58 EST KBR awarded contract for ammonia synthesis technology from Wuhuan Engineering - KBR has secured a contract for its ammonia synthesis technology from Wuhuan Engineering, a leading Chinese EPC Contractor, for the Talcher fertilizer unit as part of a benchmark coal-to-urea project in India. Under the terms of the contract, KBR will provide License and Basic Engineering Design, or LBED, catalyst, and proprietary process equipment for the plant, based on KBR's highly efficient ammonia synthesis technology. The project is part of the Government of India's efforts to increase domestic urea capacity for fertilizer production, reducing India's reliance on imported urea and fertilizer. At present, there are no operational coal-to-urea plants in India.