Stockwinners Market Radar for December 30, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:59 EST Ecology & Environment trading halted, pending information request

19:12 EST Microsoft says North Korea-linked cyberattackers stole sensitive information - Microsoft said in a blog post that on December 27, a U.S. district court unsealed documents detailing work Microsoft has performed to disrupt cyberattacks from a threat group the company calls Thallium, which is believed to operate from North Korea. Microsoft said its court case against Thallium, filed in the U.S. District Court for the Eastern District of Virginia, resulted in a court order enabling Microsoft to take control of 50 domains that the group uses to conduct its operations. With this action, the sites can no longer be used to execute attacks. Microsoft's Digital Crimes Unit (DCU) and the Microsoft Threat Intelligence Center have been tracking and gathering information on Thallium, monitoring the group's activities to establish and operate a network of websites, domains and internet-connected computers. This network was used to target victims and then compromise their online accounts, infect their computers, compromise the security of their networks and steal sensitive information. Based on victim information, the targets included government employees, think tanks, university staff members, members of organizations focused on world peace and human rights, and individuals that work on nuclear proliferation issues. Most targets were based in the U.S., as well as Japan and South Korea, Microsoft said.

18:37 EST BrightSphere CEO buys 50K shares of common stock - In a regulatory filing, BrightSphere disclosed that its CEO Guang Yang bought 50K shares of common stock on December 27th-December 30th. The total transaction size was $507K.

17:42 EST Meritor up 9.3% at $25.49 after entering S&P SmallCap 600 index effective 1/6

17:33 EST NW Natural files Oregon general rate case - Northwest Natural Gas Company, dba NW Natural, a wholly owned subsidiary of Northwest Natural Holding Company, filed for a general rate increase with the Public Utility Commission of Oregon. The filing would result in a net revenue increase of $71.4 million to recover costs associated with investments to strengthen and reinforce the natural gas system, provide necessary system maintenance and operational resiliency, and technology upgrades. If approved as filed, the typical residential customer using 53 therms per month would see an average monthly bill increase of about $6.43. A commercial customer using 242 therms a month would see an average monthly bill increase of about $25.40. NW Natural's request will not affect customer bills for the 2019-2020 winter season. The filing will be reviewed by the OPUC and other stakeholders in a process that could take up to 10 months. New rates are expected to be effective Nov. 1, 2020.

17:29 EST Aecom awarded $101M Army contract modification - Aecom was awarded a $101M modification to contract for enhanced army global logistics enterprise army prepositioned stocks-5 supply and transportation logistics support services. Work will be performed in Camp Arifjan, Kuwait; and Doha, Qatar, with an estimated completion date of January 2, 2021. FY20 operations and maintenance, Army funds in the amount of $48.03M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:22 EST NexPoint Residential to replace Avon in the S&P SmallCap 600 at open on 1/6 - NexPoint Residential Trust (NXRT) will replace Avon Products (AVP) in the S&P SmallCap 600 effective prior to the open of trading on Monday, January 6. Natura & Co. Holding is acquiring Avon Products in a deal expected to be completed soon pending final conditions.

17:19 EST Core Laboratories cuts Q4 view, reduces dividend - Core Laboratories announced revised guidance from continuing operations for the fourth quarter of 2019, initial first quarter 2020 guidance and a reduction of its future quarterly dividend. The decline in U.S. onshore activity has proven to be more pronounced than originally forecast in Core Lab's third quarter earnings release on 23 October. The U.S. rig count quarter-to-date is down approximately 11%, with U.S. completion activity tracking downward over 20%, primarily affecting Core's Production Enhancement segment. In addition, client discussions required to advance large international and offshore projects have progressed slower than expected. These developments have negatively impacted the fourth quarter of 2019 financial results for Core's Reservoir Description segment.

16:32 EST Recycling Asset declares initial liquidating distribution of $1.02 per share - Recycling Asset Holdings, Inc, formerly known as Industrial Services of America, Inc., declared an initial liquidating distribution of $1.02 per share payable on January 14, 2020 to shareholders of record as of January 13, 2020. The company formally changed its name to Recycling Asset Holdings, Inc. as of December 27, 2019. On December 16, 2019, the company announced that it had closed on the sale transaction contemplated by its previously announced definitive asset purchase agreement with River Metals Recycling LLC, pursuant to which River Metals has acquired substantially all of the assets of the company and its wholly-owned subsidiaries and assumed certain liabilities of the company and its wholly-owned subsidiaries. As previously announced, following completion of the Transaction, the company has begun dissolution. Today's announced declaration is the initial liquidating distribution amount as determined by the company's board of directors. Additional monies may be distributed over time based on cash available, after reflecting any reserve for future contingent liabilities, operating costs and any other uses of cash. The company intends to communicate future distribution amounts, if any, to shareholders as more information related to future contingencies, operating costs and other uses of cash becomes available. The company will close its transfer books on the Final Record Date.

16:31 EST Amerco CEO buys 1,910 shares of common stock - In a regulatory filing, Amerco disclosed that its CEO Edward Shoen bought 1,910 shares of common on stock on December 27th. The total transaction size was $713K.

16:18 EST Urovant Sciences submits vibegron NDA to FDA - Urovant Sciences announced that it has submitted a new drug application, or NDA, to the FDA seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder, or OAB, with symptoms of urge urinary incontinence, urgency and urinary frequency. The NDA for vibegron is supported by a clinical development program, which included over 4,000 patients with OAB. In a pivotal efficacy and safety study, once-daily 75mg vibegron met all primary and key secondary efficacy endpoints, and demonstrated a favorable safety profile.

16:14 EST SunPower sees 3% of company's global workforce to exit as part of restructuring - In a regulatory filing, SunPower reported that on December 27 the company adopted a restructuring plan to realign and optimize workforce requirements in light of recent changes to its business, including the previously announced planned spin-off of Maxeon Solar Technologies. In connection with the restructuring plan, which includes actions implemented in the fourth quarter of 2019 and is expected to be completed by mid-2023, the company expects between 145 and 160 non-manufacturing employees, representing approximately 3% of the company's global workforce, to exit the company over a period of approximately 12 to 18 months. Between 65 and 70 of these employees in the SunPower Technologies business unit and corporate have largely been informed and are expected to exit the company following the spin-off and completion of transition services. As the SunPower Energy Services business unit hones its focus on distributed generation, storage, and energy services, 80 to 90 employees exited or are expected to exit the company during the fourth fiscal quarter of 2019 and the first half of 2020. The company expects to incur restructuring charges totaling approximately $16M-$22M, consisting primarily of severance benefits of between $8M-$11M and retention benefits of between $8M-$11M, primarily associated with the retention of employees impacted by the spin-off transaction and certain key research and development employees. A substantial portion of such charges have been and are expected to be incurred in the fourth quarter of fiscal 2019 and the first quarter of fiscal 2020, and the company expects between $14M-$19M of the charges to be cash, the filing stated.

16:07 EST Great Lakes Dredge announces $83M in dredging awards - Great Lakes Dredge & Dock Corporation announced the receipt of several major dredging awards totaling $83M. The awarded work includes: Charlotte/Sarasota Regional Beach Project, $30.5M; South Atlantic Region Harbor Dredging, $13.9M; Chester, Pennsylvania Modification Project, $13.7M; Hunting Island State Park Project, $11.4M; and Tybee Island Shore Protection Project, $13.8M.

16:04 EST Bank OZK names Carmen McClennon as Chief Retail Banking Officer - Bank OZK has promoted Carmen McClennon to Chief Retail Banking Officer, a newly created role. McClennon will lead the ongoing transformation of Bank OZK's retail banking sales, service and delivery. Her responsibilities include oversight of digital banking, customer care centers, branch business development and administration, marketing, public relations and corporate communications. McClennon joined Bank OZK in 2019 after serving for nearly two decades in consumer banking leadership roles in Canada and the U.S

15:40 EST Crane in pact to buy Circor's Instrumentation & Sampling business for $172M - Earlier on Monday, Crane (CR) confirmed it was entering into a definitive agreement, dated December 23,to acquire CIRCOR International's (CIR) Instrumentation & Sampling Business for $172M million on a cash-free and debt-free basis, subject to a working capital adjustment. For the full year ended December 31, 2018, I&S generated $83M in revenue with operating income margin of 19%. I&S manufactures valves, fittings, regulators and sampling systems serving chemical, refining, upstream oil and gas, and industrial end markets.

15:05 EST CenturyLink says Michael Glenn to succeed Perry as chairman - Earlier on Monday, CenturyLink announced that Glen F. Post, III has decided not to stand for re-election at the company's 2020 Annual Shareholder Meeting. "After 34 years of service as a CenturyLink director, I have decided to retire from the Board," Post said. "I leave with a great sense of confidence in Jeff and our leadership team, of pride in our accomplishments together and a real optimism for our future. I am honored to have worked with so many great people to make it so. I will continue to closely follow the company and I encourage our employees to keep their feet firmly grounded in our Unifying Principles of honesty, integrity and fairness as they continue to push this great company forward." In addition to Post's retirement from the Board, current non-executive Board Chairman Harvey Perry will retire effective May 2020 under the Company's director retirement policy. Upon Perry's retirement, T. Michael Glenn will assume the position of Chairman of the Board. Current Vice Chairman Bruce Hanks will continue to serve in that role. The Company also announced today that it has appointed Hal Jones to its Board of Directors, effective Jan. 1, 2020. Jones was recommended to the Board by Southeastern Asset Management. With his election, the Board will comprise 14 members until the 2020 Annual Shareholder Meeting, at which point the Board intends to put forth a slate of 11 directors, 10 of whom will be independent and several of whom will have joined since 2015.

14:51 EST Geo Group announces contract with U.S. Marshals Service - Earlier today, the GEO Group announced that GEO Secure Services has signed a new managed-only contract with the U.S. Marshals Service for the government-owned, 512-bed El Centro Service Processing Center in California. The contract will have a term of 8 years and 9 months, inclusive of option periods, effective December 23. The contract is expected to generate approximately $29M in annualized revenues for GEO and create more than 240 full-time jobs. "We're pleased to have been able to build on our long-standing partnership with the U.S. Marshals Service to help the agency meet its need for bed space and quality management services in California," said George C. Zoley, GEO's Chairman and Chief Executive Officer.

14:24 EST Ford says reservations 'officially full' for first edition of Mustang Mach-E - Reservations for the First Edition of the Mustang Mach-E are "officially full," announced Ford (F), which added that other models like the Premium edition and the GT are still available for pre-order. In announcing the reservation milestone, Ford also noted that more than 80% of U.S. customers are reserving Mach-E with an Extended Range Battery, about 55% are opting for all-wheel drive and "more than a quarter of all reservations are coming from California." The upcoming Mustang Mach-E will compete with electric vehicles offered by Tesla (TSLA) and others. Reference Link

14:09 EST Raytheon confirms $768M award from U.S. Air Force - Raytheon announced Raytheon Missile Systems Co. was awarded a $768,283,907 non-competitive fixed-price incentive contract for Advanced Medium Range Air-to-Air Missile Production Lot 33, as announced by the Department of Defense on December 27. This contract provides for the production of the AMRAAM missiles, captive air training missiles, guidance sections, AMRAAM telemetry system, spares and other production engineering support hardware. Work will be performed in Tucson, Arizona, with an expected completion date of Feb. 28, 2023. This contract involves unclassified foreign military sales to Australia, Belgium, Canada, Denmark, Indonesia, Japan, Kuwait, Morocco, Netherlands, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey and United Kingdom, which accounts for 47% of the contract value.

14:06 EST Bluerock Residential announces $50M share repurchase - Bluerock Residential Growth REIT announced that its Board of Directors has authorized plans for the repurchase of an aggregate of up to $50M of its outstanding shares of Class A common stock.

13:12 EST Eli Lilly announces patent lawsuit ruling in its favor - Eli Lilly and Company (LLY) announced that the U.S. District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta vitamin regimen patent would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent's expiration in May 2022. The ruling came in the case of Eli Lilly and Company v. Apotex Inc. "We are pleased with today's District Court ruling finding the Alimta vitamin regimen patent would be infringed by the competitor's proposed products," said Michael J. Harrington, Lilly's seniorVP and general counsel. "Lilly's extensive research to discover the Alimta vitamin regimen patent deserves intellectual property protection. We depend on strong and effective intellectual property protection to support our investment in the next generation of breakthrough medicines." On August 9, the U.S. Court of Appeals for the Federal Circuit Court ruled in favor of Lilly in appeals by Dr. Reddy's Laboratories (RDY) and. Hospira, affirming the June 2018 district court's decisions finding infringement of Lilly's patent under the doctrine of equivalents. Today's ruling means Apotex will be prevented from launching its alternative salt form of pemetrexed until the patent expires. Lilly expects Apotex to appeal.

12:35 EST Nestle completes CHF20B buyback, will start new buyback program of up to CHF20B - Nestle announced that it has completed its 20B share buyback program initiated on July 4, 2017. Since July 4, 2017, Nestle has repurchased 225,186,059 of its shares for a total of CHF20B at an average purchase price per share of CHF88.82. A total of 136,160,000 repurchased shares were cancelled by the Annual General Meetings held on April 12, 2018 and on April 11, 2019. As a result, the share capital of Nestle was reduced to currently CHF297,600,000. The Annual General Meeting 2020 of Nestle will decide upon the cancellation of the remaining 89,026,059 repurchased shares. Nestle will start a new share buyback program of up to CHF20B as announced on October 17, 2019. Nestle plans to commence repurchases on or after January 3, 2020. The new share buyback program shall be completed by the end of December 2022. Concurrently with this press release, Nestle has published the details of the program in a buyback notice. The volume of monthly share buybacks will depend on market conditions. Should any extraordinary dividend payments or sizeable acquisitions take place during this period, the amount of the share buyback will be reduced accordingly.

11:11 EST Gemphire Therapeutics sees NeuroBo Pharmaceuticals merger closing on Dec. 30 - Gemphire Therapeutics (GEMP) announced that its pending merger with NeuroBo Pharmaceuticals is currently expected to close after market hours today, Monday, December 30, subject to satisfaction or waiver of all closing conditions. As previously announced, Gemphire's stockholders voted to approve the proposals required to complete the merger transaction. In connection with these approvals, the board of directors of Gemphire has approved a reverse stock split of Gemphire's common stock at a ratio of one new share for every 25 shares outstanding, which is expected to become effective immediately prior to the consummation of the merger. Immediately following the closing, the combined company will be renamed "NeuroBo Pharmaceuticals, Inc.", and is expected to begin trading on The Nasdaq Capital Market on a post-reverse stock split basis under the new ticker symbol "NRBO" on Tuesday, December 31.

10:02 EST Blink Charging reports approval of BIRD match-funding for DC project - Blink Charging announced the approval of the Israel-U.S. Binational Industrial Research and Development, or "BIRD," Energy Program's match-funding for the Blink and Chakratec project for DC fast-charging solutions, "Boosting EV Charging through Energy Storage System." The BIRD Energy Program is funded by the U.S. Department of Energy and Israel's Ministry of Energy together with the Israel Innovation Authority. Blink Charging is partnering with Chakratec, an Israeli eMobility company, to "bring a robust DC fast charging solution to the United States which can be deployed virtually anywhere, regardless of the location's existing power grid capabilities," the company stated.

10:00 EST Maxar Technologies rises 19.7% - Maxar Technologies is up 19.7%, or $2.82 to $17.11.

09:52 EST Great Panther announces $10M concentrate prepayment with IXM Group - Great Panther announces that its wholly owned subsidiary, Minera Mexicana el Rosario, S.A. de C.V., has entered into a $10M concentrate prepayment agreement with the IXM Group. MMR wholly owns and operates the company's Mexican mining operations. In consideration of an off-take agreement with a subsidiary of IXM at market-based commercial terms for 100% of the gold-silver concentrates produced from the Guanajuato Mine Complex in 2020 and 2021, IXM has agreed to advance a $10M prepayment to MMR on December 30, 2019. The prepayment will be repaid on December 31, 2020 and will bear interest at an annual rate of 3-month USD LIBOR plus 5%. Great Panther has issued a guarantee to IXM with respect to the prepayment. There is no hedging of the price of gold or silver associated with the off-take or prepayment agreement. "We are pleased to be partnering with IXM in Mexico for our GMC concentrates over the next two years," stated Jeffrey Mason, Interim President and CEO. "Securing the sale of this off-take at competitive market terms, while strengthening our balance sheet with $10M at an attractive cost of capital, positions us well to achieve our strategic objectives as we move into 2020."

09:47 EST Shinhan Financial falls -4.3% - Shinhan Financial is down -4.3%, or -$1.72 to $37.86.

09:47 EST Rite Aid falls -7.5% - Rite Aid is down -7.5%, or -$1.53 to $18.77.

09:47 EST Maxar Technologies rises 14.4% - Maxar Technologies is up 14.4%, or $2.06 to $16.35.

09:31 EST Tech Data says HSR Act waiting period for merger expired on Dec. 26 - In a regulatory filing, Tech Data (TECD) disclosed that at 11:59 p.m., Eastern time, on December 26, 2019, the waiting period with respect to the premerger notification and report form under the HSR Act expired. The expiration of the waiting period under the HSR Act satisfies a condition to the closing of the merger with Tiger Midco, the company stated. The closing of the merger remains subject to other customary closing conditions, including the approval of the company's stockholders and the receipt of certain other required regulatory approvals. As previously announced on November 27, Tech Data entered into an amendment to its previously announced definitive agreement in which Tiger Midco, an affiliate of funds managed by affiliates of Apollo Global Management (APO), which will acquire all of the outstanding shares of Tech Data common stock.

09:09 EST Valaris receives $200M cash payment from arbitration proceedings - Valaris announced that it has received a $200M cash payment upon the conclusion of previously disclosed arbitration proceeding. As previously disclosed, an arbitration tribunal awarded the company $180M in damages, in addition to the right to claim interest and costs, in relation to proceedings the company brought against Samsung Heavy Industries, or SHI, for losses incurred in connection with the DS-5 drilling services agreement with Petrobras. The English High Court recently denied the parties' applications for leave to appeal the tribunal's $180M damages award. Following this decision, the parties reached an agreement and SHI has paid Valaris $200M in cash. This payment, along with the previously disclosed settlement and normalization of its business relationship with Petrobras, concludes the company's dispute surrounding the DS-5 drillship.

09:06 EST Alternus Energy acquires Zonepark Rilland, 11.75MW solar plant for EUR10.5M - Alternus Energy announced the acquisition of Zonepark Rilland B.V. and its 11.75 MW ground-mounted solar photovoltaic power plant in Rilland, the Netherlands, from Cooperatie Unisun Energy U.A. for EUR$10.5M or approximately $11.8M. Rilland becomes ALTN's largest individual operational Solar PV park and enjoys a 15-year government counterparty 'Feed-in-Tariff' contract at fixed sales prices, in addition to a Power Purchase Agreement with a local energy operator. The combined contracts provide long-term predictable positive cash flows to Alternus and as the park is already operational it will be immediately revenue and income accretive to Alternus. Based on current energy production Rilland is expected to add approximately $1.4M in annual revenues for at least 15 years at average 75% gross margins. The acquisition of the Rilland park brings group contracted recurring revenues from operational parks to over $5.7M annually, over twice the revenues set to be recorded for 2019. Once all currently owned projects become operational, annual recurring revenues are expected to be over $7.3M from existing assets. The Rilland park purchase price, which may change as a result of a working capital adjustment and earn-out of up to EUR$0.5M depending on the future performance, includes assumption of a third-party senior bank debt facility in the amount of approximately EUR$7.2M. Alternus funded EUR$1.85M of the purchase price through the issuance of a EUR$2.15M bond issued to a leading European Renewable Energy Fund. Additionally, ALTN issued a EUR$1.7M loan to Unisun which is due by January 31, 2020.

09:02 EST Aesthetic Medical announces opening of two satellite clinics - Aesthetic Medical International Holdings announced the openings of two new satellite clinics - Fenghua Pengai Aesthetic Clinic and Deqing Pengai Aesthetic Clinic. The Company holds the majority interest of both new satellite clinics. Fenghua Pengai Aesthetic Clinic is located at Fenghua District, Ningbo City, Zhejiang Province, with floor space of 263 square meters and Deqing Pengai Aesthetic Clinic is located at Deqing County, Huzhou City, Zhejiang Province, with floor space of 130 square meters.

08:44 EST Cellular Biomedicine engages independent advisors in review of alternatives - Cellular Biomedicine announced that the special committee of its board of directors has retained Jefferies Group as its independent financial advisor and White & Case LLP as its independent legal advisor. The special committee was formed to evaluate strategic alternatives for CBMG, including the preliminary non-binding proposal letter, dated November 11, submitted by a consortium led by Bizuo Liu, the CEO of CBMG, certain other senior management members of CBMG, Hillhouse Bio Holdings and TF Capital Ranok. and also including Dangdai International and Mission Right, wherein the consortium has proposed to acquire all outstanding shares of common stock of CBMG for US$19.50 per share in cash.

08:38 EST Digital Ally announces patent for capturing vehicle identification markings - Digital Ally announced the soon to be addition of U.S. Patent No. 10,521,675 to the Company's patent portfolio. The '675 Patent is the first of its kind for the Company, allowing the software from the recording video cameras to scan film frame by frame to capture and store legible vehicle markings, such as license plate characters. The '675 Patent will be useful for law enforcement officers when conducting traffic stops and especially at nightfall when objects may be obscured by challenging lighting conditions and interfere with the camera's ability to capture legible markings or characters. When a recording is activated by various triggers the recording camera system will initiate two base scans, considering ambient light levels, light gains, shutter speed and white balance. If vehicle markings are legibly captured, the system will automatically store and upload the frame in the Company's back-office solution for the law enforcement agency's use.

08:35 EST Pivotal Software trading halted, news dissemination

08:34 EST Auris Medical forms subsidiary for projects in tinnitus, hearing loss - Auris Medical Holding announced the formation of a new subsidiary, Zilentin Ltd., to bundle its development projects for the treatment of tinnitus and hearing loss in a separate entity. Upon completion of the transfers from other Group companies, Zilentin AG shall own all tangible and intangible assets related to the development of tinnitus therapeutics and hearing loss therapeutics. Zilentin Ltd. is domiciled in Zug, Switzerland.

08:32 EST Everi Holdings acquires assets from Micro Gaming Technologies - Everi Holdings announced that its wholly owned subsidiary Everi Payments Inc. has acquired certain strategic assets of Micro Gaming Technologies, a privately owned provider of self-service casino loyalty and marketing products and promotional tools and apps. The acquisition also provides Everi with a portfolio of customer locations where MGT's solutions are currently installed, including at properties of many key Everi customers. Under the terms of the transaction, Everi acquired certain assets of MGT for an initial payment at the time of closing of $15M, with a further $5M to be paid April 1, 2020 and $5M on December 24, 2021. Everi expects to fund the acquisition from existing cash on hand and future cash flow.

08:10 EST Hemp, Inc. announces support of USDA's new insurance option for hemp - Hemp announced its support for the U.S. Department of Agriculture's new crop insurance option for hemp growers in select counties of 21 states in 2020. The insurance program will provide Actual Production History coverage under 508(h) Multi-Peril Crop Insurance. The MPCI coverage is for hemp grown for grain, fiber, and CBD oil for the 2020 crop year. This offering comes in addition to the Whole-Farm Revenue Protection coverage program available to hemp growers that was announced earlier this year. This new pilot insurance program is open to eligible producers in certain counties in Alabama, California, Colorado, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, Montana, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Tennessee, Virginia, and Wisconsin. Additionally, beginning with the 2021 crop year, hemp will be insurable under the Nursery crop insurance program and the Nursery Value Select pilot crop insurance program. Hemp will be insurable if it is grown in containers and in accordance with federal regulations, any applicable state or tribal laws, and terms of the crop insurance policy.

08:08 EST AerCap signs agreement with AirSial to lease three Airbus A320 aircraft - AerCap (AER) announced it has signed an agreement with AirSial Limited, a privately-owned Pakistani startup airline, for the lease of three used Airbus (EADSY) A320 aircraft. The aircraft are scheduled to deliver in Q2 of 2020 and will be the first aircraft to be delivered to the airline.

08:06 EST Bombardier renews operations, maintenance contract for AirTrain JFK - Bombardier Transportation announced that it renewed a contract with the Port Authority of New York and New Jersey to provide operations and maintenance services for the Authority's automated transit system at John F. Kennedy International Airport in New York. The contract is valued at approximately $309M and covers a period of five years. Bombardier's scope of work under the contract includes: 24-hour train operations and passenger assistance; maintenance of the vehicle fleet; maintenance of the tracks and power supply and signalling systems; and maintenance of all facilities on the system such as stations and platforms.

08:04 EST Principia Biopharma expects final data for Phase 3 PEGASUS trial 2H21 - Principia Biopharma announced updated anticipated timing for final results in its ongoing pivotal Phase 3 clinical trial of PRN1008 data in patients with pemphigus, as well as complete response rates from its Phase 2 Part B open-label trial. "We are delighted to see the interest in our Phase 3 PEGASUS trial and through the hard work of our investigators, study coordinators and our own clinical team, we believe the accelerated enrollment timelines now project us to have final data in the second half of 2021 as opposed to the first half of 2022," said Dolca Thomas, MD, Principia's CMO. "And we are pleased to see that the complete response rate in the Phase 2 Part B trial was 40 percent despite most patients being initially treated at a sub-therapeutic dose 400 mg once daily." Among the 15 patients dosed in Part B of the Phase 2 trial, nine achieved the primary endpoint of control of disease activity by week four on low dose corticosteroids. 12 of 15 patients achieved CDA by week 12. Nine of the 15 patients have achieved a PDAI score of 1 or 0. Safety of PRN1008 is consistent with Phase 2 Part A trial and has been well-tolerated in Part B with no treatment related serious adverse event reported.

08:02 EST Jazz Pharmaceuticals enrolls first patient in JZP-458 study - Jazz Pharmaceuticals announced that the first patient has been enrolled in the pivotal Phase 2/3 clinical study for JZP-458, a recombinant Erwinia asparaginase molecule that uses a novel Pseudomonas fluorescens expression platform. The study, conducted in collaboration with the Children's Oncology Group, or COG, is evaluating JZP-458 as a potential treatment for pediatric and adult patients with acute lymphoblastic leukemia, or ALL, or lymphoblastic lymphoma, or LBL, who are hypersensitive to E. coli-derived asparaginases. Hypersensitivity reactions affect up to 3% of patients with ALL and LBL who are treated with E. coli-derived asparaginase.

08:02 EST Avis Budget appoints Joe Ferraro as interim CEO - Avis Budget Group announced that its Board of Directors has appointed Joe Ferraro, President, Americas, as Interim CEO, effective January 1, 2020. Ferraro's appointment reflects the previously announced departure at year-end of Larry De Shon, President and CEO. In connection with Ferraro's role as Interim CEO, Izzy Martins, CFO, Americas, will serve as Interim President, Americas. Martins has been with Avis Budget Group for 15 years in a number of senior strategic and financial roles. Avis Budget Group's CEO Search Committee, led by Director Lynn Krominga, Chair of the Corporate Governance Committee of the Board of Directors, is conducting a thorough search process to identify a permanent CEO.

07:32 EST Acceleron, Fulcrum Therapeutics announce pulmonary research collaboration - Acceleron Pharma (XLRN) and Fulcrum Therapeutics (FULC) announced they have entered into a collaboration and license agreement to identify small molecules designed to modulate specific pathways associated with a targeted indication within the pulmonary disease space. Under the agreement, Acceleron will have access to Fulcrum's unique, proprietary product engine and target identification platform with the potential to identify small molecules that control the expression of genes known to impact specific pathways associated with a pulmonary disease of interest. Acceleron and Fulcrum will collaborate on the identification of therapeutic targets and small molecule drug candidates for those targets. Acceleron will be responsible for all development and commercialization activities for any potential therapeutics identified via this platform. Fulcrum will receive a one-time, upfront payment of $10M as well as reimbursement for relevant R&D costs. Fulcrum will also be eligible to receive research, development and commercial milestone payments of up to $295M for a first product commercialized and up to a maximum of $143.5M in additional milestone payments for all subsequent products commercialized. Fulcrum will additionally receive tiered royalty payments in the mid-single-digit to low double-digit range on net sales.

07:13 EST BioXcel Therapeutics initiates Phase 3 studies of BXCL501 - BioXcel Therapeutics announced the initiation of its SERENITY program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. Topline data from both Phase 3 trials are expected in mid-2020.The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients 18 to 75 years of age. SERENITY I will enroll patients with agitation associated with schizophrenia, with each arm receiving either BXCL501 at 120 micrograms, 180 micrograms or a placebo. SERENITY II will evaluate patients with agitation associated with bipolar disorder, also with each of three arms receiving either BXCL501 at 120 micrograms, 180 micrograms or a placebo. The primary endpoint of the trials is reducing acute agitation measured by the Positive and Negative Syndrome Scale, examining the Excited Component change from baseline compared to placebo. A key secondary endpoint includes determining the earliest time where an effect on agitation is apparent as measured by the change from baseline in PEC total score.

07:10 EST Sol-Gel says Phase 3 Twyneo trials meet all co-primary enpoints - Sol-Gel Technologies announced top-line results from two pivotal Phase 3 clinical trials for Twyneo, an investigational, combination of microencapsulated tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream, which demonstrated statistically significant improvement on all co-primary endpoints in the treatment of patients with acne vulgaris. Twyneo was also found to be well-tolerated. The primary endpoints for both trials included: the proportion of patients who succeeded in achieving at least a two grade reduction from baseline and Clear or Almost Clear at Week 12 on a 5-point Investigator Global Assessment scale; an absolute change from baseline in inflammatory lesion count at Week 12; and an absolute change from baseline in non-inflammatory lesion count at Week 12. If approved, Twyneo has the potential to be the first acne vulgaris treatment to bring together benzoyl peroxide and a potent retinoid, tretinoin, in a once-daily cream - enabled using the Company's proprietary microencapsulation technology. To assess the efficacy and safety of Twyneo, 858 subjects, aged nine and older, with moderate-to-severe acne were enrolled in two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials at 63 sites across the U.S. Subjects were randomized at a 2:1 ratio to be treated once-daily with either Twyneo or vehicle cream for 12 weeks. The co-primary endpoints for both trials included: the proportion of patients who succeeded in achieving at least a two grade reduction from baseline and Clear or Almost Clear at Week 12 on a 5-point Investigator Global Assessment scale; an absolute change from baseline in inflammatory lesion count at Week 12; and an absolute change from baseline in non-inflammatory lesion count at Week 12. In trial SGT-65-04, 38.5% of patients treated with Twyneo achieved success in IGA versus 11.5% in the vehicle treated group. In trial SGT-65-05, 25.4% of patients treated with Twyneo achieved success in IGA versus 14.7% in the vehicle group. In trial SGT-65-04, the absolute change from baseline of inflammatory lesion count for Twyneo was -21.6 versus -14.8 for the vehicle group. In trial SGT-65-05, the absolute change from baseline of inflammatory lesion count for Twyneo was -16.2 versus -14.1 for the vehicle group. In trial SGT-65-04, the absolute change from baseline of non-inflammatory lesion count for Twyneo was -29.7 versus -19.8 for the vehicle group. In trial SGT-65-05, the absolute change from baseline of non-inflammatory lesion count for Twyneo was -24.2 versus -17.4 for the vehicle group. In both trials, Twyneo was found to be well-tolerated and the majority of local skin reactions, when reported, were mild and improved over time. There were no treatment-related serious adverse events and 4 unrelated serious adverse events were reported across both trials.

07:07 EST Myriad Genetics receives FDA approval of BRACAnalysis CDx for Lynparza - Myriad Genetics (MYGN) announced that the U.S. Food and Drug Administration has approved BRACAnalysis CDx for use as a companion diagnostic test by healthcare professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza. Lynparza is marketed by AstraZeneca (AZN) and Merck (MRK). BRACAnalysis CDx is the first and only FDA-approved genetic test for this indication.

07:05 EST Avanos appoints Michael Greiner as CFO - Avanos (AVNS) announced the appointment of Michael Greiner as senior VP and CFO, effective January 1, 2020. Greiner brings to Avanos more than 20 years of experience in corporate finance, accounting, treasury and M&A strategy development and execution. He most recently served as executive VP and CFO for AngioDynamics (ANGO), where he played an role in transforming and optimizing its product portfolio through both internal development and M&A. Greiner will be responsible for the company's global finance and information technology organizations and will play a leading role in the execution of its growth strategy, performance management and value creation. He will report directly to Joe Woody, Avanos' CEO.

07:04 EST Castle Biosciences announces publication of DecisionDx-Melanoma study results - Castle Biosciences announced that results from a study designed to perform a systematic review of the literature and establish the level of evidence for the Company's DecisionDx-Melanoma gene expression profile test were published in the December 2019 issue of the American Journal of Clinical Dermatology. The results show that the DecisionDx-Melanoma test achieves a higher level of evidence than determined by major organizations that publish guidelines on melanoma management. The evaluation of seven development and validation studies led the authors to classify DecisionDx-Melanoma as level I/II, I-IIIB and IIA according to AJCC, NCCN and AAD criteria, respectively, which are higher than the official unrated status conferred by the AJCC and NCCN and the II/IIIC rating designated by the AAD in the latest version of their melanoma guidelines. The authors note that the differences between the study's findings and official published ratings may be attributed to chronological issues, as many of the studies were not yet published when the organizations conducted their reviews. There was also difficulty in applying the National Comprehensive Cancer Network criteria to this prognostic test, as their guidelines were intended for evaluation of therapeutic response markers. Based on current published data, the authors find integration of the DecisionDx-Melanoma test to be useful for patients with invasive melanoma, particularly older patients with T1/T2 melanomas: For patients with invasive melanoma, DecisionDx-Melanoma may help guide the frequency of skin examinations and utilization of a sentinel lymph node biopsy surgical procedure or imaging following diagnosis of melanoma. DecisionDx-Melanoma may benefit patients aged older than 65 years diagnosed with T1/T2 melanomas in the assessment of the risks and benefits of a SLNB surgical procedure. Three additional prospective peer-reviewed clinical validity studies published in 2019 were not included in the Dubin study, due to publication after the systematic review was completed.

07:01 EST Digital Power trading halted, news pending

06:50 EST Eli Lilly announces opening of LIBRETTO-531 trial for selpercatinib - Eli Lilly announced the opening of the LIBRETTO-531 clinical trial for selpercatinib, also known as LOXO-292, for treatment-naive RET-mutant medullary thyroid cancer, or MTC, patients. This is the second Phase 3 trial to open for selpercatinib, a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection, or RET, kinase. Enrolled trial participants will be randomized to receive either selpercatinib or physician's choice of cabozantinib or vandetanib as initial treatment of their advanced or metastatic RET-mutant MTC. LIBRETTO-531 is a randomized Phase 3 clinical trial of patients with treatment-naive RET-mutant MTC. The trial will enroll 400 patients with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease. Enrolled trial participants will be randomized 2:1 to receive either selpercatinib or physician's choice of cabozantinib or vandetanib as initial treatment of their advanced or metastatic RET-mutant MTC. RET mutations may be identified using local testing. This trial's efficacy endpoints are progression-free survival, or PFS, treatment failure-free survival, or TFFS, overall survival, or OS, overall response rate and duration of response. For patients randomized to the control arm, crossover is allowed at progression.

06:32 EST Franchise Group to acquire American Freight Group in deal valued at $450M cash - Franchise Group announced it has entered into a definitive agreement under which it will acquire American Freight Group in an all cash transaction valued at approximately $450M from an affiliate of The Jordan Company, L.P. and other stockholders of American Freight. Upon the closing of the Transaction, Franchise Group's systemwide revenue, which is defined as total sales for both franchise and company units, will exceed $2.4B. The Transaction is expected to be completed in the first quarter of 2020, subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as well as other customary closing conditions.

06:25 EST Axsome Therapeutics announces AXS-07 met primary, secondary endpoints - Axsome Therapeutics announced that AXS-07, Axsome's novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, met the two regulatory co-primary endpoints and significantly improved migraine pain and most bothersome symptoms as compared to placebo in the MOMENTUM Phase 3 trial. AXS-07 also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain. MOMENTUM was a randomized, double-blind, placebo- and active-controlled trial which enrolled only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire, or mTOQ-4. A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07, rizatriptan, MoSEIC, meloxicam, or placebo, to treat a single migraine attack of moderate or severe intensity. In addition to a history of inadequate response, enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes including cutaneous allodynia, severe migraine pain intensity, obesity and morning migraine. The study was conducted pursuant to a FDA special protocol assessment, or SPA. AXS-07 met the two regulatory co-primary endpoints by demonstrating, with high statistical significance, a greater percentage of patients as compared to placebo achieving pain freedom and absence of most bothersome symptom two hours after dosing. Superiority of AXS-07 to rizatriptan and MoSEIC meloxicam was established as specified in the SPA, by demonstration of a greater percentage of AXS-07 patients achieving sustained pain freedom from two to 24 hours after dosing, compared to rizatriptan and MoSEIC meloxicam, as well as to placebo. The positive results on both co-primary endpoints along with the demonstration of component contribution support the filing of an NDA for AXS-07 in the acute treatment of migraine. AXS-07 provided greater and more sustained migraine pain relief compared to placebo and rizatriptan, which translated to a significant reduction in rescue medication use for AXS-07 compared to placebo and rizatriptan. The percentage of patients experiencing sustained pain relief from two to 24 hours after dosing was 53.3% for AXS-07, compared to 33.5% for placebo and 43.9% for rizatriptan. Sustained pain relief from two to 48 hours was also experienced by a statistically significantly greater proportion of AXS-07 patients, compared to placebo and rizatriptan patients. Rescue medication was used by 23.0% of AXS-07 patients, compared to 43.5% of placebo and 34.7% of rizatriptan patients. AXS-07 provided rapid relief of migraine pain with the percentage of patients achieving pain relief with AXS-07 being numerically greater than with rizatriptan at every time point measured starting at 15 minutes, and statistically significantly greater than with rizatriptan by 60 minutes. The proportions of patients experiencing pain relief 1.5 hours after dosing were 60.5% for AXS-07 compared to 52.5% for rizatriptan and 48.3% for placebo. AXS-07 was statistically significantly superior to rizatriptan on several other secondary endpoints including Patient Global Impression of Change and return to normal functioning at 24 hours.AXS-07 was safe and well tolerated in the trial. The most commonly reported adverse events with AXS-07 were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%. There was one serious adverse event in the AXS-07 arm which was deemed by the investigator not to be related to study drug. The MOMENTUM study was conducted pursuant to an SPA with the FDA. The SPA provides agreement that the overall MOMENTUM trial design and planned analysis adequately address objectives that, if met, will support the regulatory submission for approval of AXS-07 for the indication of acute treatment of migraine in adults with or without aura. Based on FDA feedback, Axsome believes that MOMENTUM will be the only efficacy trial required to support an NDA filing for AXS-07 for the acute treatment of migraine. Axsome plans to file the NDA in the second half of 2020. AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC meloxicam and rizatriptan. AXS-07 is thought to act by inhibiting CGRP release, reversing CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain signal transmission, and central sensitization. Axsome's MoSEIC(TM) technology significantly increases the speed of absorption of the meloxicam component after oral administration while maintaining a long plasma half-life. AXS-07 is covered by 21 issued U.S. and international patents providing protection out to 2036, and Axsome maintains worldwide rights. Detailed study results, including additional secondary endpoints, will be submitted for presentation at upcoming medical meetings and for publication. AXS-07 is also being evaluated in the INTERCEPT Phase 3 trial which is a randomized, double-blind, placebo-controlled study evaluating the early treatment of migraine with AXS-07. In contrast to the ongoing MOMENTUM trial in which patients with a history of inadequate response treated migraine attacks once they have become of moderate or severe intensity, in the INTERCEPT trial, patients are to administer AXS-07 at the earliest sign of migraine pain.

06:00 EST Maxar Technologies to sell MDA to Northern Private Capital for C$1B -

05:11 EST Dr. Reddy's announces launch of Sodium Nitroprusside Injection in U.S. market - Dr. Reddy's Laboratories announced the launch of Sodium Nitroprusside Injection, 50 mg/2 mL Single-dose Vial, the therapeutic generic equivalent of Nitropress Injection, 50 mg/2mL vial, approved by the FDA. Dr. Reddy's Sodium Nitroprusside Injection is available in single-dose 50 mg/2 mL vials.