Stockwinners Market Radar for September 09, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:28 EDT Twitter drops 1% to $41.72 after Musk finds another reason to end deal

17:47 EDT Ocwen issues statement on new FHFA, Ginnie Mae eligibility requirements - Ocwen issued the following statement in response to the minimum financial eligibility requirements for enterprise seller/servicers and Ginnie Mae issuers announced by the Federal Housing Finance Agency, or FHFA, and Ginnie Mae. "We are currently in compliance with the new FHFA and GNMA liquidity and capital standards and expect to be in compliance when they take effect in September 2023, with the exception of the GNMA risk-based capital ratio. We are having discussions with GNMA with respect to their risk-based capital requirements, which take effect at year-end 2023. We are evaluating our alternatives, as well as the costs and benefits of achieving compliance with the GNMA risk-based capital requirements. GNMA forward servicing and originations is not a material portion of our business activities, comprising approximately 4% of our total servicing UPB as of June 30, 2022 and less than 10% of our year-to-date origination volume as of August 31, 2022. The alternatives we are evaluating include but are not limited to external investor solutions, structural solutions or exiting GNMA forward originations and owned servicing. Regardless, we expect we will continue to subservice GNMA forward mortgages and originate, subservice and own GNMA Reverse mortgages (or HECMs), as we do not believe these activities will be impacted by the new regulations. We intend to manage our business appropriately to achieve compliance with the risk-based capital standards when these rules take effect. We expect to continue to repurchase shares under our previously announced share repurchase program."

17:14 EDT Raytheon Technologies awarded $183.97M Air Force contract - Raytheon has been awarded $183.97M for Advanced Synthetic Aperture Radar System, or ASARS-2B sensors. This contract provides for ASARS Sensors and supplemental equipment. Work will be performed in El Segundo, California, and is expected to be complete by Aug. 16, 2027. This award is the result of a sole source acquisition. FY21 and FY22 Air Force procurement funds in the amount of $63.6M are being obligated at the time of award. Air Force Life Cycle Management Center is the contracting activity.

16:45 EDT Landec receives noncompliance notice from Nasdaq - Landec announced that it received a notice from the Listing Qualifications Department of Nasdaq stating that the company is not in compliance with Nasdaq Listing Rule 5250 because the company failed to timely file its annual report on Form 10-K for the year ended May 29 with the Securities and Exchange Commission. The notice has no immediate effect on the listing or trading of the company's securities on the Nasdaq Global Select Market. The notice states that the company has 60 calendar days from the date of the Notice, or November 1, to submit a plan to regain compliance with the Listing Rule. If Nasdaq accepts the Company's plan to regain compliance, then Nasdaq may grant the company up to 180 calendar days from the prescribed due date of the Form 10-K, or February 28, 2023, to file the 2022 Form 10-K to regain compliance.

16:18 EDT MSG Sports CEO Andrew Lustgarten to step down, David Hopkinson named COO - MSG Sports announced that Andrew Lustgarten, MSG Sports' president and CEO, is stepping down from his position at the end of the calendar year, and will join MSG Sports' board of directors, effective January 1, 2023. In addition, the company announced that David Hopkinson, who joined MSG Sports in 2020 as executive VP MSG Sports, president of team business operations, has been named president and COO, effective immediately. In his new role as president and COO, Hopkinson will be responsible for setting the company's business strategy and overseeing all aspects of business operations for its collection of professional sports franchises - the New York Knicks, New York Rangers, Westchester Knicks, Hartford Wolf Pack, Counter Logic Gaming and Knicks Gaming. The company has chosen not to name a new CEO at this time and MSG Sports executive chairman James Dolan will continue to oversee team operations for the Knicks and Rangers.

16:01 EDT Spectrum trading halted, news pending

14:52 EDT Siga's Tpoxx generally well tolerated as monkeypox treatment, CDC says - Siga Technologies' Tpoxx is generally well tolerated, and new data support continued access to treatment during the current monkeypox outbreak, the Centers for Disease Control and Prevention announced. Tpoxx was approved by the Food and Drug Administration for treatment of smallpox based on data obtained from animal models as there are no safety or efficacy data regarding its use in patients with monkeypox virus infection. Among 549 patients with monkeypox virus infection treated with Tpoxx under an Expanded Access Investigational New Drug protocol, 99.8% received it orally as an outpatient. Among 369 patients, few adverse events were reported, the CDC announced today. Shares of Siga are up 5% to $14.19 in afternoon trading. Reference Link

13:12 EDT Baker Hughes reports U.S. rig count down 1 from last week to 759 rigs - Baker Hughes reports the U.S. rig count is down 1 from last week to 759, with oil rigs down 5 to 591, gas rigs up 4 to 166 and miscellaneous rigs unchanged at 2. The U.S. rig count is up 256 rigs from last year's count of 503 with oil rigs up 190, gas rigs up 65 and miscellaneous up 1.

12:13 EDT AMTD Digital Inc trading resumes

12:02 EDT Roche announces VENTANA PD-L1 Assay receives CE IVD approval - Roche (RHHBY) announced that the VENTANA PD-L1 Assay is available in countries accepting the CE mark as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo, a PD-1 inhibitor therapy developed by Regeneron.

12:00 EDT Biotie Therapies falls -10.7% - Biotie Therapies is down -10.7%, or -$4.27 to $35.51.

12:00 EDT StarTek rejects preliminary, non-binding $4.65 per share proposal from CSP - The special committee of the board of directors of Startek announced that it has rejected the preliminary, non-binding proposal, dated August 8, by CSP Management Limited and certain of its affiliates to acquire all the shares of Startek that CSP does not already own for $4.65 per share in cash. CSP is currently the beneficial owner of approximately 56% of the outstanding shares of Startek. "Foros, the Committee's financial advisor, notified CSP on August 21, 2022 that the Committee had determined that the proposed price of $4.65 was inadequate and explained the basis for this determination as described in the preceding paragraphs of this press release. Since that time, rather than submitting a revised proposal, CSP has repeatedly requested more 'specific directional guidance on how [the Committee] is thinking about value and price.' The Committee considered this request by taking into account that CSP already possesses the full Forecast and has understood since August 21 that the Committee is using this Forecast for its financial analysis of proposals by CSP. After considering this factor, as well as the Committee's objective of maximizing value for shareholders, the Committee determined and informed CSP that it would be inappropriate and redundant to provide additional directional guidance to CSP beyond the explanations already provided to CSP. The Committee has reiterated to CSP that the Committee remains available to evaluate and respond to a revised proposal by CSP. There can be no assurance that any revised proposal or definitive offer will be made or accepted, that any agreement will be executed, or that any transaction will be consummated," the company stated.

12:00 EDT Annovis Bio rises 14.7% - Annovis Bio is up 14.7%, or $1.79 to $13.98.

11:57 EDT NIH announces start of Phase 3 trial evaluating Siga's TPOXX for monkeypox - A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States, the National Institutes of Health announced. Study investigators aim to enroll more than 500 people from clinical research sites nationwide. The trial is sponsored by the National Institute of Allergy and Infectious Diseases, or NIAID, part of the NIH. Tecovirimat, manufactured by the pharmaceutical company SIGA Technologies, is approved by the U.S. Food and Drug Administration for the treatment of smallpox, the NIH noted. Reference Link

11:37 EDT Teck to install antimicrobial copper surfaces for Thompson Rivers University - Thompson Rivers University and Teck Resources announced a partnership to improve health and safety for staff, students and faculty on campus through the use of antimicrobial copper on high-touch surfaces. Through Teck's Copper & Health program, Teck is installing more than 650 antimicrobial copper surfaces at three key buildings on the Kamloops campus: Old Main, the Campus Activity Centre and the Chappell Family Building for Nursing and Population Health.

11:11 EDT Health Canada authorizes Pfizer-BioNTech COVID vaccine for kids over 6 months - Health Canada authorized the use of the Pfizer (PFE) and BioNTech's (BNTX) Comirnaty COVID-19 vaccine in children six months to four years of age. "This is the second COVID-19 vaccine authorized in Canada for this age group," the agency stated. Health Canada has authorized a three-dose primary series of three micrograms each, with three weeks between the first and second doses and eight weeks between the second and third doses. For comparison, the primary series for children 5 to 11 years of age is two doses, 10 micrograms each, and for people 12 years of age and older it's two doses, 30 micrograms each.

10:52 EDT Alphabet's Verily announces $1B investment round, leadership changes - Verily, a subsidiary of Alphabet, announced a $1B dollar investment round led by Alphabet, that will be used to support the expansion of Verily's businesses focused on precision health. Verily is also announcing new roles for the company's top leadership. "As the company enters its next phase of growth, company founder Andy Conrad will become Executive Chairman of the Verily Board and current president Stephen Gillett will be promoted to Chief Executive Officer, with both changes effective January 2023. These new roles are the result of thoughtful succession planning led by Conrad and the board and in recognition of the skills and experience required to lead Verily as it becomes a more operationally and commercially focused company executing on its precision health strategy. Gillett joined Verily from Google in 2020 as an operational advisor to the company and to lead Verily's effort to establish a Cybersecurity Center of Excellence. In November of that year he was named Chief Operating Officer. Before joining Verily, Gillett was co-founder and CEO of Chronicle, an Alphabet cybersecurity company that is now part of Google Cloud. He continues to be an active advisor to GV and X. Prior to Alphabet, Gillett held a number of executive roles at companies in a variety of industry sectors including Best Buy, Starbucks and Symantec. Separately, Deepak Ahuja, CFO, has decided to leave Verily for another opportunity. He will remain an advisor to Verily but depart his current role at the end of September. Verily will begin a search for his replacement immediately," the company announced.

10:35 EDT BioNTech reports 'encouraging' Phase 1/2 data for CAR-T candidate BNT211 - BioNTech SE presented what it calls "positive" follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the company's novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors. "The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels," the company stated. The data were presented in the Investigational Immunotherapy Proffered Paper Session at the European Society for Medical Oncology, or ESMO, Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany. "The updated data read-out presented at ESMO (data cut-offs: June 15, 2022 for safety and August 16, 2022 for efficacy) included data from 22 patients (21 evaluable for efficacy) who received CLDN6 CAR-T cells at dose levels 1 alone or combined with CARVac. Tumor indications included testicular cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, sarcoma, gastric cancer and one patient with a tumor of unknown primary origin. Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 showed encouraging signs of clinical activity and was well tolerated. All 22 patients showed robust, dose-dependent CAR-T cell expansion after infusion with cell frequencies close to 10(9) total counts in dose level 2. At the cut-off date, available data demonstrated the long-term persistence of CAR-T cells observed in some patients for more than 100 days, and in one patient for 200 days. Two patients have been treated without lymphodepletion as preconditioning and a strongly reduced CAR-T expansion was observed. Adverse events, including cytokine release syndromes and dose limiting toxicities were manageable. One transient occurrence of neurotoxicity grade 1 and one grade 3 CRS were observed that quickly resolved. Efficacy assessment of the 21 evaluable patients showed a best overall response rate of 33% and a disease control rate of 67% with one complete response, six partial responses and seven patients with stable disease," the company reported.

10:23 EDT Immunocore Holdings trading resumes

10:21 EDT Wolfspeed to build Materials manufacturing facility in Chatham County, NC - Wolfspeed announced it will build a multi-billion-dollar Materials manufacturing facility in Chatham County, North Carolina. The investment is targeted to generate a more than 10 fold increase from Wolfspeed's current Silicon Carbide production capacity on its Durham campus, supporting the company's long-term growth strategy, accelerating the adoption of Silicon Carbide semiconductors across a wide array of end-markets and unlocking a new era of energy efficiency. The facility will primarily produce 200mm Silicon Carbide wafers, which are 1.7x larger than 150mm wafers, translating into more chips per wafer and ultimately, lower device costs. These wafers will be used to supply Wolfspeed's Mohawk Valley Fab, which opened earlier this year as the world's first, largest and only fully automated 200mm Silicon Carbide fabrication facility. Phase one construction is anticipated to be completed in 2024 and cost approximately $1.3B. Between 2024 and the end of the decade, the company will add additional capacity as needed, eventually occupying more than one million square feet on the 445-acre site. State and local funding, including a Job Development Investment Grant from the North Carolina Department of Commerce, will support the development of the facility's first phase and represents an approximately $1B incentive package from the State, County and local governments. In addition, the company hopes to apply for and obtain federal funding from the CHIPS and Science Act to accelerate the construction and build-out of the facility. Over the next eight years, the company intends to continue to invest, looking to create roughly 1,800 jobs.

10:10 EDT Kimberly-Clark appoints Tamera Fenske to Chief Supply Chain Officer - Kimberly-Clark (KMB) announced the appointment of Tamera Fenske to the role of Chief Supply Chain Officer, effective September 19. Fenske joins Kimberly-Clark after most recently having served as senior vice president of manufacturing and supply chain for 3M Company (MMM), where she led the end-to-end supply chain for the company in the U.S. and Canada across all its business groups and markets.

10:00 EDT InMed Pharmaceuticals Inc trading resumes

10:00 EDT Blue Apron falls -7.2% - Blue Apron is down -7.2%, or -56c to $7.27.

10:00 EDT Azure Power rises 10.0% - Azure Power is up 10.0%, or 53c to $5.82.

10:00 EDT Eve Holding rises 11.6% - Eve Holding is up 11.6%, or 86c to $8.25.

09:47 EDT Scor ADR falls -5.9% - Scor ADR is down -5.9%, or -$1.65 to $26.22.

09:47 EDT ADC Therapeutics falls -9.5% - ADC Therapeutics is down -9.5%, or -62c to $5.90.

09:47 EDT Sprinklr rises 11.6% - Sprinklr is up 11.6%, or $1.34 to $12.90.

09:40 EDT ShiftPixy trading resumes

09:35 EDT ShiftPixy trading halted, volatility trading pause

09:24 EDT IMAC Holdings completes third cohort of Phase 1 trial of mesenchymal stem cells - IMAC Holdings announces it has completed the third cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson's disease. The third cohort consists of five patients with bradykinesia due to Parkinson's disease receiving an intravenous infusion of a high concentration stem cell treatment. The third and final cohort of the Phase 1 clinical trial was completed on Tuesday, September 6, 2022.

09:23 EDT Lithium Corp. retains KLM Geoscience for Phase I CSAMT survey - Lithium Corporation announced the Company has retained KLM Geoscience, LLC of Las Vegas to conduct an initial Phase I Controlled Source Audio-frequency Magnetotelluric Survey on the Company's 4,728 acre San Emidio lithium-in-brine prospect in Washoe County, Nevada. The company said, "The property had been under a Joint Venture agreement since September 2021, however the Joint Venture partner recently indicated they want to focus their efforts elsewhere, and hence let the agreement lapse. While we are disappointed the arrangement is being discontinued, the Company views this as a great opportunity to move this exciting property forward on the continuum towards development." Lithium Corporation identified the San Emidio lithium-in-brine property in the early 2010's through geochemical prospecting, ultimately seeing values as high as 80 mg/L lithium in near-surface brines. The Company conducted a gravity geophysical survey and followed that up with direct push drilling in 2012 that outlined a lithium-in-brine anomaly at moderate depths, returning values as high as 23 mg/L Li. Lithium Corporation permitted the property for a deeper drill program but focus on other properties, an earlier option agreement, and two subsequent downturns in the price of Lithium precluded initiating the drill program. In order to return the property back on track, it was decided a CSAMT survey would be a perfect complement to the existing database and a great aid in determining what sites will be permitted for drilling once the survey is complete, and the data compiled and interpreted. KLM, the contractor, indicated they will commence the survey in early November.

09:19 EDT Live Current Media signs LOI to implement Cascade's Web3 infrastructure - Live Current Media announces that it has signed a letter of intent to collaborate on a project to augment the current product offering of Kast and to incorporate Cascade Live's e-commerce and ticketing solution into Live Current's Kast video streaming platform.

09:17 EDT Terreno Realty executes lease in New York City - Terreno Realty announced that it has executed an early lease renewal, assignment, and expansion in Jamaica Queens, New York with a global logistics provider totaling 86,000 square feet. The early lease renewal of 44,000 square feet, which was to expire in February 2023, will now expire April 2030. The five expansion spaces total 23,000 square feet which is vacant currently and will expire April 2030. The assignment of an existing 18,000 square foot lease at the property will expire April 2030. Terreno Realty Corporation acquires, owns and operates industrial real estate in six major coastal U.S. markets: Los Angeles; Northern New Jersey/New York City; San Francisco Bay Area; Seattle; Miami; and Washington, D.C.

09:05 EDT Steve Aoki joins DraftKings as brand ambassador for DraftKings Marketplace - DraftKings and Steve Aoki announced that the two-time Grammy-nominated DJ and producer has agreed to become an official brand ambassador of DraftKings Marketplace. Aoki will support DraftKings' Web3 efforts, with an emphasis on the Reignmakers franchise, an NFT-based fantasy sports series where players will be able to build a collection of NFT player cards with which they can draft a lineup for use in fantasy sports-style games. Aoki will collaborate on and promote digital collectibles that are exclusive to DraftKings Marketplace. These digital collectibles are intended to represent Aoki's interests and focus on the intersection of sports, entertainment and culture. The first collection, the Aoki 2022 All-Star Access Pass, is slated to drop on Wednesday, September 14, and customers who purchase the collection will receive special access to private Reignmakers Football contests during the 2022 professional football season.

09:02 EDT Mawson to sell Georgia Bitcoin Mining Facility, miners to CleanSpark for $42.5M - Mawson Infrastructure (MIGI) announced it has entered into definitive agreements with CleanSpark (CLSK) to sell its Sandersville, Georgia Bitcoin Mining Facility, and 6,468 ASIC Bitcoin Miners to CleanSpark for up to a maximum total purchase price of $42.5M, subject to reaching certain earn-out commitments, with closing expected in early October. Mawson has executed definitive documentation to sell its Sandersville, Georgia Bitcoin Mining Facility for approximately $33M plus power deposits, at a premium to book value, and 6468 ASIC Bitcoin Miners for an additional $9.48M. As part of the $33M of consideration, Mawson will receive up to approximately $11M in CleanSpark stock, which if the full amount is achieved would result in Mawson owning approximately 5.5% of the outstanding common stock of CleanSpark. Mawson intends to use the proceeds of sale to reduce debt and to focus near-term expansion activities at its Midland and Sharon Bitcoin Mining Facilities in Pennsylvania, with total energy capacity available for Bitcoin Mining of 220 megawatts. Mawson's existing and pipeline sites include its Australian operations and its 120-megawatt Bitcoin Mining Facility in Texas. These sites combined have a cumulative 360 megawatts of energy capacity available for Bitcoin Mining, which is capable of operating at approximately 12.0 Exahash.The agreement has been approved by the organizations' respective boards of directors and is subject to customary closing conditions. CleanSpark and Mawson expect to close the transaction in early October.

08:38 EDT Forza X1 says eight patents in process with the USPTO - Forza X1 provided a detailed update on its intellectual property roadmap for the next twelve months and offered a status report on its patents currently pending with the United States Patent and Trademark Office. "Patenting IP related to our designs and innovation is an essential aspect of our business," states Joseph Visconti, Executive Chairman and Chief of Product Development of Forza X1, Inc. "Intellectual property rights allow our Company the opportunity to design, build and test innovative products that can be protected under the United States patent protection laws and give us the ability to compete against larger companies. Our IP roadmap is intended to help guide the Company's trajectory for the next year so that it may design, build, and test new technologies as fast as possible." The Company currently has eight patents in process with the USPTO. "Our engineers have worked on several aspects of our future FX1 boat models to elevate the customer experience," explains Visconti. "Our team constantly meets to discuss exciting possibilities with each other. We also consider feedback and suggestions from our collaborators, vendors, and other boating industry participants and enthusiasts to gain outside perspectives." Some examples of the Company's current pending patents are designs to enable a higher level of maneuverability on the water, increase engine efficiency through its cooling system, allow for a buildable and modular outboard engine construction, and permit owners to operate a single-handed trailering process. In the coming weeks and months, Visconti indicates that one of Forza's priorities is to transition its six provisional patent applications into full applications so that it may obtain the patent protection associated with full patents. In addition to the patents pending with the USPTO, Forza's goal over the next year is to file at least ten new provisional applications. The Company expects to file two new provisional applications soon and has several other ideas waiting to be vetted.

08:36 EDT Forza X1 provides update on intellectual property initiative - Forza X1 provided a detailed update on its intellectual property, or IP, roadmap for the next twelve months and offered a status report on its patents currently pending with the United States Patent and Trademark Office, or USPTO. "Patenting IP related to our designs and innovation is an essential aspect of our business," states Joseph Visconti, executive chairman and chief of product development of Forza X1, Inc. "Intellectual property rights allow our Company the opportunity to design, build and test innovative products that can be protected under the United States patent protection laws and give us the ability to compete against larger companies. Our IP roadmap is intended to help guide the Company's trajectory for the next year so that it may design, build, and test new technologies as fast as possible." The company currently has eight patents in process with the USPTO. In addition to the patents pending with the USPTO, Forza's goal over the next year is to file at least ten new provisional applications. The company expects to file two new provisional applications soon and has several other ideas waiting to be vetted. "As part of our year-long roadmap, Forza is considering other areas of focus for our IP development that to create barriers to entry for other companies. The biggest issue we are looking to address is extending the range of electric boats so our customers can maximize their time on the water on a single charge," states Visconti. Forza's engineers are examining improvements to outboard motor efficiency, utilizing lightweight materials, investigating various structural battery composites, implementing new hull designs, and working on fast-charging capability.

08:34 EDT ABVC BioPharma selects additional Vitargus Phase II study site - ABVC BioPharma announced a new clinical site in Australia has been selected to participate in the Phase II clinical study of Vitargus, the first bio-degradable vitreous substitute to facilitate retina re-attachment surgery. The new site, located at the Sydney Eye Hospital in Sydney, New South Wales, will join East Melbourne Eye Group in East Melbourne, Victoria, Australia and Ramathibodi Hospital and Srinagarind Hospital in Thailand, to participate in the study. The Sydney Eye Hospital is a well-established site for clinical trials with over 10 years' experience including 23 completed and 22 on-going ophthalmology studies. The site has sufficient staff and resources to conduct the trial to a high standard with a potential enrollment rate of 10 subjects per week.

08:33 EDT Coca-Cola chief platform services officer Barry Simpson to step down - Coca-Cola announced that Barry Simpson will step down from his role as chief platform services officer. Simpson will conclude his role September 30. He will remain with the company as a senior advisor through February 2023. Simpson has led the company's platform services organization since it was created in 2021. Platform Services provides scaled services, data and technology across the company's networked organization. When Simpson steps down, the platform services organization will be restructured under two leaders, beginning October 1. Neeraj Tolmare will serve as chief information officer and will lead digital and technology services. A leader will be named later to head other service teams. Both executives will report to John Murphy who, as previously announced, becomes president and chief financial officer October 1.

08:29 EDT Crypto names up in pre-market as bitcoin rises to two-week high above $21,000 MicroStrategy - Stocks levered to bitcoin prices are rebounding in pre-market trading as the cryptocurrency has rallied above the $21,000 overnight to its highest level in two weeks. Bit Digital (BTBT) is up 6.1% at $1.56, Riot Blockchain (RIOT) is up 9.3% at $8.15, Marathon Digital (MARA) is up 9.2% at $14.48, MicroStrategy (MSTR) is up 7.9% at $253.00 and Coinbase Global (COIN) is up 7.7% at $78.73.

08:17 EDT Arcutis Biotherapeutics says STRATUM Phase 3 trial met primary endpoint - Arcutis Biotherapeutics announced new data from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for children ages 9 and above and adults with moderate to severe seborrheic dermatitis were presented orally at the Academy of Dermatology and Venereology Congress. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp. The study met the primary endpoint with 80.1% of individuals treated with roflumilast foam achieving 'IGA Success' compared to 59.2% of patients treated with vehicle at week eight. IGA Success was defined as an IGA score of clear or almost clear plus a greater than or equal to2 grade improvement from baseline. Improvement with roflumilast foam was seen early, with roflumilast separating statistically from vehicle on IGA Success at week two, the first timepoint assessed. Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints in the trial, including itch, scaling, and erythema. More than 60% of individuals with a Worst Itch-Numerical Rating Score of 4 or higher at baseline treated with roflumilast foam achieved a greater than or equal to4-point reduction in itch at Week 8. More than 50% of individuals treated with roflumilast foam achieved an erythema score of 0 at week 8. More than 50% of individuals treated with roflumilast foam achieved a scaling score of 0 at week 8. Roflumilast foam was well-tolerated. The incidence of Treatment Emergent Adverse Events was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events. Overall, the most common adverse events in the study population included COVID-19, urinary tract infection, nasopharyngitis, and nausea. Over 90% of patients who were randomized to roflumilast foam in the study completed the full eight weeks, and there were few discontinuations due to adverse events. Roflumilast foam demonstrated favorable local tolerability with no evidence of irritation in greater than98% of patients as assessed by the investigator and no or mild sensations in reported by greater than92% across all timepoints and treatment groups. Arcutis plans to submit an NDA for roflumilast foam for the treatment of seborrheic dermatitis to the U.S. Food and Drug Administration in the first quarter of 2023.

08:10 EDT Activision Blizzard to reveal latest details on Call of Duty on September 15 - Activision will reveal the latest details on the future of Call of Duty on Thursday, September 15. The franchise showcase event titled "Call of Duty: Next" will feature new details on Call of Duty: Modern Warfare II multiplayer, as well as the upcoming Modern Warfare II multiplayer beta, the new Call of Duty: Warzone 2.0 and Call of Duty: Warzone Mobile.

08:07 EDT AstraZeneca, Merck report long-term results from AOLA-1 and SOLO-1 trials - Long-term follow-up results from the PAOLA-1 and SOLO-1 Phase III trials of Lynparza, jointly developed and commercialized by AstraZeneca (AZN) and Merck (MRK), with or without bevacizumab demonstrated clinically meaningful improvements in overall survival, or OS. Further results showed class-leading progression-free survival, or PFS, in combination with bevacizumab for homologous recombination deficiency, or HRD-positive patients, versus active comparator, bevacizumab, and as monotherapy for patients with BRCA mutations, versus placebo, respectively. Both trials which were conducted in biomarker-selected, newly diagnosed patients with advanced ovarian cancer in the 1st-line maintenance setting also demonstrated a consistent safety profile. The results for PAOLA-1 and SOLO-1 were presented on September 9 at the 2022 European Society of Medical Oncology, or ESMO, and SOLO-1 results were published in Journal of Clinical Oncology. Ovarian cancer is one of the most common gynecologic cancers, with a poor prognosis and a high mortality rate. Over two thirds of patients are diagnosed with advanced disease, and approximately 50%-70% of these patients die within five years. Up to one in five women with advanced ovarian cancer have a BRCA mutation, and roughly half of women have HRD-positive tumors. Updated results from the PAOLA-1 Phase III trial demonstrate that Lynparza plus bevacizumab increased median overall survival to 56.5 months versus 51.6 months with bevacizumab alone, in patients with newly diagnosed advanced ovarian cancer irrespective of HRD status. This increase was not statistically significant. In HRD-positive patients, Lynparza plus bevacizumab provided a clinically meaningful improvement in overall survival, reducing the risk of death by 38% versus bevacizumab despite PAOLA-1 having 30% Stage IV patients. 65.5% of patients treated with Lynparza plus bevacizumab were still alive at five years versus 48.4% of those treated with bevacizumab alone. Lynparza plus bevacizumab also improved median PFS to almost four years versus 17.6 months with bevacizumab plus placebo and 46.1% of patients treated with Lynparza plus bevacizumab remain progression free at five years versus 19.2% of patients treated with bevacizumab alone. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials, with no new safety signals. Updated results from the SOLO-1 Phase III trial demonstrate that Lynparza provided a clinically meaningful improvement in overall survival, or OS, versus placebo in patients with BRCA-mutated newly diagnosed advanced ovarian cancer, reducing the risk of death by 45%. Median OS was still not reached with Lynparza versus 75.2 months with placebo. At the seven-year descriptive OS analysis, 67% of Lynparza patients were alive versus 47% of placebo patients and 45% of Lynparza patients versus 21% of placebo patients were alive and had not received a first subsequent treatment. Additional data showed median time to first subsequent therapy was 64 months with Lynparza versus 15.1 months with placebo. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials, with no new safety signals.

08:05 EDT Lee Enterprises announces Public Service Journalism team - Lee Enterprises has added a 12-member team of experienced, veteran investigative and data-focused reporters to provide the industry's most impactful local journalism. The Public Service Journalism team is comprised of 12 experienced reporters - four each in Lee's West, Midwest and East regions - who will collaborate with staff members in Lee's newsrooms across the country to augment the work of local reporting networks. This new reporting team brings expertise in various topical backgrounds, ranging from public safety to public health, from state government to the environment. The Public Service Journalism team will assist with access to public records, track taxpayer money and government spending, examine data related to health, crime and safety issues and serve as watchdogs for communities across the county. In their previous reporting roles both inside Lee newsrooms and in other markets, these team members' work has helped free the innocent, put the guilty behind bars and change laws. The team includes a Pulitzer Prize finalist; three members of the nationally renowned ProPublica Local Reporting Network; a grant recipient from the Pulitzer Center on Crisis Reporting; a regional Edward R. Murrow Regional Award winner; top national award recipients from Investigative Reporters and Editors and the national Society of Professional Journalists; and an investigative reporter and researcher for the Pulitzer Prize-winning Better Government Association in Chicago.

08:03 EDT Jiuzi Holdings debuts first custom EV, signs purchase agreement with DFSK - Jiuzi Holdings announced that its subsidiary Hangzhou Jiuyao New Energy Automobile Technology has entered into a purchase agreement with Chongqing Dongfeng Fengguang Automobiles Sales, a subsidiary of Dongfeng Sokon Motor, DFSK Motor. Pursuant to the Agreement, by the end of 2022, DFSK Motor will deliver 5,000 micro electric passenger cars customized for Jiuyao based on its best-selling model "Dongfeng Mini EV Candy". "We are extremely pleased to see that our debut in the customized EV market is successful," said Mr. Shuibo Zhang, CEO of Jiuzi Holdings, Inc. "Our CP clients not only supply ride-hailing companies with transport vehicles, but also sell or rent vehicles to individual customers as car dealers. Supported by JZXN's capital strength and professional operation, we plan to work with other EV manufacturers to launch more customized SUV and MPV models in order to meet our CP clients' diversified requirements."

07:49 EDT Shawcor receives C$35M contract award for Darwin Pipeline Duplication project - Shawcor announced that its pipe coating division has been awarded a definitive contract by Allseas to provide anti-corrosion, internal flow coat, and concrete weight coatings for the Darwin Pipeline Duplication project, located offshore Northern Australia. The value of the award is approximately C$35M. The work will be executed from Shawcor's Kabil, Indonesia facility, commencing in 2023.

07:46 EDT Dish director buys $1.84M in common stock - In a regulatory filing last night, Dish disclosed that its director James Defranco bought 110K shares of common stock on September 6th in a total transaction size of $1.84M. Shares of Dish are up 2.4% in premarket trading at $18.22.

07:18 EDT J.M. Smucker releases 2022 Corporate Impact Report - The J.M. Smucker issued its 2022 Corporate Impact Report, including its Environmental, Social and Governance, ESG, Disclosure Report, detailing its commitment to responsible business practices and continued progress on its Thriving Together agenda. This agenda came to life in many important ways this past fiscal year. Some notable highlights include: Supported delivery of more than 23 million meals to people and pets in need; Acted as a founding sponsor of Opening Track, a unique music education program from Boys and Girls Clubs of Northeast Ohio; Donated more than $1.2 million to the Red Cross and United Way; Launched initial Employee Resource Groups; Worked with a number of external conservation partners; The Company recognizes its responsibility to support all constituents and provide updates on progress made toward its ESG goals. "We have high expectations for the important role we must play in support of our communities and planet, and recognize our stakeholders share in our passion," said Mark Smucker, Chair of the Board, President and Chief Executive Officer. "Our Corporate Impact Report and ESG disclosure are opportunities to keep these engaged constituents informed while also sharing our sincere appreciation to our employees and partners who helped us deliver these results."

07:12 EDT Mogu announces $10M share repurchase program - Mogu announced that its board of directors has authorized a new share repurchase program, where the company is authorized to repurchase up to $10M of its shares, effective until August 31, 2023. The company expects to fund the repurchases under this program with its existing cash balance.

07:09 EDT Eos Energy appoints Jeff Bornstein to board of directors - Eos Energy Enterprises (EOSE) announced that Jeff Bornstein, former CFO and Vice Chairman of GE (GE) and Managing Partner at Generation Capital Partners and Whipstick Ventures has joined the Eos Board of Directors as of September 7, 2022.

07:08 EDT Tiziana Life Sciences CMO purchases 100,000 common shares - Tiziana Life Sciences announces that it has been notified that Matthew Davis, its Chief Medical Officer, purchased 100,000 common shares at $0.76 per share.

07:05 EDT AirNet Technology CEO Guo to resign, Dan Shao to succeed - AirNet Technology (ANTE), formerly known as AirMedia Group, announced changes in its board of directors and management. Dan Shao, the spouse of Herman Man Guo, has been appointed as the Company's chief executive officer to replace Guo, effective from September 9, 2022. Guo has resigned as chief executive officer of the Company for personal reasons, effective from September 9, 2022. Guo will continue to serve as the chairman of the Board and interim chief financial officer of the Company. Shao has served as a managing director of Air Media International, a company wholly owned by Shao, and as a managing director of Air Joy Media Private Limited, a subsidiary of AirNet, since December 2013 and November 2019, respectively. The Board has also nominated and appointed Shao as a director of the Board, effective from September 9, 2022. Upon the effectiveness of Shao's appointment, the Board will consist of six directors, including three independent directors.

07:00 EDT Asensus Surgical, Saiseikai Shiga Hospital enter agreement for Senhance system - Asensus Surgical announced Saiseikai Shiga Hospital in Ritto, Japan has entered into an agreement to lease and utilize a Senhance Surgical System.

06:50 EDT Pfizer announces FDA, EMA acceptance of regulatory submissions for ritlecitinib - Pfizer announced that the U.S. Food and Drug Administration accepted for filing the New Drug Application for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is expected to make a decision in the second-quarter 2023. The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same patient population with a decision anticipated in the fourth-quarter 2023. Ritlecitinib is an investigational oral once daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. The submissions were based on previously announced topline results from the pivotal and dose-ranging Phase 2b/3 ALLEGRO study and an ongoing Phase 3 ALLEGRO-LT open-label, long-term study. Results from the ALLEGRO Phase 2b/3 study were presented at the 2021 European Academy of Dermatology and Venereology Congress and the 2022 American Academy of Dermatology Annual Meeting. Initial data from the ongoing ALLEGRO-LT study will be presented at the 2022 EADV Congress. Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023.

06:32 EDT Air Lease announces lease placement of two Airbus A321neo LR with HiSky - Air Lease Corporation announced long-term lease placements for two new Airbus A321neo LR aircraft with HiSky. Scheduled to deliver to the European carrier in March 2023 from ALC's order book with Airbus, these two new A321neo LRs join one Airbus A319 and four A320s currently on lease to the airline from ALC and its managed vehicles, Blackbird I and II.

06:09 EDT BitNile announces planned spinoffs creating four public companies - BitNile Holdings (NILE) announced plans that will upon completion result in its having separated into four public companies. The Company will host a conference call at 2:00 PM Pacific Time on Monday, October 17, 2022 to provide additional information on the planned spin-offs of the Company's subsidiaries, summarized below: TurnOnGreen, Inc., an electric vehicle charging and power solutions company, became a publicly traded company on September 6, 2022 pursuant to its acquisition by Imperalis Holding, a publicly traded subsidiary of BitNile that intends to change its name to TurnOnGreen, Inc. as soon as practicable; Gresham Worldwide, a global provider of proprietary, purpose-built electronic solutions to militaries and leading defense companies, among other products, became a publicly traded company on September 8, 2022 pursuant to closing of a share exchange agreement with Giga-tronics Incorporated (GIGA); Ault Alliance, a diversified holding company focused on Bitcoin mining, data center operations, commercial lending, activist investing, oil exploration, hotel operations and other commercial real estate holdings, is intended to become a public reporting company in the first half of 2023; and BitNile will after the planned spin-offs retain sufficient capital to continue development of a new Bitcoin marketplace platform to be discussed on the October 17, 2022 conference call. The spin-offs, whether completed or planned, will upon completion result in the distribution of substantially all of the Company's nearly $600M assets to its shareholders, who will become owners of four public companies. Regarding TurnOnGreen, as previously announced, the Company anticipates setting a record date whereby stockholders of BitNile will receive a dividend of securities of TurnOnGreen. BitNile expects to distribute to its stockholders approximately 140M shares of TurnOnGreen common stock and warrants to purchase an additional 140M shares of TurnOnGreen common stock, subject to regulatory approval and compliance with U.S. federal securities laws. The Company plans to cause TurnOnGreen to apply to have the warrants publicly traded. The Company plans to have Ault Alliance become a public reporting company in the first half of 2023. The capital structure, leadership team and board of directors will be determined and announced at a later time. The proposed spin-off to stockholders is subject to the satisfaction of customary conditions, including approval by the Company's board of directors, private letter rulings from the Internal Revenue Service and/or tax opinions from counsel, and the filing and effectiveness of a Form 10 registration statement with the U.S. Securities and Exchange Commission.

05:09 EDT DirecTV Go expands streaming service with Harmonic VOS 360 cloud SaaS platform - Harmonic announced that DirecTV Go, a Vrio company, is streaming more than 100 linear channels with Harmonic's VOS 360 cloud SaaS platform. The Harmonic SaaS platform is deployed by providers in the media and entertainment industry for efficiently streaming linear channels and live sports events.