Stockwinners Market Radar for October 04, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:49 EDT Facebook CTO says services 'may take some time' to become 100% functional - Facebook CTO Mike Schroepfer tweeted: "Facebook services coming back online now - may take some time to get to 100%. To every small and large business, family, and individual who depends on us, I'm sorry." Reference Link

18:39 EDT Rep. Ocasio-Cortez calls for breakup of Facebook following outage - U.S. Representative Alexandria Ocasio-Cortez, a Democrat from New York, tweeted: "If Facebook's monopolistic behavior was checked back when it should've been (perhaps around the time it started acquiring competitors like Instagram), the continents of people who depend on WhatsApp & IG for either communication or commerce would be fine right now. Break them up." Reference Link

18:25 EDT IBM CEO expects mid-single digit revenue growth over next few years - In an interview on CNBC's Mad Money, Arvind Krishna said IBM should see mid-single digit revenue growth over the next few years. In the medium-term, he expects high-single digit growth for consulting, and mid-single digit growth for IBM's software business. Krishna sees tremendous opportunity in cybersecurity.

18:01 EDT Celanese to raise prices on all acetate tow product grades by 40c per kg - Celanese announced it will raise prices of all acetate tow product grades sold globally by $0.40/kg or EUR 0.34/kg. This price increase will be effective for orders shipped on or after October 18, 2021, or as contracts otherwise allow. "Over the past 18 months, the entire industry has been confronted with a great number of challenges which structurally impact all producers. New regulatory and legislative restrictions have increased the complexity of manufacturing and portfolio requirements, leading to high utilization rates; logistics complexities including equipment and operator availability have added cost and lead-time uncertainties; and major production costs have risen sharply in response to sector demand, conversions and availability," said Harald Bruggeman, Vice President Commercial, Acetate Tow, for Celanese.

17:23 EDT Alaska Air Chairman Tilden sells almost $300K in company shares - Alaska Air Chairman Bradley Tilden sold 4,875 shares of company stock at $60.74 per share, on October 1, for a total transaction amount of $296,098.

17:06 EDT Paccar sees Q3 truck deliveries of 33,000 vehicles - The ongoing global semiconductor shortage continues to affect some industries including the automotive sector. The semiconductor shortage has reduced PACCAR's truck deliveries in the third quarter of 2021 by approximately 7,000 vehicles. PACCAR's third quarter 2021 truck deliveries are estimated to be approximately 33,000 vehicles, compared to 40,100 vehicles delivered in the second quarter of 2021. PACCAR anticipates that the semiconductor shortage and associated production inefficiencies will continue in the fourth quarter. PACCAR expects global truck production to strengthen when the supply disruptions are resolved. Global demand for the new Kenworth, Peterbilt and DAF trucks is very strong.

17:01 EDT Parsons awarded contract to compete for potential $68M U.S. Navy contract - Parsons has won a contract to compete for a potential $68M multiple-award contract to support the enterprise communications and networks division at the Naval Information Warfare Center Pacific for technical development, engineering, and strategic communications in joint and coalition environments. The contract has a three-year base period with four one-year options and will provide continuing command, control, communications, computer and intelligence systems engineering support.

16:57 EDT Agrify spikes 9% after announcing acquisition of cannabis extraction companies - Shares of Agrify, a company that develops "precision" hardware and software grow solutions for the indoor agriculture marketplace are up $1.63 per share in after-hours trading or approximately 9% to $20.10 per share after announcing it had acquired Precision Extraction Solutions and Cascade Sciences, from Sinclair Scientific. "This accretive and transformative acquisition offers us a number of critical benefits including giving us direct access to the thriving global cannabis extract vertical, which is expected to grow to $24B by 2028, increasing our potential customer base by approximately 50%, and nearly doubling our annual revenue in 2021," said CEO Raymond Chang.

16:32 EDT Horace Mann sees Q3 catastrophe losses in $35M-$40M range - Horace Mann "announced Q3 catastrophe losses are expected to be in the range of $35M to $40M, pretax, most notably driven by the effects of Hurricane Ida. Estimated losses from that storm are approximately $20 million to $25 million, largely due to policyholder losses in the Gulf states. In total, there were 24 events designated as catastrophe losses in the period by Property Claims Services compared with 30 events in the third quarter of 2020 and 17 events in the third quarter of 2019. The company continues to assume fourth-quarter catastrophe losses will be in line with the company's $7M to $9M 10-year average." CEO Marita Zuraitis states: "Third-quarter results will reflect continued strong net investment income performance, the first steps toward the sales trends we have been anticipating and the growing value of our diversification into the Supplemental business line. We will update our full-year 2021 guidance and comment on our 2022 outlook when we report third-quarter results."

16:28 EDT Resources Connection in strategic pact with consulting firm Kotter - RGP announced a strategic alliance with Kotter, "a global consulting firm that specializes in helping organizations lead through complex change. The partnership enables RGP and Kotter to accelerate joint business development initiatives, while building out their respective capabilities and increasing strategic value for clients. "We are seeing businesses across every industry adopt transformation and change initiatives more rapidly than ever before amid this rapidly evolving 'now of work' environment," said RGP CEO Kate Duchene. "Kotter's credibility and expertise in the science of change - grounded in Dr. John Kotter's empirical research at Harvard Business School over the past 40-plus years - naturally aligns with our business transformation and change management capabilities and enhances the value we provide to our clients. We are excited to integrate Kotter's proven methodology to help our clients deliver seemingly impossible results at unprecedented speed, "the company said in an earlier statement.

16:28 EDT Zeta acquires tech platform, data from Apptness, terms not disclosed - Zeta announced the acquisition of the technology platform and data from Apptness, a digital technology company with proprietary audience engagement technology. Founded in 2015, Apptness operates a digital survey platform that provides comprehensive capabilities to engage consumers on sites across the open web, deliver proprietary insights and audiences to marketers, and provide publishers with new monetization opportunities. The acquired platform will be directly integrated into the Zeta Marketing Platform, expanding and enriching the Zeta Data Cloud with over 45M monthly incremental high fidelity consumer signals. Dominik Szabo, CEO of Apptness, stated, "Apptness has differentiated itself with a strong team focused on driving innovation through dynamic and cutting-edge technology. We believe our product will complement Zeta's approach to delivering high-value return for customers. Our sales and engineering teams are proud to join this incredible organization and be a part of this rapidly growing company."

16:23 EDT Gladstone Commercial says portfolio occupancy 97%, September cash rents paid - Gladstone Commercial provided the following business update regarding its portfolio performance during a time of market volatility related to, among other factors, the global COVID-19 pandemic. 99% of September cash base rents have been paid and collected. Portfolio occupancy is in excess of 97%, as of September 30. We remain within a small subset of U.S. equity REITs that have maintained their dividend rate and payment of distributions in tandem with this high level of rental collections during the COVID-19 pandemic. We continue to execute our growth strategy. Year-to-date, we have acquired $45.855M of industrial properties, totaling 367,716 square feet, across eight properties, at an average GAAP capitalization rate of 7.7%, with a weighted average lease term of 15.5 years. On September 20, we announced that we entered into a five-year lease with a rated, investment grade tenant for half of our 320,000 square foot office building located at 717 Parmer Lane in Austin, Texas. We continue to strengthen our team with the hiring of Ryan Carter as an Executive Vice President responsible for acquisitions and the management of existing assets in the West and Midwest regions. Since January 1 and through September 30 we have issued 1.2M shares of common stock for net proceeds of $24.2M. We continue to have ample liquidity and a strong capital structure. As of September 30, our current available liquidity is approximately $33.6M via our revolving credit facility and cash on hand," noted the company in a statement.

16:22 EDT Lululemon board approves $500M boost to share repurchase program - In a regulatory filing, Lululemon said that, on October 1, 2021, its board of directors approved a $500M increase in the remaining authorization of the company's existing stock repurchase program from $141.2M to $641.2M. The repurchase authorization has no time limit and does not require the repurchase of a minimum number of shares. Common shares may be repurchased on the open market or in privately negotiated transactions, including under plans complying with the provisions of Rule 10b5-1 and Rule 10b-18 of the Securities Exchange Act of 1934. The timing and actual number of common shares to be repurchased will depend upon market conditions, eligibility to trade, and other factors.

16:19 EDT Erytech Pharma declares maximum tolerated dose of rESPECT trial - Erytech Pharma announced the maximum tolerated dose, or MTD, has been declared in a Phase 1 investigator sponsored clinical trial, or IST, named rESPECT, of its lead product candidate eryaspase for the first-line treatment of pancreatic cancer, defining the recommended dose for future clinical trials in this indication at 100 U/kg. The rESPECT IST is a single arm, dose escalating Phase 1 clinical trial to evaluate the safety of eryaspase in combination with modified Folfirinox. The trial includes pancreatic cancer patients who have received no prior chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer. Folfirinox is one of the most commonly utilized first-line chemotherapy regimens for the treatment of pancreatic cancer, despite its toxicity. Patients were treated across two dose cohorts of 75 U/kg and 100 U/kg eryaspase, with three and six patients included, respectively. After review of the safety data, the dose escalation committee concluded that the novel combination of mFolfirinox plus eryaspase was well tolerated with no DLT. Consequently, the MTD has been declared at a dose of 100 U/kg eryaspase. Interestingly, all six patients evaluated for response achieved disease control, four patients with objective response and two with stable disease. The trial will continue to enroll additional patients at the 100 U/kg dose level to further assesss the safety and clinical activity. The declared MTD of 100 U/kg eryaspase corresponds with the dose currently being used in clinical trial in second-line patients and it can now be taken forward into future late-stage clinical studies in first-line pancreatic patients. Full disclosure of both safety and efficacy information will be made at a future medical congress.

16:17 EDT Azek names Samara Toole as Chief Marketing Officer - Azek has appointed Samara Toole as the company's Chief Marketing Officer. As a member of AZEK's leadership team, Toole will help strengthen the company's brand prominence and ensure consumers and customers have a stellar and consistent experience with the company. Most recently, Toole served as CMO of California Closets.

16:14 EDT T2 Biosystems announces BARDA exercises Option 2A providing additional $6.4M - T2 Biosystems announced that the Biomedical Advanced Research and Development Authority, or BARDA, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has exercised contract Option 2A providing an additional $6.4M of funding for the multiple year cost share contract between BARDA and T2 Biosystems.

16:12 EDT Nabriva Therapeutics publishes data on anti-inflammatory activity of Xenleta - Nabriva Therapeutics published the first data to demonstrate the anti-inflammatory activity of Xenleta. Xenleta is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia in adults. In this nonclinical study of inflammatory lung disease, Xenleta potently inhibited inflammation caused by the migration of neutrophils in the lungs of mice. Importantly, Xenleta also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone and greater than that of azithromycin, a macrolide antibiotic commonly utilized for its anti-inflammatory properties. In this study, the anti-inflammatory effects of Xenleta were evaluated in a mouse model of lung inflammation induced by a toxin called lipopolysaccharide that simulates acute respiratory distress syndrome, or ARDS, similar to that seen with SARS-CoV-2 infection. Single subcutaneous doses of lefamulin resulted in reductions of several measurements of inflammation: dose-dependent reductions of bronchoalveolar lavage fluid neutrophil cell counts, pro-inflammatory cytokine, chemokine and MMP-9 levels that were comparable to or more potent than single oral/intraperitoneal dexamethasone or subcutaneous azithromycin.

16:09 EDT Novavax names Denny Kim, M.D. as SVP, Chief Safety Officer - Novavax announced the appointment of Denny Kim, M.D., MPH to the newly created role of Senior Vice President, Chief Safety Officer and Head of Global Vaccine Safety. Dr. Kim will report to Filip Dubovsky, M.D., MPH, FAAP, Executive Vice President and Chief Medical Officer. Novavax also announced the promotions of Raburn Mallory, M.D. to Senior Vice President, Head of Clinical Development, and Marco Cacciuttolo, Ph.D. to Senior Vice President, Process and Analytical Development.

16:07 EDT Group 1 Automotive acquires two dealerships in Texas - Group 1 Automotive announced the acquisition of Classic Chrysler Dodge Jeep Ram of Denton and Classic Mazda of Denton within the greater Dallas-Fort Worth metro area of Texas. These two stores are expected to generate approximately $150M in annualized revenues.

16:06 EDT Galapagos presents new data from SELECTION Phase 3 program at UEGW - Galapagos announced results of two post-hoc analyses from the SELECTION and SELECTION LTE studies, which are part of the investigational clinical program for filgotinib, for the treatment of patients with moderately to severely active UC. These analyses showed clinical benefits of continued dosing with filgotinib 200mg, an oral once-daily JAK1 preferential inhibitor, in patients who did not respond at week 10. Separately, HRQoL benefits of filgotinib 200mg treatment versus placebo, in patients with UC were shown. These data will be presented at the UEGW virtual 2021 congress .

16:06 EDT Cal-Maine Foods announces strategic investment in MeadowCreek - Cal-Maine Foods announced the company's Board of Directors has approved a strategic investment that will specialize in high value commercial product solutions targeting specific needs in the food industry. The initial focus will include hard-cooked and extended shelf-life egg product lines. The new entity, located in Neosho, Missouri, will operate as MeadowCreek Foods, LLC. Cal-Maine Foods will capitalize MeadowCreek with up to $18.5M in debt and equity to purchase property and equipment and to fund working capital. Cal-Maine Foods will retain a controlling interest in the venture. The MeadowCreek management team will be led by Ronald B. Bennett. Cal-Maine Foods will serve as the preferred provider to supply specialty and conventional eggs that MeadowCreek needs to manufacture egg products. MeadowCreek's marketing plan will expand Cal-Maine Food's reach in the foodservice and retail marketplace and bring new opportunities in the restaurant, institutional and industrial food products arena.

16:03 EDT DermTech names L'Oreal executive Keraudy to board of directors - DermTech (DMTK) announced the appointment of Nathalie Gerschtein Keraudy, President of the Consumer Products Division of L'Oreal (LRLCY), to its board of directors. "Nathalie has tremendous experience in building brands that consumers, clinicians, and the world recognize and trust," said Matt Posard, the Chairman of DermTech's board of directors. "Her unique and diverse perspectives will complement our efforts to make DermTech the trusted brand for genomic products that transform dermatologic care."

16:01 EDT Scientific Games wins two major contracts from Pennsylvania Lottery - Scientific Games announced it won a 10-year base contract from the Pennsylvania Lottery to provide its world-leading instant games and Scientific Games Enhanced Partnership for lottery instant game services, as well as a 10-year base contract to provide lottery gaming systems services across the network of nearly 10,000 Pennsylvania Lottery retailers in the Commonwealth. Supplying the Pennsylvania Lottery since its inception nearly 50 years ago, Scientific Games has a proven record, partnering with the Lottery to responsibly drive record proceeds, including 10 consecutive years of $1 billion+ profits for programs benefitting older Pennsylvanians.

15:36 EDT Amplify Energy trading resumes

15:31 EDT Amplify Energy trading halted, volatility trading pause

15:01 EDT Engine No. 1 announces investment in GM, support for all-electric fleet plans - Engine No. 1 formally announced its investment in and support for General Motors' "vision to transform its business to create an all-electric fleet and enhance long-term shareholder value." Engine No. 1 said it "has had very constructive and collaborative two-way conversations with GM. The firm's Total Value Framework places a tangible value on GM's commitment to BEVs and supports the economic case for the company's transition plans." Chris James, founder of Engine No. 1, added: "GM's goal to go 100% electric by 2035 signals one of the largest transformations in the history of the auto industry and creates an opportunity to re-center the battery supply chain in America. The company's early lead on battery technology, along with Mary Barra and the board's leadership, creates tremendous advantages. There's a narrative that only tech companies can move quickly to embrace change and win as the world changes. We don't think that's true. With the right leadership at the board and management level, incumbent companies can transform themselves and their own industry by aggressively investing in the near term in order to drive value creation over the long-term. GM has that leadership."

14:53 EDT Cleveland-Cliffs' UAW workers ratify 3-year contract at Rockport Works - Cleveland-Cliffs announced that its employees represented by the United Auto Workers Local 3044 have ratified a three-year labor contract for its Rockport Works operation. The new contract is effective from October 1, 2021 through September 30, 2024. The new contract will cover approximately 350 UAW-represented workers at Rockport. Lourenco Goncalves, Chairman, President and CEO, stated, "Our union workforce is at the core of not just what we do but American manufacturing as a whole, and we are pleased to continue our commitment to good-paying middle class jobs with a new labor agreement at Rockport. Our local team at Rockport is committed to the long-term health and success of our Company, our country, and our environment, and as such, we were able to get a deal done that is fair and equitable for both sides." Mr. Goncalves added, "We embrace our Unions as partners and allow for participation in our success. Our partnership is a powerful one, and with this latest deal, we will maintain our competitive cost structure in flat-rolled steel relative to any of our peers."

14:05 EDT AstraZeneca to pay $560,000 on alleged pay discrimination, DOL reports - The U.S. Department of Labor's Office of Federal Contract Compliance Programs has entered into a conciliation agreement with AstraZeneca to resolve alleged race and gender-based pay discrimination affecting 318 female and Hispanic employees at its North American commercial headquarters in Wilmington. Under the agreement, AstraZeneca agreed to pay $560,000 in back pay and interest to the 318 employees. Reference Link

13:29 EDT Northern Trust wants employees to be vaccinated by November 9, says Gasparino - Charles Gasparino of Fox Business Netword said via Twitter: "Northern Trust's new vaccination policy gives employees until Nov 9 to get vaccinated or exempted from vaccination or face 'disciplinary action up to and including termination.'" Reference Link

12:48 EDT IsZo announces dismissal of appeal by Nam Tai Property - IsZo Capital Management LP, which beneficially owns approximately 15% of the outstanding shares of Nam Tai Property, announced that the Eastern Caribbean Court of Appeal has dismissed Nam Tai's appeal against the Eastern Caribbean Supreme Court's March 2021 decision to void the company's October 2020 $170M private placement with Kaisa Group Holdings Limited's wholly-owned subsidiary, Greater Sail Limited, and West Ridge Investment Company Limited. The Court of Appeal's three-member panel unanimously decided to dismiss Nam Tai's appeal, IsZo said, adding that "The decision from the Court of Appeal follows the Court finding that Nam Tai's Board of Directors acted for an improper purpose when initiating the highly-dilutive private placement last year. Nam Tai told shareholders at the time that it initiated the transaction in order to 'mitigate meaningful risks to our financial stability,' but the Court rightly found that it was initiated in order to maintain Kaisa's de facto control over the Company and undermine IsZo's efforts to reconstitute the Board at a requisitioned meeting of shareholders."

12:33 EDT Some T-Mobile users reporting problems, says DownDetector - Reference Link

12:14 EDT Facebook users reporting outages, DownDetector says - Reference Link

12:10 EDT Pfizer, BioNTech receive CHMP positive opinion for Covid vaccine booster in EU

12:00 EDT Global Blue falls -17.1% - Global Blue is down -17.1%, or -$1.28 to $6.22.

12:00 EDT Amplify Energy falls -42.0% - Amplify Energy is down -42.0%, or -$2.41 to $3.34.

12:00 EDT Earthstone Energy rises 14.8% - Earthstone Energy is up 14.8%, or $1.42 to $10.95.

11:35 EDT Focus Universal Inc trading resumes

11:30 EDT Focus Universal Inc trading halted, volatility trading pause

11:24 EDT Clear Secure announces Health Pass integration with Apple's Health app - CLEAR (YOU) announced earlier that Apple (AAPL) iPhone users can now securely share verifiable health records from the Apple Health app with CLEAR's Health Pass. "With iOS 15, iPhone users who have downloaded and stored verified COVID-19 vaccination records in the Health app are now able to securely share them for use on their Health Pass for seamless access to CLEAR's nationwide network of Health Pass partner locations," the company stated.

10:33 EDT Lockheed Martin opens advanced production facility in Alabama - Lockheed Martin announced the grand opening of an advanced production facility in Courtland, Alabama, focused on hypersonic strike production. Capitalizing on critical digital factory capabilities to deliver this technology, the corporation is working closely with the U.S. Department of Defense to deliver new 21st-century warfare capabilities. The facility represents Lockheed Martin's commitment to establishing northern Alabama as the base of the company's hypersonic strike programs. The 65,000-square-foot Hypersonic Missile Assembly Building 4 is built on the digital foundation that Lockheed Martin has prioritized through mission-driven transformation efforts across the enterprise to meet customer needs with speed and agility while bolstering U.S. manufacturing capability. The second Conventional Prompt Strike production facility onsite, this location integrates critical digital transformation advancements such as robotic thermal protection application capabilities, smart torque tools and mixed-reality capabilities for training and virtual inspections. The machines in this facility also will connect to the company's Intelligent Factory Framework early next year, which digitally links production facilities and assets across the Lockheed Martin enterprise to help enable unprecedented insights into the health, status and optimization of operations. The Courtland site houses one of four manufacturing facilities Lockheed Martin is opening in the United States within one year.

10:25 EDT Protagonist announces data from Phase 2 Rusfertide study at AASLD meeting - Protagonist Therapeutics announced earlier that an abstract highlighting new results from its Phase 2 study of rusfertide in hereditary hemochromatosis, or HH, has been selected for oral presentation at The Liver Meeting 2021, hosted by the American Association for the Study of Liver Diseases, or AASLD, taking place virtually November 12-15. As previously announced on September 17, Protagonist's rusfertide clinical trials have been placed on clinical hold by the U.S. Food and Drug Administration. The company it is "working closely with the FDA to determine next steps for the rusfertide development program." Dinesh Patel, Ph.D., President and CEO of Protagonist, added: "We are pleased to have this opportunity to share new data on rusfertide that establishes clinical proof-of-concept in hereditary hemochromatosis. We are especially pleased and honored that this data has been selected by AASLD for an oral presentation. The Liver Meeting brings together the world's most esteemed experts in hepatology." In the abstract, Protagonist reported that sixteen patients, 10 male/6 female, were enrolled. Mean age and weight were 62.5 years and 88.1 kg, respectively. Average prestudy phlebotomy rate was 0.27 phlebotomies/month compared to 0.03 phlebotomies/month during study. Baseline TSAT was 45.0% compared to an average of 30.4% during study. Serum iron were reduced from 24.5 micromol/L prestudy to an average of 17.7 micromol/L during the study. LIC values were maintained at prestudy levels. There was no significant difference in average serum ferritin post-treatment relative to baseline. Average serum transferrin post-treatment was similar to baseline. Improvements were noted in SF-36 Role Physical and Role Emotional subcomponents. All treatment-related AEs were characterized as CTCAE grade 1 or 2. The conclusion states: "Rusfertide demonstrated a pharmacologic effect in reducing TSAT and serum iron. These pharmacodynamic effects corresponded with a reduced need for phlebotomy during the study, control in LIC and improvements in patient reported outcomes. These data indicate rusfertide was well tolerated in patients with HH and controls LIC in the absence of phlebotomy, supporting development of rusfertide as a treatment for HH." Reference Link

10:12 EDT Prudential announces creation of Prudential Retirement Strategies - Prudential Financial announced the creation of Prudential Retirement Strategies, a new U.S. business that will serve the retirement needs of both individual and institutional customers. Effective today, this new business, to be led by Dylan Tyson, president, Prudential Retirement Strategies, will combine the company's Individual Annuities business and Retirement Institutional Investment Products, which includes pension risk transfer and international reinsurance, among others. The company said, "The move positions Prudential with unique breadth and scale in the retirement marketplace to protect critical financial outcomes for individuals and institutions." Yanela Frias, previously president of Prudential Retirement, will become president of Prudential's Group Insurance business. Frias also retains responsibility for Prudential's full-service retirement plan recordkeeping and administration business until its sale to Empower Retirement closes, which is expected in the first quarter of 2022, pending customary regulatory approvals. Prudential's U.S. Insurance and Retirement Businesses portfolio, led by Feeney, includes oversight of Group Insurance, Individual Life Insurance, Retirement Strategies, and the Retail Advice and Solutions organization, as well as key support functions, which include Enabling Solutions and Enterprise Capabilities. Feeney continues to report to Executive Vice President and Head of U.S. Businesses Andy Sullivan.

10:08 EDT Cushman & Wakefield acquires S.C. operations of Morton G. Thalhimer - Cushman & Wakefield announced the firm has acquired the South Carolina operations of its long-time alliance member Morton G. Thalhimer, Inc., including three offices located in Charleston, Greenville and Columbia. The company said, "Founded in Glen Allen, Virginia, in the early 20th century, Thalhimer brings experience in a variety of services, including tenant representation, landlord representation, property disposition, buyer representation, property management, project management and development. Operating as a unified team, Cushman & Wakefield and alliance member firms integrate the strength of local talent, relationships and market intelligence with the full capacity of Cushman & Wakefield's resources and platform." Brett Gray, Managing Principal based in the firm's Charlotte, North Carolina, office, will oversee South Carolina operations.

10:03 EDT DraftKings expands with addition of office at UnCommons in Las Vegas - DraftKings announced its latest office location to be based out of Las Vegas, where the company expects to eventually have an expanded team of more than 1,000 employees. The company's new 90,000-square-foot technology hub will occupy much of an entire building at UnCommons, Matter Real Estate Group's 40-acre modern workplace and stylized mixed-use community coming to Southwest Las Vegas in early 2022. The DraftKings' new Las Vegas office will be the second largest for the company and will closely model its Boston headquarters, complete with a customized DraftKings-branded floor plan and collaborative workspaces, as well as access to a variety of entertainment and workstations.

10:01 EDT Priority Technology appoints Praveer Kumar as CTO, Sean Kiewiet as CSO - Priority Technology Holdings announced several new roles among its leadership team. New leadership roles include: Sanj Goyle, former CEO of Finxera, Inc., will lead Priority's consumer finance division; Praveer Kumar, former Chief Technology Officer of Finxera, was appointed Priority's new CTO, a position previously held by Sean Kiewiet; Kiewiet has been named to the newly created position of Chief Strategy Officer; Carlos Navarro, formerly with JP Morgan Chase and Elavon, has joined the company as Chief Revenue Officer.

10:00 EDT Offerpad Solutions falls -17.8% - Offerpad Solutions is down -17.8%, or -$1.50 to $6.95.

10:00 EDT Natural Resource Partners rises 8.4% - Natural Resource Partners is up 8.4%, or $2.09 to $26.91.

10:00 EDT Peabody Energy rises 11.4% - Peabody Energy is up 11.4%, or $1.79 to $17.44.

09:47 EDT Owlet falls -26.6% - Owlet is down -26.6%, or -$1.46 to $4.02.

09:47 EDT Peabody Energy rises 7.3% - Peabody Energy is up 7.3%, or $1.14 to $16.79.

09:47 EDT Teekay LNG rises 7.6% - Teekay LNG is up 7.6%, or $1.20 to $16.89.

09:37 EDT Neogen, FFA announce 2022 sponsorship agreement - NEOGEN Corporation announced that it has renewed its sponsorship agreement with the National FFA that will support the organization's 2022 Supervised Agricultural Experiences Grants. Under the terms of the agreement, NEOGEN will donate $2 to the National FFA Foundation for each bottle of Prozap StandGuard Pour-on horn fly and lice control solution that is sold from October 1, 2021, through March 31, 2022, up to a total of $250,000. StandGuard Pour-on is a powerful, low-dose, and easy-to-use treatment that provides season-long lice control for beef cattle with one application.

09:34 EDT IMAC acquires Louisiana Orthopaedic & Sports Rehab Institute - IMAC Holdings announces its expansion into Louisiana with the acquisition of the Louisiana Orthopaedic & Sports Rehab Institute, located in Baton Rouge. LOSI is a practice management company serving the Baton Rouge community since 1988. LOSI's founder, Allen Johnston, M.D., will continue to see patients at 1940 O'Neal Lane and join IMAC as a Medical Director, expanding the company's in-house expertise in orthopedic and sports medicine. Dr. Johnston graduated from the Louisiana State University School of Medicine in New Orleans in 1979 and specializes in Orthopedic Surgery and Orthopedic Trauma Surgery. LOSI was acquired on October 1, 2021, for an undisclosed combination of cash and common stock, consistent with IMAC historical transaction multiples. The center will join other IMAC Centers which access IMAC's acute injury service line providing physicians, lawyers, and referral sources a toll-free hotline for around-the-clock access to schedule patients with acute sports, accident, and work-related injuries. This enables early and appropriate assessment of acute injuries for proper medical management.

09:34 EDT BetMGM, Puyallup Tribe of Indians establish partnership - BetMGM announced an exclusive market access partnership with the Puyallup Tribe of Indians to operate retail sports betting at the Emerald Queen Casino in Washington state. "Today's announcement marks another key moment in the expansion of BetMGM as we extend our western footprint into Washington," said BetMGM CEO Adam Greenblatt. "The Puyallup Tribe and Emerald Queen Casino are ideal partners for us as they represent the same high-level of service, amenities and experiences that is built into our DNA at BetMGM." Emerald Queen Casino operates two properties in Fife and Tacoma, an expansive gaming enterprise owned by the Puyallup Tribe. Pending regulatory approvals, sports betting will be available at both locations in the near future.

09:33 EDT Kraft Heinz completes purchase of Assan Foods - The Kraft Heinz Company announced that it has completed the purchase of Assan Foods from privately held Turkish conglomerate Kibar Holding. The proposed deal was first announced on June 11, 2021. Assan Foods has been a certified Kraft Heinz production partner since 2019, Kraft said in a statement. "Assan Foods makes high-quality sauces and tomato products that we believe fit perfectly into our International Zone's growth strategy focused on Taste Elevation, and expands our presence in a part of the world that holds tremendous long-term opportunity for our company and our brands," said Rafa Oliveira, International Zone President at Kraft Heinz. "We're excited to officially welcome Assan Foods employees to the Kraft Heinz table."

09:31 EDT Kontrol Technologies receives initial BioCloud order from international HVAC - Kontrol Technologies has received an initial BioCloud order, following the signing of a Memorandum of Understanding with an international heating, cooling and ventilation on September 21st, 2021. Kontrol and the HVAC company continue to work towards a definitive distribution agreement and the potential of international manufacturing. The HVAC company is part of large global industrial conglomerate which designs, manufactures, and distributes its proprietary products through more than 30,000 distributors globally.

09:30 EDT United Fire Group announces search for CFO - UFG announced that Dawn Jaffray, Executive Vice President and Chief Financial Officer, has resigned from UFG. Ms. Jaffray notified UFG that she has accepted an opportunity to serve as Chief Financial Officer for another company within the insurance industry. UFG has appointed Kevin W. Helbing and Randy L. Patten to serve as Interim Co-Chief Financial Officers as the organization executes its search for a new CFO. Both previously served as controllers of UFG. Ms. Jaffray's departure will be effective October 10, 2021. She will work with each of the Interim Co-CFOs to transition responsibilities. UFG immediately commenced a search for the role of CFO.

09:27 EDT The Metals Company provides business update, reaffirms capital outlook - The Metals Company reaffirmed its development and capital outlook and provided a business update. TMC reaffirmed its development and capital plan through the third quarter of 2023, when it expects to submit its application to the International Seabed Authority for an Exploitation Contract for its NORI-D contract area in the Clarion-Clipperton Zone of the Pacific Ocean over 1,000 miles off the US western seaboard. As of September 30, 2021, TMC held cash and cash equivalents of approximately $113 million, which it believes will enable it to achieve four key milestones by the end of the third quarter of 2023. These include: Completion of a pilot plant program to process and refine polymetallic nodules into critical metals including nickel, copper, cobalt and manganese which are essential to the transition to clean energy and electric vehicles; Construction and deployment of the pilot collection system to lift nodules to the surface and transport them to shore where they can be processed with near-zero solid waste, no tailings or deforestation, and with careful attention to limit harm to the integrity of the deep-ocean ecosystem; Completion and submission of the Environmental Impact Assessment, a key part of one of the most comprehensive deep-sea research programs to date; and Submission of an application to the ISA for an exploitation contract for its NORI-D area of the CCZ, which is estimated to contain 356 million metric tonnes of wet nodules containing high-grade nickel, copper, cobalt and manganese mineral resources. Following the completion of the business combination between DeepGreen Metals Inc. and Sustainable Opportunities Acquisition Corp. on September 9, 2021, there have been a number of developments related to the advancement of TMC's business and strategy, including: The 228-meter-long former drill ship renamed the Hidden Gem arrived in Rotterdam on September 21, 2021, to begin its conversion into what is expected to be the first ship classified as a sub-sea mining vessel by the American Bureau of Shipping. TMC and its partner Allseas expect the vessel to be operational for pilot nodule collection tests in 2022. TMC completed the pilot smelting phase of its pyrometallurgical campaign, deriving an alloy comprised of high-grade battery metals. The smelting work was conducted in Canada in partnership with Expert Process Solutions with support from Hatch and Optimize Group. The Company launched its fourth environmental campaign this year, Expedition 5C, advancing its multi-year deep-sea research program intended to establish a rigorous environmental baseline and characterize the potential impacts of its proposed nodule collection operations, with researchers from the University of Hawaii at Mnoa, University of Maryland, Texas A&M and the Japan Agency for Marine-Earth Science and Technology. The International Seabed Authority continues to work against a two-year deadline to finalize regulations regarding deep sea mining by July 9, 2023, pursuant to the Republic of Nauru exercising its sovereign rights under Section 1, paragraph 15 of the 1994 Agreement relating to the Implementation of Part XI of the United Nations Convention on the Law of the Sea. This notice has obliged the ISA to complete the adoption of exploitation regulations within two years of the request made by the member state. If the ISA has not completed the adoption of such regulations within the prescribed time and an application for approval of a plan of work for exploitation, as TMC's subsidiary NORI intends to submit, is pending before the ISA, the ISA shall nonetheless consider and provisionally approve such plan of work. An in-person ISA Council & Assembly meeting in Kingston, Jamaica has been scheduled for December 6 - 15, 2021.

09:23 EDT Turning Point granted Breakthrough Therapy designation for repotrectinib - Turning Point Therapeutics announced the U.S. Food and Drug Administration granted a seventh regulatory designation to lead drug candidate, repotrectinib. Repotrectinib was previously granted Breakthrough Therapy designation in ROS1- positive metastatic non-small cell lung cancer patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as four Fast-Track designations in: ROS1-positive advanced NSCLC patients who are ROS1 TKI naive; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy; and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments. Repotrectinib was also granted an Orphan Drug designation in 2017.

09:22 EDT Provectus provides update on research into oral administration of PV-10 - Provectus provided an update on the Company's research into the systemic administration of Provectus' investigational immunotherapy, PV-10, for the treatments of hematology, oncology, and virology indications, in conjunction with the Company's efforts to expand its intellectual property. Hematology: On August 5, 2021, the U.S. Patent and Trademark Office published Provectus' patent application entitled "Composition and Method for Oral Treatment of Leukemia", containing: In vivo data of mice with acute lymphoblastic leukemia that received oral PV-10 and displayed increased survival. Provectus expects these and other related data from the hematology program to be published in a peer-reviewed medical journal in 2022. Oncology: On September 30, the USPTO published the Company's patent application entitled "Treatment of Solid Cancerous Tumors by Oral Administration of a Halogenated Xanthene", containing: In vivo data of mice with adenomatous polyposis coli multiple intestinal neoplasia that received oral rose bengal and displayed increased survival in both prophylactic and therapeutic settings. Virology: On September 30, the USPTO also published Provectus' patent application entitled "Novel Uses of Halogenated Xanthenes in Oncology and Virology", containing: In silico data of rose bengal's docking-based binding affinity to the main protease of the severe acute respiratory syndrome coronavirus 2, the virus' spike protein, and different variants of the spike protein, and In vitro data of PV-10's activity against SARS-CoV-2 in African green monkey kidney cell and human lung epithelial cell models, and of PV-10's synergistic activity with remdesivir in a Vero cell model. Provectus expects that data from the oncology and virology programs would be published when appropriate. The Company routinely files for patent protection in key countries in Asia, Europe, and North America.

09:20 EDT Ford reports September U.S. sales down 17.7% to 156,614 vehicles - Ford reports September U.S. sales totaled 156,614 vehicles, down 17.7% compared to the same month of last year. Ford said: "September's results made Ford the number No. 1 seller of vehicles in the U.S. for the month. August improvements in production and inventory paid off in September, with Ford's retail sales up 34.3% over the previous month, boosting Ford's retail share for the month to an estimated 12.9% - up 3.8 percentage points over August... Going into October, Ford's gross stock totaled 236,000 - up 21,000 vehicles compared to the start of September. Vehicles are moving from dealer lots to customers at the fastest pace this year, while 31% of retail sales where from previously placed customer orders. This compares to 6% last year... Ford's electrified vehicle portfolio continues to attract new customers to the brand at a higher rate than Ford overall - at a conquest rate that is 6 points above. September brought another new record for Ford electrified vehicles. Ford's electrified vehicle sales hit 9,150 - up 91.6% over last year. F-150 Lightning reservations have now surpassed the 150,000 mark, with over 75% of these reservations coming from outside of Ford."

09:18 EDT Terreno Realty acquires property in Woodinville, WA for $23.6M - Terreno Realty acquired an industrial property located in Woodinville, Washington on October 1, for a purchase price of approximately $23.6M.

09:17 EDT Ford reports September U.S. sales down 17.7% to 156,614 vehicles

09:15 EDT Apple says Watch Series 7 orders start Friday, October 8 - Apple announced Apple Watch Series 7, which it says features "the largest and most advanced Apple Watch display ever and a reengineered Always-On Retina display with significantly more screen area and thinner borders," will be available to order beginning Friday, October 8, at 5 a.m. PDT and available in stores starting Friday, October 15. Apple Watch Series 7 starts at $399 in the U.S., Apple Watch SE starts at $279 in the U.S., and Apple Watch Series 3 starts at $199 in the U.S. Reference Link

09:15 EDT Watts appoints Monica Barry as Chief Human Resources Officer - Water Technologies (WTS) announced the appointment of Monica Barry as Chief Human Resources Officer. Ms. Barry comes to Watts from Colfax Corporation (CFX) where she served as Vice President, Talent Management, Organizational Development and Corporate HR Business Partner from February 2020 to September 2021. Prior to joining Colfax, Ms. Barry served as Vice President, Global Talent, Learning & Development and Inclusion from July 2015 to January 2020 and as Vice President, Human Resources, Health Sector from August 2012 to October 2015 for Johnson Matthey, PLC. Ms. Barry has also held human resources management positions with The Campbell Soup Company and FMC Corporation. Ms. Barry holds a Bachelor of Science degree from West Virginia State University and an Executive Master of Business Administration degree from Loyola University in Maryland.

09:14 EDT Stonepeak to acquire Teekay LNG in $6.2B transaction - Teekay LNG Partners L.P. (TGP) and Stonepeak announced that they have entered into an agreement and plan of merger. Under the Merger Agreement, investment vehicles managed by Stonepeak will acquire all the issued and outstanding common units representing limited partner units in Teekay LNG, including approximately 36.0 million common units owned by Teekay Corporation (TK), and 100 percent of Teekay's ownership in Teekay LNG's general partner, Teekay GP which includes an economic ownership interest equivalent to approximately 1.6 million Teekay LNG common units, for $17.00 per common unit or common unit equivalent in cash representing an enterprise value of $6.2 billion, including consolidated and proportionate joint venture net debt, and $1.5 billion in common unit equity value. The $17.00 per unit acquisition price represents a premium of 8.3 percent to the closing price of Teekay LNG's common units on October 1, 2021 and premiums of 12.3 percent and 17.5 percent to the volume-weighted average price of Teekay LNG's common units over the last 60 and 180 days, respectively. The Transaction is the result of a review by Teekay GP's Board of Directors of strategic alternatives available to Teekay LNG. The Conflicts Committee of Teekay GP, comprised of independent directors and advised by its own independent legal and financial advisors, determined that the Transaction was advisable and in the best interests of Teekay LNG and its unitholders unaffiliated with Teekay and unanimously approved the Transaction. In considering its recommendation, the Conflicts Committee of Teekay GP was advised by Houlihan Lokey Capital, Inc. Subsequently, acting upon the recommendation of the Conflicts Committee, the Board of Directors of Teekay GP unanimously approved the Transaction and recommended that all Teekay LNG's common unitholders vote in favor of the Merger Agreement on the terms presented. The Transaction has been approved by the Board of Directors of Teekay GP and Teekay, including the unanimous approval of the Conflicts Committee of Teekay GP, and is targeted to close by the end of 2021. The Transaction remains subject to approval by a majority of Teekay LNG's common unitholders at a special meeting to be held in connection with the Transaction, and the satisfaction or waiver of certain customary closing conditions. Teekay, which currently owns approximately 41 percent of Teekay LNG's outstanding common units, has entered into a Voting and Support Agreement to vote in favor of the merger. As part of the Transaction, Teekay will transfer to Teekay LNG the ownership of the management services companies that currently deliver the operations for Teekay LNG and certain of its joint ventures under existing management services contracts. Promptly after the completion of the Transaction, the common units of Teekay LNG will be delisted from the New York Stock Exchange. The Series A and B preferred units of Teekay LNG are expected to remain outstanding and continue to trade on the New York Stock Exchange following the completion of the Transaction.

09:11 EDT RealReal expands consignment to additional categories - The RealReal founded National Consignment Day to raise awareness of the importance of resale in creating a more sustainable future for fashion and to drive shoppers to take action by recirculating items they no longer wear. To honor the holiday this year, the company is making luxury consignment easier and more expansive than ever before. Today, on the fifth annual National Consignment Day, The RealReal is launching four new circular initiatives to more significantly reduce fashion's impact: Expanding Luxury Consignment To Additional Categories: With the introduction of luxury sports and outdoor gear, collectibles and electronics, The RealReal now gives its consignors the ability to sell a broader assortment of items than any other luxury resale marketplace. Increasing Selling Flexibility With Buy Up Front: The RealReal gives consignors more choice than ever before on how they want to sell: consign, trade or get paid instantly for items they recirculate. Its Get Paid Now program offers on-the-spot payments across a wide range of brands and items, expanding nationally next week. Teaming Up With Luxury Fashion Leader Mytheresa To Drive Recirculation in U.S.:The RealReal has joined forces with leading global luxury fashion e-commerce platform Mytheresa to drive resale engagement among its rapidly growing U.S. customer base. Mytheresa will reward both its customers and The RealReal's with shopping credit for recirculating their bags and supporting the circular economy. Launching Circular ReSource Lab: An important part of the conversation about driving circularity in fashion is addressing the vast amount of items that can't live on in their current state. Today, The RealReal is launching Circular ReSource Lab, an innovation lab where it will test, learn and share to create impactful solutions to the fashion waste crisis.

09:10 EDT Converge Technology acquires LPA Software Solutions - Converge Technology Solutions is pleased to announce it has acquired business data analytics firm, LPA Software Solutions,. Headquartered in Rochester, NY with personnel in Upstate New York, Dallas, Houston, Charlotte, Boston, Pittsburgh, and Columbus, LPA provides business analytics solutions and professional services in analytics, data science, artificial intelligence, financial performance management, data governance, data integration, location analytics, and data sets. Designated as one of the full-service IBM Platinum Partners that sells, understands, and implements IBM Business Analytics software, LPA proudly supports hundreds of clients and numerous successful implementations across ten major industries.

09:08 EDT EV firm Vicinity Motor in strategic pact with JB Poindexter business unit, EAVX - Vicinity Motor announced that it has entered into a strategic collaboration agreement with the JB Poindexter business unit, EAVX, whose mission is to envision and develop next generation alternative fueled commercial work truck bodies. This collaboration will integrate EAVX bodies with the existing Vicinity bus and truck motor chassis.

09:07 EDT Relmada says FDA won't need two-year carcinogenicity study for REL-1017 filing - Relmada Therapeutics provided regulatory and development updates regarding its ongoing late-stage clinical program for REL-1017 in major depressive disorder, or MDD. RELIANCE III, the new ongoing monotherapy trial, aims to randomize 364 patients and it is expected to be completed in the second quarter of 2022. In addition, in order to support potential regulatory submissions seeking approval for REL-1017 as monotherapy and adjunctive treatment, the FDA confirmed that, based on what is known at this time, Relmada will not be required to conduct a two-year carcinogenicity study of esmethadone, or REL-1017, as sufficient pre-clinical safety data have been generated to date. The FDA also confirmed that Relmada does not need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the data provided so far and the data generated by the Phase 3 program will be adequate to evaluate the cardiac safety profile of REL-1017. "We are pleased that the RELIANCE III monotherapy registrational Phase 3 trial is up and running. We believe that this advancement is indicative of the significant potential of REL-1017 to treat MDD. Importantly, conducting RELIANCE III as a Phase 3 study may meaningfully reduce the time to potential approval for REL-1017 as MDD monotherapy. We are continuing to actively enroll patients into RELIANCE I and RELIANCE II, our MDD adjunctive treatment pivotal trials, as well as into the new RELIANCE III monotherapy study. Meanwhile, RELIANCE OLE, the open label extension safety study, which is enrolling patients from RELIANCE I, II AND III, as well as de novo patients, is progressing steadily," said Dr. Paolo Manfredi, CSO of Relmada Therapeutics.

09:07 EDT Fortiva Retail Credit renews partnership with Vivint Smart Home - Fortiva Retail Credit (ATLC) announced a multi-year renewal of its exclusive relationship with Vivint Smart Home (VVNT). As part of the renewal, Fortiva Retail Credit will offer an expanded number of term lengths. This further demonstrates Vivint's commitment to provide its customers with a variety of financing options. Building off an already successful program, which has grown during the pandemic, Fortiva Retail Credit will continue to expand the Vivint relationship beyond the 175,000 customers that have already been able to enhance their lives with Vivint's smart home technology financed through Fortiva.

09:05 EDT Itau Corpbanca launches rights offerings in connection with capital increase - ITAU CORPBANCAy announced the launch of its rights offerings in connection with the capital increase approved by the Company's shareholders on July 13, 2021. Pursuant to the capital increase, the Company is authorized to issue up to 461,111,111,111 additional common shares. The Company is offering 461,111,111,111 new common shares in the Republic of Chile and outside Chile, including common shares represented by American Depositary Shares. Each ADS represents 1,500 common shares. If fully subscribed in the rights offerings, 461,111,111,111 new shares would be placed for Ch$1.80 per share for a total of Ch$830,000,000,000, or approximately US$1,058,228,041.77, based on the Company's own exchange rate of Ch$784.33 per US$1.00 as of September 23, 2021. Each common share held of record as of 11:59 p.m. on September 28, 2021 will entitle its holder to approximately 0.899892716148 of a transferable preemptive right to subscribe for newly issued common shares. Each full Preemptive Share Right entitles the holder to subscribe for one new common share at a share subscription price of Ch$1.80 per share, payable in cash in Chilean pesos. One full Preemptive Share Right is required to subscribe for one new common share at the share subscription price. The Company will only accept subscriptions for whole common shares and will truncate or reduce any subscriptions submitted with respect to fractional rights to the nearest whole number of Preemptive Share Rights that may be exercised.

09:04 EDT Pizza Inn signs NIL deal with Arkansas State running back Lincoln Pare - Pizza Inn, a subsidary of RACE Restaurant Group, announced it has kicked off a partnership with Arkansas State second year running back, Lincoln Pare. Pare will work with the Pizza Inn brand on and off the field through autograph sessions at local restaurants, curated social media content and creation of a special discount code for use by his local community.

09:04 EDT Qualcomm and SSW Partners to acquire Veoneer for $37 per share in cash

09:02 EDT Verb Technology to host verbLIT on October 7 - Verb Technology announced that it will host its first technology showcase event called verbLIT, to be broadcast over the Company's verbLIVE, shoppable video platform. The Company's Leading Interactive Technology Symposium highlights its leading-edge, interactive video-based sales tools that increase sales productivity and customer engagement.

09:00 EDT TriLink extends EyeGene partnership for COVID-19 vaccine development - riLink BioTechnologies announced that it expects to supply its proprietary CleanCap mRNA capping technology and the modified nucleoside, uridine triphosphate, to EyeGene for production of EyeGene's mRNA COVID-19 vaccine, EG-COVID, which recently received approval to begin clinical trials from the South Korean Ministry of Food and Drug Safety. This collaboration with EyeGene is expected to represent the first clinical-stage program to use GMP-grade modified uridine triphosphate, with an intended use for further processing, manufactured by TriLink. TriLink and EyeGene met on September 21, 2021, at the KORUS Global Vaccine Business Roundtable held in New York, to discuss their continued collaboration as EyeGene advances development of its vaccine into phase 1 clinical testing and beyond.

08:58 EDT The Real Brokerage launches operations in Iowa - The Real Brokerage announced its launch of operations in Iowa. Real is now operating in 36 states, the District of Columbia and Canada. As part of the expansion, the Coluzzi Real Estate team will be joining Real. The team has with 15 core team members, including agents and construction workers.

08:56 EDT AgiiPlus, Goldenbridge Acquisition announce merger agreement - AgiiPlus announced that it has entered into a definitive merger agreement on September 30 for a business combination with Goldenbridge Acquisition, a British Virgin Islands special purpose acquisition company. Upon consummation of the transaction contemplated by the Merger Agreement, Goldenbridge will reincorporate to the Cayman Islands by merging with AgiiPlus Global Inc., a Cayman Islands exempted company and wholly owned subsidiary of Goldenbridge, and concurrently with the reincorporation merger, AgiiPlus Corporation, a Cayman Islands exempted company and wholly owned subsidiary of AgiiPlus Global, will be merged with and into AgiiPlus, resulting AgiiPlus being a wholly owned subsidiary of AgiiPlus Global. Upon the closing of the transactions, the combined company is expected to remain NASDAQ-listed under a new ticker symbol "AGII". Founded in 2016, AgiiPlus has grown to become a leading work solutions provider for rapid-change, quick-pivot enterprises in China and Singapore. To adapt to fierce competition and rapidly evolving market demands, companies are adjusting their business models to foster more agility to meet such demands. These transformative enterprises generally have organizational structure characteristics that are more flexible with higher technological attributes and are primarily focused on business development, which requires a one-stop solution that can dynamically meet various demands over their business life cycles. Relying on its proprietary technologies, AgiiPlus offers transformative integrated working solutions to its enterprise customers, including a digital office marketplace to match enterprises with landlords, customized prefabricated renovation with smart building solutions, high quality flexible workspace with plug-in software and on-demand enterprise services. As of June 30, 2021, AgiiPlus has served over 7,500 enterprise clients and 95,000 online members with a comprehensive managed area of more than 500,000 square meters. AgiiPlus has accumulated over 8,500,000 foot traffic for managed buildings and operates 50 physical agile working centers across Tier-1 and gateway cities in China and Singapore. AgiiPlus has generated a compounded annual revenue growth rate of approximately 158% from 2016 to 2020. Revenues in 2020 increased by 23.7% compared to 2019, despite the COVID-19 pandemic. The current management team of AgiiPlus will continue to run the combined Company after the transaction. Under the terms of the Merger Agreement, Goldenbridge's wholly owned subsidiary AgiiPlus Global will acquire AgiiPlus, resulting in AgiiPlus Global being a listed company on the Nasdaq Capital Market. At the effective time of such transactions, AgiiPlus' shareholders and management will receive 52 million ordinary shares of AgiiPlus Global. All shares held by existing AgiiPlus shareholders will be subject to lock-up agreements for a period of twelve months following the date the transaction closes, subject to certain exceptions The proposed transactions contemplated by the Merger Agreement valued the combined company at an estimated equity value on a pro-forma basis of approximately $578 million assuming no redemptions from the trust account.

08:53 EDT Toll Brothers, PGIM Real Estate announce JV for Georgia rental community - Toll Brothers and PGIM Real Estate have announced the formation of a new joint venture to develop Momentum Midtown, a 36-story, 376-unit luxury rental apartment community at 1018 West Peachtree Street in the heart of Atlanta's tech community. The joint venture has secured a $96 million construction loan facility from Wells Fargo Bank N.A. The debt and equity financing were arranged by Toll Brothers' in-house Finance Department. Toll Brothers Apartment Living will manage the development, marketing, leasing and property management of 1018 West Peachtree. Momentum Midtown is located within a five-minute walk of the Georgia Institute of Technology campus in Atlanta's Midtown community between the Downtown and Buckhead neighborhoods. With superior access to I-75/85, GA-400, MARTA rail stations, and Hartsfield-Jackson International Airport, the property benefits from convenient access to many of the area's major transportation corridors, employment centers and employers, including FORTUNE 500 companies such as Google, NCR, AT&T, and Coca-Cola. Atlanta has the South's second-largest pool of tech workers and the property's adjacency to Georgia Tech and its location two blocks south of Google's planned 475,000 square foot Midtown office, places it at the center of Atlanta's tech innovation community.

08:50 EDT PDS enrolls first stage of checkpoint inhibitor naive patient arm in trial - PDS Biotechnology announced the completion of enrollment for the first stage of the checkpoint inhibitor naive arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus-associated head and neck cancer. 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine. VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor. The second group of patients have failed multiple treatments including checkpoint inhibitor therapy. As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1. If objective response is achieved among at least four of the first 17 patients in the CPI naive arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naive arm. The trial is being conducted in collaboration with Merck & Co.

08:49 EDT Milestone Scientific says Memorial Regional Hospital begins use of CompuFlo - Milestone Scientific reported that Memorial Regional Hospital in Hollywood, Fla., has begun the use of the CompuFlo Epidural Instrument. Memorial Regional Hospital is the flagship facility of the healthcare system and is one of the largest hospitals in Florida. Additionally, Milestone has received approval to eventually supply its CompuFlo Epidural and CathCheck Verification System disposables across Memorial Healthcare System network of hospitals, which also includes Joe DiMaggio Children's Hospital, Memorial Regional Hospital South, Memorial Hospital West, Memorial Hospital Miramar and Memorial Hospital Pembroke.

08:47 EDT Janssen presents new data on safety profile for STELARA - The Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis of STELARA pooled safety data from 13 clinical studies across approved indications, showing rates of key safety events among adults 60 years and older treated with STELARA for up to five years were similar to rates observed with placebo during the control phase of these trials. Approved indications included adults with moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis , moderate to severe plaque psoriasis and active psoriatic arthritis. These data represent an important patient population as patients 60 years old and older are at a higher risk of disease and therapy-associated morbidity. Pooled Safety data show: Data from 13 Phase 2 and 3 studies, including six studies in CD/UC and seven studies in PsO/PsA for STELARA, were pooled. Number of events across pooled indications per 100 PYs were as follows: Overall rates for adverse events per 100 PYs were no greater for STELARA than placebo; overall rates for infections per 100 PYs were similar between STELARA and placebo; rates of serious AEs and serious infections were similar between STELARA and placebo treatment groups; and no increased risk of malignancy with STELARA was observed based on a comparison of observed versus expected malignancies. Overall, the safety profile of STELARA-treated patients 60 years old and older from the long-term pooled safety dataset across approved indications did not demonstrate higher rates on STELARA versus placebo. These data are among 13 total abstracts, including three other oral presentations, two posters of week 12 data for TREMFYA in the treatment of adults with moderately to severely active CD from the GALAXI study, and two late breakers Janssen is presenting at UEGW. TREMFYA is not currently approved for the treatment of CD in the United States.

08:45 EDT Marathon Digital produces 1,252.4 bitcoins in Q3 - Marathon Digital Holdings published unaudited bitcoin production and miner installation updates for September 2021 and announced a new $100 million revolving line of credit with Silvergate Bank. Corporate Highlights as of October 1, 2021: Produced 1,252.4 new minted bitcoins during Q3 2021, increasing production by 91% quarter-over-quarter; Produced 340.6 new minted bitcoins during September 2021, increasing total bitcoin holdings to approximately 7,035 with a fair market value of approximately $336.3 million; Cash on hand was approximately $32.9 million and total liquidity, defined as cash and bitcoin holdings, was approximately $369.1 million; Received approximately 26,960 top-tier ASIC miners from Bitmain year to date with an additional 8,459 ASIC miners currently in transit; Existing mining fleet consists of 25,272 active miners producing approximately 2.7 EH/s; Successfully added DMG Blockchain to MaraPool; On October 1, 2021, obtained a $100 million revolving line of credit, secured by bitcoin and USD, with Silvergate Bank. As of October 1, 2021, Marathon's mining fleet has produced approximately 2,098 newly minted bitcoins during 2021. By month, the Company's bitcoin production was as follows: As a result, Marathon currently holds approximately 7,035 BTC, including the 4,812.66 BTC the Company purchased in January 2021 for an average price of $31,168 per BTC. On October 1, 2021, the fair market value of one bitcoin was approximately $47,798, implying that the approximate fair market value of Marathon's current bitcoin holdings is approximately $336.3 million. As of October 1, 2021, Bitmain has delivered approximately 26,960 top-tier ASIC miners to the Company's mining facility in Hardin, MT. In September, global logistics issues began to impact shipments, elongate delivery times, and affect the original deployment schedule of miners. While deliveries of miners may continue to fluctuate in the near-term, based on current estimates, the Company still anticipates all previously purchased miners to be delivered by mid-2022. At that time, the Company's mining fleet is expected to consist of approximately 133,000 miners, generating approximately 13.3 EH/s. On October 1, 2021, Marathon secured a $100 million revolving line of credit with Silvergate Bank, which is a leading provider of innovative financial infrastructure solutions and services for the growing digital currency industry. Under the terms of the agreement, Marathon may utilize the RLOC for general corporate purposes related to the Company's bitcoin mining business, including but not limited to, the acquisition of bitcoin mining equipment. The RLOC, which is secured by bitcoin and USD, will be initially available for one year and may be renewed annually by agreement between Silvergate Bank and Marathon.

08:43 EDT Akerna closes $17M acquisition of 365 Cannabis - Akerna announced it has closed the acquisition of 365 Cannabis, a cannabis ERP and business management software system built on Microsoft's Dynamics 365 Business Central, in a $17M deal. "The 365 Cannabis acquisition represents the final piece of the puzzle for connecting cannabis compliance with mainstream ERP offerings to give our clients a choice between all of the most popular financial and operational systems," said Jessica Billingsley, Akerna CEO. "We are proud to offer cannabis operators the most comprehensive cannabis technology ecosystem of the best-in-class tax, financial, compliance, consulting, training, data analytics, product development, and more." Akerna has partnered with SAP, Sage Intacct, and other leading financial and tax planning providers to offer cannabis operators a solution for each stage of their evolution - from startup to multistate operator - while maintaining regulatory compliance through Akerna's compliance gateway. The acquisition of 365 Cannabis accelerates the deployment of this strategy with the addition of Microsoft capabilities, further establishing Akerna as the most robust cannabis-compliant ERP system offering a complete portfolio of mainstream tax and financials.

08:41 EDT Agile announces addition of Twirla to preferred drug position at Medi-Cal - Agile Therapeutics announced that the California Medicaid Program, Medi-Cal, has placed Twirla on the preferred drug formulary list as of October 1, 2021. This development secures a preferred position for Twirla on the formulary for Medi-Cal and related programs which provide health care to approximately 15 million beneficiaries. As of October 1, 2021, the preferred drug list placement for Medi-Cal will apply to those beneficiaries who receive their pharmacy benefit through fee-for-service plans and related programs like the Family Planning, Access, Care and Treatment Program, with the remainder of beneficiaries gaining access as of January 1, 2022.

08:41 EDT Frontier Communications appoints Charlon McIntosh CCOO - Frontier Communications announced that Charlon McIntosh has been appointed Chief Customer Operations Officer. Ms. McIntosh will report directly to President and Chief Executive Officer Nick Jeffery and lead enterprise-wide customer operations that deliver superior customer service experiences across Frontier. Charlon McIntosh Most recently, Ms. McIntosh was Humana's Senior Vice President of Group Military Specialty Service and Business Operations, responsible for all customer support and operations for the Employer Group, Military and Specialty lines of business. During her time at Humana she was also Head of Customer Experience, developing and enabling Humana's customer strategy, driving prioritization of experience improvement initiatives and investments, and supporting the design and transformation of the end-to-end customer experience. Using digital technology and automation, she helped modernize the customer experience and create simple and personalized care for Humana's members and providers.

08:38 EDT Realm Therapeutics provides regulatory, development updates on REL-1017 - Relmada Therapeutics provided regulatory and development updates regarding its ongoing late-stage clinical program for REL-1017 in major depressive disorder, MDD. RELIANCE III, the new ongoing monotherapy trial, aims to randomize 364 patients and it is expected to be completed in the second quarter of 2022. In addition, in order to support potential regulatory submissions seeking approval for REL-1017 as monotherapy and adjunctive treatment, the FDA confirmed that, based on what is known at this time, Relmada will not be required to conduct a two-year carcinogenicity study of esmethadone, as sufficient pre-clinical safety data have been generated to date. The FDA also confirmed that Relmada does not need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the data provided so far and the data generated by the Phase 3 program will be adequate to evaluate the cardiac safety profile of REL-1017. "We are pleased that the RELIANCE III monotherapy registrational Phase 3 trial is up and running," said Dr. Paolo Manfredi, CSO of Relmada Therapeutics. "We believe that this advancement is indicative of the significant potential of REL-1017 to treat MDD. Importantly, conducting RELIANCE III as a Phase 3 study may meaningfully reduce the time to potential approval for REL-1017 as MDD monotherapy. We are continuing to actively enroll patients into RELIANCE I and RELIANCE II, our MDD adjunctive treatment pivotal trials, as well as into the new RELIANCE III monotherapy study. Meanwhile, RELIANCE OLE, the open label extension safety study, which is enrolling patients from RELIANCE I, II AND III, as well as de novo patients, is progressing steadily."

08:37 EDT Selecta Biosciences, Takeda announce strategic licensing agreement - Selecta Biosciences (SELB) announced that it has entered into a strategic licensing agreement with Takeda Pharmaceutical Company Limited (TAK) to develop targeted, next-generation gene therapies for two indications within the field of lysosomal storage disorders. The collaboration leverages Selecta's ImmTOR platform to enable redosing of transformative therapies. Under the terms of the agreement, Selecta is entitled to receive an undisclosed upfront payment and up to $1.124 billion in future additional payments over the course of the partnership that are contingent on the achievement of development or commercial milestones or Takeda's election to continue its activities at specified development stages. Selecta is also eligible for tiered royalties on future commercial sales.

08:36 EDT Heron Therapeutics announces filing of supplemental NDA for ZYNRELEF - Heron Therapeutics announced submission of a supplemental New Drug Application, NDA, for ZYNRELEF extended-release solution for an expanded indication. ZYNRELEF is currently indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. At a recent Type C meeting with the U.S. Food and Drug Administration, Heron gained agreement on the content of the supplement for expansion of the ZYNRELEF indication statement to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures without the need for additional clinical studies. This submission is based on the consistent safety, efficacy and pharmacokinetic data from previously completed clinical trials. Alignment was also reached with the FDA on the data needed to support a future supplemental NDA to further expand the ZYNRELEF indication statement to broadly include soft tissue and orthopedic surgical procedures with pharmacodynamic, pharmacokinetic and safety data from a limited number of additional procedures. The studies in these additional surgeries are already in progress with the plan to submit the next supplement in the second half of 2022. "Our Type C meeting with the FDA was very positive, with alignment on next steps for the submission of two sequential supplemental NDAs designed to expand the ZYNRELEF indication statement in a stepwise fashion. The first label expansion is designed to significantly increase the annual number of indicated surgical procedures and the second label expansion is anticipated to broadly cover 14 million targeted surgical procedures. Based on the strength of the clinical data already generated with ZYNRELEF, the FDA agreed Heron could immediately submit the first supplement, which we have done," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Submission of the first supplement within three months of launching ZYNRELEF is a major accomplishment, with the second supplement planned for next year."

08:34 EDT AMC Entertainment sets new post-reopening weekend attendance record - AMC Entertainment announced it just set a new post-reopening record for weekend attendance, as well new post-opening records for ticket admission revenues and food & beverage sales. This was driven by the openings of Venom: Let There Be Carnage in the United States and the latest James Bond movie, No Time To Die, overseas. From Thursday September 30 through Sunday October 3, more than 2.4M people watched movies at U.S. AMC theatre locations in the United States. An additional more than 1.4M moviegoers visited AMC's theatres overseas. This brought total AMC attendance globally to approximately 3.9M, a new post-reopening record. Venom: Let There Be Carnage opened to a reported $90M for its domestic opening weekend. That estimate would make Venom: Let There Be Carnage the second-largest October opening in domestic box office history. Internationally, the success of Odeon Cinemas was driven by No Time To Die which opened to an overseas industry-wide $119M. No Time To Die also shattered various ticket sale records, including in the United Kingdom where Saturday ticket admissions revenue was the highest for one day of any film in the entire James Bond franchise dating back to its launch in 1962, some 59 years ago. No Time To Die will open in the United States this week, on October 8. Venom: Let There Be Carnage will open in Europe next week, on October 15.

08:33 EDT Greenlane appoints independent director Donald Hunter as Chairman - Greenlane Holdings, announced the appointment of independent director Donald Hunter as Chairman of the Board, effective September 30. Aaron LoCascio, the former Chairman of the Board, will remain on the Company's Board of Directors.Mr. Hunter's appointment reaffirms Greenlane's commitment to strong corporate governance and independent oversight.

08:32 EDT Centessa announces $300M financing agreement with Oberland Capital - Centessa Pharmaceuticals announced that it has entered into a $300 million financing agreement with funds managed by Oberland Capital Management. Oberland Capital will purchase up to $300 million of 6-year, interest-only, senior secured notes from the Company under the following terms: $75 million funded October 4, 2021; $125 million available to be funded in tranches of $75 million and $50 million within 24 months of First Purchase Date at the option of the Company; $100 million available to fund M&A, in-licensing, or other strategic transactions, at the option of the Company and Oberland Capital. The Notes are interest-only for the full 6-year term; principal on the Notes will be due October 4, 2027, with certain contingent and capped payments due up to ten years from First Purchase Date; Flexible structure with no financial covenants. This $300 million facility, combined with the Company's existing cash balance as of June 30, 2021, provides access to over $900 million to advance the Company's pipeline of clinical and pre-clinical programs and enables the Company to pursue strategic business development opportunities.

08:30 EDT Pioneer Power announces 'one-time' E-Bloc order from SoCalGas for $500K - Pioneer Power Solutions announced that its newly introduced E-Bloc integrated power center product will be utilized in Southern California Gas Company's H2 Hydrogen Home prototype. The one-time order is valued at approximately $500,000, and the Company expects it to be delivered in the fourth quarter of 2021. SoCalGas' H2 Hydrogen Home is a state-of-the-art demonstration project aimed at showing the role hydrogen could play in attaining California's goal of achieving carbon neutrality. Pioneer Power's E-Bloc system is a packaged electrical infrastructure solution that will integrate and control the various distributed energy resources, including an H2 Fuel Cell, PV solar and energy storage, to form an islanded microgrid that can support the power needs of the prototype two-story model home, eliminating the need for connectivity to a public utility grid. Natural gas, water and sewer will be the only utilities connected to the home.

08:29 EDT DTE Energy moves forward with plan to build MIGreenPower solar project - DTE Energy announced the company is moving forward with a plan to build its first MIGreenPower community solar project in Washtenaw County. The 20-megawatt facility will be the largest in the region and is designed to support the City of Ann Arbor and Pittsfield Township with achieving their clean energy goals. Additionally, all DTE Electric customers will have the opportunity to subscribe to this project. MIGreenPower is a voluntary renewable energy program that enables DTE customers to match their energy use to the company's wind and solar projects. Program participation accelerates the development of new wind and solar projects, moving the state closer to a carbon neutral future. This new community solar project will be located on a capped landfill and on a greenfield site owned by the City of Ann Arbor. If built, the City of Ann Arbor will serve as the project's anchor tenant, meaning it would agree to purchase power not subscribed by other customers. Pittsfield Township will be prioritized as the project's first subscriber and will use the project to reach its 100% renewable energy goal. DTE is issuing an open Request for Proposal for the engineering, procurement and construction of the project and anticipates that the project will begin generating energy in 2023.

08:26 EDT Certara completes acquisition of Pinnacle 21 - Certara announced the completion of the previously announced transaction to acquire Pinnacle 21, a provider of SaaS solutions for clinical data fitness, regulatory compliance and submission readiness. At closing, equity holders of Pinnacle 21 received approximately $250 million in cash consideration and 2,239,717 shares of Certara restricted common stock, subject to certain customary closing adjustments. The transaction is expected to be accretive to Certara's revenue, revenue growth, and adjusted EBITDA. Certara will update financial guidance when the Company releases third quarter 2021 earnings in November.

08:26 EDT Enlivex Therapeutics announces publication of data from Phase Ib Allocetra trial - Enlivex Therapeutics announced the peer-reviewed publication of clinical data from the Company's Phase Ib sepsis trial in Frontiers in Immunology, a leading journal in its field publishing rigorously peer-reviewed research articles. The paper, entitled "Apoptotic Cells for Therapeutic Use in Cytokine Storm Associated With Sepsis - A Phase Ib Clinical Trial" was published in collaboration with researchers at Hadassah-Hebrew University Medical Center and The Wohl Institute for Translational Medicine. Data presented in the paper compared 10 patients admitted to the intensive care unit with sepsis who were treated with Allocetra plus standard-of-care with 37 matched controls with sepsis who received only standard-of-care treatment at the same hospital from 2014-2019. Control patients were matched by age, gender, severity of the septic condition reflected by Sequential Organ Failure Assessment score, and infection source. The clinical trial was conducted at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel. Key data and conclusions from the paper include: Allocetra-treated patients had a mortality rate of 0% at the end of the study's 28-day follow-up period compared to a mortality rate of 27% in matched historical controls. Allocetra-treated patients exhibited rapid resolution of organ dysfunction and had significantly shorter ICU stays compared to matched controls. All patients had elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that steadily decreased following Allocetra treatment. No serious related adverse events or definite treatment-related adverse events were reported with Allocetra treatment. Allocetra is currently being evaluated in patients with pneumonia-associated sepsis in a randomized, placebo-controlled Phase IIb trial and in COVID-19 patients with acute respiratory distress syndrome in a separate randomized, placebo-controlled Phase IIb trial. Top-line data from both trials are expected in the second quarter of 2022.

08:24 EDT Keros Therapeutics presents results from preclinical study of RKER-012 - Keros Therapeutics announced that it presented results from a preclinical study of KER-012 at the American Society for Bone and Mineral Research 2021 Annual Meeting held October 1 through 4, 2021. RKER-012 prevented loss of bone volume, bone volume fraction and trabecular number, and reduced trabecular separation in a rodent PAH model. RKER-012, a Novel Activin Receptor Type II Ligand Trap, Protected Rats from Pulmonary Arterial Hypertension-Associated Bone Loss in a SUGEN/Hypoxia Model: Keros combined administration of SUGEN5416, a tyrosine kinase inhibitor of vascular endothelial growth factor receptors 1/2, with exposure to chronic hypoxia to recapitulate the biology of pulmonary arterial hypertension. A research form of KER-012 was tested in this SUGEN/hypoxia rat model of PAH. Adult male rats were subjected to SH and received either vehicle or 20 mg/kg RKER-012 twice weekly for four weeks. Rats maintained under normal oxygen conditions received only vehicle. Relative to normoxic controls, vehicle-treated SH rats had reduced bone volume, lower bone volume fraction, reduced trabecular number and increased trabecular separation. In contrast to the reduced parameters observed in vehicle-treated SH rats, treatment with RKER-012 increased bone volume, led to a higher bone volume fraction, increased trabecular number and decreased trabecular separation. Bone volume, bone volume fraction, trabecular number and trabecular separation remained equivalent to normoxic controls, which suggests that RKER-012 protected rats from PAH-induced bone loss.

08:22 EDT i3 Verticals announces acquisitions, cash consideration paid at closing was $60M - i3 Vertical announced an acquisition "that further strengthens" its focus in the Company's Healthcare vertical, said the company. The acquisition was effective on October 1. The acquired business provides comprehensive revenue cycle management and related administrative and consulting services for hospitals, including academic teaching institutions with residents, practice groups and healthcare providers primarily in the southeast. "This business leverages its secure and customizable proprietary software, seamless integrations with various medical records systems, and established relationships with payers to offer its customers prompt and reliable services.," noted the company in a statement,The Company will discuss this acquisition in further detail during its upcoming fourth quarter and year-end earnings call in November. Chairman and CEO Greg Daily commented, "This business significantly expands our presence in the Healthcare vertical. It is a rock-solid company with robust software capabilities, decades of experience with revenue cycle management, and a seasoned management team that is accustomed to growth and high customer satisfaction. This is our fourth acquisition in the Healthcare vertical, and we are pleased to continue to execute our acquisition strategy with a focus on high-growth verticals." The aggregate cash consideration paid at closing was $60,000,000.

08:20 EDT Inhibikase Therapeutics announces interim 3 month results from IkT-148009 study - Inhibikase Therapeutics announced interim three-month results from its ongoing chronic toxicology studies of oral IkT-148009 administered in rats and non-human primates. The company's ongoing toxicology studies of IkT-148009 are designed to meet the regulatory requirements for chronic dosing in humans, which include daily oral administration in rats for six months and in NHPs for nine months. In addition to these requirements, Inhibikase has added three-month dosing cohorts in rats and NHPs to support evaluation in Parkinson's patients for up to three months in its planned Phase 2a study. Today's update includes interim results at three months from both animal species, across which the toxicology profile for IkT-148009 improved the longer the drug was dosed. "As a highly selective kinase inhibitor, IkT-148009 has demonstrated it is distinct in its ability to discriminate against the target enzyme, c-Abl, without engaging other targets in the Abelson enzyme family, including c-KIT and PDGFRa-b. We believe this property may enable IkT-148009 to offer best-in-class safety, avoiding the most harmful side-effects commonly associated with c-Abl inhibitors the longer they are dosed in patients," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "We are pleased to share interim data from ongoing chronic toxicology studies that support this hypothesis, indicating a more favorable profile in rats and non-human primates given extended treatment with IkT-148009. These learnings, coupled with the absence of clinically significant adverse events in our Phase 1 study, add to our growing confidence in the safety and tolerability of IkT-148009. Taken together with efficacy signals observed preclinically, we look forward to evaluating IkT-148009 in a planned Phase 2a study, subject to FDA agreements, to see how this profile translates into patients with Parkinson's disease." Following FDA review of these three-month toxicology results, and subject to agreement with the Agency, the Company plans to initiate a Phase 2a study in 2022 to evaluate daily oral administration of IkT-148009 in up to 120 Parkinson's patients out to three months.

08:19 EDT Steelcase appoints Sara Armbruster as president, CEO - Steelcase announced today Sara Armbruster has succeeded Jim Keane as president and chief executive officer. Keane, who previously announced his plan to retire in January 2022, will continue at Steelcase as vice chair until his retirement from the company. Since joining Steelcase in 2007, she has held global executive leadership roles in multiple businesses, including Steelcase Education, Steelcase Health and PolyVision Corporation. Armbruster has a proven track record of delivering growth and innovation through strategic, results-oriented leadership. Her diverse responsibilities have included leading information technology, global design research, new business initiatives and the company's global COVID crisis response team. As CEO, Armbruster will focus on global growth strategies designed to meet evolving customer needs and will continue the company's long legacy of excellence in environmental, social and governance issues. Steelcase recently released its 2021 Impact Report, which shares progress made against goals in each of these areas, along with the company's vision to use business as a force for good.

08:18 EDT Enphase Energy expands into Italy - Enphase Energy announced it has further strengthened its presence in the European residential solar market with its expansion into Italy. Enphase will provide the IQ 7 family of microinverters to residential installers across Italy. The Enphase microinverter systems for Italy include the IQ 7 family of microinverters, the Q-Relay safety devices, and the Enphase Envoy communications gateways, which connect Enphase systems to the Enphase Enlighten monitoring platform and make per-panel energy monitoring and insights for operations and maintenance easy. The Enphase microinverter systems meet Italy's stringent regulatory requirement.

08:17 EDT Bally's announces $350M share repurchase authorization - Bally's (BALY) announced that its Board of Directors has increased the company's existing share repurchase authorization to $350M in outstanding shares of common stock. With the closing of the Gamesys (JKPTF) acquisition and the company's new $4.065B comprehensive debt package, the Bally's Board of Directors found it appropriate to increase the company's existing share repurchase authorization to maximize flexibility on capital allocation opportunities to drive long-term shareholder value. Under the repurchase program, Bally's can make repurchases from time to time using a variety of methods, including open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods, consistent with jurisdictional and U.S. Securities and Exchange requirements. The repurchase program does not obligate Bally's to acquire any particular amount of ordinary shares, and the repurchase program may be suspended or discontinued at any time at Bally's discretion.

08:15 EDT HireQuest acquires HR tech start-up Recruit Media, no terms - HireQuest announced that it has acquired Recruit Media "an HR tech start-up with a next-gen SaaS recruitment platform. The transaction was paid for with cash on hand and a modest revolver draw," the company said. Recruit Media enables candidates to create rich multimedia profiles to better differentiate themselves and convey their skills to potential employers. It also streamlines communications with text-based chat as well as in-app video chat. "The acquisition of Recruit Media brings us to the forefront of staffing and recruiting technology and enables us to differentiate our value in the eyes of our workforce and clients. Recruiting qualified workers is a pain point for businesses across America. This platform focuses on reducing this friction point, increasing throughput to our franchisees," commented Rick Hermanns, HireQuest's President and Chief Executive Officer. "Many of the features and solutions of the Recruit Media platform have been on our internal technology road map for a number of years. This acquisition accelerates that road map, saving us years of development, and provides a more robust base to build upon. Technology increasingly influences all aspects of our business and with the acquisition of Recruit Media we enable our franchisees, employees, and clients to interact with one another more efficiently. We're very excited about the opportunities this creates for our franchisees today and the opportunities it opens up for us in the future."

08:15 EDT Esports Entertainment, Alpha Esports Tech announce partnership - Alpha Esports Tech announced that it has signed a partnership with Esports Entertainment Group's newly rebranded subsidiary EEG Labs. EEG Labs was previously known as Genji. The Company and EEG Labs will develop a new computer vision tech system that allows the Company's online platform, GamerzArena, to conduct automated scoring for popular games such as Call of Duty and Fortnite. The new computer vision tech simplifies match scoring and allows GamerzArena to detect many common types of fraudulent activity, such as falsifying game outcomes. An additional benefit of this new technology involves tournament results being available instantly on the leaderboards on GamerzArena. The automated tech will allow users to have an added sense of trust for the results of tournaments and contests due to the consistency of the computer vision tech around scoring. EEG Labs will also deploy its computer vision tech to extract data from additional sources and contests to optimize content plans for the Company.

08:14 EDT ProQR Therapeutics appoints Theresa Heggie as CCO - ProQR Therapeutics announced the appointment of Theresa Heggie as Chief Commercial Officer reporting to Daniel de Boer, Founder and CEO. In this newly created leadership position, Ms. Heggie will be responsible for overseeing the Company's commercial strategy and global commercial operations. She joins as the Company prepares for the top-line results from its Phase 2/3 pivotal Illuminate trial of sepofarsen for CEP290-mediated LCA10 in the first half of 2022. Ms. Heggie most recently served as Chief Executive Officer of Freeline Therapeutics. In connection with her appointment as Chief Commercial Officer, Ms. Heggie has stepped down from the Supervisory Board of ProQR.

08:13 EDT RedHill Biopharma announces more data on opaganib global Phase 2/3 study - RedHill Biopharma reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants. These new results are from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen up to 60% at baseline. Patients with FiO2 less than or equal to 60% are still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask. "We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease. The data indicates opaganib's potential to provide an effective option, in an easy to take and distribute pill-form, to help prevent patient deterioration and mortality," said Dror Ben-Asher, RedHill's CEO. "Pinpointing the most relevant target patient population is particularly challenging with novel drugs, novel mechanisms of action and a previously unknown disease. This trial and these data have given us a clear indication of which groups of patients are likely to benefit the most from opaganib." Analyses of the FiO2 up to 60% patient subset from the opaganib Phase 2/3 study, the approximate median for FiO2 levels in the study, who were treated with either opaganib or placebo in addition to standard-of-care demonstrate consistent benefit across endpoints, in this subset of hospitalized moderately severe patients. Given the post-hoc characteristics of this subset, statistical inferences of significance cannot be formally attributed. The Company also conducted a Sensitivity Analysis to account for missing data interpretability: Mortality: Opaganib treatment resulted in a statistically significant 62% reduction in mortality; Reaching Room Air by Day 14: 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo - an efficacy benefit of 21% with opaganib; Median time to discharge: Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42; Safety: Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations.

08:13 EDT NetApp to acquire cloud optimization firm CloudCheckr, no terms disclosed - NetApp announced that it has signed a definitive agreement to acquire CloudCheckr. Financial details of the transaction are not being disclosed. As private and public sector organizations together with managed service providers have deepened investments in cloud services over the last few years, cloud cost has emerged as an obstacle to a company's acceleration to cloud. This acquisition extends Spot by NetApp's leading FinOps offerings by combining critical cost visibility and reporting from the CloudCheckr platform with continuous cost optimization and managed services from Spot by NetApp. Bringing these capabilities together will enable organizations to better understand and continuously improve their cloud resources and realize the benefits of cloud faster and at scale. NetApp continues to invest in the innovation and growth of the Spot by NetApp portfolio as a core component of its cloud strategy. The acquisition of CloudCheckr complements and expands the Spot by NetApp portfolio to create an industry leading suite of CloudOps services, and builds on the company's recent acquisition of Data Mechanics. With CloudCheckr, the Spot by NetApp portfolio will offer comprehensive cost visibility, analytics, management, and optimization to help enterprises and managed service providers continuously control their cloud infrastructure resources.

08:11 EDT Global Crossing Airlines announces LOIs for three A320 aircraft - Global Crossing Airlines Group announces the signing of letters of intent to acquire three Airbus A320 Passenger aircraft from two major aircraft lessors. The Aircraft were previously operated by Virgin America/Alaska Airlines and have full latest technology WiFi capability. Subject to the execution of definitive lease agreements, all three aircraft will be delivered and placed into service at GlobalX over the next 90 days.

08:10 EDT Arcutis Biotherapeutics submits topical roflumilast cream NDA to FDA - Arcutis Biotherapeutics announced it has submitted a new drug application to the U.S. Food and Drug Administration for roflumilast cream for the treatment of mild-to-severe plaque psoriasis. Roflumilast cream is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4, an enzyme that drives overactive immune responses. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments. Arcutis' submission is supported by positive data from Arcutis' pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy of roflumilast cream 0.3%. Roflumilast met its primary endpoint and had an 'IGA Success' rate of 42.4% compared to a vehicle rate of 6.1%, and 37.5% compared to a vehicle rate of 6.9%, in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA Success, Psoriasis Area Severity Index-75, reductions in itch as measured by the Worst Itch-Numerical Rating Scale, and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary. In trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.

08:09 EDT Curaleaf completes the acquisition of Los Suenos - Curaleaf has successfully completed the previously announced acquisition of Los Suenos Farms and its related entities, the largest outdoor grow in Colorado. Boris Jordan, Executive Chairman of Curaleaf, stated, "We're very excited about the closing of the Los Suenos acquisition. The vertical integration of our business in Colorado significantly strengthens Curaleaf's market presence in the second largest state cannabis market in the U.S. This deal provides Curaleaf with a high-quality, efficient, and low-cost supply of biomass to support our wholesale and retail customers in Colorado and, once interstate commerce is allowed, on a regional scale. Overall, our newly expanded cultivation capacity will allow us to better serve Colorado's $2.2B annual cannabis market opportunity." Following the successful completion of the Los Suenos acquisition, Curaleaf gains three Pueblo, Colorado outdoor cannabis grow facilities covering 66 acres of cultivation capacity including land, equipment and licensed operating entities; an 1,800 plant indoor grow; and two retail cannabis dispensary locations serving adult use customers. As the largest cannabis biomass producer in the state, the Los Suenos facilities will help fuel the Company's Select brand's already market-leading presence in Colorado with a variety of best-in-class cannabis products distributed to nearly 2,000 locations across 18 states. Bob DeGabrielle, Los Suenos founder and Colorado cannabis industry expert, will continue to oversee the Los Suenos operation and will take responsibility for Curaleaf's Colorado wholesale and retail businesses.

08:08 EDT CytomX Therapeutics appoints Alan Ashworth to board of directors - CytomX Therapeutics announced the appointment of Alan Ashworth to the company's board of directors. Dr. Ashworth is president, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center; senior vice president for cancer services, UCSF Health; a professor of medicine, division of hematology/oncology, department of medicine; and E. Dixon Heise Distinguished Professor in Oncology. Previously, he was chief executive officer of the Institute of Cancer Research and director of the Breakthrough Breast Cancer Center in London, U.K.

08:07 EDT Eagle Bulk Shipping announces dividend policy, share repurchase program - Eagle Bulk Shipping announced that the Company has instituted a dividend policy and a USD 50 million share repurchase program in conjunction with the closing of a USD 400 million comprehensive refinancing. Under the dividend policy, the Board of Directors intends to authorize the payment of quarterly cash dividends equal to a minimum of 30% of net income, but not less than $0.10 per share. The first dividend is scheduled to be based on the Company's Q3 2021 financial results, with payment in November. Purchases under the share repurchase program will be at the Company's discretion. The Refinancing, which closed on October 1, 2021, has significantly improved the Company's capital structure and increased financial flexibility, resulting in a reduction of approximately USD 8 million in annual interest expense, as well as an extension of the nearest bank debt maturity to the end of 2026. The new USD 400 million senior secured credit facility is comprised of a USD 300 million term loan and a USD 100 million revolving credit facility which will both be secured by 49 vessels. The Facility bears an interest rate of LIBOR plus a margin of between 2.10% and 2.80%, depending on leverage and meeting certain sustainability-linked criteria, including alignment of fleetwide carbon intensity with a decarbonization trajectory consistent with IMO targets. Proceeds from the Facility were used to repay all amounts outstanding under three existing facilities: Eagle Bulk Holdco LLC Revolving Credit Facility, Eagle Bulk Shipco LLC Senior Secured Bonds and Eagle Bulk Ultraco LLC Credit Facility. Following the Refinancing, USD 50 million remains available under the new revolving credit facility and four of the Company's vessels are outside of the Facility's collateral package and are unencumbered.

08:06 EDT HubSpot appoints Stephanie Cuthbertson as Chief Product Officer - HubSpot (HUBS) announced that Stephanie Cuthbertson will be joining the Executive Leadership Team as Chief Product Officer, effective October 4th, 2021. Cuthbertson joins HubSpot from Google (GOOG;GOOGL) where she spent eight years leading product management, design, and UX in Google Ads and Android. As HubSpot's Chief Product Officer, Cuthbertson will lead the product management, product design, and UX research organizations in close partnership with the engineering team.

08:05 EDT Zosano Pharma granted Type C Meeting with FDA regarding M207 NDA - Zosano Pharma announced the company has been granted a Type C written response only meeting with the U.S. Food and Drug Administration regarding the resubmission of the M207 505(b)(2) New Drug Application following receipt of preliminary top-line results from the pharmacokinetic study. The PK study included 48 healthy volunteers and evaluated approximately 2,500 samples utilizing lots of M207 produced with two different pieces of manufacturing equipment. The study was designed to evaluate safety and the pharmacokinetics of drug exposure levels compared to an intranasal control formulation of two 5 mg doses of zolmitriptan. The safety assessment showed that M207 was generally well tolerated, consistent with previous studies. The preliminary data from the PK analysis showed that there were no outliers with unexpected high plasma concentrations of zolmitriptan, which was a focus of the FDA, as identified in the Complete Response Letter for the original M207 NDA. Drug plasma concentration levels from M207 produced with equipment A were within range and comparable to the intranasal control. Drug plasma concentration levels of M207 produced with equipment B were lower compared to control and to M207 produced by equipment A, but within ranges consistent with approved therapeutic dose levels of zolmitriptan. The FDA had also raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of M207 in the company's clinical trials. Unless and until the company resubmits an NDA and potentially receives FDA approval, the company is unable to estimate a timeframe for product launch or revenues for 2022, if any, or beyond.

08:04 EDT Apria appoints Christopher Lee as CAO - Apria announced the appointment of Christopher Lee as Chief Accounting Officer, a newly created position. Mr. Lee will report to Debra Morris, Apria's CFO. He joined Apria in February 2009 and has risen internally to his most recent role as Senior Vice President, Accounting and Finance. Mr. Lee will oversee all aspects of Apria's accounting function, including financial reporting, controls and operations. He will also continue to lead the development, implementation and management of enterprise-wide practices, systems and internal controls.

07:51 EDT Ameresco teams with Wells County, Indiana on jail facility renovation - Ameresco announced its partnership with Wells County, Indiana on a comprehensive jail facility renovation and modernization project. Ameresco's selection as project partner follows a competitive bidding process and the rollout of a comprehensive audit of Wells County's jail facility. The audit highlighted several improvement areas for the county jail, including needed upgrades to its mechanical, electrical and plumbing infrastructure, as well as a solution to the facility's inmate containment issues. To address these issues, Ameresco will replace the jail's existing HVAC units, update its lighting with LED retrofits both inside and outside, redesign its parking lot, upgrade its controls system and remodel and build a new facility addition. Implemented improvements will enhance occupant and correctional staff safety while also saving the facility $560,000 annually. The renovations will also allow the facility to double its intake area to effectively contain inmates who may have infectious diseases, creating a safer environment for all who occupy and work at the facility. "The jail is now 35 years old and some of the original HVAC equipment is in need of replacement. In addition, the jail operations needs have changed as we now house Level 6 inmates who may require mental health and substance abuse counseling as well as other educational programs," said Wells County Sheriff Scott Holliday. "We need to adapt to these requirements, make changes to address the Covid-19 pandemic concerns and create a safe working environment for our corrections staff." Project construction will begin in October 2021 and is expected to reach completion by October of 2022.

07:50 EDT Heritage Cannabis enters medical cannabis supply agreements - Heritage Cannabis announced its subsidiary Opticann has signed two supply agreements with two well established Australian companies for the supply of medical cannabis products. The first shipment of medical cannabis CBD/CBDA filmstrips totaling $60,000 was recently completed.

07:47 EDT Stealth Biotherapeutics completes a $25M debt financing with Horizon Technology - Stealth BioTherapeutics (MITO) announced completion of a $25M long-term debt facility led by Horizon Technology Finance (HRZN). Stealth has drawn down $15M under the facility with an additional $10M available upon achievement of a predetermined milestone. "We are pleased to partner with Horizon to address our funding needs in a manner that balances our near-term capital requirements with our sensitivity to shareholder dilution," said Reenie McCarthy, CEO. "This transaction strengthens and extends our financial resources as we plan to initiate several new clinical trials in the coming months, progress our commercial planning for Barth syndrome, for which we have recently submitted an NDA that is subject to FDA review, and prepare for Phase 2 data readout in extra-foveal geographic atrophy associated with dry AMD." Fifteen million dollars of the $25M facility was funded upon closing and $5.7M of which was utilized to payoff Stealth's existing term loan with Hercules Capital. The additional $10M available under the facility may be funded upon Stealth achieving a predetermined milestone. Each advance under the debt facility will be repaid in 48 monthly payments consisting of 18 monthly payments of interest only, followed by 30 monthly payments of principal and accrued interest, and will be payable monthly in arrears. The interest-only period may be extended to 24 months contingent upon Stealth achieving certain milestones, followed by 24 monthly payments of principal and accrued interest. In connection with the financing, Stealth issued Horizon warrants to purchase up to 13,636,364 ordinary shares at an exercise price of 11c per share. Proceeds from the facility will be used to support the ongoing clinical development of key investigational product candidates within Stealth's pipeline and for general working capital purposes.

07:45 EDT AnPac Bio announces results from general population cancer risk study - AnPac Bio-Medical Science announced it has achieved a significant milestone and positive result in its general population cancer risk assessment tests and subsequent follow-up study on enrolled individuals whom obtained further check-ups and diagnosis at healthcare providers using their cancer and disease diagnostic tools. As of September 30, 2021, healthcare providers have confirmed 2,067 cancer, pre-cancer, and disease cases, which includes 22 identified types of cancer, 25 identified types of pre-cancer, and multiple other related diseases. An initial analysis showed that confirmed cases are strongly correlated to CDA test score, confirming that the CDA test is an effective method to initially screen the population for risks associated with cancer. AnPac Bio's follow-up study involved enrolling high, medium, and low risk groups of individuals based on their CDA test scores following CDA testing of a large, asymptomatic population, recommending enrolled individuals to obtain follow-up check-ups at healthcare providers, following up with enrolled individuals via phone interviews, and analyzing interview results and data. As of September 30, 2021, 14,806 individuals in the high, medium and low risk groups were contacted and interviewed, and 2,067 individuals were confirmed as cancer, pre-cancer or other disease patients. Based on an initial analysis of the most recent follow-up data and results, CDA technology is an effective initial screening tool for asymptomatic general population for multiple cancer types, pre-cancer types and other related diseases. The confirmed cancer and pre-cancer cases detected 22 types of cancer and 25 types of pre-cancer, including esophageal cancer and thyroid cancers that currently lack effective biomarkers for early screening and detection. The data demonstrates that CDA technology is also very effective in finding pre-cancer diseases as confirmed pre-cancer cases are much higher than those of confirmed cancer cases, which is very attractive and meaningful for cancer prevention. However, the confirmed cases are highly likely to be under-reported because only cases from individuals that we were able to successfully contact are recorded, some enrolled subjects did not give full final diagnosis results when contacted, and as an on-going follow-up study, more confirmed cases will likely be developed and recorded over time. Developing a viable pre-cancer and early-stage cancer screening technology is critical to detect cancer early and to save patient lives. However, its development and progress has been relatively slow, despite decades of heavy investments and efforts by leading scientists and research groups. One of the key factors has been the lack of leading detection experts to develop sensitive technologies for low level signal collection and processing. AnPac Bio has built a unique team of physicists, and experts with extensive experience from semiconductor and AI-based computational analysis to build the unique CDA technology platform. Over the past 12 years, AnPac Bio's team has innovated and developed biophysics-based detection technology, in which biophysical properties of blood are detected and analyzed for early-stage cancer screening and detection. The Company has been a staunch champion of the concept of multi-cancer detection through developing its CDA technology. The measurement of biophysical properties for cancer detection can detect multiple cancer types earlier, more cost effectively, with higher sensitivity and specificity, and through relatively simple sample requirements and test procedures. These features make AnPac Bio's CDA technology perfectly suited for screening general population for cancer affordably.

07:43 EDT Inozyme presents data from ENPP1 Deficiency Development Program - Inozyme Pharma announced the presentation of data from the Company's ENPP1 Deficiency Natural History Study and its gene therapy program for the treatment of ENPP1 Deficiency. The data were presented at the American Society for Bone and Mineral Research 2021 Annual Meeting held October 1-4. ENPP1 Deficiency is a progressive condition that manifests as a spectrum of disease. Those who present in utero or infancy are typically diagnosed with generalized arterial calcification of infancy, which is characterized by extensive vascular calcification and neointimal proliferation, resulting in myocardial infarction or cardiac or multiorgan failure. The condition is lethal in an estimated 50% of affected babies. Children and adults with ENPP1 Deficiency typically experience rickets and osteomalacia, also termed autosomal-recessive hypophosphatemic rickets type 2, and can exhibit a range of signs and symptoms that can include hearing loss, arterial calcification, cardiac, and neurological involvement. There are no approved treatments for ENPP1 Deficiency. Title: ENPP1-Deficient Patients Present With Both Skeletal Complications and Ectopic Calcification: This cross-sectional, retrospective study assessed data from 74 patients with confirmed ENPP1 variants. A total of 46% of patients demonstrated skeletal disease, with an estimated 90% of all patients expected to develop skeletal complications by 25 years. Cardiac disease was reported in 58% of patients with skeletal complications, as well as high rates of calcification of the aorta and other arteries. GACI was not reported in 25% of patients with skeletal complications; however, some of these individuals reported arterial calcification or cardiac complications. Thirty patients received conventional therapy with calcitriol and phosphate. Young ENPP1-deficient patients are at risk for skeletal complications over a broad age spectrum, warranting continued monitoring well into adolescence. As skeletal manifestations have a similar phenotype to other forms of FGF23-mediated hypophosphatemia, a history of calcification or cardiovascular disease should trigger consideration of ENPP1 Deficiency as the etiology. These data highlight implications for the appropriate diagnosis and treatment of patients with ENPP1 Deficiency. Title: Treatment with an AAV vector expressing ENPP1-Fc prevents ectopic tissue calcification and restores bone parameters in Enpp1-deficient mice. This dose-response study assessed the pharmacological effects of AAV-ENPP1-Fc, an adeno-associated virus vector expressing a modified human ENPP1-Fc under a tissue-specific promoter, when administered to murine mouse models of ENPP1 Deficiency. Clinically relevant endpoints, including plasma PPi levels, tissue calcium content assessed by a colorimetric assay, and bone parameters, were measured after 10 weeks. At 12 weeks of age, vehicle-treated mutant mice showed profound defects in long bones, including lower trabecular number and thickness and thinner cortical bone in femora, and clear signs of rickets in the growth plate. One single intravenous injection of AAV-ENPP1-Fc resulted in a robust and durable increase in plasma ENPP1 activity for the duration of the study. AAV-ENPP1-Fc administration also led to a dose-dependent increase in plasma PPi levels and prevention of soft tissue calcification. Treatment at high dose prevented pathological calcification in all the tested organs and restored bone parameters. Findings demonstrate the potential of AAV-ENPP1-Fc gene therapy to treat ENPP1 Deficiency.

07:40 EDT Novocure, Zai Lab say last patient enrolled in China TTFields combo study - Novocure (NVCR) and Zai Lab Limited (ZLAB) announced that the final patient has been enrolled in a Novocure-sponsored phase 2 pilot trial conducted by Zai Lab evaluating the safety and efficacy of Tumor Treating Fields TTFields in combination with chemotherapy as a first-line treatment in patients with gastric adenocarcinoma. Final data collection is expected in the first half of 2022. "The execution of this phase 2 pilot trial in gastric cancer reflects our commitment to bringing Tumor Treating Fields to as many patients as possible in Greater China," said Alan Sandler, M.D., President and Head of Global Development, Oncology at Zai Lab. "Gastric cancer is the third most common cancer in China in incidence and mortality and a significant unmet medical need. Late diagnosis contributes to poor prognosis in advanced gastric cancer patients. This trial, conducted entirely in China, showcases Zai's capabilities as we partner with Novocure to expand treatment options for gastric cancer patients in China." "We believe that Tumor Treating Fields' mechanism of action is broadly applicable to treat solid tumor cancers," said Asaf Danziger, Novocure's Chief Executive Officer. "We look forward to seeing results from this phase 2 pilot trial with our partner, Zai Lab, and to further exploring the potential of Tumor Treating Fields as a treatment for gastric cancer."

07:40 EDT Adamis Pharmaceuticals appoints Meera Desai to board of directors - Adamis Pharmaceuticals announced the appointment of Meera Desai, Ph.D., as a new director and member of the company's board of directors. Dr. Desai replaces Roshawn Blunt, who retired from the Board effective October 1, 2021. Dr. Desai is the founder and managing partner of Silicon Valley-based Karana Biotech, a boutique advisory firm focused on guiding pharmaceutical and biotech clients through complex international licensing, commercialization, and other strategic transactions.

07:37 EDT Miniso expands footprint in India with seven new stores - MINISO has opened seven new stores within September in India, taking the total number of stores to more than 150. The newly opened stores are located in Kolkata, Vellore, New Delhi, Pasighat, Gandhidham, and Sikar. "We see a huge potential of the Indian market and remain committed to establishing ourselves as one of the top lifestyle brands in this dynamic country," said Li Lin, General Manager of MINISO India. "Our expansion has been possible due to our swift action in response to the pandemic and our approach of combining offline and online retailing that has given our partners confidence in the MINISO brand in India. Despite the price of imported products in India increasing, we have managed to avoid price fluctuation by optimizing our online channels and expand our procurement and product lines. Following these changes, we look forward to continuing to surprise and delight our customers in our new stores."

07:36 EDT Select Energy Services closes acquisition of Agua Libre Midstream - Select Energy Services announced that, effective October 1, 2021, it has successfully closed on the acquisition of substantially all of the assets of Agua Libre Midstream and certain water-related assets and operations of Basic Energy Services and assumed liabilities in connection therewith, in each case pursuant to the terms of the stalking horse asset purchase agreement previously entered into with Basic and Agua Libre and following approval by the U.S. Bankruptcy Court for the Southern District of Texas on September 23, 2021 pursuant to Section 363 of the U.S. Bankruptcy Code. As consideration for the acquisition, Select has issued 902,593 shares of Class A common stock and paid $14.5M in cash to Basic to close the transaction, subject to standard post-closing adjustments. John Schmitz, Chairman, President and CEO, stated, "This acquisition significantly expands our produced water infrastructure footprint and further increases the Company's revenue weighting towards production-related services and solutions. This acquisition is a continuation of our strategic effort to improve and bolster our base business, advance our technology and diversification efforts, and execute on strategic consolidation opportunities. With this transaction, we will be adding more than 550,000 barrels per day of permitted daily disposal capacity in in Texas, New Mexico, Oklahoma and North Dakota, with approximately 50% of this capacity in the Permian Basin. When combined with our existing assets, this brings our company-wide permitted daily disposal capacity to approximately 2 million barrels per day... As we all know, water is vital to the health, economic, and social well-being of the communities we all live in and work in and our goal is to develop sustainable water solutions with a shared commitment to conservation. In fact, we believe that sustainable water and chemical solutions are critical to the ongoing energy transition and Select will play an important role in the advancement of solutions that are designed to meet the sustainability goals of, not only our customers, but all stakeholders. We believe the Agua Libre asset base provides a significant opportunity to continue to develop and advance these objectives," concluded Schmitz.

07:35 EDT Oragenics awarded $250,000 research grant for lantibiotics - Oragenics announced that it was awarded a small business innovation research grant in the amount of $250,000 for the company's continued research and development of lantibiotics, including its collaborative program with the Biomolecular Sciences Institute at Florida International University, or FIU. The grant provides Oragenics with funding to develop novel lantibiotics for the treatment of ESKAPE pathogens.

07:34 EDT Pacira notified of ANDA filing for EXPAREL generic - Pacira BioSciences has received a Paragraph IV Certification Notice Letter advising that eVenus Pharmaceutical Laboratories, Inc. of Princeton, New Jersey, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking authorization for the manufacturing and marketing of a generic version of EXPAREL in the United States. In the Notice Letter, eVenus alleges that the claims of an FDA Orange Book-listed patent are invalid, unenforceable and/or will not be infringed by eVenus's manufacture, use, or sale of the product described in eVenus's ANDA submission. The '495 patent marks the first deliverable from the company's comprehensive patent strategy. This Paragraph IV challenge does not account for several additional patents that are forthcoming that include three allowed patents, two of which Pacira will file for Orange Book listing, and additional patents pending. These new patents will establish multiple layers of patent protection and extend the company's proprietary position for EXPAREL into the 2040s. In February 2018, the FDA published rigorous criteria for proving bioequivalence to multivesicular liposomal bupivacaine. Matching comparative characteristics must be conducted on at least three batches of an ANDA product with at least one batch manufactured at commercial scale and include liposome composition, internal aqueous environment of the liposome, and in vitro drug release rates. Pacira is currently assessing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against eVenus. Pacira intends to vigorously defend its intellectual property rights relating to EXPAREL.

07:33 EDT Atara Biotherapeutics to receive $45M in tabelecleucel deal with Pierre Fabre - Atara Biotherapeutics and Pierre Fabre announced an exclusive commercialization agreement for tabelecleucel in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus, or EBV-positive cancers. Atara will retain full rights to tab-cel in other major markets, including North America, Asia Pacific, and Latin America. Under the terms of the agreement, Atara will receive an upfront payment of $45M, and up to approximately $320M in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application, or MAA, for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease, which is on track for November. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre. Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel is the company's lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study.

07:30 EDT OraSure awarded $109M contract for U.S. Department of Defense for InteliSwab - OraSure Technologies announced that it has been awarded a $109 million contract from the U.S. Department of Defense, in coordination with the Department of Health and Human Services, to build additional manufacturing capacity in the United States for InteliSwab COVID-19 rapid tests as part of the nation's pandemic preparedness plan. InteliSwab is a remarkably simple test that rapidly detects active COVID-19 infection. It was granted three Emergency Use Authorizations by the Food and Drug Administration in June for professional point-of-care use, prescription home use, and over-the-counter use. The federal funding will expand OraSure's production capacity by 100 million tests annually, by March 2024. An existing OraSure location in Bethlehem, Pennsylvania, will be retrofitted to accommodate increased manufacturing and an additional new facility will be added in another U.S. location to be determined. In addition to this contract, OraSure also has internally funded expansion plans to achieve 120 million tests annually by the second quarter of 2022.

07:30 EDT Xenon Pharmaceuticals trading resumes

07:28 EDT MannKind announces first patient enrolled in INHALE-1 study of AFREZZA - MannKind Corporation announced the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza in combination with basal insulin vs. multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.Enrollment is underway at several sites, including AM Diabetes & Endocrinology Center in Bartlett, Tenn., where the first patient was enrolled. In all, approximately 260 patients are planned to be enrolled at more than 30 sites across the United States.

07:27 EDT Emerita Resources receives assays for drill holes from Infanta project - Emerita Resources announces that it has received assays for five additional drill holes from the Infanta drill program at the Iberia Belt West Project. In addition to the diamond drilling, the Company has received partial results from its ongoing geophysical program that are highly encouraging. The geophysical program has been suspended until after October 20, 2021 due to hunting season in the area. Drill hole IN010 was the highlight of the current set of drill holes as it intersected 4.5 meters grading 2.4% copper, 11.2% lead, 21.1% zinc and 153.1 g/t silver and 0.54 g/t gold from 99.2 meters. Drill Hole IN013 intersected 2.2 meters grading 2.6% copper, 4.6% lead, 7.1% zinc, 196.2 g/t silver and 0.28 g/t gold from 135.6 meters which is the deepest intersection to date. Drill Hole IN009 intersected 10.5 meters grading 0.9% copper, 1.9% lead, 3.4% zinc, 55.3 g/t silver and 0.36 g/t gold from 104.2 meters. The geophysical survey is approximately 50% completed and identified significant new targets as well as demonstrating conductors associated with the known deposits persist to depths well below the existing drilling to at least 400 meters. Geological mapping and geophysical data indicate the mineralized horizon occurs within large structural blocks, bound by east-west oriented reverse faults. Importantly, this has resulted in a repetition of the mineralized horizon, and greatly expands the prospectivity for new deposits to the north of the Infanta horizon. Anomalies identified in the northern horizon are newly identified and have never been drilled. Intersection widths are expected to be approximately 90%-95% of true width. Assays were conducted at ALS Laboratories, a certified independent assay lab. Emerita has engaged the consulting firm, IGT, a specialized geophysical contractor based in Madrid, with broad international experience and a great deal of experience in the Iberian Belt in Spain and Portugal. The Geophysical survey carried out by IGT in 2013 in the vicinity of Aguas Tenidas mine was instrumental in the discovery of the Magdalena deposit, the most recent economic VMS deposit discovery in the Iberian Belt. The applied method was a combination of a gravimetry and Time Domain Electromagnetic surveys. Emerita is using the same combination of surveys that led to the successful discovery of the Magdalena deposit. The initial part of Emerita's geophysical campaign consisted of the acquisition and interpretation of the gravimetric raw data, from previous surveys carried out by the Spanish Geological Service. The gravimetric data shows two clear Bouguer anomalies separated by 800m to 1.0Km that run in parallel for about 7.0 Km in an East-West direction. The anomaly in the south is coincident with the mineralized horizon that hosts the Infanta Deposit and El Cura. The anomaly in the north has never been drilled. Both anomalies occur within the limits of the IBW exploration permit. Follow up of the gravimetric anomalies is ongoing using TEM methods, using the TURAM mode. The TEM method uses a large transmitter loop which can allow detection up to 700 - 800 meters deep. The size of the loop is 2000 meters by 1000 meters. Surveying using a mobile loop configuration is also being employed where considered more appropriated than the fix loop. The lines are setup perpendicularly to the main mineralization trend. When completed, the survey is expected to comprise 41,000 meters of fixed loop and 10,000 meters of mobile loop data. To date, 40% and 60% of the measurement with the fixed loop and the mobile loop, respectively, have been completed. The program has been temporarily suspended to accommodate the hunting season in the area. Numerous TEM anomalies over 150 Hz have been identified in the IBW project to date. From east to west, the first anomal is an 800 m long EW oriented conductor located near the eastern limit of the property and remains open to both ends. In the central area a discrete anomaly is coincident with the mineralized lenses being drilled in La Infanta. This conductor continues to the west for more than 2.0Km and the conductive plate extends beyond 400 meters depth. A third conductor is coincident with the Bouguer gravity anomaly in the north in an area that has never been drilled. Particularly intense is the anomaly detected in the western part of the IBW property, where the la Romanera deposit is located. These anomalies remain open along the east and west direction because the survey is not yet completed in this area. The area between Infanta and Romanera and to the west of Romanera are pending and will be completed after hunting season in October. The work to date is greatly improving the Company's geological understanding of the Project. A very important development is the recognition that the rocks are contained within structural blocks and that the mineralized horizon appears to have been repeated to the north of the Infanta deposit which essentially doubles the prospective stratigraphy in that area. This interpretation is supported by structural mapping and geophysical data as noted above. The orange coloured lines on Figure 2 in the center of the Project and at Romanera are planned but not yet surveyed, and will be completed following the hunting season. West of Infanta on the last line surveyed there is a one line strong conductor that appears to be the edge of the mineralized zone associate with El Cura. The small red polygon near Infanta illustrates the area where the Company is drill testing and shows that Emerita has only begun testing a very small portion of this Project.

07:24 EDT Microbix Biosystems makes early repayment of 9% interest debenture - Microbix Biosystems announces that it has completed the early repayment of a debenture series on which it owed C$ 1.3 million and was paying an interest rate of 9.0%. This debenture was issued on January 31, 2014 for an outstanding amount C$ 2.0 million and was subsequently being repaid via quarterly payments of interest and principal of $61,100. At October 1, 2021, the balance owing on this debenture was C$ 1,331,758 which has now been fully-repaid. The repayment was made on the basis of a debenture provision permitting early repayment given at least 90 days' notice. Microbix elected to fully repay this debenture due to its strong cash flow generation, which has resulted in a positive cash balance of C$ 10.0 million at September 30, 2021, additional to which Microbix has an undrawn line of credit of up to C$ 2.0 million on which it would pay an interest rate of 4.45%. It therefore made little sense to keep this 9% debenture outstanding until its scheduled maturity date of January 31, 2029. Management calculates that this early repayment will add C$ 244,400 to annual cash flow, also meaningfully reducing interest-related outlays and improving the strength of Microbix's balance sheet. As a counterpoint to the very real financial benefits of the early repayment of this debenture, there will be a one-time and non-cash charge upon Microbix's earnings in the fiscal first quarter ending December 31, 2021. This one-time and non-cash charge is created due to this early and complete repayment expunging capitalized costs associated with the terms of issuance of the debenture that were being expensed over the full term of the debenture. Under the associated "IFRS" accounting rules, the amount of that one-time and non-cash expense is estimated at $0.5 million, which will be charged against Microbix's earnings for Q1 2022 and the fiscal-year ending September 30, 2022 ("Fiscal 2022"). For clarity, Microbix expects that it will remain strongly net earnings and cash flow positive for Q1 2022 even with this one-time and non-cash charge, as it should be for the broader 12-months of Fiscal 2022.

07:23 EDT MannKind announces first patient enrolled in INHALE-1 study of Afrezza - MannKind announced the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza in combination with basal insulin vs. multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.

07:21 EDT Lyra Therapeutics presents Phase 2 LANTERN follow up data, LYR-210 PK data - Lyra Therapeutics announced that new, "positive" LYR-210 data from the LANTERN 6-month post-treatment evaluation and recently completed pharmacokinetic study, were the subject of two oral presentations at the 67th Annual Meeting of the American Rhinologic Society, or ARS, on October 1-2. Joanne Rimmer presented the LANTERN 6-month post-treatment outcomes, which showed continued safety and that about half of treated chronic rhinosinusitis, CRS, patients experienced a durable response six months post LYR-210 removal. Randall Ow presented the PK study outcomes, which showed that Mometasone Furoate, MF, blood levels were constant over the 56 days. LANTERN Study and 6-Month Post-Treatment Safety Follow-up: In the Phase 2, multicenter, blinded, randomized, controlled, dose-ranging LANTERN study of LYR-210 in surgically naive adult CRS patients who had failed previous medical management, LYR-210 was shown to be safe and well-tolerated over the 24-week treatment period. LYR-210 demonstrated significant, rapid, durable, dose-dependent, global symptom improvement, based on composite Cardinal Symptoms, CS, scores and Sino-Nasal Outcome Test, SNOT-22, achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. After 24 weeks, LYR-210 drug matrices were removed, and patients then underwent a 24-week post-treatment follow-up. The main objective of the post-treatment period was to assess long-term safety post-removal. Key results include: LYR-210 continued to show strong safety through 24 weeks post-treatment with no increased incidence of treatment-related AEs; and approximately 50% of patients experienced a durable response post-removal of LYR-210, with no worsening of Cardinal Symptom scores from the Week 24 baseline, compared to approximately 90% of control patients who either experienced a worsening of Cardinal Symptom scores from the Week 24 baseline or required a rescue treatment. LYR-210 Pharmacokinetic Study: The study was designed to characterize the early PK profile and systemic exposure of mometasone furoate, MF, of two doses of LYR-210 for up to 56 days. Plasma MF concentrations were evaluated at nine different time points throughout the study: one hour post-placement of LYR-210, and Days 2, 3, 7, 14, 21, 28, 42, and 56. Key results include: LYR-210 was safe and well-tolerated with zero serious adverse events, and achieved 100% placement success; LYR-210 delivered a constant and steady daily dose of MF over the 56 days; approximately 20% of the drug was released from LYR-210 during the 56-day study period, supporting the established 24-week drug profile; and LYR-210 achieved clinically relevant improvement in SNOT-22 within 2 weeks of treatment, with 37.5% of patients reporting a normal SNOT-22 score on Day 56.

07:19 EDT Altimmune announces initiation of 12-week Phase 1b trial of pemvidutide - Altimmune announced that it has enrolled the first patient in a Phase 1b clinical trial of pemvidutide in subjects with non-alcoholic fatty liver disease. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis, the most severe form of NAFLD. The trial is being conducted at multiple sites in the United States with Dr. Stephen Harrison, a renowned expert in the field of NASH and liver diseases, serving as the Principal Investigator. This double-blind, randomized, placebo-controlled study will enroll approximately 72 diabetic and non-diabetic overweight and obese adult patients with a liver fat content greater than 10% as measured by MRI-PDFF. Pemvidutide will be administered weekly at one of three dose levels versus placebo over 12 weeks. The primary efficacy endpoint is change in liver fat content from baseline, as measured by MRI-PDFF. Secondary efficacy endpoints include weight loss, serum lipid profile, hemoglobin A1c, adiponectin, and inflammatory and fibrosis markers. The study is expected to read out topline results in the first half of 2022. Based on the findings of the NAFLD study, the Company intends to initiate a 52-week biopsy driven Phase 2 NASH study in 2022. NAFLD is a precursor to NASH, characterized by the buildup of excess fat in liver cells, usually as a consequence of obesity. It is estimated that more than 100 million people in the United States have NAFLD, and it is now the most common form of liver disease in children. If unaddressed, the condition may progress to NASH, where the liver is chronically inflamed and becomes fibrotic, and eventually cirrhosis. The World Hepatitis Alliance recently reported that NASH is now the most common reason for a liver transplant in women, older patients and people receiving Medicare insurance in the United States. Altimmune believes the treatment of obesity is the cornerstone of treating NASH and its co-morbidities and views the treatment of obesity and NASH as significant unmet medical needs that can be addressed through significant weight loss. In a 12-week Phase 1 study in Australia, subjects receiving pemvidutide achieved mean weight losses of 4.9%, 10.3%, and 9.0% at 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with the placebo group experiencing a mean weight loss of 1.6%. Weight loss occurred rapidly and consistently over 12-weeks. Side effects were mild to moderate, with no serious or severe treatment-emergent adverse events. Importantly, pemvidutide was well-tolerated without the need for dose titration, and no discontinuations due to adverse events were reported. An Investigational New Drug application in NASH recently cleared the U.S. Food and Drug Administration review, enabling this 12-week Phase 1b trial in subjects with NAFLD. The Company has also commenced a drug-drug interaction trial in Australia and plans to initiate a trial of glucose control in patients with type 2 diabetes in the U.S. later this year. Topline data from all three trials are expected in the first half of 2022. The Company intends to file a second IND application in obesity in 2021 with plans to initiate a 48-week, Phase 2 obesity trial in H1 2022.

07:17 EDT Tonix Pharmaceuticals completes acquisition of infectious disease R&D center - onix Pharmaceuticals Holding announced it has completed the acquisition of its new research and development center located in Frederick, Md. The approximately 48,000 square foot facility will support Tonix's expanding infectious disease pipeline, including: TNX-1800 - a live virus vaccine designed to protect against COVID-19; TNX-801 - a live virus vaccine designed to protect against smallpox and monkeypox; TNX-3500 - a small molecule antiviral under development to treat COVID-19; TNX-2100 - a peptide based skin test to measure functional T cell immunity to SARS-CoV-2. Tonix purchased the RDC from Southern Research, a collaborating partner on TNX-1800 and TNX-801 development. The center is operational with a dedicated staff of scientists and technicians. The main building was constructed as a biosafety level -3 facility but has been operating at BSL-2. Tonix plans to make appropriate upgrades and seek certification for BSL-3 so that research may be conducted on live SARS-CoV-2- and other pathogens. The RDC in Frederick, Md. will complement Tonix's Advanced Development Center being constructed in New Bedford, Mass., and its Commercial Manufacturing Center planned in Hamilton, Mont. The ADC will house laboratories dedicated to process analytical development and pilot manufacturing of the Company's vaccine candidates for clinical trials. The CMC is expected to support commercial scale manufacturing of vaccine products.

07:15 EDT BioCryst reports inducement grants under Nasdaq listing rule - BioCryst Pharmaceuticals announced that the compensation committee of BioCryst's board of directors granted nine newly-hired employees inducement options to purchase an aggregate of 178,500 shares of BioCryst common stock on September 30, 2021 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $14.37 per share, which is equal to the closing price of BioCryst common stock on the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

07:14 EDT Xenon Pharmaceuticals announces topline results from Phase 2b 'X-TOLE' trial - Xenon Pharmaceuticals reported topline results from the Phase 2b X-TOLE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of XEN1101 - a differentiated Kv7 potassium channel modulator - administered as adjunctive treatment in adult patients with focal epilepsy. The trial met its primary efficacy endpoint with XEN1101 demonstrating a statistically significant and dose-dependent reduction from baseline in monthly focal seizure frequency when compared to placebo. Additional primary and secondary measures included a pairwise comparison of each active dose to placebo and a responder analysis with the proportion of patients who achieved a 50% or greater reduction in monthly focal seizure frequency from baseline. Designed as a randomized, double-blind, placebo-controlled, multicenter study, the Phase 2b X-TOLE clinical trial evaluated the clinical efficacy, safety, and tolerability of XEN1101 administered as once-daily adjunctive treatment in adult patients with focal epilepsy. The study included a total of 325 randomized and treated subjects in the safety population and 323 subjects in the modified intent to treat population for the efficacy analyses. Subjects had an average age of 40.8 +/- 13.3 years, and 8.9%, 40.3%, or 50.8% of the subjects were on and continued taking one, two, or three stable background anti-seizure medications throughout the study, respectively, and failed a median of 6 previous ASMs prior to study entry. The median baseline seizure frequency across the study groups was approximately 13.5 per month. Of the 285 subjects who completed the double-blind period, 96.5% entered the open-label extension to evaluate the long-term safety, tolerability, and effectiveness of XEN1101. Key Efficacy Findings: The primary objective of the study was to assess the dose response trend of XEN1101 in reducing monthly focal seizure frequency, based on a ranked ANCOVA model. The median percent reduction in monthly focal seizure frequency was 52.8% in the XEN1101 25 mg group, 46.4% in the XEN1101 20 mg group, and 33.2% in the XEN1101 10 mg group compared to 18.2% in the placebo group. The monotonic dose response relationship between the XEN1101 active dose groups compared to placebo was statistically significant. These data demonstrated a highly statistically significant dose-response relationship for XEN1101 in the adjunctive treatment of focal seizures in adult patients with a history of difficult-to-treat seizures. In addition, XEN1101 demonstrated a statistically significant reduction from baseline in monthly focal seizure frequency in pairwise comparisons to placebo for all three XEN1101 doses. The median percent reduction in monthly focal seizure frequency was 52.8% in the XEN1101 25 mg group, 46.4% in the XEN1101 20 mg group, and 33.2% in the XEN1101 10 mg group compared to 18.2% in the placebo group. Statistical significance was achieved for all dose groups compared to placebo with 2-sided p-values of pless than0.001 for 25 mg vs. placebo, pless than0.001 for 20 mg vs. placebo, and p=0.035 for 10 mg vs. placebo. A key secondary endpoint of the study was a responder analysis, which compared the proportion of study subjects treated with XEN1101 who achieved a greater than or equal to50% reduction in monthly focal seizures versus placebo. The percentage of subjects who achieved a greater than50% reduction in monthly focal seizures was 54.5% in the XEN1101 25 mg group, 43.1% in the XEN1101 20 mg group, and 28.3% in the XEN1101 10 mg group compared to 14.9% in the placebo group. Statistical significance was achieved for all dose groups compared to placebo with 2-sided p-values of pless than0.001 for 25 mg vs. placebo, pless than0.001 for 20 mg vs. placebo, and p=0.037 for 10 mg vs placebo. These marked reductions in seizures were associated with statistically significant improvements in overall status, as assessed by physicians using the Clinical Global Impression of Change and by subject self-reporting using the Patient Global Impression of Change scales in the XEN1101 25 mg group. In addition to the statistically significant CGI-C and PGI-C in the XEN1101 25 mg group, the XEN1101 20 mg group was statistically significant in PGI-C, while the XEN1101 20 mg group in CGI-C and the XEN1101 10 mg group for both CGI-C and PGI-C showed numerical improvements over placebo but were not statistically significant. Key Safety and Tolerability Findings: XEN1101 was generally well-tolerated in this study with adverse events consistent with other ASMs. The incidence of treatment-emergent adverse events was higher in the treatment groups as compared to the placebo group, with 62.3% of patients in the placebo group, 67.4% of patients in the XEN1101 10 mg group, 68.6% of patients in the XEN1101 20 mg group, and 85.1% of patients in the XEN1101 25 mg group experiencing at least one TEAE. The most common TEAEs across all XEN1101 dose groups were dizziness, somnolence, fatigue, and headache. Two TEAEs of urinary retention were reported in the active treatment groups, one of which required a dose reduction, and both subjects remained on drug with no other changes or intervention. Electrocardiogram interval changes were infrequent and evenly balanced between placebo and active treatment groups. There have been no TEAEs of pigmentary abnormalities reported during the double-blind phase of the study or in preliminary analysis during the ongoing open-label extension to date with approximately 70 subjects now treated more than 12 months. The incidence of treatment-emergent serious adverse events was similar in all four arms of the study with 2.6% of patients in the placebo group, 4.3% of patients in the XEN1101 10 mg group, 3.9% of patients in the XEN1101 20 mg group, and 2.6% of patients in the XEN1101 25 mg group experiencing at least one treatment-emergent SAE. There were 3.5% of subjects in the placebo group, 2.2% of subjects in the XEN1101 10 mg group, 13.7% of subjects in the XEN1101 20 mg group, and 15.8% of subjects in the XEN1101 25 mg group that had an AE leading to treatment discontinuation. Xenon intends to gather input from the U.S. Food and Drug Administration and other regulatory agencies to continue planning the future clinical development of XEN1101. In addition, the X-TOLE open-label extension, which has been expanded to three years, is expected to generate important long-term data for XEN1101.

07:13 EDT Xencor in plamotamab licensing pact with Janssen for $100M upfront, milestones - Xencor (XNCR) announced an exclusive collaboration and worldwide license agreement with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize plamotamab and novel XmAb B-cell targeting bispecific antibodies that are designed to conditionally activate T cells through the CD28 co-stimulatory receptor. Plamotamab is a CD20 x CD3 XmAb bispecific antibody and is currently completing a Phase 1 dose-escalation study in patients with CD20-expressing hematologic malignancies. "The treatment landscape in B-cell lymphoma will potentially be redefined by CD20 x CD3 bispecific antibodies, such as plamotamab, and the best outcomes for patients will require creative combination approaches using complementary mechanisms of action. We are delighted to collaborate with Janssen's leading scientists to expand the scope of the plamotamab program, particularly as we explore opportunities to combine with novel B-cell targeted CD28 bispecific antibodies that can potentially selectively enhance T-cell cytotoxic activity," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "This collaboration complements our plans to initiate combination clinical trials of plamotamab with tafasitamab and lenalidomide, and it expands our strategy to develop multiple highly active chemotherapy-free regimens for B-cell cancers." Under the terms of the agreement, Janssen will receive worldwide exclusive development and commercialization rights to plamotamab, whether as a monotherapy or in combination regimens. Xencor will collaborate with Janssen on further clinical development of plamotamab with Janssen paying 80% and Xencor paying 20% of costs, including those for a subcutaneous formulation anticipated to enter clinical trials in 2022. In parallel, Xencor will continue, at its own expense, a previously announced clinical collaboration to evaluate the combination of plamotamab, tafasitamab and lenalidomide in patients with B-cell lymphoma, including a Phase 2 trial in relapsed or refractory diffuse large B-cell lymphoma anticipated to start in late 2021 or early 2022. Xencor will receive an upfront payment of $100 million, and Johnson & Johnson Innovation - JJDC, Inc. will purchase $25 million of newly issued shares of Xencor common stock. Xencor will be eligible to receive up to $1.188B in potential development, regulatory and sales milestone payments, as well as tiered royalties on net sales of products developed under the agreement, ranging from mid-teen to low-twenties percentages for products containing plamotamab and plamotamab/CD28 bispecific antibody combinations. Separate terms apply to CD28 bispecific antibodies commercialized outside of a plamotamab combination, where Xencor retains an option to co-fund development costs in exchange for higher royalties and the right to co-detail such products in the United States.

07:11 EDT Bitfarms expands Quebec mining operations with 14 MW of hydro power - Bitfarms increased its corporate hashrate to over 1.6 Exahash per second through the expansion of operations at its Cowansville, Quebec, facility and the installation of 450 newly arrived Bitmain S19j Pro miners. The Cowansville expansion is a completely new 17 MW facility, which replaces Bitfarms first Bitcoin mining facility of 4 MW constructed in 2017. Leveraging 4 years of experience, design, and engineering advances, this facility is expected to generate greater operating efficiencies, more robust capabilities, better controls, and lower sound emissions. Hydro Quebec has commenced delivering power to the facility, effective as of October 1, 2021. The expansion increases Bitfarms' operational mining infrastructure in Quebec approximately 19% to 82 MW. Through the redeployment of existing miners and the installation of an additional 450 Bitmain S19j Pro miners, Bitfarms has increased the corporate hashrate from approximately 1.5 EH/s to approximately 1.6 EH/s.

07:10 EDT Surface Oncology sees cash runway through 2023 - Surface has expanded its existing debt facility with K2 HealthVentures, increasing the capacity to $50M. Based upon its current operating plan, including the SRF388 first-line HCC randomized Phase 2 clinical study, which includes the extended debt facility, Surface maintains a projected cash runway through 2023.

07:09 EDT Surface Oncology announces randomized Phase 2 study of SRF388 - Surface Oncology announced details about its plan to initiate a randomized Phase 2 clinical study evaluating SRF388, a potential first-in-class antibody against IL-27, in combination with Roche's atezolizumab and bevacizumab, in patients with treatment-naive hepatocellular carcinoma. Initiation-enabling activities are underway, and the Company expects to dose the first patient in early 2022. The blinded, randomized Phase 2 study is expected to enroll approximately 100 first-line patients with unresectable or metastatic HCC. Patients will be randomized to receive either SRF388 or a placebo in combination with atezolizumab and bevacizumab. The study will primarily evaluate investigator-assessed PFS of SRF388 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab. Secondary endpoints from the trial will include safety, overall response rates and duration of response. Because this is a blinded study, Surface does not expect to have detailed clinical data prior to study conclusion, but does anticipate a futility analysis in early 2023 and final data in the first half of 2024. Initial data presented at the American Society of Clinical Oncology Annual Meeting earlier this year showed SRF388 was well tolerated at all doses tested, set the recommended Phase 2 dose at 10 mg/kg every four weeks and demonstrated evidence of monotherapy activity.

07:08 EDT Centene expands Medicare Advantage offerings for 2022 - Centene announced it plans to expand its Medicare Advantage offerings, offering its range of Medicare Advantage plans in 1,575 counties across 36 states during the 2022 Medicare Annual Enrollment Period. Today, Centene serves more than 1.1M Medicare Advantage members across 33 states. Beginning in 2022, the company will offer plans in 327 new counties, representing a 26% increase, and three new states, including Massachusetts, Nebraska, and Oklahoma, bringing its total number of Medicare Advantage states to 36. Overall, Centene's expanded footprint will reach 48 million Medicare-eligible adults across the country. "As our national footprint continues to grow, we are focused on creating one Medicare brand to better align with our strategy and goals, help us deliver on our mission, and, most importantly, better serve our 1.1 million Medicare Advantage members across the country," said Rich Fisher, SVP and CEO of Medicare for Centene.

07:05 EDT Digihost Technology produces 133.02 BTC during Q3 - Digihost Technology is pleased to provide unaudited Bitcoin production updates for the quarter ended September 2021. Corporate Highlights for September 30, 2021: Produced 133.02 BTC during the quarter, increasing total holdings to 452.24 BTC representing a fair market value of approximately $19.9 million as at September 30, 2021. Diversified holdings with the conversion of 31.62 BTC into Ethereum during the quarter, bringing total ETH holdings to 1,000.89 representing a fair market value of approximately $3.0 million as at September 30, 2021. Total digital asset inventory value consisting of BTC and ETH of approximately $22.9 million at the end of September. Cash on hand at September 30th was approximately $17.2 million, and total cash and digital asset holdings was approximately $40.1 million. Year-to-date deposits on equipment and infrastructure to be completed in Q4 2021 pertaining to the Company's core business of approximately $24.8 million. Pursuant to its May 12, 2021 press release, the Company is on target to put online the approximately 9,900 newest generation miners it has purchased before the end of 2021. Once fully installed, these miners will increase the Company's current hashrate to between approximately 925PH and 1.1EH. Michel Amar, the Company's CEO, stated: "We are extremely pleased with the continued success achieved by Digihost and are proud to report that in Q3 2021 we successfully mined a higher fair market value of Bitcoin than in any previous quarter since the Company's inception. Our operations delivered a record number of coins this quarter despite voluntarily giving up peak hours of mining for five days during the month of August during peak community energy demand." Amar continued, "As a Company, we are prepared to begin receiving a large quantity of new generation miners in Q4 2021. We remain especially well situated to scale up and thrive in the current mining environment and to increase our hashrate to up to 1.5 EH in by Q1 2022. We are committed to operating our business growth in an environmentally conscious way and our priority is to sustain our focus on green energy and ESG initiatives."

07:05 EDT Enanta plans discontinuation of NASH FXR agonist programs internally - Enanta Pharmaceutical provides an update on its two clinical stage farnesoid X receptor, FXR, agonists, EDP-305 and EDP-297, for the treatment of non-alcoholic steatohepatitis, NASH. A pre-planned interim analysis of a subset of patients through week 12 in the Phase 2b ARGON-2 study of EDP-305 as a monotherapy and data from its Phase 1 clinical study of EDP-297 provided meaningful information on dose selection and characterization for these compounds. Enanta has made a business decision to prioritize combination approaches through an out-licensing strategy for further development of these two programs and does not plan to continue further development internally. "Looking at a broad range of doses in NASH patients, our interim analysis of EDP-305 in ARGON-2, in comparison to clinical data from ARGON-1, indicates that the 1.0 mg dose of EDP-305 provides the best balance of efficacy and tolerability," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "We believe that the multiple mechanisms in development for NASH today, which reflect the complex pathophysiology of this disease, make it likely that a combination approach with FXR agonists will ultimately provide the optimal treatment regimen for patients. Given this evolving landscape, we have decided to discontinue the 72-week ARGON-2 study early in favor of pursuing a combination regimen. Based on the significant data generated to date, we believe EDP-305, our lead, late-stage candidate, which has been administered in almost 600 patients for up to 12 weeks, and EDP-297, our follow-on candidate, are well-positioned to be an important component of a combination therapy to bring a much-needed treatment to patients with NASH. Going forward, we are eager to concentrate our resources on developing oral drug candidates for treating hepatitis B virus, and human respiratory diseases including respiratory syncytial virus and SARS-CoV-2."

07:04 EDT AlloVir granted orphan drug designation for posoleucel from FDA - AlloVir announced that the FDA has granted orphan drug designation, or ODD, to posoleucel for the treatment of virus-associated hemorrhagic cystitis, or HC. Posoleucel is an investigational, allogeneic, off-the-shelf, multi-virus specific T cell therapy under development for the treatment and prevention of serious diseases caused by six devastating viral pathogens: BK virus and the related polyomavirus JC virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus and adenovirus.

07:02 EDT Helix Acquisition Corp (Class A Stock) trading halted, news dissemination

06:59 EDT Community Bank System to acquire Elmira Savings Bank in $82.8M transaction - Community Bank System (CBU) and Elmira Savings Bank (ESBK) announced that they have entered into a definitive agreement pursuant to which Community Bank System's bank subsidiary, Community Bank, N.A., will acquire Elmira Savings Bank, in an all cash transaction representing total consideration valued at approximately $82.8 million. Under the terms of the agreement, shareholders of Elmira will receive $23.10 in cash for each share of common stock they own. The transaction has been unanimously approved by the boards of directors of both companies.This transaction will provide natural market enhancement and extension for both institutions, joining two high-quality, low-risk banks with long histories of personalized customer service and commitment to their communities. Elmira provides Community Bank, N.A. with improved presence in several Central New York and Southern Tier markets, including Elmira, Corning, and Ithaca, with total assets of $648.7 million, deposits of $551.2 million, net loans of $465.3 million, and 12 branch offices across a five county area. Upon completion of the transaction, the combined company is expected to have over $15.4 billion in assets. Community Bank System expects the transaction to be approximately $0.08 per share accretive to its 2022 GAAP earnings and $0.09 per share accretive to cash earnings, excluding one-time transaction costs, and expects the transaction to be approximately $0.15 per share accretive to its 2023 GAAP earnings and $0.16 per share accretive to cash earnings, excluding one-time transaction costs. The merger is expected to close in the first quarter of 2022 and is subject to customary closing conditions, including approval by the shareholders of Elmira and required regulatory approvals.

06:56 EDT Sonic Automotive appoints Thien Truong as CRO of EchoPark Automotive - Sonic Automotive announced the appointment of Thien Truong as Chief Revenue Officer of EchoPark Automotive, the Company's growing nationwide pre-owned vehicle segment, effective October 4, 2021. Truong joins Sonic's pre-owned vehicle segment from Brightloom, where he served as the company's President and Chief Revenue Officer.

06:55 EDT Digital Media Solutions launches Protect Health Insurance Agency - Digital Media Solutions announced the launch of Protect Health Insurance Agency as an approved agency to sell health insurance policies. Protect Health Insurance Agency was a key strategic initiative for DMS in 2021, launching just in time for the 2021 AEP/OEP period. Protect Health Insurance Agency is expected to start producing revenue in the fourth quarter of this year, with more meaningful contribution expected in 2022 and beyond. Using its new DBA, Protect Health Insurance Agency, DMS will continue its meaningful focus on the insurance industry, benefiting from continued secular tailwinds as the digital transformation of ad spend continues to accelerate, and demand from consumers and advertisers remains strong. Insurance, inclusive of auto, home, life and health, remains the largest vertical for DMS. DMS works with the top insurance providers, actively growing the list of insurance providers, agents - and now consumers - who buy from DMS. The recent acquisition of Crisp Results will continue to support the ongoing growth of the DMS health insurance business, aiding in the company's efforts to grow within the insurance space and guide consumers through the sales funnel from start to finish.

06:53 EDT Madrigal Pharmaceuticals announces support of Fatty Kiver Foundation - Madrigal Pharmaceuticals announces its support of the Fatty Liver Foundation, the leading patient advocacy organization focused on the diagnosis, treatment and support of Americans with non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis. Madrigal and the Fatty Liver Foundation will ring the Nasdaq closing bell to raise awareness of the need for more evidence-based screening and testing to improve diagnosis and staging of NAFLD/NASH. NAFLD is estimated to afflict more than 16 million Americans. NASH is the more severe form of NAFLD. There are more than 5 million NASH patients with significant fibrosis in the U.S. Once NASH progresses to significant liver fibrosis, the risk of adverse liver outcomes increases dramatically. In fact, NASH is currently the leading cause of liver transplants in the U.S. Additionally, patients with NASH and/or advanced fibrosis, as well as NAFLD patients with concomitant type 2 diabetes, are at high risk for adverse cardiovascular events and increased mortality. Madrigal is providing an unrestricted grant to support FLF's NAFLD Screening Fund whose primary objective is to scale-up evidence-based screening and testing for NAFLD in a community setting. These efforts would support, and potentially boost, the non-invasive screening needed to identify asymptomatic disease and diagnosing NAFLD/NASH patients at various points of progression.

06:51 EDT Ocwen announces closing with RMS to acquire Reverse Mortgage Servicing - Ocwen Financial Corporation announced that its wholly-owned subsidiary, PHH Mortgage Corporation, has completed the previously announced transaction with Reverse Mortgage Solutions and its parent, Mortgage Assets Management to acquire substantially all of the RMS reverse mortgage servicing platform and all of the outstanding equity interests in the RMS Real Estate Owned business, REO Management Solutions. MAM is a subsidiary of investment funds managed by Waterfall Asset Management. Concurrent with the closing of the transaction, PHH became the subservicer under a five-year subservicing agreement for reverse mortgages owned by RMS and MAM and assumed approximately 350 reverse servicing and REO employees. In addition, certain third-party subservicing agreements were assigned from RMS to PHH. As a result, PHH became the subservicer for approximately 57,000 reverse mortgages, or approximately $14.3 billion in unpaid principal balance, which were transferred to PHH's reverse servicing platform concurrent with the closing. Additionally, PHH expects to begin servicing its owned portfolio of approximately 34,000 reverse mortgages, or a UPB of approximately $6.7 billion, in the fourth quarter of 2021, subject to final approvals by counterparties and other customary approvals and conditions. The aggregate purchase price at closing was approximately $12.4M, subject to certain holdbacks and adjustments.

06:39 EDT Annexon appoints Ted Tednock as CIO, Larry Mattheakis as CSOProtagonist Therapeutics - Annexon (ANNX) announced the appointment of Ted Yednock, Ph.D., as chief innovation officer, and the appointment of Larry Mattheakis, Ph.D., as chief scientific officer. Yednock has served as Annexon's CSO since 2013. As CIO, he will remain a member of the executive committee, serve as chairman of the Scientific Advisory Board and continue to strengthen and integrate Annexon's key scientific findings and collaborations. Dr. Mattheakis was previously the senior vice president of discovery biology and translational research at Protagonist Therapeutics (PTGX).

06:36 EDT Kraton enters partnership with Plastship - Kraton announced a partnership with Plastship by offering CirKular+ performance enhancement and compatibilization additives on Plastship Additives Selector platform. Plastship, an European platform for recyclate procurement, is a subsidiary of RIGK GmbH, a German recycling scheme operator. By joining Platship's Additive Selector platform, CirKular+ can further enhance the performance and processability of post-consumer and post-industrial resins and broaden PCR end-use applications.

06:33 EDT Avivagen to hold webcast on deal with AB Vista - Avivagen announced it will be holding a webcast on Wednesday, October 6th at 10:30 A.M. EDT to discuss its recent sales agreement with AB Vista that was announced on Friday, October 1, 2021.

06:32 EDT Sage Therapeutics, Biogen announce data from LANDSCAPE, NEST programs - Sage Therapeutics (SAGE) and Biogen (BIIB) announced new data from the LANDSCAPE and NEST clinical development programs evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder and postpartum depression presented at the 34th European College of Neuropsychopharmacology Congress, taking place October 2-5, 2021. Presentations include data from the WATERFALL Study, a Phase 3 placebo-controlled trial evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as well as the open-label SHORELINE Study in MDD and cross-study analyses from across the LANDSCAPE and NEST programs. Collectively, the studies show reductions in depressive symptoms with zuranolone-treated patients such as consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3. Zuranolone has demonstrated a consistent safety profile in the totality of clinical data to date, with no evidence of withdrawal, weight gain, sexual dysfunction, euphoria, or sleep disruption; symptoms that are typically the cause of treatment discontinuation with current standard of care antidepressants. In pooled analyses from the LANDSCAPE and NEST programs of SF-36v2, a patient self-reported measure of general health, zuranolone treatment led to rapid improvement in quality of life and overall health across all functioning and well-being domains at Day 15 and across all domains at Day 42. Additional data presented summarized clinical data from the literature on onset of effect of current treatment options in MDD demonstrating there is a need for new treatment options with the potential for rapid response. "The collection of data presented at ECNP showcases the LANDSCAPE and NEST programs, in totality, where we have seen a very consistent and differentiated profile for zuranolone. The efficacy data across the clinical development programs have demonstrated a rapid onset of activity, consistent reductions in depressive symptoms and a two-week treatment regimen that may offer the potential to treat-as-needed. The data also include a robust safety database with more than 3,500 patients treated, showing that zuranolone has been well tolerated to date," said Steve Kanes, CMO at Sage Therapeutics. "We believe these data represent the potential for a benefit-risk profile for zuranolone that may be differentiated from the most prescribed depression drugs on the market, and may be welcomed by patients, if approved."

06:19 EDT TransUnion appoints Susan Muigai as CHRO - TransUnion (TRU) has hired Susan Muigai as Executive Vice President, Chief Human Resources Officer, effective October 4. She will be responsible for leading TransUnion's human resource strategy and function and nurturing a high-performance culture to help achieve the company's vision and strategy. She will focus on all elements of organization transformation - structure, culture, employment brand, talent and engagement - as well as oversee HR fundamentals like compensation, benefits and HR systems. Muigai joins TransUnion from Walmart (WMT), where she served most recently as Senior Vice President, People, for Walmart International supporting 550,000 employees across 23 countries.

06:15 EDT CN announces special meeting of shareholders on March 22 - CN announced that it has scheduled a Special Meeting of Shareholders in response to a requisition by CIFF Capital and TCI. The Special Meeting is scheduled to be held at 9:00 a.m. Eastern Time on Tuesday, March 22, 2022. TCI and CN have mutually agreed to the date of the Special Meeting. The company said, "CN remains committed to executing its ambitious, long-term, sustainable growth strategy, and is grateful for early expressions of support for this plan that it has received from valued shareholders, customers, partners and other key stakeholders. The Company has best-in-class corporate governance and a strong shareholder engagement program as it continues to focus on operational excellence, a customer-first culture, innovation and ESG leadership. CN's strategic plan follows a year of significant governance enhancements including the addition of three new independent directors and achieving gender parity among independent directors ahead of plan. At the Company's most recent Annual General Meeting, all directors received greater than 95% of votes in favour, and CN's say-on-pay resolution passed with 97.7% support. TCI's motives for its requisition are dubious...As recently as CN's AGM in April 2021, by all accounts it appears that TCI voted in favour of all resolutions, including director nominees, say-on-pay and the Climate Action Plan. It was only after CN disrupted TCI's and CP's plans for KCS with a revised bid that TCI increased its stake in CN and began attacking the company publicly to try to force its own agenda. The proxy contest initiated by TCI is misguided, costly and not in the best interest of CN's shareholders or its other stakeholders."

06:12 EDT Ensign Group acquires two nursing facilities in Texas, one facility in Idaho - The Ensign Group announced that it acquired the operations of the following skilled nursing facilities in Texas and Idaho: River Pointe of Trinity Healthcare and Rehabilitation Center, a 98-bed skilled nursing facility located in Trinity, Texas; Park Village Healthcare and Rehabilitation, a 150-bed skilled nursing facility located in De Soto, Texas; and Skyline Transitional Care Center, a 80-bed skilled nursing facility located in Boise, Idaho. The acquisitions were effective October 1, 2021 and will be subject to a long-term, triple net lease. This acquisition brings Ensign's growing portfolio to 245 healthcare operations, 22 of which also include senior living operations, across thirteen states. Ensign owns 95 real estate assets.

06:08 EDT ReneSola receives environmental approval for 12 MW solar plant in Spain - ReneSola announced that it recently received the environmental approval for its 12 MW solar plant located in the municipality of Caravaca in the region of Murcia in Southern Spain. The environmental approval is a milestone towards bringing the project to the "ready-to-build" phase. Construction is expected to begin in early 2022. Additionally, the company has opened a sales and business development office in Madrid, Spain to expand its sales network and customer service capabilities in the region.

06:05 EDT Earthstone Energy to acquire Midland Basin assets for $73.2M - Earthstone Energy announced that it has entered into definitive agreements to acquire privately held operated assets located in the Midland Basin from two sellers unaffiliated with Earthstone. The aggregate purchase price of the bolt-on acquisition is approximately $73.2M consisting of $49.2M in cash, subject to customary purchase price adjustments, and approximately 2.6M shares of Earthstone's Class A common stock valued at $24M based on a closing share price of $9.20 on September 30. The bolt-on acquisition is expected to close by the middle of the Q4 with an effective date of July 1. Assets include average daily production of 4,400 Boepd during September and projected next twelve months adjusted EBITDAX of approximately $42M with $116M PDP PV-10 as of July 1 as well as associated reserves of approximately 13.3 MMBoe. The consideration for the transaction consists of 2,611,111 shares of Earthstone's Class A common stock, which represents approximately 3% of the total outstanding Class A and Class B common stock on a pro forma basis, and approximately $49.2M of cash, subject to customary purchase price adjustments from the July 1 effective date to closing. Earthstone intends to fund the cash portion of the consideration and fees and expenses with cash on hand and borrowings under its revolving credit facility, which currently has a borrowing base of $650M. As of August 31 and adjusting for the current borrowing base of $650M, Earthstone had liquidity of approximately $365M based on the $363.4M of undrawn borrowing base capacity and $1.2M in cash.

06:03 EDT Maxar Technologies awarded G-EGD contract renewal by U.S. government - Maxar Technologies announced it has been awarded an Option Year 2 contract renewal by the U.S. National Geospatial-Intelligence Agency for the Global Enhanced GEOINT Delivery program. The contract, which began September 1, 2021, is valued at $44 million. This is the second of three option years for the contract, which has a total value of up to $176M. With this award, Maxar will continue to provide more than 400,000 U.S. government users with unclassified, online and offline, on-demand access to high-resolution commercial imagery from Maxar in addition to geospatial data from other industry providers. Since 2011, the G-EGD program has enabled warfighters, first responders, intelligence analysts and civil government users to tap into Maxar's 125-petabyte historical imagery library and daily imagery collections for time-sensitive, mission-critical planning and operations.

05:46 EDT Galapagos completes DIVERSITY patient enrollment, assumes responsibility - Galapagos (GLPG) announced randomization of the last patient into the multi-center, global DIVERSITY Phase 3 study. The study is designed to evaluate the efficacy and safety of filgotinib, a JAK1 preferential inhibitor, in the induction and maintenance of remission in patients with Crohn's Disease, or CD. The DIVERSITY study enrolled 1,374 participants with moderately to severely active CD, including biologic-naive and biologic-experienced patients. In agreement with Gilead (GILD), Galapagos will assume sponsorship of and operational and financial responsibility for the ongoing DIVERSITY clinical study, evaluating filgotinib in CD, and its long-term extension study. The parties intend to complete the transfer no later than June 30, 2022. Under the terms of the agreement and upon completion of the transfer, Gilead will make a one-time payment of $15M to Galapagos in consideration for Galapagos assuming responsibility for the DIVERSITY clinical study. From April 1, 2022, Galapagos will also be solely responsible for all development costs for the DIVERSITY clinical study. In addition, if the European Medicines Agency grants regulatory approval of filgotinib for the treatment of CD based on data from the DIVERSITY trial, then royalties payable by Galapagos to Gilead will be reduced by 30% across all filgotinib indications and will become 5.6 to 10.5% of net sales in Europe. These royalties are payable as of 2024. Gilead remains responsible for commercial activities outside of Europe.

05:29 EDT Perion Network acquires Vidazoo for $93.5M - Perion Network announced the acquisition of Vidazoo, a technology company that enables both advertisers and publishers to deliver high impact content and advertising to consumers. Perion acquired Vidazoo for a total amount of $93.5M, consisting of $35M in cash upon closing with an additional maximum of $58.5M structured as a performance earn-out, if certain EBITDA-based targets are achieved. Vidazoo, founded in 2014 by Daniel Slivkin, Gal Dagan and Roman Svichar, and headquartered in Tel Aviv, is a video monetization platform which allows digital publishers to generate new, incremental revenue through its set of video products. Under the terms of the acquisition agreement, Perion has acquired all the shares of Vidazoo for $35M in cash upon closing, with an additional maximum of $58.5M structured as a performance earn-out through 2023. The earn-outs are tied to EBITDA-based metrics that would be paid in full if Vidazoo generates $32.4M of adjusted EBITDA in aggregate, through the end of 2023. If Vidazoo achieves all of its performance goals through 2023, the total maximum consideration would be $93.5M.

05:21 EDT Hyatt opens first JdV by Hyatt branded hotel in Italy - Hyatt announced the opening of the first JdV by Hyatt branded hotel in Italy - The Tribune Hotel. The newly renovated property, operated by AG Group's AG Hotels, features 52 bedrooms. It joins Hyatt's existing portfolio in Italy.

05:16 EDT Amazon announces start of Black Friday deals - Amazon has released "Black Friday-worthy" deals, giving customers the opportunity to start shopping now. The company is hiring for 125,000 regular full-time and part-time jobs in fulfillment and logistics in cities and towns across the U.S.

05:09 EDT Arthur J. Gallagher acquires Manchester Underwriting Agencies, terms undisclosed - Arthur J. Gallagher announced that its specialist underwriting subsidiary Pen Underwriting has acquired 100% of UK-based Manchester Underwriting Agencies and its wholly owned subsidiary, Manchester Underwriting Management, or MUM. Terms of the transaction were not disclosed. Founded in 2010 by Charles Manchester as a specialist underwriting agency, MUM has grown organically and through bolt-on acquisitions into a managing general agent with five locations in the UK. MUM specializes in providing professional indemnity and management liability coverages for SMEs through its independent retail broker clients. The business will become part of Pen Underwriting and Charles Manchester will continue to lead MUM.