Stockwinners Market Radar for June 18, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:24 EDT Northrop Grumman awarded $458.01M Navy contract - Northrop Grumman was awarded a $458.01M cost-plus-incentive-fee and cost-plus-fixed-fee contract for fiscal 2022-2026 shipyard field operations, program management, systems engineering, documentation, logistics and hardware production activities in support of the Columbia and Dreadnought Fleet Ballistic Missile Program. This contract action contains option line items. Work is expected to be completed November 30, 2027. FY20 shipbuilding and conversion funds in the amount of $10,000; FY21 shipbuilding and conversion funds in the amount of $14.92M and FY22 shipbuilding and conversion funds in the amount of $61.67M are obligated on this award. No funds will expire at the end of the current fiscal year. This contract is being awarded to the contractor on a sole source basis under 10 U.S. Code 2304 and was previously synopsized on the System for Award Management online portal. Strategic Systems Programs is the contracting activity.

17:02 EDT Brooklyn ImmunoTherapeutics receives noncompliance notification from Nasdaq - Brooklyn ImmunoTherapeutics announced that it received a notice from Nasdaq stating that the company is not in compliance with the minimum bid price requirement of $1.00 per share under the Nasdaq Listing Rule 5450 based upon the closing bid price of the company's common stock for the 30 consecutive business days prior to the date of the notice. The notice has no immediate effect on the listing or trading of the company's common stock on Nasdaq.

16:51 EDT New Residential to rebrand to Rithm Capital - New Residential Investment Corp. announced today it has entered into agreements providing for the internalization of the company's management function. In conjunction with the internalization, the company announced plans to change its name and rebrand as Rithm Capital Corp. Under the Internalization Agreement, the parties have terminated the Management and Advisory Agreement, dated May 7, 2015, effective as of June 17, 2022. In connection with the termination of the Management Agreement, the company has agreed to pay FIG LLC $400M, with $200M paid on the Effective Date, $100M payable on September 15, 2022 and $100M payable on December 15, 2022. As a result of the termination of the Management Agreement, NRZ has ceased to be externally managed and now operates as an internally managed REIT. The company will continue to be managed by its current senior leadership team, with Michael Nierenberg as Chairman of the Board, Chief Executive Officer and President and Nick Santoro as Chief Financial Officer and Chief Accounting Officer. In addition, the company intends to retain employees of the Manager who currently serve in key roles at the company, including, but not limited to, those who support NRZ's investment, legal, accounting, tax and treasury operations. The company estimates that the internalization will result in approximately $60M-$65M of cost savings, or 12c-13c per diluted share, per year.

16:36 EDT Versus Systems receives Nasdaq notification over bid price deficiency - Versus Systems Inc. announced that the company received written notification from The Nasdaq Stock Market LLC on June 14, 2022, that the company is not in compliance with the minimum bid price requirement set forth in Nasdaq Rules for continued listing on Nasdaq. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the company's common shares for the 30 consecutive business days from May 2, 2022 to June 13, 2022, the company no longer meets the minimum bid price requirement.

16:31 EDT Northfield Bancorp announces $45M share repurchase program - Northfield Bancorp announced that its board of directors has authorized a new stock repurchase program of up to $45M of the company's outstanding common stock, 1c par value per share. The company anticipates conducting such repurchases beginning on June 22, in accordance with a Rule 10b5-1 trading plan.

16:06 EDT Connect Biopharma receives noncompliance notification from Nasdaq - Connect Biopharma announced it received a letter from the Listings Qualifications Department of Nasdaq indicating that, for the last thirty consecutive business days, the bid price for the company's American Depositary Shares, or ADSs, had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5550.

16:02 EDT Medigus receives Nasdaq notice of bid price deficiency - Medigus Ltd. announced that it has received a notification letter from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market LLC notifying the company that, for the last 30 consecutive business days, the closing bid price for the company's American Depositary Shares has closed below a minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The Nasdaq deficiency letter has no immediate effect on the listing of the company's ADSs, and its ADSs will continue to trade on The Nasdaq Capital Market under the symbol "MDGS" at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until December 13, 2022 to regain compliance with Rule 5550(a)(2). If the company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to December 13, 2022 to regain compliance. If at any time before December 13, 2022, the bid price of the company's ADSs closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that the company has achieved compliance with Rule 5550(a)(2).

15:55 EDT Kentucky First Federal trading halted, volatility trading pause

14:03 EDT Kroger recalling store brand aspirin, ibuprofen over failure to meet PPPA rule - The CPSC said that Kroger is recalling Kroger brand aspirin and ibuprofen due to a failure to meet child resistant packaging requirements as well as a risk of poisoining. The recalled over-the-counter products contain the regulated substances aspirin and ibuprofen which must be in child resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children. The company recalled about 209,430 units of the product.

13:54 EDT Avista's Clean Energy Implementation Plan approved by WUTC - Avista Utilities, an operating division of Avista Corp., filed its first Clean Energy Implementation Plan with the Washington Utilities and Transportation Commission in October 2021. Yesterday, the plan was approved by the WUTC. Avista was the first utility to file a CEIP in the State of Washington and the first investor-owned utility to reach approval. Avista's CEIP is a road map of specific actions to be taken over the next four years to show the progress being made toward clean energy goals established by the Clean Energy Transformation Act, which was passed by the Washington legislature and enacted into law in 2019. CETA requires electric supply to be greenhouse gas neutral by 2030 and 100% renewable or generated from zero-carbon resources by 2045. "This plan builds upon our longstanding commitment to environmental stewardship and sustainability," said Jason Thackston, Avista's senior vice president of energy resources. "Our own clean energy goals and those set forth in CETA are ambitious, but we are committed to finding a path to get there in a way that balances reliability and affordability. This CEIP includes benchmarks created with customer input that has been invaluable to this process and helps ensure we are benefitting all our customers. Since filing in October, we have worked closely with commission staff and other stakeholders to develop proposed conditions that strengthen the plan."

13:01 EDT Baker Hughes reports U.S. rig count up 7 to 740 rigs - Baker Hughes reports that the U.S. rig count is up 7 from last week to 740 with oil rigs up 4 to 584, gas rigs up 3 to 154 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 270 rigs from last year's count of 470 with oil rigs up 211, gas rigs up 57 and miscellaneous rigs up 2. The U.S. Offshore Rig Count is up 1 to 16, up 3 year-over-year. The Canada Rig Count is up 15 from last week to 156, with oil rigs up 10 to 104, gas rigs up 5 to 52. The Canada Rig Count is up 39 rigs from last year's count of 117, with oil rigs up 30, gas rigs up 9.

12:00 EDT Range Resources falls -9.7% - Range Resources is down -9.7%, or -$2.82 to $26.36.

12:00 EDT Daily S&P Biotech Bear 3x Shares falls -17.9% - Daily S&P Biotech Bear 3x Shares is down -17.9%, or -$11.64 to $53.21.

12:00 EDT Miniso rises 16.0% - Miniso is up 16.0%, or $1.01 to $7.31.

11:56 EDT VBI Vaccines treatment of glioblastoma granted FDA orphan designation - VBI Vaccines' treatment of glioblastoma was granted FDA orphan designation, according to a post to the agency's website. Reference Link

11:13 EDT Preferred Apartment investors approve acquisition by BREIT - Preferred Apartment Communities announced that, at the reconvened special meeting of stockholders held Friday, its stockholders approved the acquisition of PAC by Blackstone Real Estate Income Trust, Inc. Based on the preliminary voting results provided by the independent Inspector of Election, over 99% of votes cast were in favor of the transaction. The transaction is expected to close on or about June 23, 2022, subject to the satisfaction or waiver of customary closing conditions. Under the terms of the merger agreement announced on February 16, 2022, among other things, each share of PAC common stock issued and outstanding at the effective time of the merger will be automatically cancelled and converted into the right to receive, in accordance with the terms of the merger agreement, an amount in cash equal to $25.00 per share, without interest. Upon closing of the transaction, PAC common stock will no longer be listed on any public market.

10:35 EDT Seattle Genetics trading resumes

10:30 EDT Seattle Genetics trading halted, volatility trading pause

10:17 EDT JE Cleantech Holdings Ltd trading resumes

10:00 EDT Hersha Hospitality falls -5.4% - Hersha Hospitality is down -5.4%, or -51c to $8.97.

10:00 EDT Daily S&P Biotech Bear 3x Shares falls -10.7% - Daily S&P Biotech Bear 3x Shares is down -10.7%, or -$6.97 to $57.88.

10:00 EDT Sunnova Energy rises 11.4% - Sunnova Energy is up 11.4%, or $2.00 to $19.55.

09:47 EDT Zhong Yang Financial Group Ltd trading resumes

09:47 EDT Terran Orbital falls -4.8% - Terran Orbital is down -4.8%, or -25c to $5.00.

09:47 EDT Dingdong rises 8.0% - Dingdong is up 8.0%, or 33c to $4.49.

09:47 EDT Alibaba rises 9.6% - Alibaba is up 9.6%, or $9.71 to $111.17.

09:35 EDT Pharming Group NV (ADS) trading resumes

09:30 EDT Pharming Group NV (ADS) trading halted, volatility trading pause

09:23 EDT Pfizer-BioNTech COVID-19 vaccine granted EUA for children 6 months, older - Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced the U.S. Food and Drug Administration granted emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-microgram dose series for children 6 months through 4 years of age. The 3-microgram dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.

09:10 EDT Moderna receives EUA for COVID-19 vaccine for children 6 months of age, older - Moderna announced that it has received emergency use authorization from the U.S. Food and Drug Administration for its COVID-19 vaccine in young children ages 6 months through 5 years of age at a dose level of 25 microgram. The company has also received emergency use authorization for a 50 undefined two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 undefined two-dose regimen for adolescents aged 12 through 17 years old. The two-dose regimens, with doses tailored for each age group given one month apart, are well-timed to initiate protection for the start of the school year, as children return to higher-risk classroom and daycare settings.

09:05 EDT Sana presents data at ISSCR 2022 on transplanted allogeneic, hypoimmune cells - Sana Biotechnology presented data showing survival of transplanted allogeneic, hypoimmune cells of several different types in a variety of locations in non-human primates, NHPs. Data were presented during sessions at the International Society for Stem Cell Research, ISSCR, 2022 Annual Meeting. Survival of HIP-modified islet cells for type 1 diabetes: In this study, allogeneic primary pancreatic islet cells were HIP edited and transplanted intramuscularly into a healthy NHP without immunosuppression as proof-of-concept. The imaging showed that transplanted cells survived for the duration of the studywith no evidence of a systemic immune response, including no T cell activation, antibody production, or NK cell activity as seen previously with other HIP edited cell types in NHPs. Autoimmune mice: In this study, syngeneic or allogeneic mouse islet cells were transplanted intramuscularly without immunosuppression into diabetic autoimmune mice, split into three cohorts. The unmodified cells disappeared rapidly in the allogeneic setting as well as in the syngeneic setting. The HIP islet cells survived in all five diabetic mice for the duration of the study, and glucose levels dropped, demonstrating therapeutic function of the HIP islet cells. Survival of HIP-modified cardiomyocytes: In this study, allogeneic iPSC-derived cardiomyocytes were transplanted without immunosuppression into the hearts of healthy NHPs split into two cohorts. After two months, injection sites were recovered, and local immune cells were analyzed for their donor-specific cell recognition and killing. While local immune cells kill unmodified cardiomyocytes, HIP cardiomyocytes were not recognized by these immune cells. Survival of HIP-modified retinal pigmental epithelial, RPE, cells: In this study, allogeneic iPSC-derived RPEs were transplanted into the eye of healthy NHPs without immunosuppression split into two cohorts. The first cohort received unmodified allogeneic iPSC-derived RPE, while the second cohort received allogeneic HIP iPSC-derived RPE. The unmodified cells were almost completely eliminated in all NHPs within three weeks, with significant T cell activation, antibody production and local microglial activation, demonstrating in this context that the eye is not an "immunoprivileged" site. The HIP RPE survived in all three monkeys for the duration of the study, and there was no evidence of a systemic immune response, including no T cell activation, antibody production, microglial or NK cell activity. Two weeks after the initial dose, the NHPs were re-injected with the same cell type into the second eye, so that the NHPs received a total of two doses. These data suggest the potential to re-administer HIP RPE cells.

08:55 EDT FDA authorizes Moderna and Pfizer-BioNTech vaccines for kids down to 6 months - The U.S. Food and Drug Administration announced it has authorized emergency use of the Moderna (MRNA) COVID-19 Vaccine and the Pfizer (PFE) and BioNTech (BNTX) COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization, or EUA, to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. Reference Link

08:51 EDT Amerant Bancorp announces extension of exchange offer - Amerant Bancorp announced that it is extending to 5:00 p.m. New York City Time on June 21, 2022, its offer to exchange up to $30,000,000 aggregate principal amount of outstanding unregistered 4.25% Fixed-to-Floating Rate Subordinated Notes due 2032 for an equal principal amount of its 4.25% Fixed-to-Floating Rate Subordinated Notes due 2032 that have been registered under the Securities Act of 1933 in order to allow additional holders to tender in the exchange offer. Except for the extension of the expiration date, all of the terms of the exchange offer remain as set forth in the Company's prospectus, dated May 16, 2022. The Old Notes were issued on March 9, 2022 in a transaction exempt from registration under the Act. The terms of the New Notes are substantially identical to the terms of the Old Notes, except that the New Notes have been registered under the Act, are not subject to restrictions on transfer, and do not entitle their holders to registration rights or special interest. As of 5:00 p.m. New York City time, on June 16, 2022, the original expiration date of the exchange offer, $15,250,000 in principal amount of the outstanding Old Notes, representing 51% of the outstanding principal amount of the Old Notes, had been validly tendered in exchange for an equal aggregate principal amount of the New Notes.

08:46 EDT City of East Dublin, Georgia selects Omniq 's Q Shield system - OMNIQ announced that the Company has been selected by the City of East Dublin to deploy its QShield vehicle recognition systems technology and its cloud based citation management platform to identify any vehicle driving through the city which is on a National Crime Information Center data base or the Georgia Bureau of Investigations Database and cite violators who drive through the city with outstanding traffic violations.

08:39 EDT Limelight completes acquisition of Yahoo's Edgecast, rebrands as 'Edgio' - Yesterday, Edgio (EGIO) announced the successful completion of Limelight's (LLNW) acquisition of Edgecast. "Edgio solutions combine the power of the world's best performing edge platform with the most complete set of capabilities for web applications, APIs and video content - continuing on its strategy to improve profitability and growth. Edgio now delivers about 20% of the world's internet traffic from instant-loading websites to high-demand content for 20,000 leading digital companies such as Amazon, Sony, Kate Spade, Microsoft, Sun TV, Verizon, Disney, TikTok and Twitter... Building on this platform, Edgio will immediately improve its revenue profile to include a balance of both usage-based and SaaS-like margin profiles. The expansion of cross- and up-sell opportunities coupled with increased channel capabilities support planned growth improvements. On a pro-forma basis, the largest client will be approximately 13% of revenue, with no other client exceeding 10%. Profitability will benefit from annual run-rate cost synergies of greater than $50 million, including approximately $30-35 million of COGs related to colocation and internet peering expenses, and approximately $15-20 million of operating expense savings. Edgio expects to achieve approximately half of the $50 million in synergies in the first two quarters after closing. Additionally, the $30 million cash investment by Apollo Funds further strengthens the balance sheet to support continued growth initiatives. Based on these drivers, Edgio will continue building growth and profitability momentum in the near term toward its longer term strategic target of a balanced rule-of-40 performance," the company stated. Management intends to provide a combined financial outlook for calendar year 2022 in conjunction with the release of its second quarter 2022 financial results, Edgio added.

08:36 EDT H&R Block announces benefits to advance inclusivity for LGBTQ+ community - In an effort to more fully support LGBTQ+ associates, H&R Block HRhas added to and enhanced its associate health and wellbeing offerings. These benefits offer support for associates searching for culturally competent providers, and covers transition procedures for transgender associates through the medical plan. As part of the process to increase equity for the LGBTQ+ community, H&R Block reviewed its medical and prescription benefits and compared those to the World Professional Association of Transgender Health standards of care. While the company was well aligned with these standards as of last year, the enhancements ensure that the company is now fully aligned with WPATH. The company has added the Inclusive Care program, available to qualifying associates and eligible dependents through the company's Anthem medical plan, which acts as a concierge and support program for those in the LGBTQ+ community. It helps connect them with culturally competent providers who are more knowledgeable about the unique needs of the LGBTQ+ community. This resource can also guide patients through the complexities of gender transition procedures and ensure the care team is aligned on the appropriate treatment plans. In addition, earlier this year, H&R Block implemented a combined $30,000 lifetime maximum benefit for eligible associates to provide infertility, surrogacy or adoption support.

08:33 EDT Paltalk releases Windows version of ManyCam 8.0 - Paltalk announced the release of the Windows version of ManyCam 8.0, an upgrade to its recently acquired asset. ManyCam is a live streaming software and virtual camera that allows users to deliver professional live videos on streaming platforms, video conferencing apps and distance learning tools.

08:32 EDT ReShape Lifesciences enters warrant exercise transaction for $2.5M in proceeds - ReShape Lifesciences announced that it has entered into a warrant exercise agreement with an existing accredited investor to exercise outstanding warrants to purchase up to an aggregate of 3.7M shares of the company's common stock. In consideration for the immediate exercise of the existing warrants for cash, the exercising holder received new unregistered warrants to purchase up to an aggregate of 3.7M of the company's common stock. In connection with the exercise, the company also agreed to reduce the exercise price of the 3.7M exercised warrants and 1.6M remaining unexercised warrants to $0.6665, which is equal to the most recent closing price of the company's common stock on The Nasdaq Capital Market prior to the execution of the warrant exercise agreement. The new warrants are exercisable immediately upon issuance at an exercise price of $0.6665 per share and have a term of exercise equal to seven and one-half years. The company agreed to file a resale registration statement on Form S-3 within 30 days with respect to the new warrants and the shares of common stock issuable upon exercise of the new warrants. The warrant exercise agreement and the new warrants each include a beneficial ownership limitation that prevents any of the investors from owning more than 4.99% of the company's outstanding common stock at any time. The gross proceeds to the company from the exercise of the existing warrants was approximately $2.5M, prior to deducting placement agent fees and estimated offering expenses. The company intends to use the net proceeds for commercial growth, working capital and general corporate purposes.

08:21 EDT WISeKey's WISe.Art, China Museum of Finance to auction Jiaozi NFT - WISeKey International Holding has joined forces with The China Museum of Finance to offer NFTs with the launch of WISe.ART NFT platform. The WISe.ART NFT Platform is an Ethereum scaling and infrastructure development and available with Ethereum-compatible blockchains. To launch this cooperation, the WISe.ART platform will auction am NFT of the world's first paper money created in China in 1024. The Jiaozi NFT is the digital twin of the world's first government-issued paper currency featuring elements of modern paper money for circulation management and reserve payment. The paper currency was issued on January 12, 1024, in Chengdu, Sichuan, China by the Jiaozi Affairs, the earliest central bank. The bank operated for more than 400 years.

08:12 EDT Allegiant Travel reports preliminary May traffic up 47.3% y/y - Reports May: Passengers up 39.8%; capacity up 16.9%; load factor up 17.9 pts; departures up 9.4%. All figures for scheduled service on y/y basis.

08:09 EDT FTC issues statement on HCA Healthcare, Steward abandoning proposed merger - Federal Trade Commission Bureau of Competition Director Holly Vedova issued the following statement regarding the decision by Utah healthcare competitors HCA Healthcare and Steward Health Care System to abandon their proposed merger: "For the second time in a week, parties who proposed an anticompetitive hospital merger have called their deal off after the FTC filed a complaint to block the deal. This transaction, like the RWJBarnabas Health/Saint Peter's transaction that was abandoned two days ago, should never have been proposed in the first place. This should be a lesson learned to hospital systems all over the country and their counsel: the FTC will not hesitate to take action in enforcing the antitrust laws to protect healthcare consumers who are faced with unlawful hospital consolidation. Had this transaction been allowed to proceed, it would have combined the second and fourth largest healthcare systems in Salt Lake City and the Wasatch Front region of Utah, resulting in higher prices, less innovation, and lower quality care for patients. I am glad that patients and healthcare providers will not have to endure any more uncertainty while waiting for courts to rule on the FTC's legal challenges. I would like to congratulate and thank all of our incredibly talented staff who worked on this matter. Today's result would not have been possible without their exceptional skill, hard work, and dedication to the FTC's mission." Reference Link

08:05 EDT SeaWorld names Michelle Adams as CFO and Treasurer - SeaWorld announced that Michelle Adams will assume the role of CFO and Treasurer effective June 17. Adams served as the CFO of The Cosmopolitan of Las Vegas where she was responsible for oversight of the company's day-to-day external and internal accounting and reporting functions, driving business transformation and process improvement across the organization, and playing a key role in the successful sale of The Cosmopolitan of Las Vegas last month. Prior to joining The Cosmopolitan of Las Vegas, Adams was the Partner-in-charge of the Hospitality and Gaming Industry Group at RubinBrown LLP and a Manager at Deloitte & Touche LLP.

08:03 EDT Kazia Therapeutics' paxalisib granted FDA Orphan Drug Designation - Kazia Therapeutics is pleased to announce that the United States FDA has awarded Orphan Drug Designation to Kazia's paxalisib for the treatment of atypical rhabdoid / teratoid tumors, a rare and highly-aggressive childhood brain cancer.

08:02 EDT VYNE Therapeutics completes enrollment in Phase 2a trial of FMX114 - VYNE Therapeutics announced the completion of enrollment in the Phase 2a study of FMX114 for the treatment of mild-to-moderate atopic dermatitis, AD. FMX114 is VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation in AD. The Phase 2a segment of the FMX 114 study is designed to evaluate four weeks of FMX114 treatment in patients with AD compared to vehicle control. Due to the impact of COVID-19 on enrollment and other operations related to the original trial sites in Australia, the Company activated additional clinical trial sites in the United States to support patient enrollment and expedite completion of the study. With enrollment now completed, the Company expects to report top-line efficacy results in approximately 6 to 8 weeks. "We have been encouraged by the early efficacy results from the Phase 1b segment of the FMX114 trial showing that, based on ADSI scoring, two weeks of FMX114 treatment demonstrated a statistically significant improvement in the signs and symptoms of AD as well as acceptable safety and pharmacokinetics," said David Domzalski, Chief Executive Officer of VYNE Therapeutics. "We look forward to reporting the results of the Phase 2a segment of the study in approximately 6 to 8 weeks."

08:02 EDT AbbVie: FDA approves SKYRIZI to treat Crohn's disease - AbbVie announced that the U.S. FDA has approved SKYRIZI as the first and only specific interleukin-23 inhibitor for the treatment of adults with moderately to severely active Crohn's disease. In two induction and one maintenance clinical trials, SKYRIZI demonstrated significant improvements in endoscopic response and clinical remission compared to placebo, as both an induction and maintenance therapy.

07:45 EDT Shift4 Payments CEO buys $876K in common stock - In a regulatory filing, Shift4 Payments disclosed that its CEO Jared Isaacman bought 27.7K shares of common stock on June 16th in a total transaction size of $876.2K.

07:34 EDT Wellbeing Digital's KGK announces clinical trial results of GJ 191 - Wellbeing Digital Sciences announces that a clinical study conducted by its wholly owned subsidiary KGK Sciences has shown positive results of its GJ 191 supplementation in treating osteoarthritis. GJ 191 is a natural health product developed by Chenland Nutritionals, Inc. and is a formulation of three Traditional Chinese Medicinal ingredients including Epimedium, Salvia miltiorrhiza, and Dioscorea extracts. In the recent study conducted by KGK investigating GJ 191 supplementation, results showed it to be safe and efficacious in improving knee joint function in adults with knee osteoarthritis and self-reported knee pain who were otherwise healthy. This randomized, double-blind, placebo-controlled intervention demonstrated that supplementation with GJ 191 provided reductions in current knee pain at 6 and 12 weeks, whereas those taking Placebo reported no improvements. Additionally, after 12 weeks, 53% of participants supplemented with GJ 191 reported a clinically important improvement in knee OA symptoms. Comparatively, only 38% of participants in the Placebo group reached the same threshold. Seventy-two males and females between 40-73 years were enrolled in this study. Participants consumed either GJ 191 or Placebo daily for 12 weeks.

07:32 EDT Cytokinetics provides regulatory update for omecamtiv mecarbil - Cytokinetics announced that, in response to a request from the U.S. Food and Drug Administration, FDA, the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related to the company's new drug application, NDA. After an initial review of the company's submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission. "We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil," said Robert Blum, Cytokinetics' President and Chief Executive Officer. "We are committed to bringing forward our first-in-class cardiac myosin activator, which may provide an important treatment option for patients suffering from worsening heart failure."

07:27 EDT SciPlay shareholder sends letter to board regarding Light & Wonder negotiations - Engine Capital, which owns 7.4% of SciPlay (SCPL), announced that it has sent the below letter to the independent members of the company's board of directors. "Engine Capital is the second-largest Class A shareholder of SciPlay Corporation with an ownership position of 7.4%. We invested in SciPlay due to the attractive category dynamics of social casino games including high player stickiness and long-tenured games, the Company's ability to grow revenue per paying user and payer conversion, its ability to take share in the higher growth casual segment, and its very attractive valuation. As you know, Light & Wonder (LNW), Inc. ("Light & Wonder"), SciPlay's parent company, IPO'ed a portion of SciPlay in 2019 and continues to own 81% of SciPlay. At the time of going public, SciPlay paid $255 million for a perpetual licensing agreement that entitled the Company exclusive access to all content created at Light & Wonder until the third anniversary of the IP License Agreement and non-exclusive access to all IP created or acquired after the third anniversary (the "New Content").1 As indicated on its most recent earnings call, SciPlay is currently negotiating an extension of this IP agreement with Light & Wonder. On May 13, 2022, we sent you a private letter expressing our concerns regarding these negotiations. Since then, we have had multiple discussions with management, which have only heightened our initial concern that an extension of this IP is unnecessary. We have repeatedly asked to meet privately with the independent directors to share our views on this topic but were told that such a meeting would be inappropriate, which is why we have been forced to make our concerns public. In summary, we believe that an extension of this IP agreement is of little value to SciPlay and that potential conflicts of interest could lead SciPlay to provide an unnecessary payment to Light & Wonder. Specifically, we are concerned that SciPlay's management, who is negotiating this agreement with Light & Wonder, is conflicted since its members report to Barry Cottle, the Executive Chairman of SciPlay, who is also the CEO of Light & Wonder. Given the related-party nature of this negotiation and these potential conflicts of interest, we are requesting that the Board form a special committee of independent directors to handle these negotiations and appoint a Lead Independent Director to strengthen the Company's governance. According to the existing IP Agreement, SciPlay has non-exclusive access to Light & Wonder's New Content for its existing games only. As a result, the only basis for SciPlay to pay additional money to Light & Wonder to extend the IP agreement would be to secure the following rights: 1) to ensure it is able to use the New Content on an exclusive basis in its existing games, and 2) to be able to use the New Content in new games that were not in existence at the time of the signing of the original IP agreement... In conclusion, we are deeply troubled by these developments and are requesting that 1) any negotiation to extend this IP agreement be made by a newly created special committee of the Board and 2) the Board appoint a Lead Independent Director. We are again requesting a meeting with you as soon as possible to discuss the content of this letter. We have given a lot of thought to this topic and believe we can be helpful to the independent directors. We are reserving all of our rights under Nevada law and otherwise to take whatever actions we may deem necessary in order to protect our interests and the best interests of all SciPlay shareholders from any activities that involve the waste of corporate assets and/or unjustified related-party transactions."

07:21 EDT Instructure names Shiren Vijiasingam as Chief Product Officer - Instructure announced that Shiren Vijiasingam has been named the company's new chief product officer, effective June 20th. Vijiasingam will play a pivotal role in building the Instructure Learning Platform and driving growth through product adoption. Vijiasingam joins Instructure with over two decades of product experience and more than ten years in education technology. He previously served as Chief Product Officer, both at Newsela, a K-12 content platform and General Assembly, the pioneer of career transformation education.

07:13 EDT Scholar Rock announces new data from TOPAZ trial extension period - Scholar Rock announced new data from the Phase 2 TOPAZ trial extension period evaluating patient outcomes after 24-months of treatment, which support sustained and continued improvement with apitegromab for non-ambulatory patients with Types 2 and 3 SMA receiving an SMN therapy. Detailed results are being presented by Thomas Crawford of Johns Hopkins Medicine and the lead principal investigator of the TOPAZ trial, during a podium presentation at the Cure SMA Research & Clinical Care Meeting. TOPAZ evaluated apitegromab across a broad age range of patients with Types 2 and 3 SMA. All 35 non-ambulatory patients and 12 of 23 ambulatory patients were receiving nusinersen maintenance therapy. The primary efficacy endpoint for the non-ambulatory population was mean change from baseline in HFMSE. Additional endpoints included mean change from baseline in RULM, an assessment specifically designed for upper limb function in patients with SMA. The HFMSE is a validated measure for the assessment of gross motor function in SMA, while the RULM is validated to evaluate upper limb motor performance by evaluating tasks which correspond to the ability to perform various everyday activities with their hands and arms. For this 24-month evaluation, an observed case analysis was conducted, which pooled all the non-ambulatory patients and was based upon the available data for given timepoints. This analysis population included patients receiving either low dose or high dose apitegromab and did not exclude any patients who had missed apitegromab doses due to study site access restrictions from COVID-19. Non-ambulatory patients with valid HFMSE assessments had sizable, sustained gains in HFMSE scores at 24 months from baseline, while RULM scores continued to increase at 24 months. Dose response continued to be observed across the 24 months of apitegromab administration based upon HFMSE scores and pharmacodynamic data, with signs that there may be further HFMSE increases as non-ambulatory patients originally receiving the low dose switched to the high dose treatment. Data at 24-months for ambulatory patients with Type 3 SMA suggest stability of Revised Hammersmith Scale, or RHS, scores in patients receiving 20 mg/kg of apitegromab and nusinersen. The mean RHS change from baseline at 24-months was -0.7 points for the apitegromab and nusinersen subgroup and -2.8 points for the apitegromab monotherapy subgroup. A subset of individuals in Cohort 1 had RHS improvements, as reflected by 42.9% and 23.8% of patients having 1-point and 3-point RHS increases from baseline at 24 months respectively. Of the 55 patients who completed the 24-month TOPAZ extension period, 54 have opted to continue treatment in the 36-month extension period. Consistent with the 12-month safety data, no serious safety risks were identified as part of the analysis of the cumulative 24-month data. The incidence and severity of adverse events were consistent with the underlying patient population and background therapy. The five most common treatment-emergent adverse events. or TEAEs, were headache, pyrexia, upper respiratory tract infection, cough, and nasopharyngitis. No deaths or serious adverse reactions have been observed with apitegromab. A total of 14 serious TEAEs have been reported over the 24-month treatment period, all assessed by the respective trial investigator as unrelated to apitegromab.

07:11 EDT Dana awarded $2.7M grant to develop e-Powertrain for OX Delivers - Dana announced that its operation in Birmingham, United Kingdom, has been awarded a $2.7M grant to develop an e-Powertrain for OX Delivers - the world's first flat-pack utility vehicle destined for emerging markets in Africa.

07:08 EDT Bitfarms enters new equipment financing agreement, reduces credit facility - Bitfarms (BITF) entered into an equipment financing agreement, with initial funding of $37M, with NYDIG. In addition, the Company reduced its $100M Bitcoin-backed credit facility with Galaxy Digital (BRPHF) by $34M to $66M via the sale of 1,500 of its BTC holdings. The NYDIG equipment financing agreement provides non-dilutive funding of Bitfarms' miners to support growth in Quebec. The agreement provides equipment financing at an interest rate of 12% per annum collateralized by the miners at the Company's Leger and Bunker facilities, funded as the assets are installed and become operational. Initial funding of $37M, or $36M net of closing fees of $740,000, has been completed with additional fundings contemplated in July and October 2022 as construction continues at the Bunker and more equipment is installed. This latest equipment financing is distinct from Bitfarms' previously announced $32M equipment financing agreement with BlockFi Lending. Bitfarms elected to reduce its $100M BTC-backed credit facility to $66M, funded through the sale of 1,500 BTC. Borrowings under this credit facility stand at $66M as of June 15, 2022. This facility, which the Company entered into with Galaxy on December 30, 2021, expires on June 30, 2022. Bitfarms and Galaxy are in discussions to renew the facility upon expiration.

07:04 EDT OTC Markets Group welcomes Vitalhub to OTCQX - OTC Markets Group announced VitalHub has qualified to trade on the OTCQX Best Market. VitalHub Corp. upgraded to OTCQX from the Pink market.

07:03 EDT First Advantage expands board of directors with appointment of Price - First Advantage (FA) announced the appointment of Bridgett Price to the Board of Directors as an independent director and member of the Audit Committee. With the addition of Dr. Price, the Company's Board of Directors now has eight members. Dr. Price is currently the Global Human Resources Officer for Consumer, Development, and Operations disciplines at Marriott International (MAR), which she joined in 2000.

07:03 EDT Dana awarded $2.7M grant to develop e-Powertrain for OX Delivers - Dana announced that its operation in Birmingham, United Kingdom, has been awarded a $2.7M grant to develop an e-Powertrain for OX Delivers. The OX Delivers truck has been engineered to tackle the toughest terrain and will be shipped as a flat pack and assembled in the destination country. The truck is powered by Dana's Spicer Electrified eS4500i e-Drive Unit, which combines an electric motor, inverter, gearbox, and software in a complete e-propulsion system.

07:02 EDT TE Connectivity announces additional $1.5B share repurchase plan - TE Connectivity announced that its board of directors has authorized an increase in its share repurchase program by an additional $1.5B.

06:48 EDT Pfizer, Myovant Sciences announce results of Phase 3 SPIRIT 1, SPIRIT 2 studies - Myovant Sciences (MYOV) and Pfizer (PFE) announced that results of the Phase 3 SPIRIT 1 and SPIRIT 2 studies of investigational once-daily relugolix combination therapy in over 1,200 women with moderate to severe pain associated with endometriosis were published in The Lancet. As previously reported, both studies achieved their co-primary endpoints by demonstrating clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain in women with endometriosis. SPIRIT 1 and 2 each met their co-primary endpoints with 75% of women in the relugolix combination therapy group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively. For non-menstrual pelvic pain, relugolix combination therapy achieved a clinically meaningful reduction in 59% and 66% of women, compared with 40% and 43% of women in the placebo groups. In SPIRIT 1, seven key secondary endpoints, and in SPIRIT 2, six key secondary endpoints comparing relugolix combination therapy with placebo at Week 24 achieved statistical significance, including reductions in dyspareunia and opioid use. In addition, more women treated with relugolix combination therapy groups were opioid free at Week 24 compared with placebo. In both studies, relugolix combination therapy was associated with a generally well-tolerated safety profile, including bone mineral density loss of less than1% over 24 weeks. Seven key secondary endpoints in SPIRIT 1 and six key secondary endpoints in SPIRIT 2 comparing relugolix combination therapy with placebo at Week 24 also achieved statistical significance. These endpoints include changes in mean dysmenorrhea, non-menstrual pelvic pain, overall pelvic pain, impact of pain on daily activities as measured by the Endometriosis Health Profile-30 pain domain, the proportion of women not using opioids, the proportion of women not using analgesics, and change in mean dyspareunia. While the seventh endpoint for the SPIRIT 2 study - reduction in analgesic use - did not achieve statistical significance, possibly due to the low number of average pills per day and variability in day-to-day pill consumption, a post-hoc analysis of SPIRIT 2 showed that the percentage of patients who were analgesic-free at end of treatment was greater among women in the combination therapy group than the placebo group. The most frequently reported adverse events in both relugolix combination treatment and placebo groups were headache, nasopharyngitis, and hot flushes.

06:45 EDT Theramex: European Commission grants Marketing Authorization for Yselty - The European Commission has granted Marketing Authorization for Yselty, an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids in adult women of reproductive age. This announcement is in partnership with ObsEva. The EC decision follows the Committee for Medicinal Products for Human Use confirmation of positive opinion in April. In February, Theramex entered into a strategic licensing agreement with Obseva, a leading biopharmaceutical company in novel therapies, to commercialize and market the introduction of linzagolix across international markets outside of the U.S., Canada, and Asia.

06:01 EDT Secoo Holding approved to transfer listing to Nasdaq Capital Market - Secoo Holding announced that on June 16, the Listing Qualifications department of the Nasdaq Stock Market approved the company's request to transfer the listing of the company's American Depositary Shares from the Nasdaq Global Market to the Nasdaq Capital Market. The transfer is expected to take effect at the opening of business on June 17. The transfer of the company's listing to the Nasdaq Capital Market is not expected to have any impact on trading in the company's ADSs. The company's ADSs will continue to trade uninterruptedly under the symbol "SECO."

05:07 EDT Volvo invests SEK 50M for 10% of Connected Energy - Volvo Energy invests in the UK-based, second-life battery energy storage specialist Connected Energy in order to further accelerate Volvo Group's battery business and sustainability opportunities. Volvo Energy is investing approx. SEK 50M for 10% in the UK-based second-life battery energy storage specialist Connected Energy.