Stockwinners Market Radar for June 06, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:39 EDT Cathie Wood's ARK Investment bought 167.6K shares of UiPath today

20:37 EDT Cathie Wood's ARK Investment bought 87K shares of Roku today

19:09 EDT Eli Lilly presents new data for Mounjaro in type 2 adult diabetes - The company states: "New data from a mechanism of action study and new analyses of the global registration program for Eli Lilly and Company's Mounjaro injection were presented at the American Diabetes Association's 82nd Scientific Sessions, adding to the robust body of data about Mounjaro for the treatment of adults with type 2 diabetes. More than 20 presentations on Mounjaro were accepted for disclosure at the ADA's Scientific Sessions. Additional results of a phase 1 mechanism of action study were presented in an oral presentation on Monday, June 6 during the "Incretin Based Therapies" session. This study was a 28-week, randomized, double-blind, parallel study to evaluate the effect of Mounjaro 15 mg compared to placebo and to injectable semaglutide 1 mg. The primary endpoint, previously disclosed, compared the effect of Mounjaro 15 mg versus placebo on total clamp disposition index at 28 weeks. The secondary objectives presented today at ADA compared the effects of Mounjaro 15 mg to placebo and to injectable semaglutide 1 mg on energy intake, appetite and body composition in adults with type 2 diabetes as measured by change from baseline. At 28 weeks, participants taking Mounjaro had significantly greater reductions in weight and in fat mass compared to those taking injectable semaglutide 1 mg and placebo."

18:36 EDT United Airlines director buys $2.24M in common stock - In a regulatory filing, United Airlines disclosed that its director Edward Shapiro bought 50K shares of common stock on June 2nd in a total transaction size of $2.24M.

18:15 EDT GoHealth names Vijay Kotte as CEO and Jason Schulz as CFO - GoHealth "announces a series of leadership appointments intended to create strong value for shareholders and all stakeholders. The company has named Vijay Kotte as CEO and Jason Schulz as CFO, both effective June 6, 2022. Upon assuming the role of CEO, Mr. Kotte will also join the Company's Board of Directors."

17:35 EDT American Express director Leonsis sells 4,005 common shares - In a regulatory filing, American Express director Theodore Leonsis disclosed the sale of 4,005 common shares of the company on June 3 at a price of $166.6305 per share.

17:12 EDT Concert Pharmaceuticals director Aldrich acquires over 200,000 common shares - In a regulatory filing, Concert Pharmaceuticals director Richard Aldrich disclosed the purchase of 210,526 common shares of the company on June 6 at a price of $4.75 per share.

17:07 EDT Avangrid appoints Pedro Azagra Blazquez CEO - Avangrid announced Pedro Azagra Blazquez has officially assumed the role of CEO of Avangrid. Azagra brings to the team a deep familiarity with the Avangrid businesses and extensive experience in the U.S. energy sector. Azagra has served as a member of the Avangrid Board of Directors since 2019, and previously served as a member of the Board of Directors from 2014 to 2018. Azagra serves as the Chief Development Officer for Iberdrola, S.A., where he has executed more than one hundred transactions and led the international expansion of Iberdrola.

17:03 EDT TJX exec Sherr sells 46,997 common shares - In a regulatory filing, TJX Companies SEVP and group president Richard Sherr disclosed the sale of 46,997 common shares of the company on June 3 at a price of $62.25 per share.

16:58 EDT Interactive Brokers chairman sells $2.41M in common stock - In a regulatory filing, Interactive Brokers disclosed that its Chairman Thomas Peterffy sold 40K shares of common stock on June 2th in a total transaction size of $2.41M.

16:45 EDT ESSA Bancorp announces authorization for 500K shares of common stock - ESSA Bancorp "announced that its board has approved a stock repurchase program for up to 500,000 shares of its common stock. The company may repurchase the shares from time to time through open market purchases, privately negotiated stock transactions or in any other manner that is compliant with applicable securities laws."

16:42 EDT Welltower narrows Q2 EPS view to 22c-25c from 20c-25c - Additionally, the company now expects to achieve normalized funds from operations in a range of 84c-87c per diluted share as compared to previous guidance of 82c-87c per diluted share. In its Business Update presentation, the company states: "Quarter-to-date SHO portfolio spot occupancy growth of 80 bps is in line with expectations through June 3, 2022 despite the global rise in COVID-19 cases during the quarter. Heading into the peak leasing months, occupancy gains have been broad-based quarter-to-date, increasing 70 bps in the U.S., 80 bps in Canada, and 190 bps in the U.K. Pricing power remains robust with strong recognized renewal rate increases and improving street rates." Reference Link

16:36 EDT Commvault VP Riccardo Di Blasio sells over $1M in shares - Commvault VP Riccardo Di Blasio disclosed in a filing that he had sold 17,182 shares of company stock at $65.03 per share on June 2, for a total transaction amount of $1,117,345.

16:31 EDT Helbiz announces purchase of $2.02M in common stock by CEO - Helbiz announced that Salvatore Palella, Founder and CEO, purchased 2,044,676 shares of Class A Common Stock from a seller for an aggregate price of $2,019,935 which represents about 6% of the common stock. "I continue to be excited and hopeful for the future of Helbiz and the impact that we will have on the world," said Palella. "Looking forward, we will continue to focus on cutting costs, streamlining processes and on the important KPIs of our business. This purchase today is a personal commitment from me on the future of the company and our continued success."

16:26 EDT Retractable Technologies reduces workforce by 16% - Retractable Technologies reported that it has reduced its workforce by approximately 16% as a result of the substantial completion of its facility expansion efforts and the completion of U.S. government orders to provide its products for COVID-19 vaccination efforts. The staff reduction primarily affects its production, operations and logistics departments. The reduction will result in an overall annualized savings of approximately $2.1M, or 13% in annual payroll expense, and separation costs are expected to be approximately $200,000. The company expects that it will be able to maintain its current level of domestic production after the headcount reduction, and have significantly enhanced domestic production capacity upon completion of the expansion efforts.

16:22 EDT Delcath Systems announces results from COPIN trial, FOCUS trial update - Delcath Systems announced further details regarding presentations relating to its proprietary percutaneous hepatic perfusion, or PHP, system at the American Society of Clinical Oncology, or ASCO, annual meeting being held June 3-7 in Chicago, Illinois and virtually. The goal of the CHOPIN trial is to study the safety and potential synergistic effects of systemic immunotherapy ipilimumab plus nivolumab, or IPI+NIVO, when combined with Delcath's proprietary liver-targeted PHP treatment in metastatic uveal melanoma patients. The poster presented initial safety and efficacy results from the Phase 1b portion of the trial which enrolled seven patients who were treated with two courses of six-weekly PHPs combined with four courses IPI+NIVO three-weekly escalating the dosing from 1mg/kg each IPI+NIVO to IPI 1mg/kg + NIVO 3mg/kg. The poster reports a best overall response of 1 complete response, 5 partial responses and 1 stable disease accounting for an objective response rate of 85.7%. At a median follow up time of 20.2 months, 4 patients have an ongoing response. Currently the median progression free survival is 22.4 months, and all patients are still alive. Updated efficacy and safety results from the single-arm phase 3 FOCUS trial in metastatic uveal melanoma including overall response rate, or ORR, median duration of response, or mDOR, disease control rate, or DCR, median progression free survival, or mPFS, and overall survival, or OS, data were presented that were largely consistent with prior presentations. In addition, predefined exploratory analyses comparing PHP to a best-alternative-care arm enrolled prior to the trial's protocol amendment to a single-arm study were included. Updated values reflect the latest data from clinical sites. OS data continues to mature with a final, predefined analysis expected in May 2023, two years after the study's last treatment. As of last analysis the FOCUS trial results are as follows: A 36.3% ORR in the Treated Population, including 8% complete responses with a mDOR of 14 months. A DCR of 73.6%, a median PFS of 9.03 months and a median OS of 19.25 months. PHP analyses against the BAC arm yielded statistically significant results on ORR, DCR and mPFS. While OS data continues to mature, as of the last analysis, the median OS for the PHP arm is 19.25 months vs. 14.49 months for BAC. Final analysis expected in 2023.

16:17 EDT Delcath Systems presents update on PHP system at ASCO - Delcath Systems "announced further details regarding presentations relating to its proprietary percutaneous hepatic perfusion, or PHP, system at the American Society of Clinical Oncology Annual Meeting being held June 3-7, 2022, in Chicago, Illinois and virtually. The goal of the CHOPIN trial is to study the safety and potential synergistic effects of systemic immunotherapy ipilimumab plus nivolumab when combined with Delcath's proprietary liver-targeted PHP treatment in metastatic uveal melanoma patients. The poster presented initial safety and efficacy results from the Phase 1b portion of the trial which enrolled seven patients who were treated with two courses of six-weekly PHPs combined with four courses IPI+NIVO three-weekly escalating the dosing from 1mg/kg each IPI+NIVO to IPI 1mg/kg + NIVO 3mg/kg. The poster reports a Best Overall Response of 1 complete response, 5 partial responses and 1 stable disease accounting for an Objective Response Rate of 85.7%. At a median follow up time of 20.2 months, 4 patients have an ongoing response. Currently the median progression free survival is 22.4 months, and all patients are still alive."

16:17 EDT SmileDirectClub appoints interim CFO Crawford as Chief Financial Officer - SmileDirectClub announced the appointment of Troy Crawford as its Chief Financial Officer, effective June 6. Crawford has served as the interim CFO since January 8, the company noted. "After a national search, we determined our best candidate was already in house and are pleased to officially appoint Troy to the SmileDirectClub leadership team. In his interim CFO role, Troy demonstrated financial discipline and focus, among many other instrumental skills, to drive our plans for improved business performance and near-term profitability. We look forward to his continued contributions as we address our tremendous untapped market opportunity and deliver future growth and value for our shareholders," said David Katzman, CEO and Chairman of SmileDirectClub.

16:16 EDT TrueCar acquires Digital Motors, terms not disclosed - TrueCar announced its acquisition of Irvine, California based Digital Motors. The acquisition is intended to accelerate TrueCar's plan to deliver a robust digital car buying and selling experience with its TrueCar+ marketplace. Digital Motors' automotive retail and financial technology platform gives auto dealers, OEMs, lenders and other stakeholders the ability to augment their physical presence with a digital storefront or marketplace that offers a seamless omnichannel car buying experience to consumers. "With TrueCar+, we are creating an asset-light marketplace where consumers have easy and transparent access to a national inventory of vehicles and our dealers have efficient and turn-key access to a national audience of consumers," said Mike Darrow, President and CEO of TrueCar. "Our acquisition of Digital Motors is a key step in the acceleration of that marketplace, providing immediate access to new capabilities to enable the development of a secure online purchasing and financing experience. In addition, we believe the acquisition will help us to target and attract more dealers, brands, OEMs, lenders and other partners to the TrueCar+ ecosystem," Mr. Darrow continued. TrueCar has financial flexibility to invest in its business with approximately $235M in cash and equivalents on its balance sheet at the end of the first quarter of 2022.

16:12 EDT Vincerx Pharma to reduce headcount by 33% as part of cost reduction measures - Vincerx Pharma announced an update to its strategic priorities and the streamlining and realignment of resources to support its key value-generating indications and programs and extend its estimated cash runway into late 2024. The company is prioritizing VIP152 clinical studies to focus on: Monotherapy in patients with high grade B-cell lymphoma characterized by translocations of MYC and BCL-2 or BCL-6. Monotherapy in patients with high-risk chronic lymphocytic leukemia, or CLL. Combination with Bruton tyrosine kinase inhibitor in patients with high-risk CLL. The company is continuing to prioritize advancement of bioconjugation assets .Streamlining and realigning resources to support prioritized VIP152 indications and advancement of the bioconjugation programs. Reducing full-time employees by 33%. Implementing additional cost reduction measures. Extending estimated cash runway into late 2024. "Given the unprecedented market conditions, we are making a strategic decision to focus our resources on our ongoing double-hit DLBCL and CLL clinical trials and our next-generation bioconjugation platform to deliver the greatest benefit in these patients as well as maximize value for our shareholders," said Ahmed Hamdy, CEO of Vincerx. "The VIP152 program was designed as a signal-seeking program," added Hamdy. "Nineteen (19) patients with various MYC+ cancers have been treated. We saw stable disease in 3 patients with ovarian cancer (with one of the three patients completing cycle 6). Despite this preliminary signal in ovarian cancer, the combination of challenging market conditions and the promising VIP152 preclinical and clinical data we have seen in double-hit DLBCL and CLL patients create a compelling rationale for us to focus our efforts on these two indications." "We continue to be excited about our preclinical bioconjugation platform-a diverse, modular platform of linkers and payloads that can be conjugated with antibodies and small molecules to create novel targeted therapeutics for a broad range of solid tumors and hematologic malignancies and remain on track to file an IND in the second half of this year for VIP236. We also remain on track to file an IND in the second half of 2023 for our initial antibody drug conjugate (ADC), VIP943. We believe our ADCs represent a paradigm-shifting technology with a proprietary and highly differentiated linker and warhead. These innovations are expected to improve efficacy and safety versus current ADCs," continued Hamdy.

16:06 EDT Remitly Global names Hemanth Munipalli as CFO - Remitly Global "announced the appointment of Hemanth Munipalli as CFO effective July 18. Remitly's current CFO Susanna Morgan will remain in the role pending Munipalli's official start as CFO in July, after which she will serve as senior advisor to support a smooth transition through September 2022."

16:02 EDT Kilroy Realty signs leases totaling 190K square feet during Q2 - Kilroy Realty Corporation announced it signed new or renewing leases on approximately 190,000 square feet in its stabilized portfolio to date during the second quarter. The leasing activity was spread across several of its West Coast markets, including San Diego, Los Angeles, Seattle and the San Francisco Bay Area. Average rents in the recently executed leases were up approximately 22% on a cash basis and 39% on a GAAP basis over the prior leases. The average term of the agreements was 7.5 years and approximately 90% were new leases. In 2022, KRC has signed new or renewing leases on over 375,000 square feet in its stabilized portfolio. The portfolio is currently 93% leased. Included in the 190,000 square feet of leasing activity was a new 11-year lease with Blue Shield of California for 72,000 square feet of office space at the recently modernized Aero Campus in the Long Beach Airport submarket. Additionally, the company signed an approximately 8-year lease with a media & entertainment company for 58,000 square feet in Santa Monica. With the completion of these transactions, KRC's stabilized portfolio has no expirations greater than 40,000 square feet until 2023.

15:41 EDT Xbox game 'Forza Horizon 5' surpasses 20M players, VGC reports - Microsoft-published video game "Forza Horizon 5," exclusive to Xbox consoles and PC, has passed 20M total players in its first seven months of availability, VideoGamesChronicle's Chris Scullion reports. Microsoft's Xbox unit has previously called the game's launch its "biggest launch ever," the author notes. Reference Link

14:56 EDT Regeneron treatment of multiple myeloma granted orphan designation - Regeneron's treatment of multiple myeloma was granted orphan designation by the FDA, according to a post to the agency's website. Reference Link

14:45 EDT Apple says iPad to get external display link support

14:40 EDT Apple unveils new Game Center social updates for iPadOS 16 - Says new Game Center updates coming to iPadOS 16 later this year. Says such updates also coming to Mac and iPhone.

14:34 EDT Apple previews macOS Ventura, available this fall - Apple previewed macOS Ventura, the latest version of the company's desktop operating system, which the company said "takes the Mac experience to a whole new level." Apple added: "Stage Manager gives Mac users an all-new way to stay focused on the task in front of them while seamlessly switching between apps and windows. Continuity Camera uses iPhone as the webcam on Mac to do things that were never possible before, and with Handoff coming to FaceTime, users can start a FaceTime call on their iPhone or iPad and fluidly pass it over to their Mac. Mail and Messages come with great new features that make the apps better than ever, while Safari - the world's fastest browser on Mac - ushers in a passwordless future with passkeys. And with the power and popularity of Apple silicon, and new developer tools in Metal 3, gaming on Mac has never been better." The developer beta of macOS Ventura is available to Apple Developer Program members starting today. A public beta will be available to Mac users next month. macOS Ventura will be available this fall as a free software update.

14:32 EDT Apple says M2 to take 'breakthrough performance' of M1 chip 'even further' - Apple announced M2, which it said is "beginning the next generation of Apple silicon designed specifically for the Mac." Apple added: "Built using second-generation 5-nanometer technology, M2 takes the industry-leading performance per watt of M1 even further with an 18 percent faster CPU, a 35 percent more powerful GPU, and a 40 percent faster Neural Engine.1 It also delivers 50 percent more memory bandwidth compared to M1, and up to 24GB of fast unified memory. M2 brings all of this - plus new custom technologies and greater efficiency - to the completely redesigned MacBook Air and updated 13-inch MacBook Pro... The system-on-a-chip design of M2 is built using enhanced, second-generation 5-nanometer technology, and consists of 20 billion transistors - 25% more than M1. The additional transistors improve features across the entire chip, including the memory controller that delivers 100GB/s of unified memory bandwidth - 50% more than M1. And with up to 24GB of fast unified memory, M2 can handle even larger and more complex workloads."

14:31 EDT Apple unveils iPadOS 16, says will have 'big release' - Says iPadOS 16 to come with shared photo libraries, and a "big update" to mail.

14:26 EDT Apple says Capcom's 'Resident Evil Village' coming to Mac computers this year - Apple (AAPL) says macOS Ventura to get ability to pull back mail and new Passkeys privacy feature for Safari and mail. Says MetalFX Upscaling for developers coming to macOS Ventura. Says Capcom (CCOEY) video game "Resident Evil Village" coming to Mac computers later this year.

14:16 EDT Apple unveils Stage Manager feature for macOS Ventura - Says macOS Ventura to come with Stage Manager feature, which lets users focus on the app they're using without distractions. Says Stage Manager allows for improved multiple window management. Says macOS Venture to include improvements to Spotlight.

14:11 EDT Apple says new MacBook Air, MacBook Pro available next month - Says MacBook Air starts $1199, $1099 for education. Says MacBook Pro starts at $1299, $1199 for education. Says both new MacBooks available next month.

14:08 EDT Apple's new MacBook Air has silent, fanless design - Says new MacBook Air has silent, fanless design and has up to 18 hours of video playback battery life. Says new Air supports fast charge.

14:02 EDT Apple announces new MacBook Air fitted with M2 chip - Says MacBook Air is world's best-selling laptop.

13:59 EDT Apple unveils new M2 chip for Mac - Says next generation of Apple Silicon chip coming to Mac computers. Says M2 has 18% greater performance than M1 and 1.9x faster performance than the latest 10-core PC laptop chip. Says M2 has 25% more GPU performance than M1 at same power level. Says M2 comes with 24GB unified memory, four high-performance cores, and four high-efficiency cores.

13:55 EDT Apple says WatchOS 9 to get medication tracking functionality - Says new WatchOS 9 Fitness app will be available to all iPhone users. Says new Watch health app to come with AFib history feature, which is currently pending FDA clearance. Says Watch to get medication tracking functionality.

13:45 EDT SCWorx completes settlement of previously disclosed SEC matter - SCWorx announced that the Company has received final court approval for a settlement with the Securities and Exchange Commission, to resolve the SEC matter arising out of the Company's April 13, 2020 press release and the events thereafter. Without admitting or denying the allegations, SCWorx has agreed to a settlement, which has received final court approval, that includes permanent injunctions, the payment of a $125,000 penalty, and disgorgement of $471,000 with prejudgment interest of $32,761.56. SCWorx is expected to satisfy its obligation to pay the disgorgement and prejudgment interest by contributing stock, valued at $600,000 at the time of issuance, to harmed investors in a private class action settlement in Yannes v. SCWorx Corp., et al., 1:20-cv-03349 "As previously stated, I accepted the CEO role on June 1, 2021 and since that time it has been a top priority to resolve legal issues stemming from the April 13, 2020 press release. The SCWorx Officers and Directors are happy to put the SEC matter behind us and dedicating our full efforts towards growing our data management services for healthcare providers," said Tim Hannibal, SCWorx CEO, "The SCWorx management and Board of Directors would like to thank the staff at the SEC for its assistance in resolving this matter. The Company recorded an accrual for the full amount of this penalty in the first quarter of 2022, which was reflected in our 10-Q financial results."

13:43 EDT Apple says iOS 16 will include Spacial Audio Profile - Says iOS 16 to get redesigned Home App. Says iOS 16 to also include new features for CarPlay. Says CarPlay to be more deeply integrated with vehicle's systems.

13:34 EDT Apple introduces Safety Check in effort to protect domestic abuse victims - Says introducing Safety Check, a feature that allows users to review and reset access settings for people in abusive relationships. Says Safety Check allows users to turn off location sharing, manage app access, and seek help.

13:28 EDT Apple News to get more sports-related features - Says ApplePay to get "pay later" features. Says bringing new Apple Maps to 11 more countries soon. Says Apple Maps to get multi-stop routing feature. Says Apple News to get more sports-related features, will be available in U.S., U.K., Canada, and Australia.

13:18 EDT Apple says iOS 16 brings SharePlay feature to Messages app - Says iOS 16 to give Messages new features, including ability to edit or unsend texts and mark threads as unread. Says iOS 16 brings SharePlay feature to Messages app. Says iOS 16 also includes updates to dictation in Messages. Says iOS 16 also has better Siri integration.

13:11 EDT Apple unveils iOS 16 with new lockscreen features - Says iOS 16 offers new intelligence, sharing, and communication features. Says new lockscreen featuers coming with iOS 16. Says iOS 16 notifications improved in Live Activities. Comments taken from Apple's Worldwide Developers Conference keynote event.

12:14 EDT Musk says waiving due diligence does not mean accepting understated bots - Tesla (TSLA) CEO Elon Musk responded with "correct" to the tweet: "$TWTR can be liable for omissions of OR misleading material facts. Waiving due diligence DOES NOT mean you have to accept a fraudulent disclosure (understated bots)."

12:13 EDT Axon halts drone project, ethics panel members resign - Axon founder and CEO Rick Smith said on Sunday: "Axon was founded on our mission to protect life. All of us here at Axon are focused on identifying solutions that can stop mass shootings and save lives. We are constantly challenging ourselves to think differently and outside the box because too many families and communities have endured unspeakable tragedy. We recently introduced new ideas and concepts to achieve these objectives. One of them is an early-stage concept that we felt was worthy of exploring further and to share into the important public debate that is happening. This concept is to use non-lethal drones with TASER weapon capabilities, pre-installed in public spaces, that may able to stop a mass-shooting in a matter of minutes. We felt it was important to have a conversation about this potential technology transparently with the public. Our announcement was intended to initiate a conversation on this as a potential solution, and it did lead to considerable public discussion that has provided us with a deeper appreciation of the complex and important considerations relating to this matter. I acknowledge that our passion for finding new solutions to stop mass shootings led us to move quickly to share our ideas. However, in light of feedback, we are pausing work on this project and refocusing to further engage with key constituencies to fully explore the best path forward. I announced a potential delivery date a few years out as an expression of what could be possible; it is not an actual launch timeline, especially as we are pausing that program." Smith also said: "We are also committed to enhancing our processes to better leverage alternative opinions to fuel our learning and innovation. This includes views from our ethics advisory panel, which can provide deeper insight into our constituencies and can inform solutions that accomplish our goal of saving lives while also balancing the important interests of our different stakeholders. Making the world a safer place is a big task, and there are complicated issues we need to address. It is unfortunate that some members of Axon's ethics advisory panel have chosen to withdraw from directly engaging on these issues before we heard or had a chance to address their technical questions. We respect their choice and will continue to seek diverse perspectives to challenge our thinking and help guide other technology options that we should be considering." Shares of Axon are down 1.4% to $101.64 in midday trading.

12:02 EDT JetBlue commits to more jobs, better pay in message to Spirit team members - JetBlue (JBLU) released a letter and video message to Spirit (SAVE) Team Members who are following the upcoming shareholder vote and JetBlue's proxy campaign. The message was released to ensure that Spirit Team Members are aware of JetBlue's commitment to them should a combination with Spirit move forward, JetBlue says. "JetBlue has an incredibly strong culture and set of values, and we know you do too. If we have the opportunity to move forward as one company, we plan to offer you the benefits of working for JetBlue: We offer higher pay and better benefits than either Spirit or Frontier (ULCC). A combined JetBlue and Spirit will grow and add more well-paying jobs across our network. As we said before, we will match retention incentives for all those who have been promised them. We believe it is critical that great talent stays through the transition and pursues long-term careers with JetBlue. We are proud to have never furloughed any Crewmembers or sent a WARN Act notice in our 22-year history, and we continue to stand behind our no furlough commitment... For all the good things we want you to know about JetBlue, it's no secret that we are still emerging from the pandemic, and this is a tough business even in the best of times. While every company hits bumps in the road from time to time and faces difficult situations where reasonable people disagree, at JetBlue, we always work very hard to do the right thing by our Crewmembers and Customers in those moments, keeping our mission to 'Inspire Humanity' in mind. We have many challenges that together we can address more effectively. We can't predict how all of this will play out, but we can say one thing for certain: we will warmly welcome Spirit's 10,000-plus Team Members into JetBlue if given the opportunity. We have a chance to build with you the fifth-largest airline that Customers deserve. An airline that offers both low fares and award-winning service. An airline that truly challenges the Big Four with a product and price they can't ignore. An airline that Customers love. An airline that all of us can feel proud to say we work for every day."

12:00 EDT Starry falls -25.9% - Starry is down -25.9%, or -$2.75 to $7.87.

12:00 EDT Genius Sports rises 16.8% - Genius Sports is up 16.8%, or 52c to $3.58.

12:00 EDT UserTesting rises 18.4% - UserTesting is up 18.4%, or $1.10 to $7.08.

11:29 EDT Digital Brands told not in compliance with Nasdaq listing rules - In a regulatory filing, Digital Brands Group disclosed that on May 31, the company received a letter from the Listing Qualifications Staff of the Nasdaq Stock Market indicating that the bid price of the company's common stock had closed below $1.00 per share for 30 consecutive business days and, as a result, the company is not in compliance with Nasdaq listing rules. The filing stated: "Nasdaq's notice has no immediate effect on the listing of the company's ordinary shares on Nasdaq... If the company does not regain compliance with the bid price requirement by November 28, 2022, the company may be eligible for an additional 180-calendar day compliance period so long as it satisfies the criteria for initial listing on the Nasdaq Capital Market and the continued listing requirement for market value of publicly held shares and the company provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary... The company intends to closely monitor the closing bid price of the common stock and consider all available options to remedy the bid price deficiency to regain compliance with the minimum bid requirement."

11:15 EDT Sophia Genetics provides update on DEEP-Lung-IV study at ASCO 2022 - SOPHiA GENETICS (SOPH) provided an update on its multimodal DEEP-Lung-IV clinical study -- NCT04994795 -- at the 2022 American Society of Clinical Oncology Annual Meeting. To date, 19 sites across seven countries have signed up for participation in the study, including Roswell Park Comprehensive Cancer Center in New York. Early findings are promising and conceptually validate the potential for multimodal signatures to predict response to immuno-chemotherapy at the individual patient level, the company said, adding that first results will be discussed during SOPHiA GENETICS' joint Innovation Symposium with GE Healthcare on Monday, June 6, at 6:30 pm CDT. SOPHiA GENETICS has also entered into an agreement with GE Healthcare (GE) to utilize their Imaging Fabric Core and Imaging Fabric Annotation Template, as part of the Edison Digital Health Platform. In the context of the DEEP-Lung-IV clinical study, Imaging Fabric services will be used to visualize, segment, and annotate lung lesions for medical imaging visualization and annotation purposes. This allows SOPHiA GENETICS to further accelerate proprietary radiomics analytics workflows in the context of the study, in particular to move towards automatic whole-body tumor identification, segmentation, and quantification, the company said.

11:04 EDT Seagen, Genmab present data from tisotumab vedotin clinical development program - Seagen announced interim data from the innovaTV 205 trial, which included data evaluating tisotumab vedotin in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer who have not received prior systemic therapy, with a confirmed objective response rate of 41% and median durability of response that was not reached within almost 19 months of median follow up. Data were presented during an oral session at the American Society of Clinical Oncology 2022 Annual Meeting on June 6. Dose expansion Cohort E enrolled 33 patients with recurrent or metastatic cervical cancer who had not received any prior systemic therapy. At the time of data cutoff, the confirmed ORR among 32 evaluable patients was 41% with 16% of patients achieving complete responses and 25% of patients achieving partial responses. Median duration of response was not reached. Median progression-free survival was 5.3 months. Building on data presented at the European Society for Medical Oncology Congress 2021, additional longer-term follow-up data from Cohorts D and Cohort F of the innovaTV 205 trial were also included in the ASCO 2022 oral presentation. In Cohort E, the most common treatment-emergent adverse events were alopecia, diarrhea, epistaxis, conjunctivitis, and nausea. Prespecified adverse events of interest with tisotumab vedotin included ocular, peripheral neuropathy, and bleeding. Tisotumab vedotin in combination with pembrolizumab across lines of treatment, and with carboplatin in first-line, demonstrated a tolerable and manageable safety profile. Across all three cohorts, no new safety signals were reported outside of known adverse events associated with the individual agents. Tisotumab vedotin is approved for treatment of patients with previously treated recurrent or metastatic cervical cancer in the US and is commercialized under the tradename TIVDAK. One highlight of real-world studies presented is a poster discussion on the Cervical Cancer Geographical Burden Analyzer. This is an open access, web-based, interactive tool to visualize geographical areas in the US where cervical cancer education or healthcare resource needs are high. Additional updates from the tisotumab vedotin clinical development program were presented at the ASCO 2022 Annual Meeting, including trial-in-progress overviews for innovaTV 205/ENGOT-cx8/GOG-3024 evaluating first-line tisotumab vedotin in combination with pembrolizumab, carboplatin and bevacizumab in first-line r/mCC; and for innovaTV 207 Part D evaluating tisotumab vedotin in combination with pembrolizumab and platinum in squamous cell carcinoma of the head and neck and squamous cell non-small cell lung cancer.

10:38 EDT Centrais Electricas trading halted, news pending

10:14 EDT SailPoint slips after Thoma Bravo cuts price in Anaplan takeover - Shares of SailPoint Technologies (SAIL) are down $2.06, or 3%, to $62.24 in morning trading after Anaplan (PLAN) announced earlier that they have amended the terms of their previously announced transaction pursuant to which Anaplan will be acquired by software investment firm Thoma Bravo. Under the terms of the amended merger agreement, Anaplan stockholders will receive $63.75 per share in cash, instead of the original purchase price of $66.00 per share in cash. Previously, SailPoint announced a definitive agreement pursuant to which Thoma Bravo will acquire the company in an all-cash transaction for $65.25 per share. On June 1, SailPoint had announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to the company's pending transaction with Thoma Bravo. At that time, SailPoint had stated that the transaction was still expected to close in the second half of 2022.

10:05 EDT Fox Corp. names Gabrielle Brown as chief investor relations officer - Fox Corporation (FOXA) announced the company's new head of investor relations. Gabrielle Brown has been named Executive Vice President and Chief Investor Relations Officer for Fox Corporation. The role will be based in New York, and she will report to Steve Tomsic, CFO. Brown succeeds Joe Dorrego, who established the FOX investor relations team in 2019 and has continued in that role after being named Chief Operating and Chief Financial Officer at FOX News Media in 2020. Brown will join FOX from UBS (UBS), where she most recently served as a Managing Director specializing in the global internet and media industries.

10:03 EDT Vertex Pharmaceuticals presents data from VX-880 Phase 1/2 clinical trial - Vertex Pharmaceuticals provided additional data on patients dosed in Part A of its Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with T1D with impaired hypoglycemic awareness and severe hypoglycemia. As reported last month, both patients treated with half the target dose of VX-880 achieved glucose-responsive insulin production, improvements in glycemic control and reductions in exogenous insulin requirements. The data presented today show significant increases in the blood glucose time-in-range compared to baseline, following treatment with VX-880. Time spent in target range is a clinically important metric in diabetes management that reflects the amount of time a patient's blood glucose level is measured in the desired, target blood sugar range. The accepted American Diabetes Association/European Association for the Study of Diabetes target for time-in-range is 70%. These data were presented during the American Diabetes Association 82nd Scientific Sessions Conference on June 6, 2022 in New Orleans, Louisiana from 9:00 to 9:15 a.m. CDT as an oral abstract presentation, "Stem Cell-Derived, Fully Differentiated Islet Cells for Type 1 Diabetes". The presentation included data from both patients dosed in Part A of the study, designed to assess the safety profile of VX-880 at half the target dose. Patient 1 showed a blood glucose time-in-range increase from 40.1% at baseline to 99.9% at Day 270 and was insulin independent. Patient 2 showed a time-in-range increase from 35.9% at baseline to 51.9% at Day 150 with a 30% reduction in exogenous insulin use. VX-880 has been generally well tolerated in all patients dosed to date, with the majority of adverse events being mild or moderate. Additional Vertex presentations at ADA this year included an oral presentation, "Persistence of Impaired Awareness of Hypoglycemia, Severe Hypoglycemic Events and Suboptimal Glycemic Control Despite Advanced Diabetes Technologies", and poster, "Gaps Remain in Achieving Target T1D Glycemic Goals Despite Advanced Technologies". To date, three patients have been dosed in the Phase 1/2 study with VX-880. Two patients received half the target dose of cells in Part A of the study. A third patient has received the full target dose in Part B of the study. Vertex is also pursuing additional programs in T1D, including one in which these same stem cell-derived islets are encapsulated in an immunoprotective device to be surgically implanted without the use of concomitant immunosuppression, and another program where cells are modified to produce hypoimmune stem cell-derived islets. IND-enabling studies for the encapsulated cells program are underway, and the company remains on track to submit an IND in 2022.

10:02 EDT NextEra Energy CEO says solar tariffs pause 'an important step' to help recovery - NextEra Energy (NEE) President and CEO and NextEra Energy Partners (NEP) CEO John Ketchum issued the following statement regarding today's announcement on solar tariffs: "The Biden administration's announcement of a two-year pause on new solar tariffs is an important step to help the solar industry recover from the uncertainty of the last three months. I want to thank the administration for recognizing the challenges that trade uncertainty presents to our industry and the country and for taking this important action. NextEra Energy has and will continue to use our industry leadership to support more U.S. solar manufacturing. We look forward to working with the administration on this effort and putting hard working Americans back to work in the solar industry."

10:00 EDT ProShares UltraShort Bloomberg Natural Gas falls -14.6% - ProShares UltraShort Bloomberg Natural Gas is down -14.6%, or -$3.21 to $18.74.

10:00 EDT Aspen Aerogels rises 13.2% - Aspen Aerogels is up 13.2%, or $2.34 to $20.10.

10:00 EDT Full Truck Alliance rises 14.5% - Full Truck Alliance is up 14.5%, or $1.00 to $7.90.

09:51 EDT Amazon.com trading near $125 following 20-for-1 stock split - Amazon's previously disclosed 20-for-1 stock split became effective with the open of trading this morning. In early trading, Amazon shares are up $3.12, or 2.5%, to $125.47.

09:47 EDT Greenhill & Co. falls -8.9% - Greenhill & Co. is down -8.9%, or -$1.07 to $11.00.

09:47 EDT ProShares UltraShort Bloomberg Natural Gas falls -15.1% - ProShares UltraShort Bloomberg Natural Gas is down -15.1%, or -$3.31 to $18.64.

09:47 EDT Altus Power rises 14.3% - Altus Power is up 14.3%, or $1.02 to $8.21.

09:39 EDT Intergrated Media Technology Ltd trading halted, volatility trading pause

09:32 EDT Integrated Media's Ace Corporation enters agreement with Hainan Pansuo Art - Integrated Media Technology announces that the company's subsidiary Ace Corporation has entered into a cooperation agreement with Hainan Pansuo Art and Culture Development to establish a strategic partnership to provide one-stop blockchain traceability, automated NFT production, electronic settlement and related development and technical support.

09:30 EDT Nexa Resources CFO Rodrigo Menck resigns - Nexa Resources announces that Mr. Rodrigo Menck, Senior Vice President of Finance and Group CFO, has informed that he will be stepping down from his role of CFO as of July 06, 2022. Menck joined Nexa in 2016 and served as Head of Treasury & Investor Relations prior to being nominated as CFO in January 2019. Nexa has initiated a search to identify its next CFO and for the interim period, Mrs. Claudia Torres, head of Corporate Controller, has been appointed as CFO.

09:27 EDT Dolphin Entertainment announces change of auditor to Grant Thornton - Dolphin Entertainment announced that its Audit Committee approved the engagement of Grant Thornton as the Company's new independent registered public accounting firm, effective June 3, 2022. The Committee dismissed its prior registered independent public accounting firm on May 27, 2022. The Company is working closely with Grant Thornton and its prior registered independent public accounting firm to ensure a seamless transition.

09:26 EDT Nexa Resources CFO Rodrigo Menck to step down - Nexa Resources announced that Rodrigo Menck, senior VP of finance and group CFO, has informed that he will be stepping down from his role of CFO as of July 06. Menck joined Nexa in 2016. Rodrigo was directly involved in Nexa's IPO and through his leadership, the company was successful on fundraising in capital markets and managing its capital structure, particularly during the pandemic. Nexa has initiated a search to identify its next CFO and for the interim period, Claudia Torres, head of corporate controller, has been appointed as CFO.

09:25 EDT NLS Pharmaceutics appoints Chad Hellmann as CFO - NLS Pharmaceutics announces that Chad Hellmann has been appointed to the position of CFO. Serving most recently as CFO and co-portfolio manager of Arcus Ventures, Mr. Hellmann brings to NLS significant expertise in developing and implementing operational strategies and capital markets solutions for life sciences companies. NLS also announces that Subhasis Roy has resigned as Interim CFO and will remain a consultant to the Company through June 30, 2022 to assist with the CFO transition.

09:24 EDT ImmunityBio announces data from BCG-unresponsive NMIBC trial at ASCO - ImmunityBio announced new positive data from the company's pivotal Phase 2/3 trial for BCG-unresponsive non-muscle invasive bladder cancer NMIBC, carcinoma in situ and Phase 2 trial in advanced pancreatic cancer . The results, which were presented during the 2022 American Society of Clinical Oncology Annual Meeting, demonstrate the strong and diverse growth of ImmunityBio's immunotherapy platform that includes an IL-15 superagonist , adenovirus vaccine platform, and engineered off-the-shelf natural killer cell therapy. Together with the company's self-amplifying RNA and yeast platforms, and Toll receptor activators, along with clinical progress across a range of highly challenging cancer types and commercial-scale manufacturing capabilities, ImmunityBio believes that it is well positioned to change the paradigm of care in cancer and infectious disease. The data demonstrate a potential new option for BCG-unresponsive non-muscle invasive bladder cancer patients who were treated with Bacillus Calmette-Guerin plus N-803 and the doubling of historic overall survival rates in patients with advanced pancreatic cancer who were treated with the Nant Cancer Vaccine, N-803 , and off-the-shelf PDL1-targeted high-affinity NK cell infusion. "Collectively, bladder cancer and pancreatic cancer claim more than half a million lives globally each year, with many patients failing to respond to the current standards of care," said Sandeep Bobby Reddy, M.D., Chief Medical Officer at ImmunityBio. "In dozens of studies, we have shown that N-803 proliferates NK and T cells and thus serves as an enhancing secondary boost, augmenting the immunological response when given in combination with BCG or a checkpoint inhibitor. This mechanism of action of inducing trained innate immune memory, through the combination of N-803 and a prime, contributes we believe to the compelling results we're seeing in these important trials."

09:23 EDT BGC Partners appoints Hauf as Chief Financial Officer - BGC Partners announced the appointment of Jason Hauf as Chief Financial Officer, effective June 6, 2022. Hauf will replace Steven Bisgay, who will remain in his executive role as Chief Financial Officer and Executive Managing Director of Cantor Fitzgerald. Hauf will report directly to Howard Lutnick, BGC's Chairman and Chief Executive Officer. Hauf most recently served as Managing Director and CFO of Exos Technology and Financial Partners.

09:21 EDT Zentek provides updates on ZenGUARD patent status - Zentek is pleased to announce that on March 28, 2022, the Canadian national phase was initiated for its patent application directed to its ZenGUARD technology. Zentek's patent strategy typically begins by filing one or more provisional patent applications with the United States Patent and Trademark Office. This allows the Company to establish the earliest possible filing date for its technology. A regular utility patent application is then filed within 12 months under the Patent Cooperation Treaty. Six months later, or 18 months from the date the initial provisional patent application was filed, the patent application is published. Following publication of the patent application, the Company then has a 12-month period to enter the national phase by filing in the individual countries in which it wants to protect its intellectual property. The Company is now actively prosecuting the patent application in Canada after receiving initial feedback from the Canadian Patent Office on June 1 and intends to seek to secure patent protection for its ZenGUARD technology for personal protective equipment and for the heating, ventilation, and air conditioning markets. Zentek also reports that a second patent application directed to its ZenGUARD technology for use as a broad-spectrum antimicrobial to treat infectious disease, is expected to publish on June 20th, 2022. The application received a favourable initial opinion from the International Searching Authority, indicating that 58 out of 64 claims are considered to have met the full requirements for patentability. This opinion will be available with the publication of the patent application. The Company further reports that a patent application directed to the proprietary process for manufacturing its ZenGUARD nanotechnology at industrial scale, that simplifies and significantly reduces manufacturing costs, was filed on April 12, 2022. The company expects this patent to add an extra layer of intellectual property protection as the company commercializes ZenGUARD.

09:20 EDT Avantax welcomes ATS Advanced Trustee Strategies - Avantax welcomes ATS Advanced Trustee Strategies, an elite firm based in San Diego, California, with over $400 million in total client assets as of April 1, 2022. Led by 32-year financial services veteran Sandeep Varma, ATS Advanced Trustee Strategies specializes in advanced estate planning designed to help ensure client assets are bequeathed according to their wishes.

09:19 EDT Stereotaxis announces publication of special issue of JAFIB-EP - Stereotaxis announces the publication of a special issue of the Journal of Atrial Fibrillation & Electrophysiology focused on the use of Robotic Magnetic Navigation for the treatment of cardiac arrhythmias. The Robotics Special Issue was published in collaboration with the Society for Cardiac Robotic Navigation and includes sixteen peer-reviewed publications that document the clinical value of Robotic Magnetic Navigation, new technologies, and refined workflows across a broad spectrum of cardiac arrhythmias. The journal will also incorporate robotics as a recurring section in future editions. Physicians from 20 hospitals and universities throughout North America, Europe and Asia contributed to the sixteen publications in the Robotics Special Issue. The complete issue can be accessed at www.JAFIB-EP.com. The publications cover a wide range of topics including: Historical review and evolution of Robotic Magnetic Navigation; Reviews of clinical outcomes from large subsets of patients with atrial fibrillation, ventricular tachycardias and supraventricular tachycardias; Robotics enabling fluoro-less cardiac ablation procedures without the use of x-ray radiation; The use of Stereotaxis robotic technology in conjunction with novel preoperative imaging and a broad array of electrophysiology mapping technologies; Demonstration of TeleRobotic technology for remote catheter navigation.

09:17 EDT Cumulus Media announces preliminary results of tender offer - Cumulus Media announced the preliminary results of its "modified Dutch auction" tender offer, which expired at midnight, New York City time, on June 3, 2022. This tender offer is an initial step in the execution of the Company's previously announced $50 million share repurchase program. Based on the preliminary count by Continental Stock Transfer & Trust Company, the depositary for the tender offer, a total of 5,561,072 shares of the Company's Class A common stock were validly tendered at a purchase price of $14.50 per share and not validly withdrawn, including 110,122 shares of the Company's Class A common stock that were tendered through notice of guaranteed delivery. These shares represent approximately 29.6% of the Company's outstanding Class A common stock as of April 29, 2022. In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, the Company expects to accept for payment approximately 1.7 million shares of its Class A common stock that were validly tendered and not validly withdrawn at a purchase price of $14.50 per share, for an aggregate cost of approximately $25 million, excluding fees and expenses relating to the tender offer. The number of shares to be purchased from tendering shareholders will be pro-rated. Based on the preliminary count by the depositary, Cumulus estimates that, after giving effect to odd lot priority, the pro-ration factor for shares that will be purchased in the tender offer is approximately 30.94%. The Company also announced that it has determined to waive the condition relating to the prevailing prices in the equity markets.

09:16 EDT Radius Health, Menarini present subgroup analysis from phase 3 EMERALD trial - The Menarini Group and Radius Health announced the presentation at the 2022 American Society of Clinical Oncology Annual Meeting of data from the EMERALD phase 3 clinical trial. In a non-pre-specified subgroup analysis of patients with ER+/HER2- metastatic breast cancer without prior chemotherapy in the metastatic setting, elacestrant significantly prolonged progression-free survival compared to standard of care endocrine therapy. EMERALD study met both of its pre-specified primary endpoints of progression free survival in the overall population and in patients with ESR1 mutation; 77.8% out of the 477 patients enrolled in the trial had not received prior chemotherapy in the metastatic setting for ER+/HER2- mBC. Among these patients, elacestrant showed the following results compared to SOC: 31% reduction in the risk of progression or death in all patients and prolonged median PFS; 46% reduction in the risk of progression or death in patients with mESR1 and prolonged median PFS; At 6 months, PFS rate with elacestrant was 38.18% vs. 23.47% with SOC in the overall population, and 43.79% vs. 23.83% in the ESR1 mutation population; PFS rate at 12 months with elacestrant was 27.12% vs. 12.19% with SOC in the overall population, and 31.48% vs. 12.36% in the ESR1 mutation population. In exploratory subgroup analyses, elacestrant significantly reduced the risk of progression or death and prolonged median PFS vs fulvestrant in all patients without prior chemotherapy; median , and in patients with mESR1 without prior chemotherapy; Elacestrant had a manageable safety profile in patients without prior chemotherapy consistent with the overall population. Menarini plans to pursue combination studies and study the potential of elacestrant to be effective in addressing the highest unmet needs for ER+/HER2-patients.

09:12 EDT Gilead presents final data from ASCENT study of Trodelvy - Gilead presented final data from the Phase 3 ASCENT study of Trodelvy in patients with relapsed or refractory metastatic triple-negative breast cancer, or TNBC, who received two or more prior systemic therapies, at least one of them for metastatic disease. In a follow-up analysis from the final database lock, Trodelvy improved median progression-free survival versus physicians' choice of chemotherapy and extended median overall survival, or OS, by almost five months in the intent-to-treat population. The two-year OS rate was 20.5% in the Trodelvy arm, compared with 5.5% with physicians' choice of chemotherapy. Trodelvy also showed clinically meaningful improvements in health-related quality of life, or HRQoL, compared to chemotherapy. The results, which were consistent with the final analysis previously published in The New England Journal of Medicine, were presented at the 2022 American Society of Clinical Oncology, or ASCO, annual meeting. Trodelvy demonstrated higher clinically meaningful improvements in all five primary HRQoL domains compared to chemotherapy, which was consistent with previous reports. Metastatic TNBC is often associated with a significant decrease in quality of life, where patients may undergo many rounds of intensive chemotherapy, and assessing impact of symptom burden is especially important in this setting. Changes from baseline for Trodelvy vs. chemotherapy were -5.8 vs. -9.4 in global health status, -4.6 vs. -13.5 in physical functioning, -8.4 vs. -18.8 in role functioning, 5.1 vs. 14.0 in fatigue, and 2.8 vs. 6.8 in pain. The safety profile of Trodelvy was consistent with prior reports. Key Grade greater than or equal to3 treatment-related adverse reactions for Trodelvy compared to chemotherapy were diarrhea, neutropenia, anemia and febrile neutropenia. Treatment discontinuations due to adverse events were less than or equal to 3% in both arms. The Trodelvy U.S. Prescribing Information has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.

09:10 EDT Middlesex Water begins treating ground water for PFAS compounds - Middlesex Water Company today announced that it has completed Phase 1 construction of an advanced treatment facility at its Park Avenue wellfield that is effectively treating ground water to ensure compliance with all state and federal drinking water standards. Working in coordination with the New Jersey Department of Environmental Protection, Middlesex Water has begun a phased, start-up of its Park Avenue wellfield and is successfully introducing treated water into the distribution system. Water being delivered to customers is in compliance with all U.S. Environmental Protection Agency and NJDEP drinking water standards, including the newly established water quality standard for Perfluorooctanoic Acid, otherwise known as PFOA. The wells had been turned off since November 2021 when the Company had begun providing water from its surface water treatment plant and other sources. This plan to turn on, and treat, certain wells to support normal heightened seasonal demand was met with full approval from state regulatory agencies.

09:08 EDT Fortinet launches FortiRecon offering - Fortinet announced FortiRecon, a complete Digital Risk Protection Service offering that uses a powerful combination of machine learning, automation capabilities, and FortiGuard Labs cybersecurity experts to manage a company's risk posture and advise meaningful action to protect their brand reputation, enterprise assets, and data. FortiRecon uniquely delivers a triple offering of outside-in coverage across External Attack Surface Management, Brand Protection, and Adversary-Centric Intelligence (ACI) to counter attacks at the reconnaissance phase - the first stage of a cyberattack - to significantly reduce the risk, time, and cost of later stage threat mitigation.

09:08 EDT Zoom Video, Genesys enter strategic agreement for Zoom Phone - Zoom Video Communications and Genesys have expanded their partnership to help businesses deliver effortless customer experience by building upon their integration between Zoom Phone and Genesys Cloud CX. Together, the offerings provide organizations with an easy-to-configure and feature-rich cloud contact center and unified communications solution that enables teams to better collaborate to solve customer needs. The companies' expanded partnership includes a go-to-market relationship where Genesys will enable its global direct and indirect channel to deliver the combined Zoom Phone plus Genesys Cloud CX solution.

09:06 EDT Amgen announces FDA approved RIABNI - Amgen announced that the U.S. Food and Drug Administration has approved RIABNI, a biosimilar to Rituxan, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. "The approval of RIABNI is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system." The randomized, double-blind, comparative clinical study compared the efficacy, safety, pharmacokinetics and immunogenicity of RIABNI versus rituximab reference product in patients with moderate to severe RA. The primary efficacy endpoint, the change in disease activity score 28 using C-reactive protein from baseline at week 24, was within the predefined equivalence margin indicating equivalence in clinical efficacy between RIABNI and rituximab RP. Safety, pharmacokinetics and immunogenicity of RIABNI were similar to rituximab RP.

09:05 EDT Freedom Boat Club to surpass 50,000 memberships - Brunswick Corporation announced that Freedom Boat Club this week is expected surpass 50,000 memberships across its 360 global locations, made up of both corporate locations and a continually growing network of franchise partners. Freedom's 50,000 memberships cover more than 75,000 global members constituting a growing, energetic, and diverse community of boating enthusiasts. Freedom has become a catalyst for new and future generations of boating participation, strengthening the entire industry. Since Brunswick's acquisition of Freedom in 2019, the company has more than doubled its memberships, locations, and the number of boats in its fleet. Through organic growth and completed acquisitions of former franchise territories, even excluding synergies, Freedom's contribution to Brunswick's top-line is anticipated to double in 2022 vs. 2021 as it scales quickly to deliver its 2025 financial targets and become much more material to Brunswick's overall growth and financial performance. The growth in company operated locations has been matched by continued expansion of franchise locations which still account for more than 70 percent of all club locations. The subscription nature of Freedom revenue and earnings contributes to the growing impact of recurring revenue businesses, which also include aftermarket Parts and Accessories and repower engine sales, on Brunswick's overall revenue and earnings. Brunswick's recent acquisitions have focused heavily in this area with recent Brunswick acquisitions RELiON and Navico both having a very strong aftermarket sales mix. Brunswick's recurring revenue businesses already deliver more than 40 percent of total company earnings with a target to exceed 50 percent by 2025.

09:02 EDT Vitru reports results of first intake cycle of 2022 - Vitru reports record results of its first intake cycle of 2022. The digital education undergraduate intake cycle of Uniasselvi increased 28.6% when compared to the same period of the previous year, purely on an organic basis, reaching 223.9 thousand new students. This result confirms the resilience of its hybrid model. This substantial growth was despite the high comparison bar of the first intake cycle of 2021 and already takes into account the slight shift in the monthly distribution of the intake, which was more back-ended in the first cycle of 2021.In the case of Unicesumar, the first digital education undergraduate intake cycle of 2022 was even more impressive, increasing 54.6% when compared to the same period of the previous year, reaching 219.7 thousand new students in the 2022.1 cycle vs the 142.1 thousand students enrolled in the 2021.1 cycle.

09:01 EDT Great Elm Group announces public offering of unsecured notes - Great Elm Group announced the commencement of an underwritten public offering of unsecured notes due 2027. The Notes are expected to be listed on the Nasdaq Global Market under the trading symbol "GEGGL," and to trade thereon within 30 days from the original issue date. The interest rate and other terms of the Notes will be determined by negotiations between GEG and the underwriters. GEG expects to use the net proceeds from the offering to make investments in Monomoy Properties REIT, LLC and/or for general corporate purposes, including making opportunistic investments or refinancing subsidiary preferred stock or other indebtedness. Oppenheimer & Co. Inc., B. Riley Securities, Inc., Janney Montgomery Scott LLC and Ladenburg Thalmann & Co. Inc. are acting as joint book-running managers for the offering.

08:59 EDT First Watch Restaurant announces new menu offerings - First Watch is inviting guests to embrace the heat with a new menu of seasonally inspired dishes brimming with flavor and zest. Boasting two flavorful takes on brunch classics that celebrate authentic Mexican proteins, share-worthy muffin top griddle cakes and a fresh juice packed with everyone's summertime favorite, watermelon, this seasonal menu is sure to have the whole family dining and sipping on sunshine at their local First Watch this summer. First Watch's summer menu selections are available nationwide through August 14th and include: Barbacoa Quesadilla Benedict - Two barbacoa quesadillas prepared quesabirria-style, topped with poached cage-free eggs and covered with our Vera Cruz hollandaise, ranchero sauce and scallions. Served with seasoned black beans topped with housemade pico de gallo. Hacienda Hash - Chorizo, red bell pepper and potato hash topped with two cage-free eggs any style, Cheddar and Monterey Jack, spicy ketchup, lime crema drizzle, fresh smashed avocado and scallions. Blueberry Muffin Top Griddle Cakes - Three house-baked, butter-griddled blueberry and cinnamon streusel muffin tops, topped with warm mixed berry compote, fresh blueberries, strawberries, blackberries, housemade granola and powdered cinnamon sugar. From the Juice Bar: Watermelon Wake-Up - Watermelon, pineapple, lime and mint.

08:57 EDT Amarin to reduce U.S. commercial team by 65% from current levels - The majority of the cost savings will result from a significant workforce reduction across the Company's U.S. field force and corporate positions. Amarin will reduce its U.S. commercial team by approximately 65% from current levels and approximately 90% of pre-pandemic and pre-generic competition levels, resulting in a core team able to support branded VASCEPA revenues in the U.S. In total, these actions will result in a reduction of the total company employee base by over 40% from current levels.

08:53 EDT Datasea enters $14.99M procurement agreement for 5G messaging services - Datasea announced that Shuhai Jingwei Information Technology, a subsidiary of the Chinese operating company contractually controlled by the Company, has entered into a procurement agreement with Zhangzhou Baina Intelligent Technology. The agreement demonstrates Datasea's capability to provide rich messaging experiences through 5G at scale and revolutionize the way enterprises interact with customers. Baina is a leading provider of the smart city technology services to streamline and automate processes and help in real-time decisions. There are many ways to conceptualize a smart city and Baina specializes in smart transportation with charging pile management and smart healthcare solutions. Datasea assists Baina to evolve in the next phase of customer communication and address emerging demands for advanced features such as fee settlement and service introduction in Baina's different service scenarios. In conjunction with the 5G messaging recharge payment agreement, Shuhai Jingwei will act as the supplier and provide: 5G messaging recharge payment services of China Mobile, China Unicom, and China Telecom; A technical interface as a transmission channel for fee settlement; 5G short messages and telecommunication value-added services for Baina and its partners and clients. The term of the agreement is six months, during which the service fee will be prepaid by Baina and the total purchase amount will be approximately USD 14.99 million.

08:52 EDT NLS Pharmaceutics appoints Chad Hellmann as CFO - NLS Pharmaceutics announced that Chad Hellmann has been appointed to the position of CFO. Serving most recently as CFO and co-portfolio manager of Arcus Ventures, Mr. Hellmann brings to NLS significant expertise in developing and implementing operational strategies and capital markets solutions for life sciences companies. NLS also announces that Subhasis Roy has resigned as interim CFO and will remain a consultant to the company through June 30, 2022 to assist with the CFO transition. NLS expresses its deep appreciation to Mr. Roy for his many contributions to the Company.

08:52 EDT JBG Smith Properties increases share repurchase pact by $500M - JBG SMITH announced the sale of two assets for $344 million, as well as an increase of the Company's common share repurchase authorization by $500 million to $1 billion total. JBG SMITH closed the $198 million sale of its PenPlace development site to Amazon for the second phase of its HQ2. The 12-acre site was recently approved by Arlington County to house 3.2 million square feet of office space, including the landmark Helix building, more than 100,000 square feet of retail and approximately 2.75 acres of public open space. As previously reported, the sale of PenPlace was used to facilitate a like-kind exchange for JBG SMITH's acquisition of The Batley, a 432-unit apartment building in DC's Union Market which closed in 2021.

08:49 EDT AngloGold, Latin Metals enter definitive option agreement in Argentina - Latin Metals announces that it has entered into a binding option agreement with AngloGold Argentina Exploraciones, a wholly owned subsidiary of AngloGold Ashanti made as of May 27, 2022. Subsequently, AngloGold provided notice that all conditions precedent have been satisfied, and as a result the Option Agreement's commencement date has been established as June 2, 2022. Under the terms of the Option Agreement, Latin Metals granted to AngloGold the option to earn up to an 80% interest in the Company's Organullo, Ana Maria, and Trigal Gold projects located in Salta Province, northwestern Argentina. Under the terms of the Option Agreement, AngloGold has been granted the option to earn an initial 75% interest in the Projects by making cash payments to Latin Metals in the aggregate amount of USD $2,575,000 and spending an aggregate amount of USD $10,000,000 on exploration expenditures related to the Projects within five years of the Commencement Date. During the Option Period, Latin Metals will receive exploration results and data from AngloGold on a quarterly basis. Upon the fulfilment of the payment obligations and exploration expenditures set forth above, and the delivery by AngloGold to Latin Metals of a notice of exercise of the Option and subject to the exercise of Top-Up Right, AngloGold and Latin Metals will be deemed to have formed a joint venture for the continued exploration, development and, if warranted, commercialization of the Projects, in respect of which the initial participating interests of the parties will be, AngloGold as to 75% and Latin Metals as to 25%. Upon the exercise of the Option, AngloGold may give notice to Latin Metals of its intention to increase its interest in the Projects to 80%. The Top-Up Right may be exercised within 150 days of the Option Exercise Date by AngloGold: preparing and delivering to Latin Metals an independent Measured and Indicated Mineral Resource estimate prepared in accordance with National Instrument 43-101 Standards of Disclosure for Mineral Projects on one or more deposits contained within the Projects; and paying to Latin Metals an amount of USD $4.65 per gold equivalent ounce contained within the Measured and Indicated Mineral Resource estimate. Upon the exercise of the Top-Up Right, the parties' interests in the Joint Venture will be adjusted such that the participating interests of the parties will be AngloGold as to 80% and Latin Metals as to 20%. If and when the parties form the Joint Venture, the provisions of the agreement governing the Joint Venture will be negotiated and settled by the parties and will provide, among other things, that if the participating interest of either party falls below 10%, the interest of such party shall be converted to a 2% net smelter returns royalty, half of which can be purchased by the other party for USD $5,000,000 at any time until the date that is three months after a production decision concerning one or more of the Projects has been made.

08:47 EDT Johnson & Johnson to acquire assets of Midlands Management's units - Johnson & Johnson will expand its footprint into Texas and Oklahoma by acquiring the assets of the Wholesale Brokerage & Binding and Managing General Underwriting units of Midlands Management Corporation. Midlands is a wholly owned subsidiary of Safety National Casualty Corporation. The parties expect the transaction to close April 29, 2022. "This acquisition by Johnson & Johnson, a leading specialist in related businesses, will accelerate the growth in revenue and profitability of these business units and provide greater professional development and career advancement opportunities for the employees in these divisions," said Duane Hercules, President of Safety National. Francis Johnson, CEO, Johnson & Johnson, noted, "Adding the Midlands Management Corporation Team and their agency network to Johnson & Johnson will provide us with a terrific group of employees and agencies which will enhance our 'service first' approach to the Agents currently served by Midlands."

08:46 EDT ChemoCentryx reports safety results from Phase 1 trial of CCX559 - ChemoCentryx announced the presentation of safety results from the ongoing Phase I clinical study of CCX559, the Company's highly potent, orally administered PD-L1 checkpoint inhibitor, in patients with advanced solid tumors during a poster session at the 2022 American Society of Clinical Oncology Annual Meeting. In the ASCO poster titled, Results From an Ongoing Phase 1 Dose-Escalation Study of CCX559, an Orally Administered Small Molecule PD-L1 Inhibitor, in Patients With Advanced Solid Tumors, ChemoCentryx reported patient baseline characteristics and safety data available from the ongoing study as of April 27, 2022, from the first 13 patients enrolled across four dose cohorts: 30 mg, 60 mg, 120 mg, and 180 mg. The first-in-human Phase I study is assessing CCX559 in patients with a range of advanced solid tumors. Ten of the 13 patients enrolled have received at least two or more prior lines of systemic therapy. The primary objectives of the study are to evaluate the safety and tolerability, and to inform dose selection for the planned Phase Ib/II clinical trial. To date, there have been no dose limiting toxicities or treatment-related serious or severe adverse events reported. Two patients receiving 120 mg once daily CCX559 presented with three probable immune-related AEs, which provides supportive evidence of immune activation. There have been no treatment-related AEs reported in more than one patient. The ASCO poster also includes pharmacokinetic and pharmacodynamic data that build on the positive findings presented during the 2022 American Association for Cancer Research Annual Meeting in April, providing evidence that CCX559 is pharmacologically active and 120 mg once daily is a therapeutically relevant dose. Results presented during ASCO indicate continued dose-dependent PK exposure at Day 1 for CCX559. The mean exposure at 120 mg remains in line with preclinical projections and continues to increase at the 180 mg level. Consistent with approved antibody inhibitors of PD-L1, CCX559 demonstrates immunomodulatory activity in first cycle of treatment. ChemoCentryx expects to present additional findings from this ongoing Phase I study at major oncology conferences through 2022. The tumor types being evaluated in the Phase I study are not known to be responsive to treatment with anti-PD-1/PD-L1 therapies, and the Company plans to advance CCX559 into a Phase Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly during the second half of 2022.

08:42 EDT Liquidity Services selected to sell two offshore oil, gas helicopters - Liquidity Services is auctioning two Bell 407GX helicopters to the public through their online marketplace, AllSurplus, until June 23, 2022. The 2013 Bell 407GX Utility Helicopters have 2,893 and 2,828 flying hours respectively and each has a single Rolls Royce 250-C47b engine. Corporate maintenance records can be made available upon bidder request. The helicopters will be at auction until June 23, 2022, and bids require a refundable $5,000 deposit before being placed. The deposit goes towards the final price of the auction for the winning buyer and will be immediately refunded for all others.

08:40 EDT Seqirus completes $156M expansion to Holly Springs manufacturing facility - Seqirus, a business of CSL Limited, announced the completion of an expansion to the company's manufacturing facility in Holly Springs, N.C. The new pre-filled syringe line has received FDA approval and will support influenza vaccine production for the 2022/23 Northern Hemisphere season and beyond. Additionally, it will enhance the site's ability to respond to an influenza pandemic. The expansion, which began in 2018, cost $156M dollars to complete and will support more than 80 additional highly skilled jobs in the Holly Springs community. The expanded manufacturing facility and new pre-filled syringe line will allow Seqirus to increase its capacity to supply the U.S. market with FLUCELVAX QUADRIVALENT, the first and only cell-based quadrivalent influenza vaccine in the U.S. for individuals six months of age and older.

08:38 EDT Gevo enters partner agreement with Google Cloud - Gevo announced that it has entered into a partner agreement with Google Cloud to measure and verify the efficacy of next-generation biofuels across the supply chain via full lifecycle sustainability data tracking. Utilizing technology developed by Verity Tracking, a division of Gevo, the collaboration is expected to enable users to track and verify emissions using datasets and analytics tools from Google Cloud. The goal will be to help companies create a more data-driven approach to understanding and lowering greenhouse gas intensity globally. Together, Google Cloud and Verity expect to work on product-level engagements to address market and customer needs. Utilizing Google Cloud's analytics tools and Google Earth Engine's multi-petabyte catalog of Earth observation data, Gevo and Verity expect to provide measured verification of asset-level atmospheric emissions reductions, renewable energy-powered electricity for processing, and land-use changes with soil quality and water impacts to support Gevo's smart agriculture and carbon intensity claims, from farm to flight.

08:36 EDT American Homes, Varde Parters enter into $500M land banking facility agreement - American Homes 4 Rent and Varde Partners announced that they have entered into a land banking facility agreement. This facility provides $500M in initial capacity to acquire and develop new land opportunities as part of American Homes 4 Rent's internal development platform. The two firms have recently closed their first six land transactions into the facility, representing total acquisition and development costs of over $150M, and due diligence is underway on additional sites. "Our facility with Varde Partners will enable us to continue the strategic expansion of our development pipeline while also maintaining our commitment to a best-in-class investment grade balance sheet and reducing long-term risk," said David Singelyn, Chief Executive Officer of American Homes 4 Rent. "With a continued focus on our disciplined underwriting process and a robust pipeline of development opportunities, we are well-positioned to execute our three-pronged growth strategy in our diversified portfolio footprint while driving value for shareholders."

08:35 EDT Neurocrine presents data on sleep disturbances, OFF time - Neurocrine Biosciences presents data on sleep disturbances in Parkinson's disease demonstrating the impact of OFF episodes, or reemergence of symptoms between doses of levodopa, on falling asleep and staying asleep. These data are being shared at SLEEP 2022, the annual meeting of the Associated Professional Sleep Societies being held June 4-8 in Charlotte, North Carolina. The post-hoc analyses were conducted using baseline data from two previous Phase 3 studies of ONGENTYS capsules, an approved once-daily adjunctive treatment to levodopa/carbidopa in patients with PD experiencing OFF time. Results of this post-hoc analysis indicate that 34.4% of participants experienced an OFF episode before going to sleep for a mean duration of 1.8+/-1.2 hours. Among participants who woke up during the night, 81.0% were in an OFF state for a mean duration of 1.0 hours. Additionally, 89.4% of participants experienced an OFF episode upon waking in the morning, with the mean duration of this time to morning "ON" episode being 1.5 hours. OFF episodes can contribute to sleep impairment, a common but poorly addressed problem in patients with PD. The potential impact of OFF periods on sleep has not been well characterized.

08:33 EDT Applied Genetic to present three-month interim results from SKYLINE trial - Applied Genetic Technologies Corporation announced an encore presentation of interim data from its ongoing Phase 2 Skyline trial of AGTC-501, a recombinant AAV viral vector-based gene therapy targeting mutations in the RPGR gene in patients with X-linked retinitis pigmentosa, at the 45th Macula Society Annual Meeting taking place June 8-11, 2022, in Berlin, Germany. "We are excited to share these data from the Skyline clinical trial with the international ophthalmology community, as we believe robust improvements in visual sensitivity, along with a favorable safety profile, show great promise for AGTC-501 as a potential treatment for patients with XLRP", said Dr. Susan Schneider, Chief Medical Officer of AGTC. "We look forward to sharing future updates as we continue to progress AGTC-501 through the Vista Phase 2/3 clinical trial and towards a potential BLA submission."

08:33 EDT Bit Origin to lease 1,000 mining spots with three megawatts of power - Bit Origin has entered into a Letter of Intent with Your Choice 4 CA, a U.S. based data center operator managed by 1024 Capital, to lease 1,000 mining spots with three Megawatts of mining power in Marion, Indiana. The potential lease agreement is expected to increase productivity of approximately 12.66 BTCs per month for the Company when all miners are deployed in mid-June 2022 as scheduled. ursuant to the LOI, YCI agrees to provide Bit Origin with 1,000 hosting spots, providing approximately 100 PH/s at full capacity. The Company expects to enter into a definitive agreement in the coming days. As the transaction proceeds, the Company will publicly disclose required information either through press releases or SEC filings, as appropriate.

08:29 EDT Ovid Therapeutics presents preclinical data on OV329 - Ovid Therapeutics presented data at the 2022 Epilepsy Foundation Pipeline Conference. New preclinical data support the robust anti-seizure activity of OV329, a next-generation GABA-aminotransferase inhibitor in development for rare adult and pediatric epilepsies. Robust anti-seizure activity: Findings from preclinical seizure and epilepsy models indicate that OV329 significantly reduced focal and generalized seizures, including pharmacoresistant seizure phenotypes. Therapeutic dose with enhanced safety margin: A preclinical model of focal seizures in mice demonstrated that repeated administration of OV329 at a dose of 3 mg/kg reduced seizures by approximately 70% by the eighth day of treatment, as compared to placebo. Data presented by Ovid last month at the 2022 EILAT XVI Conference on New Antiepileptic Drugs and Devices found the same dose in rats was well-tolerated with no ocular changes observed following 45 days of repeated exposure, as compared to a generally equivalent human therapeutic dose of vigabatrim which did show ocular toxicity changes at 45 days. Potential seizure protection: A mouse model of generalized seizures showed a single dose of OV329 led to significant seizure reduction over a prolonged period. Another model using doses of OV329 at 40 mg/kg suggests that it may prevent the occurrence of seizures, and therefore, may have potential for antiepileptogenesis. In preclinical animal safety studies, OV329 was well-tolerated with no reported genotoxicity, cardiovascular or central nervous system effects at expected therapeutic doses. Importantly, in a translatable animal model, OV329 showed no adverse ocular effects at an anticipated therapeutic dose of 3 mg/kg after 45 days of dosing. In comparison, ocular effects have been seen in about half of the animals treated with vigabatrin at a generally equivalent human therapeutic dose of 300 mg/kg.

08:28 EDT Apexigen announces publication, presentation on Phase 2 PRINCE trial - Apexigen announced a peer-reviewed publication of the randomized, three-arm, Phase 2 PRINCE trial in patients with metastatic pancreatic cancer, conducted in collaboration with the Parker Institute for Cancer Immunotherapy, Bristol Myers Squibb and Cancer Research Institute. The Nature Medicine publication is titled, "Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized Phase 2 PRINCE trial." The data was also featured in an oral presentation at the 2022 American Society of Clinical Oncology Annual Meeting, taking place in Chicago from June 3-7, 2022. "We are encouraged that sotigalimab, an agonistic CD40 antibody, and separately, nivolumab, a PD-1 inhibitor, in combination with chemotherapy elicit distinct signatures of clinical and immune response that are consistent with their respective mechanisms of action," said Frank Hsu, M.D., Chief Medical Officer of Apexigen. "These findings reveal that baseline treatment-specific biomarkers may predict survival differences between these treatment regimens, as well as the potential of multi-omic, multi-parameter immune and tumor biomarker analyses to identify subsets of PDAC patients that may benefit from CD40 or PD-1 treatment in combination with chemotherapy." Key findings from the sotigalimab treatment analyses are included below: Clinical benefit for sotiga/chemo correlated with several markers including baseline helper CD4 T-cell infiltration in the tumor and a differentiated CD4 T-cell compartment and professional antigen presenting cells in circulation. A patient subset benefitting from the dual immunotherapy combination was not identified and the biomarker data are suggestive of immune exhaustion emerging post-treatment.

08:26 EDT Aveo Pharmaceuticals presents posters on tivozanib at ASCO meeting - AVEO Oncology presented three posters during the 2022 American Society of Clinical Oncology Annual Meeting highlighting data for tivozanib, the Company's oral, once-daily next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor designed to block the VEGF pathway by potently and selectively inhibiting all three VEGF receptors. Poster title: "Maturation of overall survival in TIVO-3 with long-term follow-up." - AVEO presented a poster evaluating OS with extended mean follow-up. As previously announced, at two years following the last patient in the TIVO-3 study, the mean follow-up was 17.9 months and 65% of patients experienced an event, with an OS hazard ratio of 0.99. With subsequent OS analyses and mean follow-up extended to 22.8 months, the data show that 80% of patients ultimately experienced events and the hazard ratio of OS lowered to 0.89, trending in favor of tivozanib. A conditional survival analysis was also performed which looked at OS for patients whose disease was progression free at the 12 month landmark, showing a statistically significant 55% relative reduction in the risk of death with tivozanib over sorafenib in this population. The median OS for those patients achieving 12 month PFS was 48.3 months as compared to 32.8 months, once again demonstrating the long-term benefit of tivozanib. Poster title: "Activity of tivozanib in non-clear cell renal cell carcinoma: Subgroup analysis from a phase 2 randomized discontinuation trial." - AVEO presented data from a subgroup analysis of patients with nccRCC who had no prior VEGF targeted treatment in its Phase 2 randomized discontinuation trial evaluating tivozanib. These data showed that the overall response rate at 16 weeks in all treated patients with nccRCC was 15.2% by independent radiology review. The best unconfirmed overall response rate and confirmed ORR was 31.6% and 21.1%, respectively. The disease control rate was 74%. The median PFS was 6.7 months. Safety was not analyzed by histology but there were no new safety signals and this was consistent with tivozanib labelling in the intent to treat population. The analysis concluded that tivozanib demonstrated activity and a favorable safety profile in patients with nccRCC. These data add to the body of evidence supporting VEGFR TKI use in advanced RCC, including in non-clear cell histologies. Trials in Progress Poster Presentation "TiNivo-2: A phase 3, randomized, controlled, multicenter, open-label study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma who have progressed following one or two lines of therapy where one line was an immune checkpoint inhibitor." - The Company presented a trial in progress poster for the Phase 3 TiNivo-2 trial, which is evaluating the combination of tivozanib and Bristol-Myers Squibb's OPDIVO, an antibody directed against programmed death-1, versus tivozanib monotherapy for the treatment of RCC patients progressing following prior immune checkpoint inhibitor therapy. Subjects will receive tivozanib 1.34 mg orally once daily for 21 consecutive days followed by seven days off, on the monotherapy arm, and tivozanib 0.89 mg at the same schedule in addition to nivolumab 480 mg intravenously every four weeks on the combination arm. The primary objective of the study is to compare the PFS of tivozanib in combination with nivolumab to monotherapy tivozanib. A sample size of 326 subjects, with 191 events will provide at least 80% power to detect a 50% improvement in PFS as assessed by IRR. Secondary endpoints include assessment of OS, ORR and duration of response, as well as safety and tolerability. Exploratory endpoints are to assess the quality of life and to investigate the pharmacokinetics of tivozanib. TiNivo-2 opened for enrollment during the third quarter of 2021 and currently expects to complete enrollment in the first half of 2023.

08:24 EDT Madrigal Pharmaceuticals supports International NASH Day - Madrigal Pharmaceuticals announced its support for the fifth International NASH Day, taking place on June 9, 2022. Led by the Global Liver Institute in partnership with patient groups and non-profit organizations across the globe, International NASH Day is a public education campaign launched in June 2018 to raise visibility and urgency around fatty liver disease and its more advanced form, NASH. The day includes community events and health screenings, educational briefings, media outreach, and social media campaigns globally.

08:22 EDT VBI Vaccines announces new tumor response and OS data for VBI-1901 at ASCO - VBI Vaccines announced that new tumor response and overall survival data from the ongoing Phase 2a study of VBI-1901, the Company's cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma was presented at the 2022 American Society of Clinical Oncology Annual Meeting on June 5. The expanded Phase 2a data were selected for presentation in both a poster session and a poster discussion session. "We continue to be motivated by the data seen in this Phase 2a study of VBI-1901 as we endeavor to provide new treatment options to patients with very few available to them," said David E. Anderson, Ph.D., VBI's Chief Scientific Officer. "Considering the high mortality rate among GBM patients, particularly in the recurrent setting, median overall survival of approximately 13-15 months seen in our two study arms suggests an additional survival benefit of nearly six months in comparison with historical control data in the recurrent population after treatment with a monotherapy.1 Moreover, the correlation of tumor responses and clinical response benefit observed in tandem is very encouraging. We remain in close discussion with our study investigators and scientific advisors as we move toward the next stages of development in both the recurrent and frontline GBM settings, and look forward to advancing this development program as diligently as possible."

08:21 EDT Biglari Capital issues letter to shareholders of Cracker Barrel - Biglari Capital Corp. issued the following letter to shareholders of Cracker Barrel Old Country Store. "Dear Fellow Cracker Barrel Shareholders: We are shareholders of Cracker Barrel Old Country Store, with an ownership of 2,055,141 shares, representing 8.8% of the Company's outstanding shares. On December 14, 2021, we issued a public letter to shareholders highlighting our concerns about Cracker Barrel's poor performance. Six months later, Cracker Barrel continues to lag behind its peer group, as the table below demonstrates. We believe management has neglected to focus on core issues relating to the Company's customer traffic and store-level margins. In our view, there is no sound rationale for pursuing headlong expansion of new units when a significant productivity gap persists in existing units... Over the last five years, the CEO has failed to retain customers; failed in a major acquisition, with a 100% loss within eight months; and failed to adapt to a modern post-pandemic environment. Cracker Barrel management has been consistent in losing customers and blaming external factors for its underperformance. It is time to replace CEO Sandy Cochran. Furthermore, the Company should return cash to shareholders through an aggressive share repurchase program or through a significant special dividend. We continue to see that a dollar in the hands of current management turns into less than a dollar of value for shareholders."

08:19 EDT Tanger Factory trading resumes

08:19 EDT FuelCell enters collaboration with TuNur - FuelCell Energy announced that it has executed a memorandum of understanding with TuNur Ltd., an independent renewable energy and green hydrogen developer focused on delivering low-carbon electricity and hydrogen to North Africa and Europe. Tunisia is the central point in the Mediterranean and offers huge potential for green electricity, hydrogen and ammonia for its own domestic needs and for export between Africa and Europe. The country's very high solar resource enables reliable, low-cost solar production, and the presence of a pipeline that extends from Tunisia to Italy is ideal for leveraging FuelCell Energy's electrolysis platform to generate hydrogen and transport it into Europe.

08:17 EDT Aemetis completes 20 miles of biogas pipeline, receives Merced County approval - Aemetis announced the completion of 20 miles of biogas pipeline and approval for construction of the remaining biogas pipeline in Merced County, California. Construction of the 39-mile main biogas pipeline is on schedule for completion in Q4 2022. This project milestone allows the installation of biogas pipeline in Merced County for construction of a pipeline for a total of 39 miles from the Aemetis ethanol plant in Keyes, California to dairies in Stanislaus County and Merced counties. The pressurized pipeline conveys conditioned, pressurized biogas from dairies to the Company's centralized gas cleanup facility and the Pacific Gas & Electric interconnection system to inject renewable natural gas nto the gas utility pipeline. At the Keyes plant, the biogas is upgraded to negative carbon intensity RNG for use as a transportation fuel in cars, trucks, and buses. The RNG is either delivered into the PG&E utility pipeline located onsite at the Aemetis ethanol plant, dispensed to trucks at fueling stations across California or at the RNG fueling station being built at the Aemetis plant. Previously, Aemetis announced that it received approval for the biogas pipeline from the Merced County Board of Supervisors for the Phase Two pipeline, as well as an Initial Study/Mitigated Negative Declaration for the entire pipeline project, the key approval necessary to meet the permitting requirements of the California Environmental Quality Act prior to pipeline construction. The CEQA approval confirms that mitigation measures in the biogas project will avoid or mitigate any impacts on the environment. The Company completed the permitting for 20 miles of biogas pipeline in Stanislaus County in August 2021 to connect dairies to the Aemetis biogas cleanup facility at the ethanol facility. The initial four-mile Phase 1 pipeline project was completed and commissioned in the third quarter of 2020 in conjunction with the completion of the Company's first two dairy digesters, and the 20 miles of Stanislaus County pipeline has now been completed. Additional pipeline will be added to connect digesters to the main biogas pipeline. Once complete, the Aemetis biogas digesters and clean-up facility will produce more than 1.65 million MMBtu of RNG each year. Aemetis received a negative -426 Carbon Intensity pathway for biogas from the company's first two dairy digesters, which is currently being utilized as process energy at the ethanol facility.

08:15 EDT Molecular Templates presents on PD-L1, HER2 programs at ASCO - Molecular Templates announces highlights from the two poster presentations on its clinical programs that were presented on June 5th at the 2022 American Society of Clinical Oncology annual meeting, taking place June 3 through June 7, 2022 at the McCormick Place Convention Center in Chicago, IL. Poster Title: First-in-human, dose escalation and expansion study of MT-6402, a novel engineered toxin body targeting PD-L1, in patients with PD-L1 expressing relapsed/refractory advanced solid tumors: Interim Data: Poster highlights: Data were presented on 12 patients with PD-L1+ relapsed/refractory disease across two dose cohorts: 16 mcg/kg and 24 mcg/kg. Treatment is on-going in the 32 mcg/kg cohort with no dose-limiting toxicities observed to date in the third cohort. Pharmacodynamic effects including PD-L1+ dendritic cell and monocyte cell depletion and T cell activation have been observed in the majority of patients. The extent and timing of these PD effects appear dose-related with patients in the 24 mcg/kg cohort generally showing a more rapid and profound PD effect. Patients in both cohorts demonstrated increases in IL-2. One patient in the first cohort with non-small cell lung cancer that had progressed after prior checkpoint therapy showed qualitative reduction in tumor burden. One DLT was observed in a single patient who experienced dermatitis that resolved rapidly with systemic steroids. The patient was rechallenged without incident at 24 mcg/kg. No other DLTs have been reported. Based on these findings, monotherapy will continue to be investigated and a combination approach with a PD-1 inhibitor is also being considered for select populations of patients. Poster Title: A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results: Data were presented on 35 patients with HER2+ relapsed/refractory disease across eight dose cohorts ranging from 0.5 mcg/kg to 13 mcg/kg and the breast cancer expansion cohort: Treatment is on-going with the 17 mcg/kg cohort having been closed and dosing has begun in the 23 mcg/kg cohort. No Grade 4 or 5 treatment emergent adverse events or DLTs have been identified in 35 patients, including 2 patients who were treated for 6 months or longer. Serum concentration of MT-5111 showed predictable and dose-proportional increasing exposure in the last three evaluable dose cohorts. Higher MT-5111 doses appear to saturate circulating soluble HER2 receptors with patients' HER2 levels stabilizing or decreasing at higher doses.

08:15 EDT Evoke Pharma, Ashfield Health join forces to form new global platform - Evoke announces the integration of Ashfield Health marketing and communications agencies to form a new global healthcare brand, experience, and communications platform, purpose-built to make health more human. "Our market is evolving rapidly, requiring healthcare brands and organizations to be fluid, constantly transforming, and embracing of new technology into their marketing and communications to reach and engage their audiences in the most compelling way. This was the perfect opportunity to create a genuinely different proposition to anything else in the industry - one that thrives in this type of change, giving our clients the ability and confidence to relentlessly focus on building empathetic experiences for patients that build enduring value," said Reid Connolly, CEO and Founder of Evoke. Evoke's offering is centered around global practice areas in Creative, Communications, Policy & Access, Experience, Data Science, Media, MarTech and Delivery.

08:13 EDT Novartis says Tafinlar+Mekinist had 'unprecedented efficacy' in pediatric study - Novartis announced Tafinlar+Mekinis significantly improved efficacy in patients ages 1 to 17 years old with BRAF V600 pediatric low-grade glioma, or pLGG, requiring first systemic treatment compared to chemotherapy, the current standard-of-care for these patients. In this study, patients randomized to receive Tafinlar + Mekinist experienced a statistically significant overall response rate, or ORR, of 47% compared to 11% for those randomized to receive chemotherapy. A new liquid formulation of Tafinlar + Mekinist that can be easier to administer than chemotherapy was used in this trial. The data will be highlighted today as part of an official press briefing and oral presentation at the 2022 American Society of Clinical Oncology, or ASCO, Annual Meeting, the company said. "These young patients and their families experience a heavy burden of care as BRAF V600 low-grade glioma poses a risk of neurological impairment and current standard-of-care treatment is intravenous and associated with frequent trips to the cancer clinic or hospital," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development at Novartis. "Tafinlar + Mekinist has shown unprecedented efficacy, and we will work with health authorities to bring these children the possibility of a more effective and easier to administer liquid oral treatment option as quickly as possible."

08:12 EDT New York Community Bancorp to eliminate non-sufficient fund fees - New York Community Bancorp announced the elimination of non-sufficient, NSF, uncollected, and unavailable funds fees on all of its consumer and business checking products, and the elimination of transfer fees on its overdraft shield product, effective August 1, 2022. As part of its review of the Bank's product offerings and to help customers with their cash flow needs, it also plans to launch Early Pay during the third quarter. "The Bank remains committed to its customer first philosophy" said Thomas Cangemi, Chairman, President, and Chief Executive Officer, he continued, "the elimination of these fees and the introduction of Early Pay is another step in helping our customers better manage their finances."

08:11 EDT Marriott launches 'Marriott's Bridging The Gap' hotel development program - Marriott International announced the launch of "Marriott's Bridging The Gap," a multi-year, $50M development program that aims to address the barriers to entry that historically underrepresented groups face in owning and developing hotels in the United States and Canada. Recognizing that access to capital constitutes a critical barrier to market entry, Marriott will offer financial and other incentives to qualified historically underrepresented owners and franchisees that will have a controlling equity interest in select branded projects. "At the heart of what we do every day is welcome all," said Anthony Capuano, CEO, Marriott International. "Whether that's people who stay with us, work in our hotels, meet our supply needs or develop hotels that fly one of our brand flags - all are welcome. With the establishment of Marriott's Bridging The Gap, we are creating an on-ramp to help propel historically underrepresented groups in the journey to hotel ownership more frequently and more successfully. We are excited to launch Marriott's Bridging The Gap and to continue building a more diverse owner and franchisee community."

08:10 EDT Carl Icahn to discontinue proxy contest waged at Kroger, withdraw nominees - Carl Icahn released a statement to shareholders of McDonald's (MCD) and Kroger (KR), saying in part: "My campaigns concerning McDonald's and Kroger were different from most of the companies in which I have been an activist in that both of these companies are well-performing, financially speaking. I do not believe, however, that the respective boards of directors of these companies are holding their management teams properly accountable with respect to the treatment of animals or with respect to the welfare of their employees. I feel that individuals who ignore the needless pain and suffering of animals are prone to ignore the needs of people, and, to me, the leaders at McDonald's and Kroger have reflected this notion in their compensation practices. It is unconscionable that it will take average employees at these companies multiple years to make what their CEO earns in one day. This glaring pay disparity is contributing to the wage-gap crisis our society is grappling with today, and in turn, that wage-gap crisis is a major cause of the lagging productivity in many of our companies. Admittingly, I was surprised and initially disheartened by the disappointing McDonald's vote. It is clear that shareholders, even if they are concerned about the issues we highlighted, are not willing to change the board configuration if a company is performing well financially. I congratulate the McDonald's team on their victory in this proxy engagement and, after much contemplation, given the company's financial position, I believe the same outcome will result at Kroger. I have therefore decided to discontinue my proxy contest waged at the grocer and withdraw my nominees." Reference Link

08:09 EDT Clovis announces first presentation of data from ATHENA trial - Clovis announced the first presentation of data from the monotherapy arm of the randomized, Phase 3 ATHENA trial as a late-breaking oral abstract to be presented on Monday, June 6, at the 2022 American Society of Clinical Oncology, or ASCO, annual meeting in Chicago. The data demonstrate that Rubraca as first-line maintenance treatment significantly improved investigator-assessed progression-free survival, or PFS, compared with placebo in women with advanced ovarian cancer irrespective of biomarker status. The results were simultaneously published in the Journal of Clinical Oncology. ATHENA-MONO enrolled 538 women with high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated two prospectively defined molecular subgroups in a step-down manner: HRD-positive and all patients randomized in ATHENA-MONO. For the primary endpoint of PFS by investigator review in the HRD-positive patient population, the rucaparib arm showed statistically significant improvement over the placebo arm with a hazard ratio of 0.47 representing a 53% reduction in the risk of disease progression. The median PFS for the HRD-positive patient population treated with rucaparib was 28.7 months compared to 11.3 months among those who received placebo. For the secondary endpoint of PFS by blinded independent central review, or BICR, in the HRD-positive patient population, the rucaparib arm showed statistically significant improvement over the placebo arm with a hazard ratio of 0.44 representing a 56% reduction in the risk of disease progression. The median PFS for the HRD-positive population treated with rucaparib was not reached compared to 9.9 months among those who received placebo. For the primary endpoint of PFS by investigator review in the ITT or all patients randomized population, the rucaparib arm showed statistically significant improvement over the placebo arm with a hazard ratio of 0.52 representing a 48% reduction in the risk of disease progression. The median PFS for all patients randomized in ATHENA-MONO and treated with rucaparib was 20.2 months compared to 9.2 months among those who received placebo. For the secondary endpoint of PFS by BICR in the ITT or all patients randomized population, the rucaparib arm showed statistically significant improvement over the placebo arm with a hazard ratio of 0.47 representing a 53% reduction in the risk of disease progression. The median PFS for all patients randomized in ATHENA-MONO and treated with rucaparib was 25.9 months compared to 9.1 months among those who received placebo. The safety profile observed in ATHENA-MONO was consistent with both the current U.S. and European labels for rucaparib. The most common treatment-emergent grade 3 adverse events, or TEAEs, among all patients treated with rucaparib in the ATHENA-MONO comparison were anemia or decreased hemoglobin, neutropenia or neutrophil count decreased, increased ALT/AST and thrombocytopenia or platelet count decreased. AST/ALT elevations were not accompanied by significant changes in bilirubin and there were no reports of drug induced liver toxicity as defined by Hy's Law. The discontinuation rate due to TEAEs was 11.8% for rucaparib-treated patients and 5.5% for the placebo arm; there were two deaths due to TEAEs for rucaparib-treated patients and zero for the placebo arm. Median treatment duration for the rucaparib arm was 14.7 months versus 9.9 months for the placebo arm. Myelodysplastic syndrome, or MDS/acute myeloid leukemia, or AML, was reported by two patients in the rucaparib group and no patients in the placebo group. More than 70% of patients continued to receive 500 mg BID Rubraca through month 12. Changes from baseline in FACT-O TOI scores were similar between rucaparib and placebo in the ITT population.

08:09 EDT Capstone provides 2.6 MW of microturbine energy systems for Southern California - Capstone Green Energy will be enabling two new customers in the education and agricultural sectors to achieve their energy, reliability and environmental goals. Cal Microturbine, Capstone's exclusive distributor for California, Hawaii, Nevada, Oregon and Washington, has secured two orders for Capstone Green Energy Signature Series systems in Southern California. The first order for one C600S unit will be installed for a customer in the education space, while the second order for two C1000S units will be provided to a customer in the agriculture industry. All the systems are expected to be operational by the early part of 2023. "Capstone Green Energy continues to build its portfolio as a cutting-edge provider of clean energy solutions and technology. Our distinct product lines help customers across industries and sectors in California and around the world find green energy solutions. Customers choose Capstone to meet their energy needs while boosting the reliability of their energy supply, improving predictability of energy costs and lowering their carbon footprint," said Darren Jamison, Chief Executive Officer of Capstone Green Energy.

08:07 EDT Thoma Bravo to pay $63.75 per share for Anaplan vs. prior $66 per share - Anaplan and Thoma Bravo, a leading software investment firm announced that they have amended the terms of their previously announced transaction, pursuant to which Anaplan will be acquired by Thoma Bravo. Under the terms of the amended merger agreement, which was unanimously approved by the Anaplan Board of Directors, Anaplan stockholders will receive $63.75 per share in cash, instead of the original purchase price of $66.00 per share in cash. "We believe Thoma Bravo continues to be the right partner for Anaplan, and we look forward to closing this transaction," said Frank Calderoni, Chairman & Chief Executive Officer. "We remain committed to delivering the best-in-class planning platform to solve our customer's biggest digital transformation challenges. Thoma Bravo's resources and insights will help scale Anaplan's growth strategy. We believe this partnership will deliver significant benefits to Anaplan's customers, partners and employees." Thoma Bravo and Anaplan agreed to amend the merger agreement to resolve a disagreement between the parties regarding compliance with certain terms of the merger agreement. Thoma Bravo asserted that these matters could have resulted in certain closing conditions not being satisfied. Anaplan's position is that it acted at all times in good faith in compliance with the merger agreement and that Thoma Bravo remained at all times obligated to close the original merger agreement according to its original terms. Nevertheless, the Anaplan Board agreed, after extensive consideration, to revise the merger agreement to avoid the risk of lengthy litigation over the disagreement, provide increased closing certainty for its stockholders and close on substantially the same timeline as originally agreed between the parties. Anaplan's Board also believes the terms of the amended merger agreement continue to represent a meaningful premium over the price of Anaplan's common stock prior to the execution of the merger agreement with Thoma Bravo. The parties continue to expect the transaction to close by June 30, 2022, subject to customary closing conditions, including approval by Anaplan stockholders. Upon completion of the transaction, Anaplan common stock will no longer be listed on the New York Stock Exchange, and it will become a private company.

08:05 EDT Jones Lang LaSalle publishes 2021 sustainability report - JLL released its 2021 Global Sustainability Report, providing updates on the progress it is making across its global operations, corporate supply chain, and with clients, to decarbonize cities and ensure the world's real estate evolves and adapts in a sustainable way. "JLL is determined to play its full part in partnering with our clients and communities in defining and implementing achievable pathways to net zero," said Christian Ulbrich, JLL CEO. "Our annual Global Sustainability Report illustrates the progress we are making and the ambitious targets we have committed to. As our work with World Economic Forum on establishing 10 Green Building Principles shows, we believe continued strong collaborative focus and effort will be vitally important in securing a sustainable built environment for all."

08:03 EDT EDAP TMS announces oral presentations at ISTU - EDAP TMS announced that three oral presentations will be delivered on its HIFU developments at the 21st Annual International Symposium on Therapeutic Ultrasound, which is being held June 7-10, in Toronto and virtually. Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said, "We are very pleased to have several noteworthy abstracts presented at this year's ISTU annual meeting. We believe that high intensity focused ultrasound has broad clinical utility, well beyond our Focal One core prostate cancer technology platform, and we look forward to presenting these compelling findings." Details of the presentations are as follows: Transrectal High-intensity focused ultrasoundfor the management of rectal Deep Infiltrating Endometriosis: Results of phase I clinical trials: Pr. Dubernard will present the multicentric prospective 60-patient study designed to confirm the feasibility of transrectal HIFU treatment for patients with symptomatic rectal endometriosis and to assess its safety and clinical efficiencies. The investigators conclude that HIFU can be a feasible therapy for rectal endometriosis and could be an interesting minimally invasive alternative to surgery for the treatment of rectosigmoid endometriosis if its efficacy and safety are confirmed. Comparison of HIFU lesion monitoring techniques based on B-mode images: Different monitoring techniques will be presented based on B-mode images acquired for HIFU lesion detection and applied in the context of prostate cancer. Lesion monitoring is crucial to HIFU control in clinical applications. However, open-access, ultrafast US scanners are generally not available in this setting. Four techniques based on B-mode ultrasound images were developed and compared, including passive elastography. The investigators concluded that PE demonstrated precise lesion detection, independent from uncontrolled bubble appearance. Preclinical Evaluation of a Dual-Mode CMUT Probe for Ultrasound-Guided HIFU Treatment: Dr. Suarez-Castellanos demonstrates the technical feasibility of using an ultrasound-guided high intensity focused ultrasound probe, fully developed using capacitive micromachined ultrasonic transducers. The HIFU-CMUT array showed tissue ablation capabilities with volumes compatible with localized cancer targeting, while allowing integration of an imaging array for improved visualization of targeted tissues, thus providing assets for further development of focal therapies.

07:57 EDT Vox to acquire Canadian gold royalty portfolio - Vox Royalty is pleased to announce that it has executed a binding royalty sale and purchase agreement dated June 3, 2022 with an individual prospector residing in Canada to acquire rights to three Canadian gold royalties for total consideration of up to C$1,800,000. Pursuant to the terms of the purchase and sale agreement, Vox will pay C$100,000 cash at closing and make additional cash payments or issue common shares of Vox as follows: C$500,000 or issue up to a maximum of 184,399 common shares in September 2022, C$700,000 or issue up to a maximum of 258,159 common shares in January 2023 and C$500,000 or issue up to a maximum of 184,399 common shares in December 2023. Closing of the Transaction remains conditional upon final acceptance by the TSX Venture Exchange. The royalties include a 1.0% Net Smelter Returns royalty over part of the Goldlund Project in Ontario operated by Treasury Metals, an effective 0.6% NSR royalty over the Beschefer Project in Quebec operated by Goldseek Resources under option from Wallbridge Mining Company Limited, and all personal rights held to a 1.5% NSR royalty over the Gold River deposit in Ontario, which is a satellite deposit to the Timmins West mine operated by Pan American Silver Corp.

07:52 EDT Vitalhub enters licensing agreement for adult correctional facilities in Ontario - VitalHub is pleased to announce that TREAT has been licensed for an initial six-year contract term and an option to extend for four additional years, to better track the essential medical information needed to effectively treat inmates in provincially-run adult correctional institutions across Ontario. For VitalHub, this agreement is an important and meaningful event. The six-year contract value is comprised of recurring license revenue and professional services delivered over a six-year period, totaling approximately C$9M in the initial term. The Ministry of the Solicitor General holds approximately 8,000 inmates a day across its 25 adult correctional institutions. Health care services at all correctional institutions maintain detailed health records for all detainees from the time of admission to release.

07:48 EDT Praxis Precision Medicines sees cash runway into 2024

07:47 EDT Becton Dickinson to acquire Parata Systems for $1.525B - BD and Frazier Healthcare Partners announced a definitive agreement for BD to acquire Parata Systems, a provider of pharmacy automation solutions, for $1.525B. "Parata expands BD's solutions to a new area of the high-growth pharmacy automation space and is a prime example of BD executing our disciplined M&A strategy," said Tom Polen, chairman, chief executive officer and president of BD. "Parata has a highly attractive financial profile and compelling value proposition that meets all of our rigorous investment criteria on growth, profitability and returns. With the addition of Parata, BD further advances our 2025 growth strategy around smart, connected care and enabling new care settings. We look forward to welcoming the talented Parata team to BD." The $1.525B all-cash transaction is expected to close by the end of the first half of BD's fiscal year 2023, subject to the satisfaction of customary closing conditions, including receipt of regulatory clearances. The transaction is consistent with BD's disciplined and balanced capital allocation strategy, including its financial policy framework to manage capital deployment around its 2.5 times net leverage target.

07:45 EDT Titan Medical appoints Bill Fahey as VP, manufacturing and operations - Titan Medical announced the appointment of Bill Fahey as Vice President, Manufacturing and Operations. In this new role, Mr. Fahey will be a key member of the senior leadership team and be responsible for both in-house and contract manufacturing relationships. He will also be working closely with Titan's product development and the quality and regulatory affairs teams as the company completes its Investigational Device Exemption application and, following IDE approval, proceed to human clinical trials. Most recently, he served as Senior Vice President of Engineering at Precision Spine/Spinal USA.

07:44 EDT Hillman Solutions set to join Russell 3000 Index - Hillman Solutions is set to join the broad-market Russell 3000 Index at the conclusion of the 2022 Russell indexes annual reconstitution, effective after the U.S. market opens on June 27, 2022, according to a preliminary list of additions posted June 3, 2022.

07:43 EDT CloudMD reports results of study on the outcomes of TAiCBT - CloudMD Software & Services is excited to announce the positive results of a comprehensive, evidence-based study on the outcomes of therapist assisted internet-based cognitive behavioural therapy. Since 2020, CloudMD's clinically based TAiCBT provider, MindBeacon, has treated thousands of people with clinically severe levels of depression and co-morbid anxiety. The results of the study released have proved the effectiveness of TAiCBT treatment for depression and anxiety. Depression is a leading cause of disability and absence for all Canadian employers and the leading cause worldwide, impacting 350 million people. In Canada, around 11% of men as well as 16%2 of women will be impacted by the condition throughout their lifetime. Close to half of people who suffer with depression will also experience anxiety in their lifetime, often at the same time. Knowing this, MindBeacon recently completed a study to seek the effectiveness of its depression protocol for those experiencing symptoms of both depression and anxiety, and the relationship between moderating factors, mediating factors and symptom reduction. Highlights: Conducted a comprehensive analysis of two years of data, representing 12,839 people who consented to treatment for symptoms of depression. Treated thousands of people with clinically severe levels of depression, and thousands of people with clinically severe co-morbid anxiety. 77% of clients start treatment with clinical level symptoms of depression; 56% are suffering from clinical levels of both depression and anxiety symptoms. On average, clients start treatment with a depression symptom score in the moderately severe range and finish with a score in the moderate depression range. Initial symptoms, amount of treatment readings and frequency of engagement all contribute to symptom improvement. More than half of clients with clinically severe symptoms experience reliable symptom improvement. This compares very favourably with other forms of treatment and TAiCBT studies and experience in other jurisdictions. Clients with a range of engagement patterns can benefit from TAiCBT, clients who stretch out engagement over 4 or more weeks experience optimal results. This is also consistent with past research showing that increasing engagement increases the number of clients achieving reliable clinical change. The study was based on a comprehensive analysis of two years of data from January 2020 - December 2021. Clinical levels for depression are defined as a score of 10 or more on the PHQ9. On average, clients started treatment with a depression symptom score in the moderately severe range and finished with a score in the moderate depression range. A reduction of 6 points in PHQ9 is considered a reliable change. In summary, nearly half of clients experienced a reliable change in their depression symptoms by the end of treatment. After studying the effectiveness of its TAiCBT, the Company found that more than half of clients who actively engaged with the programs for four weeks or more saw symptom improvement, even if they completed few readings. Initial symptoms, amount of treatment readings and frequency of engagement all contributed to symptom improvement in the end. The effectiveness of the Company's TAiCBT programs showcase the support the program can offer to human resources and operational leaders as they help prevent absenteeism and leave of absence while taking employees forward on their wellness journey. For carriers, the program can help reduce the duration of disability claims, prevent short-term disability, and reduce absences at work due to depression. The TAiCBT platform, with its high degree of client/therapist interaction and personalization to adapt to their individual needs and preferences throughout their treatment journey, is uniquely designed to foster continued client engagement leading to better outcomes. As shown in this study, CloudMD's TAiCBT has proven highly effective treatment for people with clinical levels of depression and comorbid anxiety. Furthermore, CloudMD's time to treatment at less than5 days is 5 times faster than the 25 days Canadians typically wait for community health, or months or more for specialized support. Earlier intervention has also been consistently shown to lead to better outcomes.

07:40 EDT Patriot One Technologies signs C$1M contract with Innovation Solutions Canada - Patriot One Technologies announced it has signed a 24-month, $1 million CAD contract with Innovation Solutions Canada to provide artificial intelligence-based solutions to improve situational awareness for first responders and firefighters. Having previously completed the Phase One proof of concept for the project under Patriot One's subsidiary, Xtract AI, Patriot One has now moved onto Phase Two, which includes creating the technology and innovations as defined in Phase One of the contract. This partnership is part of Canada's "Head Up Hands Free" program, which is aimed at helping firefighters work safer within dangerous environments.

07:37 EDT SL Green Realty announces sale of 609 Fifth Avenue for $100.5M - SL Green Realty announced the sale of the vacant office condominium at 609 Fifth Avenue to a domestic investor for a gross sale price of $100.5 million. The transaction is expected to close in June of 2022, subject to customary closing conditions. 609 Fifth Avenue is located in the heart of Manhattan's retail district on the corner of Fifth Avenue and 49th Street. The office condominium benefits from work performed as part of SL Green's repositioning of the entire building, which included a new core and elevators in addition to relocating the office lobby from Fifth Avenue to 49th Street. In May 2020, SL Green sold the retail condominium to an affiliate of the Reuben Brothers for $168.0 million.

07:36 EDT Radius Health urges shareholders to vote for director nominees - Radius Health announced that it has filed its definitive proxy statement with the Securities and Exchange Commission for its upcoming Annual Meeting of Stockholders, which will be held online on July 8, 2022. Stockholders of record as of June 3, 2022, will be entitled to vote at the meeting. In connection with the definitive proxy filing, Radius is mailing a letter to shareholders. The letter read in part, At the Annual Meeting, stockholders will elect three nominees to serve as directors of the Company and represent the interests of all stockholders. Your vote is important, and we ask for your support. This is an important time for the Company. During the first half of 2020, the Company was effectively transformed through internal activism led by the Radius Board of Directors. The Radius Board appointed a new Chairman and Chief Executive Officer. It also added five new, highly qualified directors. Under the refreshed Radius Board and new CEO's leadership, Radius has streamlined business operations, reduced pipeline risk and dramatically improved productivity, as measured by revenue per employee. These and other actions are designed to position Radius to deliver long-term shareholder value in a way that balances risk and reward within the overall context of the biopharmaceutical industry...Radius' Board and leadership team are focused on continuing to 'control what we can control' and move the Company forward. The Radius Board and the executive team have demonstrated across all areas of the Company that improvement and adjustments are a continuous part of our philosophy and operating approach. We do not sit still; we are fixing things when needed and we move forward. Given what we have outlined above and continue to focus on, it is with significant professional conviction that we urge you to vote "FOR" all three of the Company's nominees on the BLUE proxy card TODAY: Catherine J. Friedman, Jean-Pierre Garnier, Ph.D. and Andrew C. von Eschenbach, M.D."

07:33 EDT Arcturus Therapeutics says STRATUM Phase 3 trial met primary endpoint - Arcutis Biotherapeutics announced positive topline results from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for adolescents and adults with moderate to severe seborrheic dermatitis. Roflumilast foam 0.3%, an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, demonstrated significant improvements based on IGA Success and other endpoints. The study met the primary endpoint with 80.1% of individuals treated with roflumilast foam achieving 'IGA Success' compared to 59.2% of patients treated with vehicle at week eight. IGA Success was defined as an IGA score of clear or almost clear plus a greater than or equal to2 grade improvement from baseline. Improvement with roflumilast foam was seen early, with roflumilast separating statistically from vehicle on IGA Success at week two. In addition, more than 50% of patients treated with roflumilast foam achieved an IGA score of clear at week eight. Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on key secondary endpoints, including itch, scaling, and redness. Roflumilast foam was well-tolerated. The incidence of Treatment Emergent Adverse Events was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events. Overall, the most common adverse events in the study population included COVID-19, urinary tract infection, nasopharyngitis, and nausea. Over 90% of patients who were randomized to roflumilast foam in the study completed the full eight weeks, and there were few discontinuations due to adverse events. Arcutis announced in January 2021 that, based on feedback received from the FDA, the Company believes the single STRATUM study, if positive, would be sufficient basis for an NDA for roflumilast foam in dermatitis. Arcutis plans to submit an NDA in the first half of 2023. If roflumilast foam is approved by the FDA, the Company plans to leverage its existing commercial infrastructure to bring the product to market.

07:32 EDT Praxis Precision Medicines trading halted, news pending

07:29 EDT Apple's online store down ahead of WWDC event - Reference Link

07:22 EDT Gilat receives over $8M follow-on order for support of LEO constellation - Gilat Satellite Networks announced it received an over $8 million dollar follow-on order for support of gateways of a Low Earth Orbit constellation. Gilat's subsidiary, Wavestream, was chosen as the sole provider to supply Gateway Solid State Power Amplifiers to a leading satellite operator to support the LEO constellation gateways. The order is above and beyond last year's previously announced $50 million contract, which is currently being delivered.

07:19 EDT Immunocore presents new data from trials of KIMMTRaK in mCM, mUM - Immunocore Holdings presented updated clinical data from its clinical trials of KIMMTRAK in metastatic cutaneous melanoma and metastatic uveal melanoma at the 2022 American Society of Clinical Oncology Annual Meeting. In a Phase 1b trial of tebentafusp in combination with checkpoint inhibitors in mCM, the maximum target doses of tebentafusp plus durvalumab were well tolerated. In mCM patients who progressed on prior anti-PD(L)1, tebentafusp with durvalumab continues to demonstrate promising overall survival compared to recent benchmarks. Cutaneous and uveal melanoma both overexpress gp100, with greater than 80% of cutaneous melanoma tumor cells expressing gp100 by immunohistochemistry. The pattern of tumor shrinkage and its association with OS observed in mUM are replicated in this mCM study including 37% of patients with any tumor shrinkage of whom 89% lived at least 1-year. 58% of patients with any tumor increase were alive at 1-year, compared to 64% in the Phase 3 study in mUM. These data provide a rationale for a randomized study of tebentafusp monotherapy and in combination with an anti-PD1 in mCM, which the Company plans to start by year end. In an analysis of the Phase 3 trial of tebentafusp, an OS benefit observed for tebentafusp among mUM patients who have initial radiographic progression demonstrates that radiographic assessment underestimates the benefit. In a post-hoc analysis of OS following initial radiographic progression, continued treatment with tebentafusp was associated with numerically longer OS even after adjusting for the difference in key prognostic variables. Tebentafusp treatment beyond progression was tolerated without new safety signals and, in some patients, was associated with radiological stabilization of target lesions for greater than or equal to 4 months following the initial progression. In another post hoc analysis of the Phase 3 trial, the vast majority patients treated with tebentafusp either did not require corticosteroids or only received them on a single day. The most frequent reason for corticosteroid use was an emergent adverse event including CRS and rash. Corticosteroid use following the pre-specified AE guidelines was not associated with any significant impact on efficacy of tebentafusp.

07:17 EDT Ginkgo Bioworks acquires certain assets from Bitome - Ginkgo Bioworks announced that it has acquired certain assets from Bitome, a company pioneering real-time metabolite monitoring for faster biological product development. Bitome has developed technology leveraging machine learning to provide continuous monitoring of cell culture media. Bitome's continuous metabolite monitoring technology can help address this bottleneck, providing essential data on cell performance and potentially accelerating the path to production-ready organisms. Real-time data on the metabolic state of the cells in a bioreactor helps scientists better anticipate which cell lines and process conditions to select for further optimization, which in turn can reduce the number and duration of bioreactor runs that are necessary for a given project. "Ginkgo is constantly looking for opportunities to strengthen its cell engineering platform, and a central component of cell engineering is testing and optimizing strains at scale," said Barry Canton, co-founder and Chief Technology Officer at Ginkgo Bioworks. "Having evaluated Bitome's technology over the past few years, we believe their technology will allow us to accelerate the design and optimization of strains across a range of customers and industries."

07:16 EDT NioCorp announces metallurgical tests being conducted in Canada - Metallurgical testing being conducted now by NioCorp Developments in Quebec, Canada, is intended to quantify the Company's ability to extract rare earth elements from Elk Creek ore. It is also aimed at testing a carbonation process that can be used to recycle key reagents used in the removal of calcium and magnesium carbonates from the Elk Creek ore ahead of operations that are expected to extract and recover niobium, scandium, titanium, and rare earths once project financing is secured. If proven successful at the demonstration plant scale, these process improvements have the potential to reduce projected Project operating costs and capital expenditures as compared to estimates in the Project's May 2022 feasibility study, as well as to lower the Project's anticipated production of greenhouse gas emissions as compared to projections in the May 2022 feasibility study. These process improvements also could allow the Company to produce calcium and magnesium materials at purity levels that may be sold as commercial products; however, further analysis and testing is required to determine whether there are reasonable prospects for economic extraction for calcium and magnesium before they could be included in the Elk Creek Mineral Resource

07:15 EDT PolyPid announces presentation of D-PLEX 100 Phase 2 clinical data - PolyPid announced that data from a previously completed Phase 2 clinical trial of D-PLEX100 will be highlighted in a presentation at the upcoming American Microbiology Society Microbe 2022, being held on June 9-13, 2022, in Washington, D.C. The abstract, 'Incisional microenvironments and reduction in SSIs in patients treated with a local doxycycline-eluting formulation,' evaluates the effect of D-PLEX100 in combination with surgical site infection standard of care prophylaxis regimen in elective colorectal surgery. The data will be presented by Judith Steenbergen, Ph.D., President of Scientific and Medical Affairs Consulting.

07:14 EDT Axsome Therapeutics announces results of SUPPORT survey of MDD patients - Axsome Therapeutics announced the results of the SUPPORT survey of 385 patients with depression, demonstrating persistence of high levels of depressive symptoms despite treatment, substantial interference with work and daily life, low levels of patient hope, and high levels of patient dissatisfaction with current treatments. The SUPPORT survey assessed treatment experiences and expectations in patients taking antidepressants for major depressive disorder. The web-based survey was developed in collaboration with the Depression and Bipolar Support Alliance and the DBSA Peer Council; Roger McIntyre, MD, Professor of Psychiatry and Pharmacology, University of Toronto, Canada and Chair of the DBSA Scientific Advisory Board; and Greg Mattingly, MD, Associate Clinical Professor of Psychiatry at Washington University and President of the Midwest Research Group. The SUPPORT results were presented on June 1, 2022 at the American Society of Clinical Psychopharmacology 2022 Annual Meeting, held in Scottsdale, Arizona and virtually. Patients surveyed continued to experience substantial levels of depression despite being on a current antidepressant, and reported high levels of dissatisfaction with currently available treatments. Despite 85% of survey participants being currently on an antidepressant, 68% were still experiencing moderate, severe, or very severe depressive symptoms. Nearly three quarters of respondents reported they were not completely satisfied with how their current MDD treatment relieves their symptoms of depression. Nearly half reported that at least one of the side effects with their current treatment was at least somewhat bothersome. Of the survey population, 82% agreed that people with depression deserve to receive better medications than what is currently available. Patients surveyed reported substantial interference with work and daily life productivity, and exhibited low levels of hope about current and future treatments for depression. Overall, 52% reported having difficulty with work or daily life productivity as a result of depression. More than half of surveyed patients do not believe that it is possible for their depression to be in remission.

07:12 EDT Canadian Solar sells to SPIC Brasil 70% stake in 738 MWp solar projects - Canadian Solar announced it signed an agreement with SPIC Brasil, a power generation company in Brazil, to sell 70% stake in the Company's 738 MWp solar projects, Marangatu and Panati-Sitia. The Marangatu and Panati-Sitia projects, 446 MWp and 292 MWp each in size, are located in Piaui and Ceara, the Northeastern states of Brazil, covering an area of 2,200 hectares. Both projects are at advanced stage of development and are expected to begin construction in late 2022 and reach commercial operation in late 2023. Once in operation, Marangatu and Panati-Sitia are expected to be two of the largest solar power plants in Brazil and the clean electricity generated will be equivalent to powering over 900,000 households in Brazil annually. Dr. Shawn Qu, Canadian Solar Chairman and CEO, commented, "We are pleased to partner with SPIC Brasil in this transaction for the Marangatu and Panati-Sitia projects, which will meaningfully contribute towards Brazil's goal of obtaining 23% of its energy from non-hydro renewable energy sources by 2030. With the completion of this sale, Canadian Solar will have successfully monetized 2.3 GWp of utility-scale solar projects in Brazil. We will continue to execute and monetize our remaining backlog of 1.6 GWp of high-quality, contracted solar projects in Brazil. Canadian Solar is a leader in the Brazilian market, and we will expand our leadership across more Latin American markets, including Colombia and Chile".

07:11 EDT Renalytix: KidneyIntelX risk-stratified adult patients with type 2 diabetes - Renalytix announced that KidneyIntelX risk-stratified adult patients with type 2 diabetes and early-stage chronic kidney disease for key clinical outcomes, including heart failure hospitalizations and death. Individuals with diabetic kidney disease are not only at risk of kidney disease progression, but also face an increased risk of heart failure and death, due to the significant interconnection of the cardiovascular, renal, and metabolic systems. This data builds on KidneyIntelX clinically validated performance in assessing the risk for rapid progressive decline in kidney function in adult patients with DKD and was presented in an oral presentation on June 3rd at the American Diabetes Association 82nd Scientific Sessions(R) in New Orleans. The study was conducted using a subgroup analysis of KidneyIntelX in the multi-national CANagliflozin cardioVascular Assessment Study. In the CANVAS study, the team of investigators assessed the ability for KidneyIntelX to risk-stratify adult patients with DKD for their risk of clinically meaningful endpoints. Application of KidneyIntelX to this population showed that those with high-risk KidneyIntelX scores were at a three-fold higher risk for hospitalization for heart failure, severe kidney disease progression or death. Moreover, those individuals who scored as high-risk in this study were most likely to benefit from treatment with canagliflozin vs. placebo.

07:10 EDT Bausch + Lomb announces seven presentations on Biotrue products - Bausch + Lomb announced that seven presentations will feature unique research on new Biotrue Hydration Plus Multi-Purpose Solution and Biotrue Hydration Boost lubricant eye drops during the American Optometric Association's Optometry's Meeting ePosters Virtual Event, which is taking place from June 7-8, 2022. "At this year's Optometry's meeting, we look forward to sharing six research presentations on our new Biotrue Hydration Plus Multi-Purpose Solution, which is now widely available in the United States. The various presentations will highlight the unique properties of the product, including its use of hyaluronan, a moisturizer found naturally in tears, as well as clinical and antimicrobial efficacy data," said Joe Gordon, president, Global Consumer, Surgical and Vision Care, Bausch + Lomb. "We also look forward to sharing research from an evaluation of the use of Biotrue Hydration Boost eye drops with a growing consumer segment, digital gamers, and hosting attendees at many of our sponsored education events."

07:09 EDT Altair Engineering announces acquisition of Gen3D - Altair acquired Gen3D, a startup out of the University of Bath, U.K. Gen3D is a pioneer implementing the implicit geometry method for describing highly complex geometries such as lattice structures in additive manufacturing, AM. Gen3D's technology uses next-generation implicit modeling techniques to rapidly create complex geometry not practical with traditional boundary representation solid approaches. "In addition to a powerful technology that helps organizations navigate the challenges of design for additive manufacturing, the Gen3D team brings deep industry knowledge and experience in advanced additive design techniques such as generative design, topology optimization, and lattice structure generation," said James Scapa, founder and chief executive officer, Altair. The technology will be integrated into Altair Inspire.

07:07 EDT Xortx Therapeutics appoints Anthony Giovinazzo as board chair - XORTX Therapeutics is pleased to welcome and appoint Mr. Anthony Giovinazzo to the Board of Directors and as Chair of the Board. He was most recently, the co-inventor, CEO and Director of Cynapsus Therapeutics.

07:07 EDT SAIC increases stock repurchase authorization - SAIC announced that its board of directors has authorized an increase to its existing stock repurchase authorization of the company's common stock under an existing stock repurchase program. The current authorization increases the repurchase program by 8M shares in order to make available for repurchase an aggregate of approximately 8.8M shares.

07:06 EDT Timken providing bearings for GE's Haliade-X - The Timken Company (TKR) announced that it is designing and supplying main shaft bearings for GE Renewable Energy's (GE) Haliade-X, an offshore wind turbine. Each Haliade-X turbine will have a capacity of up to 14 MW and be able to generate up to 74 GWh of clean energy a year. Initial Haliade-X installations are scheduled to begin in 2023.

07:03 EDT Bristol-Myers reports three-year data from Phase 3 CheckMate -9LA trial - Bristol Myers Squibb announced three-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable survival benefits with Opdivo plus Yervoy with two cycles of chemotherapy compared to four cycles of chemotherapy in previously untreated patients with metastatic non-small cell lung cancer. With a minimum follow-up of three years, the dual immunotherapy-based combination continued to show sustained improvement in overall survival, the trial's primary endpoint, with 27% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 19% of patients treated with chemotherapy alone at three years. The long-term, durable clinical benefit of Opdivo plus Yervoy with two cycles of chemotherapy was observed at three years across patient populations that typically have a poor prognosis, including patients with PD-L1 expression less than1% and squamous histology. PD-L1 less than1%: Among patients with tumor PD-L1 expression less than1%, the OS rate was 25% for those treated with the dual immunotherapy-based combination vs. 15% for chemotherapy alone. Squamous histology: Among those with squamous histology, the OS rate was 24% for patients who received Opdivo plus Yervoy with chemotherapy, compared to 11% for those who received chemotherapy alone. In an exploratory analysis, a positive trend for OS benefit was also observed with Opdivo plus Yervoy with chemotherapy among patients with certain tumor mutations, such as STK11. No new safety signals were observed with Opdivo plus Yervoy with two cycles of chemotherapy with extended follow-up in the CheckMate -9LA trial. These data will be featured in a late-breaking poster presentation at the 2022 American Society of Clinical Oncology Annual Meeting on June 6, 2022, from 9:00 a.m. to 12:00 p.m. EDT. Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma.

07:02 EDT Bristol-Myers reports five-year data from Phase 3 CheckMate -227 trial - Bristol Myers Squibb announced five-year results from Part 1 of the Phase 3 CheckMate -227 trial, which continues to demonstrate long-term, durable survival benefits of first-line treatment with Opdivo plus Yervoy compared to chemotherapy in patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression levels. With a minimum follow-up of over five years, the longest reported for an immunotherapy combination in mNSCLC: In the primary endpoint population of patients with tumor PD-L1 expression greater than or equal to1%, the five-year survival rate for Opdivo plus Yervoy was 24%, compared to 14% for chemotherapy. In an exploratory analysis of patients with PD-L1 expression less than1%, almost three times as many patients treated with Opdivo plus Yervoy were alive at five years compared to those treated with chemotherapy. Among those who responded to treatment, more patients who received Opdivo plus Yervoy remained in response vs. chemotherapy at five years in both the PD-L1 greater than or equal to1% and less than1% subgroups. Among patients treated with Opdivo plus Yervoy who were alive at five years, approximately two-thirds did not receive any subsequent therapy for more than three years after stopping treatment. The safety profile for the dual immunotherapy combination remained consistent with previously reported data from this trial and was manageable with established protocols, with no new safety signals identified. These data will be featured in a late-breaking poster presentation at the 2022 American Society of Clinical Oncology Annual Meeting on June 6, 2022, from 9:00 a.m. to 12:00 p.m. EDT. Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma.

06:56 EDT Aecom awarded contract by Government of Canada for Faro Mine remediation - AECOM announced it has been awarded a contract by Public Services and Procurement Canada on behalf of Crown-Indigenous Relations and Northern Affairs Canada to perform remediation plan design and quality assurance support services for the Faro Mine Remediation Project. In this role, AECOM will work with the Government of Canada, affected First Nations, and additional consultants and partners to deliver environmental remediation services for Faro Mine, one of the most complex abandoned mine clean-up projects in Canada. AECOM's contract will run through March 2024 with possible extensions.

06:49 EDT Didi jumps 52% to $2.82 after report that China regulators will complete probe

06:39 EDT Veru presents final results from Phase 1b/2 study of sabizabulin - Veru announced that the final results from the Phase 1b/2 clinical study of sabizabulin, a novel oral cytoskeleton disruptor, in 80 men with metastatic castration resistant prostate cancer that progressed after receiving at least one androgen receptor targeting agent was presented at a poster session during the 2022 American Society of Clinical Oncology Annual Meeting which is being held June 3-7, 2022. Highlights of final results from the Phase 1b/2 clinical study are as follows: Safety- Sabizabulin 63mg oral daily dosing was well tolerated with no clinically significant reports of neurotoxicity or neutropenia. Efficacy- Sabizabulin administration resulted in both cytotoxic and cytostatic anticancer activity with PSA declines and objective and durable tumor responses. For patients with measurable disease, the objective response rate was 20.7%, and for all patients who received at least the 63mg dose, the median radiographic progression free survival was 11.4 months. Furthermore, the full study has been published online ahead of print: Mark Markowski et al. A Phase Ib/II study of sabizabulin, a novel oral cytoskeleton disruptor, in men with metastatic castration resistant prostate cancer with progression on an androgen receptor targeting agent. Clinical Cancer Research 2022. The Phase 3 VERACITY clinical study of men with metastatic castration resistant prostate cancer that has progressed on at least one androgen receptor targeting agent compared with the active control is enrolling with the anticipated completion of enrollment at the end of calendar 2022.

06:37 EDT Yumanity to sell YTX-7739 to Janssen for $26M, merge with Kineta - Yumanity Therapeutics announced it has entered into definitive agreements for two strategic transactions. The first definitive agreement is an asset purchase agreement for the sale of Yumanity's lead clinical-stage product candidate, YTX-7739, as well as Yumanity's unpartnered discovery-stage neuroscience product candidates and targets to Janssen Pharmaceutical, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, for $26 million in cash. In connection with the closing of the proposed transaction, Yumanity plans to distribute any remaining available cash proceeds from the sale to Yumanity stockholders via a one-time dividend, net of any amounts retained for outstanding obligations and net cash requirements associated with the proposed merger between Yumanity and Kineta. The amount of such dividend will depend on many factors and will not be determined until closer to the closing date. Under the second definitive agreement, Kineta will become a wholly-owned subsidiary of Yumanity in an all-stock transaction, resulting in a combined publicly traded company re-named Kineta, Inc., that will focus on immuno-oncology and continue Yumanity's ongoing research collaboration with Merck & Co. in amyotrophic lateral sclerosis and frontotemporal lobar dementia. Upon completion of the proposed merger, on a pro forma basis and based upon the number of Yumanity shares to be issued in the proposed merger, current Kineta stockholders are expected to own approximately 85% of the combined company and current Yumanity stockholders are expected to own approximately 15% of the combined company. The actual allocation will be subject to adjustment based on each company's outstanding equity ownership and Yumanity's net cash balance at the time of the closing of the proposed merger. The combined company expects to raise a concurrent private investment in public equity led by Growth & Value Development Inc. Kineta's IND-ready, lead asset is KVA12.1, a potential best-in-class VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. KVA12.1 may be an effective immunotherapy for many types of cancer including NSCLC, colorectal, renal cell carcinoma, head and neck, and ovarian. These initial target indications represent a significant unmet medical need with a large worldwide commercial opportunity for KVA12.1. Kineta is also developing fully human antibodies that target CD27 and CD24. These immunotherapies are engineered to address the problems of exhausted T cells and immunologically silent tumors. The Yumanity Board of Directors has unanimously approved both definitive agreements. The Kineta Board of Directors has unanimously approved the definitive merger agreement with Yumanity. The two transactions are expected to close in the second half of 2022, subject to customary closing conditions, including approval of both transactions by the stockholders of Yumanity. Janssen will acquire Yumanity's lead clinical-stage product candidate, YTX-7739, as well as Yumanity's unpartnered research and discovery-stage product candidates and targets for $26 million in cash. In connection with the closing of the proposed transaction, Yumanity plans to distribute any remaining available cash proceeds from the sale to Yumanity stockholders via a one-time dividend, net of any amounts retained for outstanding obligations and net cash requirements associated with the proposed merger between Yumanity and Kineta. The amount of such dividend will depend on many factors and will not be determined until closer to the closing date. Upon completion of the proposed merger, on a pro forma basis and based upon the number of Yumanity shares to be issued in the proposed merger, current Kineta stockholders are expected to own approximately 85% of the combined company and current Yumanity stockholders are expected to own approximately 15% of the combined company. The actual allocation will be subject to adjustment based on each company's outstanding equity ownership and Yumanity's net cash balance at the time of the closing of the proposed merger. In support of the proposed merger, the combined company is expected to close the PIPE financing concurrently with the completion of the merger. Together with the cash expected from both companies at closing, the net proceeds of the proposed merger and the PIPE financing are expected to fund the further development of Kineta's immuno-oncology portfolio. Upon closing of the proposed transaction, Yumanity Therapeutics, Inc. will be renamed Kineta, Inc., and will be headquartered in Seattle, Washington. Shawn Iadonato, Ph.D. will serve as Chief Executive Officer and Craig Philips will serve as President of the combined company. The merger agreement provides that the Board of Directors of the combined company will comprise six members, three designated by Kineta and two designated by the current Yumanity board, in addition to the combined company's Chief Executive Officer.

06:31 EDT Rivian Automotive to host first annual shareholder meeting - On Monday, June 6, 2022, at 11:00am PT / 14:00pm ET, Rivian will host its first annual shareholder meeting. A recording will be made available on Rivian's investor relations website.

06:26 EDT Network International enters strategic engagement with FreedomPay - Network International aims to transform its product proposition to the hospitality sector following its strategic engagements with next-gen fintech, FreedomPay. This collaboration with FreedomPay will enable Network as FreedomPay's preferred partner in the MEA region, to offer its hospitality merchants across the UAE and MEA region a fully integrated hospitality payments platform covering all operations including front desk reservation system, F&B, theme parks, spas, etc. The platform enables hotels and retail chains to recognise customers through their preferred method of payment with its unique omni-channel capabilities, ensuring frictionless transactions across all their properties.

06:24 EDT Digihost enters long term solar agreement with regional energy partner - Digihost Technology is pleased to announce that it has entered into a long-term deal to purchase community solar credits from a nearby community solar farm. The project is located in National Grid territory, and is being managed by the Williamsville, New York based energy supplier, EnergyMark. The community solar project is 5MW in size and will produce roughly 9,500,000 kWh's of clean electricity annually - enough to power more than 1,000 homes. Digihost's current East Delavan, New York facility will be the anchor subscriber to the project. This facility is located in New York's Zone-A region, where more than 90% of the power consumed is from zero emissions generation. The long-term Agreement will further reduce Digihost's already low carbon footprint for its BTC mining operations and allow the Company to apply the community solar credits received pursuant to the Agreement against future utility bills. The solar farm is expected to begin generating renewable electricity by Q4 2022. In pursuit of its goal to be a leading ESG organization, the Agreement was entered into by the Company in accordance with its DigiGreen Initiative, whereby Digihost is committed to achieving net zero emissions from its BTC mining operations by 2030. In addition to nearly emission free electricity at its East Delavan facility, Digihost currently participates in several Demand Response programs, which aid in grid reliability during times of heightened volatility, and further reduces carbon emissions. The Company is currently mining with greater than 90% zero emissions from its power consumption.

06:16 EDT Park Hotels & Resorts reports pro-forma occupancy of 67.9% for May - Park Hotels & Resorts provided an operational update and raised its second quarter 2022 outlook based on improving demand. Recent Highlights: Pro-forma Occupancy for May 2022 for Park's 46 consolidated hotels was 67.9%, with occupancy forecasted to be 76.3% in June 2022; Updated Q2 2022 outlook based upon improving demand to increase the outlook for RevPAR by $9 at the midpoint to $171, while Adjusted EBITDA guidance increased by 9% at the midpoint to a new range of $175 million to $195 million from the Q2 2022 outlook Park provided in May 2022; Repurchased 8.5 million shares of common stock in May 2022 at an average price of $18.33 per share, or $157 million. 12.0 million shares have been repurchased year-to-date at an average price of $18.23 per share, or $218 million; All of Park's hotels are now open following the reopening of the 1,024-room Parc 55 San Francisco - a Hilton Hotel, on May 19, 2022; Sold the 211- room Hilton Chicago/Oakbrook Suites in May 2022 for gross proceeds of $10.3 million and under contract to the sell the 128-room Hilton Garden Inn Chicago/Oakbrook Terrace for $9.4 million; Entered into a definitive agreement to sell Park's 25% interest in the joint venture that owns the 1,190-room Hilton San Diego Bayfront for gross proceeds of $157 million, which includes $55 million of Park's interest in the debt in the joint venture, with net proceeds anticipated to be approximately $102 million; Entered into a definitive agreement to sell the 195-room Homewood Suites by Hilton Seattle Convention Center for $80 million; and Year-to-date, Park has sold or is under contract to sell its interests in five non-core hotels for total gross proceeds of approximately $268 million, or 14.0x the hotels' combined 2019 Adjusted EBITDA, and at an average capitalization rate of 6.7% on the hotels' 2019 net operating income. "I am incredibly pleased to see the continued strengthening of the recovery across our portfolio," said Thomas Baltimore, Jr., Chairman and CEO of Park. "Leisure demand remains robust in our Hawaii, Florida and Puerto Rico markets, while business transient and group demand trends continue to accelerate across our urban portfolio, with the pace of improvement expected to continue over the balance of the year. As a result of the continued improvement, we are raising our Q2 2022 outlook. Additionally, with nearly $270 million of non-core assets sold or under contract at attractive pricing and $218 million in stock buybacks at a nearly 40% discount to the midpoint of our estimated net asset value, we have remained disciplined with our capital allocation priorities and execution of our value creation strategies. Overall, we are incredibly encouraged by the pace of recovery across all demand segments, with Park's portfolio currently on track to recover to pre-pandemic levels by early 2023."

06:11 EDT United Therapeutics, 3D Systems produce 3D-printed human lung scaffold - United Therapeutics Corporation (UTHR) announced that in partnership with 3D Systems Corporation (DDD) it has produced a complex 3D-printed object - a human lung scaffold - and demonstrated it at the LIFE ITSELF Conference that occurred May 31 to June 3, 2022 in San Diego. The event was organized and hosted by Dr. Sanjay Gupta and Marc Hodosh and was sponsored by CNN, United Therapeutics, and other prominent corporate leaders in healthcare Dr. Martine Rothblatt, United Therapeutics' Chairperson and CEO and Chuck Hull, 3D Systems' Co-Founder, Executive Vice President, and Chief Technology Officer for Regenerative Medicine, explained to conference attendees during a presentation entitled What's the Future of Organ Transplantation? that these 3D-printable lung scaffold designs consisted of a record 44 trillion voxels that lay out 4,000 kilometers of pulmonary capillaries and 200 million alveoli. Scientists at United Therapeutics plan to cellularize these 3D-printed scaffolds with a patient's own stem cells to create tolerable, transplantable human lungs that should not require immunosuppression to prevent rejection. "Last week, it was exciting to show the public our 3D-printed human lung scaffold, but we're thrilled to share that our 3D-printed lung scaffolds are now demonstrating gas exchange in animal models. We are regularly printing lung scaffolds as accurately as driving across the United States and not deviating from a course by more than the width of a human hair," said Dr. Rothblatt. "With the continued hard work of dedicated scientists and engineers at United Therapeutics and 3D Systems, we hope to have these personalized, manufactured lungs cleared for human trials in under five years. Our goal is to create an unlimited supply of transplantable lungs in the future. Even today, we are using a process called ex-vivo lung perfusion to add to the supply of transplantable lungs by extending by several hours the period of assessment and viability for human donor lungs, resulting in over 230 lives extended to date."

06:08 EDT NanoString unveils AtoMx Spatial Informatics Portal - NanoString Technologies announced the commercial unveiling of its new AtoMx Spatial Informatics Portal at the Spatial Multiomic Symposium at the 2022 AGBT General Meeting in Orlando, FL. Attendees of the conference will have a chance to preview AtoMx SIP at the symposium on Monday, June 6, 2022, from noon to 4:00 pm EDT. The event will be live-streamed and in-person. Visit Spatial Multiomics Symposium - NanoString to register. The AtoMx SIP is a new cloud-based informatics portal that will provide an integrated ecosystem with streamlined workflows to manage, analyze and share data from NanoString's GeoMx Digital Spatial Profiler and CosMx Spatial Molecular Imager platforms. AtoMx provides spatial biology researchers with a scalable solution reducing compute times from days to hours and enabling secure data sharing and collaboration across laboratories and institutions. By harnessing the cloud's unlimited compute power and storage capacities, AtoMx is expected to revolutionize spatial multi-omics data analysis. AtoMx will enable researchers to easily access, visualize, collaborate, analyze, and store data securely at a scale that has not been available in the spatial biology market. AtoMx provides an integrated platform to work with spatial biology data from multiple instrument systems. Built on cloud infrastructure, AtoMx provides compute capabilities that scale with datasets and the complexity of the analysis pipeline. In addition, AtoMx provides easy access to analysis methods for CosMX SMI through a pipeline orchestrator that enables users to create custom analysis pipelines and, for GeoMx DSP, the system offers all current local data analysis tools in the cloud. As datasets become available within AtoMx, the platform will enable new and innovative multi-omics data analysis methods based on artificial intelligence. AtoMx SIP will be deployed as a Software-as-a-Service offering for the academic research and pharma/biotech markets. In addition, a Virtual Private Cloud offering is also planned for those customers who may need more direct control over their data. AtoMx SIP is currently in beta testing and is expected to launch commercially in Fall 2022.

06:05 EDT PotlatchDeltic announces $131M expansion of Waldo, Arkansas sawmill - PotlatchDeltic announced that it is investing $131 million to expand and modernize its Waldo sawmill located in Columbia County, Arkansas. The project will increase the mill's annual capacity from 190 million board feet of dimensional lumber to approximately 275 million board feet. The investment will also reduce the mill's operating costs significantly. PotlatchDeltic owns three sawmills and nearly 950,000 acres of timberlands in Arkansas. The expansion is expected to create 55 new indirect jobs. The Waldo investment includes upgrades to the log yard and planer, a new saw line, and a new continuous dry kiln. The existing mill will continue to operate during the project and completion is expected by the end of 2024. PotlatchDeltic has contracted with BID Group to design, build, and equip the expansion and modernization.

06:02 EDT Starbucks affirms plans to name new CEO in Fall - Starbucks Corporation Board of Directors today provided an update to affirm the search details for the Company's next CEO. As stated during the Company's quarterly earnings call last month, the Board's search continues to be on track to identify a successor CEO in the coming months, and the Board has agreed with Schultz that he will remain as interim CEO through the first fiscal quarter of 2023. This timeline provides the company the ideal runway for a seamless transition and continuity of leadership through the 2022 holiday season, as the business transformation continues. Since returning as interim CEO on April 4, Schultz has engaged deeply with partners of all levels of the company, working directly with the leadership team to shape a strategic plan for the future of a reimagined Starbucks Coffee Company. The reinvention plan is being designed through co-creation across the organization with a focus on exceeding the expectations of both partners and customers. As the next CEO is named to the position, he or she will undergo full immersion into the Company, collaborating with Schultz directly. Driving toward an announcement this Fall, the official handoff will take place in the first calendar quarter of 2023. Thereafter, Schultz will remain on the Starbucks Board.

05:10 EDT Motorola Solutions opens innovation hub in Edinburgh - Motorola Solutions has opened an innovation hub in Edinburgh, Scotland, expanding its mobile video, video security and access control businesses while creating new employment and commercial opportunities for Scotland. Motorola Solutions' Edinburgh R&D teams will focus on cloud-based evidence management software, video security solutions and body-worn cameras, highlighting the Scottish capital's global reputation for strong engineering talent and position as the U.K.'s top innovation city outside of London.

05:03 EDT Fiserv, Trust Payments expand existing relationship - London-based Trust Payments is expanding its existing relationship with Fiserv to support the company's growth and worldwide expansion plans. The new long-term agreement builds on the companies' collaboration since 2012 and will allow Trust Payments to provide its clients with on-demand payment capabilities, enabled by acquiring-as-a-service capabilities from Fiserv.