Stockwinners Market Radar for September 12, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:56 EDT Williams-Sonoma CEO sells $3.01M in common stock - In a regulatory filing, Williams-Sonoma disclosed that its CEO Laura Alber sold 20K shares of common stock on September 9th in a total transaction size of $3.01M.

20:49 EDT Cathie Wood's ARK Investment bought 11.2K shares of Nvidia today

20:45 EDT Gorilla Technology appoints Jay Chandan as CEO - Gorilla Technology "announced the appointment of Executive Chairman Jayesh Chandan to CEO, effective immediately. Chandan succeeds founder and CEO Dr. Spincer Koh who is entering retirement following his more than two-decade long commitment to the company."

18:28 EDT Energy Transfer LP exec chairman Warren buys over 2.4M common units - In a regulatory filing, Energy Transfer executive chairman Kelcy Warren disclosed the purchase of 2,428,747 common units of the company on September 12 at a price of $12.04 per share.

18:01 EDT Electronic Arts, Koei Tecmo announce partnership on new hunting game - Electronic Arts (EA) announced a new partnership with Koei Tecmo (TKHCF) and studio Omega Force, the team behind the popular Warriors series, including DYNASTY WARRIORS and SAMURAI WARRIORS, to develop and release the next great hunting game. This original IP delivers a truly AAA experience based in fantasy feudal Japan, with more details about this exciting new title coming later this month. "It's an honor to be partnering with EA Originals and to have the support of a team with such an incredible track record of releasing groundbreaking new games," said Yosuke Hayashi, Executive Vice President of Koei Tecmo Games. "The EA team fully embraces our creative independence and have become invaluable partners offering both development and publishing support. Adding the global resources of EA with our own will help us introduce a new kind of hunting game to a global audience of players and expand our reach into global markets. I'm really looking forward to the day that gamers from around the world can play this new game."

17:50 EDT Zendesk reiterates view that consortium acquisition provides superior value - Zendesk issued the following statement reiterating its support for the proposed acquisition of Zendesk by a consortium led by Hellman & Friedman and Permira and expressing its views in response to a letter from Light Street Capital Management to the Zendesk Board of Directors related to the Consortium transaction: "The Zendesk Board continues to believe that the Consortium transaction provides superior value and certainty for all stockholders relative to the standalone alternative. The Consortium's acquisition is an agreed all-cash transaction for all Zendesk shares, delivering $77.50 per share to all Zendesk stockholders, a 34% premium to the unaffected stock price. The Consortium has arranged for debt and equity financing commitments to finance the transaction and the transaction is not subject to any financing conditions. In contrast, Light Street's eleventh-hour alternative proposal is not credible and its attempt to delay the stockholder vote is not in the best interests of our stockholders. The Zendesk Board conducted a thorough evaluation of the financial and strategic merits of Light Street's unsolicited, non-binding recapitalization proposal and determined it would not provide superior value to all stockholders. The facts remain unchanged. Light Street's recapitalization proposal, aside from Light Street's 'confidence', does not include any specificity on how Light Street would approach the core value driver of their proposed recapitalization, which is the ability to drive an operational turnaround as a highly-leveraged public company, contains problematic governance terms and is not yet supported by any committed financing. Notably, leading independent proxy advisory firm Institutional Shareholder Services observed that Light Street has 'admitted a lack of demonstrable experience with a campaign involving a recapitalization, identifying director and CEO candidates, and executing an organizational turnaround1.' Without a credible operational plan, Light Street's proposal is simply financial engineering, meaningfully increasing the risk of the standalone alternative by adding significant financial leverage and transferring control to an investor who is not paying for control and has no track record of exercising that control for the benefit of public stockholders. In view of the above, ISS expressed its support for the Consortium acquisition, highlighting: 'In light of the certainty of the value inherent in the transaction and the significant downside risk of non-approval and the standalone option, along with the insufficient detail and the execution risk inherent in Light Street's alternative proposal, support FOR the proposed transaction is warranted.'"

17:26 EDT Franklin Resources reports AUM of $1.39T as of August 31, 2022 - Franklin Resources "reported preliminary month-end assets under management of $1,387.6 billion at August 31, 2022, compared to $1,429.7 billion at July 31, 2022. This month's decrease in AUM primarily reflected the negative impact of markets and long-term net outflows."

16:53 EDT Rent The Runway drops 22% to $3.83 after lowering FY23 revenue outlook

16:36 EDT Peloton co-founders John Foley, Hisao Kushi to step down - Peloton Interactive announced changes to its leadership team. The company has accepted the resignations of John Foley as Executive Chair and Hisao Kushi as Chief Legal Officer, effective September 12, 2022 and October 3, 2022, respectively. John Foley co-founded Peloton in 2012 and is credited with leveraging his tech and business experience to build the company into the largest interactive fitness platform in the world. Having previously been the company's CEO for 10 years, he became Executive Chair in February 2022. The Board has appointed Karen Boone as Peloton's Chairperson of the Board. Boone was first elected to Peloton's Board as Audit Committee Chair in 2019 and subsequently named Lead Independent Director in October 2021. She previously served as President, Chief Financial and Administrative Officer of Restoration Hardware. Tammy Albarran will replace Kushi as Chief Legal Officer and Corporate Secretary for Peloton, effective October 3, 2022. In her new role, Albarran will manage the Legal, Compliance, and Policy functions.

16:34 EDT MiMedx's EPIFIX receives reimbursement approval in Japan - MiMedx Group announced that the Japanese Ministry of Health, Labour and Welfare approved reimbursement of EPIFIX to treat refractory or hard-to-heal lower extremity diabetic and venous ulcers. The company is in the last stages of preparing for full product launch, anticipated in the fourth quarter. The company estimates the Japanese total addressable market associated with the scope of the JMHLW reimbursement decision to be approximately $500 million based on a recently completed third party market study. The study estimated that there are more than 400,000 hard-to-heal wounds that present each year in Japan that can be treated by EPIFIX and which qualify for reimbursement under the JMHLW's decision. "Achieving reimbursement was a key pre-requisite to launch EPIFIX in Japan, and we think the awarded rate of 35,100 Yen/cm2 will be very favorable in supporting market adoption," said Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical. "We view the Japanese market as a meaningful new stream of future revenue. With this positive reimbursement decision now secured, we are moving quickly to finalize our launch sequence, which includes completing distributor agreements and training, gaining local patient experience, and building market awareness. We have been very encouraged by early physician interest and are well positioned to penetrate the market leveraging the strength of our clinical and economic data, established Key Opinion Leader relationships, and strong local society support."

16:32 EDT Victory Capital reports AUM $159.1B on August 31 - The company also reported average net assets under management for the month of August of $163.6B.

16:31 EDT Green Dot appoints Amy Pugh as general counsel - Green Dot announced the appointment of Amy Pugh as general counsel, effective immediately. Pugh joins Green Dot from Cross River Bank, where she served as associate general counsel supporting the fintech banking and digital assets teams.

16:30 EDT Vince Holding in talks with lenders to finalize wind down of Rebecca Taylor - The Company "has the made the strategic decision to wind down its Rebecca Taylor business to focus its resources on the Vince brand. The Company is in discussions with its lenders to finalize the wind down plan, which is expected to include selling off its assets and exiting its various business channels."

16:24 EDT Artisan Partners AUM as of August 31, totaled $132.7B - Artisan Partners Asset Management reported that its preliminary assets under management as of August 31, totaled $132.7B, Artisan Funds and Artisan Global Funds accounted for $63.5B of total firm AUM, while separate accounts and other AUM accounted for $69.2B.

16:23 EDT Cohen & Steers reports preliminary AUM $89.8B as of August 31 - Cohen & Steers reported preliminary assets under management of $89.8B as of August 31, a decrease of $4.2B from assets under management at July 31. The decrease was due to market depreciation of $4.2B and distributions of $180M, partially offset by net inflows of $197M.

16:22 EDT RF Industries appoints Hudson Pacific chief risk officer Kay Tidwell to board - RF Industries (RFIL) announced the addition of Kay Tidwell and Jason Cohenour to the company's board of directors. Kay Tidwell is the executive VP, general counsel and chief risk officer of Hudson Pacific Properties (HPP). Cohenour joins the board with years of executive leadership, sales, marketing, operations, and international M&A experience. He previously served as president, CEO, and director at Sierra Wireless (SWIR) from 2005 to 2018.

16:19 EDT Invesco reports preliminary AUM $1.42T as of August 31 - a decrease of 2.3% versus previous month-end. The firm experienced net long-term inflows of $2.7B in the month.

16:18 EDT Angi Inc. reports August revenue up 8%

16:16 EDT Bakkt names Chip Goodroe chief accounting officer - Bakkt Holdings announced that Chip Goodroe was appointed as its Chief Accounting Officer. In this role, Mr. Goodroe will report to Karen Alexander, Bakkt's Chief Financial Officer, and will lead the Accounting function, including SEC and regulatory reporting. "I'm pleased to welcome Chip to the team and into the role of Chief Accounting Officer," said Ms. Alexander. "He is a great fit for Bakkt given his deep accounting expertise across technology and cryptocurrency."

16:15 EDT Zymeworks reports preliminary Phase 1 ZW49 trial results - Zymeworks presented preliminary results from the company's Phase 1 clinical trial evaluating zanidatamab zovodotin for the treatment of HER2-positive tumors. The presentation, entitled "Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers", was presented by Komal Jhaveri, MD, FACP, medical oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation today during the European Society for Medical Oncology Annual Congress at the Paris Expo Porte de Versailles in Paris, France. A total of 77 patients were enrolled in this first-in-human trial, which was designed to determine the maximum tolerated dose of zanidatamab zovodotin, characterize its safety and tolerability, and evaluate anti-tumor activity in HER2-expressing cancers as monotherapy. The patients represented a variety of HER2-expressing cancers including breast, gastroesophageal, ovarian, endometrial, bladder, biliary tract, anal, colorectal, pancreatic and lung. At the time of the analysis, the maximum tolerated dose had not yet been reached. Commenting on the data, Dr. Jhaveri noted, "The preliminary results of this trial are very encouraging. Zanidatamab zovodotin dosed on an every three week schedule is active and has a manageable safety profile. I am excited to see further clinical development of zanidatmab zovodotin across a variety of HER2-expressing cancers." In the trial, zanidatamab zovodotin was shown to have a manageable safety profile with the majority of adverse events being Grade 1 or 2 in severity. In patients with HER2-positive cancers treated with zanidatamab zovodotin at 2.5 mg/kg Q3W, the confirmed objective response rate was 31% and the disease control rate was 72%. The Phase 1 clinical trial is ongoing and continues to enroll patients to study safety, tolerability and activity for an alternate qW dosing regimen. The company expects to present results of this dosing regimen at a medical meeting in 2023.

16:14 EDT IAC reports August Angi Inc. total revenue up 8% from last year - As part of its August monthly metrics disclosure, IAC also reports Dotdash Meredith total pro-forma revenue down 15%, and its Search business revenue down 31% from last year. Emerging & Other revenue was up 16% from last year. Reference Link

16:12 EDT 3D Systems adds chief corporate development officer to Andrew Johnson's title - 3D Systems announced that Andrew Johnson, the company's executive vice president, chief legal officer, is taking on expanded responsibilities as, 3D Systems announced that Andrew Johnson, the company's executive vice president, chief legal officer, is taking on expanded responsibilities as chief corporate development officer. In this role, he will not only lead the company's mergers and acquisitions but will also lead the establishment of new strategic partnerships in support of the company's expanding business needs. Mr. Johnson has been with 3D Systems for more than 16 years, and during this time has led over 60 M&A transactions for the company, and has played a key role in the development of several strategic partnerships. His strategic vision, experience, and knowledge of the additive manufacturing industry make him well suited to take on this expanded responsibility as chief corporate development officer, in addition to his current role as chief legal officer. Mr. Johnson holds a BA from Miami University, an MBA from the Ross School of Business at the University of Michigan, and a JD from the University of Virginia.. In this role, he will not only lead the company's mergers and acquisitions but will also lead the establishment of new strategic partnerships in support of the company's expanding business needs. Mr. Johnson has been with 3D Systems for more than 16 years, and during this time has led over 60 M&A transactions for the company, and has played a key role in the development of several strategic partnerships. His strategic vision, experience, and knowledge of the additive manufacturing industry make him well suited to take on this expanded responsibility as chief corporate development officer, in addition to his current role as chief legal officer. Mr. Johnson holds a BA from Miami University, an MBA from the Ross School of Business at the University of Michigan, and a JD from the University of Virginia.

16:10 EDT Crestwood divests Marcellus assets to Antero Midstream for $205M in cash - Crestwood Equity Partners LP (CEQP) announced the divestiture of its Marcellus natural gas gathering and compression assets to Antero Midstream Corporation (AM), for $205M in cash, representing a multiple of over 7 times 2023E Adjusted EBITDA, subject to customary adjustments. These assets located in Doddridge County and Harrison County, West Virginia, comprise a legacy gas system that was acquired in 2012 and was impacted in recent years by Crestwood's anchor producer focusing development activity on the rich gas window of the Southwest Marcellus Shale. As a result, Crestwood's assets have been on natural field decline since 2017 and are non-core to Crestwood's long-term growth strategy of becoming a leading midstream operator in the Williston, Delaware, and Power River basins. Crestwood intends to use the proceeds from the sale of these assets to enhance financial flexibility through a combination of debt reduction and opportunistic common unit repurchases. The transaction is expected to close in the fourth quarter, subject to customary regulatory approvals, including Hart-Scott-Rodino.

16:09 EDT AppLovin will not submit revised proposal to combine with Unity - AppLovin (APP) announced that it does not intend to submit another proposal to combine with Unity Software Inc. (U) and has withdrawn its initial proposal from August 9, 2022. AppLovin said it saw potential in combining its profitable business model and machine-learning capabilities with Unity's Create platform. "The opportunity was even more interesting given the market headwinds facing the industry," the company added. "Following careful consideration, AppLovin concluded that its path as the independent market leader is better for its stockholders and other stakeholders. AppLovin will move forward with the intention of continuing to gain market share and expand its platform." "We remain excited about the long-term growth potential of our core markets and AppLovin," said Adam Foroughi, CEO and Co-founder of AppLovin. "Our experienced and dedicated team will continue to focus on what we can control, including continual improvements to our products and technology and expanding into newer high-growth markets."

16:08 EDT Anika announces initial surgeries performed using the X-Twist Fixation System - "Anika Therapeutics announced the limited market release and the first surgeries performed using the X-Twist Fixation System. Christopher E. Baker, M.D., a prominent sports medicine physician in Tampa, Florida, was the first surgeon to use the X-Twist Fixation System earlier today."The X-Twist is a new addition to the Anika sports medicine portfolio that brings their anchor options to the highest standard in orthopedics in the market," said Christopher E. Baker, M.D., from the Florida Orthopaedic Institute in Tampa, Florida. 'the instrumentation is easy to use and intuitive, and fixation is robust. This is an anchor that can be used both knotless and as a knotted traditional anchor offering a wide spectrum of options for suture preference, including tape. In my rotator cuff repairs, this will supplement my medial row anchor in poor bone quality and will become my primary lateral row anchor. The X-Twist can easily be used for nearly any soft tissue repair within the shoulder and throughout the body.," said the company.

16:07 EDT Oracle reports Q1 total cloud revenue $3.6B, up 45% in USD, up 50% in CC - Reports Q1: Infrastructure Cloud Revenue up 52% in USD, up 58% in constant currency; Fusion ERP Cloud Revenue up 33% in USD, up 38% in constant currency; NetSuite ERP Cloud Revenue up 27% in USD, up 30% in constant currency; Cloud Application revenue $2.7B, up 43% in USD, up 48% in CC.

16:05 EDT Cheniere Energy to increase annual dividend 20% to $1.58 per share - As part of its new capital allocation plan, Cheniere Energy plans to upsize its share repurchase program by $4B for an additional 3-year authorization with potential to repurchase about 10% or more of Cheniere's market capitalization with excess capital and to increase its annualized dividend by 20% to $1.58 per common share from inaugural $1.32 per common share dividend initiated last year. The company also intends to increase its mid-single digit future growth rate of its dividend to about 10% through CCL Stage construction.

16:03 EDT WalkMe announces departure of CFO Andrew Casey - WalkMe announced the departure of CFO, Andrew Casey. After nearly three years of financial leadership, Casey is leaving to pursue another opportunity. He will remain with WalkMe on an advisory basis through WalkMe's third quarter earnings announcement to support an orderly transition. WalkMe has launched a formal search to hire Casey's permanent replacement who, along with the company's recent executive leadership team additions, will lead WalkMe's expansion efforts to capitalize on digital adoption's $34B total addressable market. In the meantime, Hagit Ynon, WalkMe's EVP of Finance & Operations, will serve as interim CFO following Casey's departure. Ynon has been with WalkMe for more than three years leading the global finance, IT, operations and facilities organizations.

15:26 EDT Fifth Third raises quarterly dividend 10% to 33c from 30c per share - The dividend is payable on October 17 to shareholders of record as of September 30.

14:28 EDT American Express CFO says consumer spending momentum holding up - Jeffrey Campbell, CFO of American Express, asked while speaking at the Barclays Global Financial Services Conference about consumer spending having increased through Q2 and whether that momentum has held up so far in Q3, replied according to a transcript: "Well, so the short answer is yes. And in fact, I said a few minutes ago that our confidence level in the multiyear growth plan we laid out back in January really higher than it was back in January. And so if you think about all of the trends that we talked about in sort of excruciating detail back on the July earnings call, they really all continued. So goods and services spending continues to look very strong. The U.S. consumer continues to look very strong. You, of course, Mark, actually see our monthly numbers in terms of credit. They continue to look far stronger than they were pre-pandemic. I would say probably the cure is that if anything have ticked up a little bit since the second quarter, it won't surprise anyone. And that is that travel and entertainment spend outside the U.S. has actually ticked up a little bit. If you think about the second quarter, you still had quite a number of cross-border travel restrictions in place around the world. The U.S. still had the requirement to get back into the U.S., you had to show a positive test. All those went away. That's helped international travel show up even more strongly in July and August. The other thing I would say that's continued to step up a little bit, Mark, is Travel & Entertainment spend on the commercial side, both by our smallest businesses, all the way up through our large Fortune 500 clients who mainly use the card for their Travel & Entertainment spend... I'll tell you, we have lots of people at American Express scouring every bit of data that we have from across the globe every day to make sure we're not missing anything, but you just don't see any significant signs of weakness anywhere in the slice of the economy that we cover as we sit here today on September 12. And I think that is reflected in both the second quarter results that we presented, the fact that the trends still look the same."

13:53 EDT Microsoft's 'Halo' studio head Ross to leave company - Bonnie Ross, the corporate vice president of Microsoft's 343 Industries, which develops games in the "Halo" franchise, will be leaving the company. "While I had hoped to stay with Halo until we released the Winter Update, I am letting you know I will be leaving 343 and attending to a family medical issue," Ross said in a statement posted on Twitter. "I am incredibly proud of the work everyone at 343 Industries has done with Halo Infinite, the Master Chief Collection, the Halo television series, and so much more. It has been an honor to serve alongside the team for the last 15 years and to be part of a universe that I love." Reference Link

13:19 EDT Starbucks announces student loan management, savings programs - Starbucks announced a set of programs, designed to support eligible employees "when it comes to two critical areas of financial well-being: savings and student loan debt." According to the company, "The new benefits, which will begin on September 19, will contribute to eligible partners' financial stability and help them manage their higher education debt. Both programs were informed by thousands of conversations with partners over the last several months as the coffee company reinvents its future." Working with Fidelity, Starbucks is introducing My Starbucks Savings. All eligible U.S. partners will be able to contribute a portion of after-tax pay on a recurring basis directly from their paycheck to a personal savings account. To incentivize savings and account growth, Starbucks will contribute $25 and $50 credits at key saving milestones up to a total of $250 per incentive eligible partner. Starbucks will also launch a Student Loan Management Benefit through Tuition.io to help eligible employees manage and optimize student loan repayments. Through this tool, eligible U.S. employees and their families will have access to new tools, resources and individual coaching to manage student loan debt, such as repayment options and loan refinancing. "Tools within the platform will help partners view all their student loan debt in one place and locate the best individual action to take based on their personal repayment scenario and goals. This could include taking advantage of income-based repayment options, refinancing and planning how best to finance education for college-bound students and parents of students," Starbucks added. Reference Link

12:47 EDT Northern Trust says repricing of existing book may be 'a little bit higher' - At the Barclays Global Financial Services Conference, Northern Trust said that a repricing of its existing book may be "a little bit lighter" than before as clients know that the company is benefiting from higher rates. The company added that Q3 expenses will be incrementally higher than previously anticipated.

12:28 EDT Shuttle Pharmaceuticals Inc trading resumes

12:00 EDT Intrepid Potash falls -7.4% - Intrepid Potash is down -7.4%, or -$3.49 to $43.43.

12:00 EDT Azure Power falls -12.6% - Azure Power is down -12.6%, or -74c to $5.13.

12:00 EDT Allego rises 19.9% - Allego is up 19.9%, or 88c to $5.30.

11:50 EDT BP North America agrees to purchase EDF Energy Services - BP (BP) announced it has agreed to purchase EDF Energy Services, expanding BP's presence in the U.S. commercial and industrial retail power and gas business. The agreement includes the purchase of EDF ES's full retail operating capabilities. Orlando Alvarez, senior vice president gas and power trading Americas, BP, said: "bp's commitment to putting the customer first has helped make us the largest marketer of natural gas in North America for the last 20 years as well as a top power marketer in the US. This acquisition will give customers access to new opportunities across the energy value chain and allow bp to provide integrated solutions that assist them in decarbonizing, managing energy spend, and increasing reliability." Subject to regulatory approvals, the deal is expected to close by the end of the year.

11:43 EDT Roku announces 2022 Roku Express, all-new Roku Wireless Bass - Roku announced two new products in their device lineup, the Roku Express player and Roku Wireless Bass. "Now with dual-band Wi-Fi, the Roku Express is more powerful than before and comes ready to stream, with a simple remote, increased storage, HDMI Cable, and an extensive library of free, live, and premium TV selections," the company said. "The newly designed Roku Wireless Bass provides high-powered sound for a theater-like experience. The subwoofer adds deep bass to a Roku Streambar, Roku Wireless Speakers, or Roku TV(TM) Wireless Soundbar at an incredible value. Available standalone, or bundled with the Roku Streambar, the Roku Wireless Bass is the simplest way to enhance the home cinema and entertainment experience." The Roku Express will be available for pre-sale starting today on Roku.com, Walmart.com, and Amazon.com for $29.99 MSRP and is expected to ship mid-October. General availability at Roku.com and at major retailers in the U.S. begins October 16. The Roku Wireless Bass is available for pre-order at Roku.com and Amazon.com, with general availability at Roku.com, BestBuy.com, and Amazon.com starting November 7 for $129.99 MSRP. The Roku Streambar & Wireless Bass bundle is available for pre-order at Roku.com, with general availability at Roku.com and BestBuy.com starting November 7 for $249.99 MSRP.

11:33 EDT Nintendo's 'Splatoon 3' sells over 3.45M units in Japan in first three days - Nintendo announced that its latest Switch exclusive title "Splatoon 3" has sold over 3.45M units in Japan within its first three days of release. The game launched September 9, 2022. Reference Link

11:09 EDT Netflix to partner with Ubisoft on three exclusive mobile games - Netflix (NFLX) and Ubisoft (UBSFY) announced plans on September 10 to create three mobile games from "some of the world's most beloved game franchises," starting in 2023. First announced at Ubisoft's annual digital event "Ubisoft Forward," the three games will expand on the "Valiant Hearts," "Mighty Quest" and "Assassin's Creed" universes, and will be available exclusively on mobile to Netflix members with no ads or in-app purchases, the companies stated. "We're thrilled to work with Ubisoft, whose track record creating memorable worlds for fans is unmatched. This partnership will provide our members with exclusive access to some of the most exciting game franchises as we continue to build a catalog of great mobile games for our members around the world," said Mike Verdu, Vice President of Games, Netflix. Reference Link

11:01 EDT Nestle exploring emerging technologies for animal-free dairy products - Nestle, announced that it is exploring emerging technologies for the development of animal-free dairy protein-based products. Nestle said: "This move complements investments the company has made in plant-based meat and dairy alternative offerings over the years to meet the growing consumer demand for nutritious, more environmentally friendly diets that also taste great." Nestle will pilot a novel product through the company's newly established U.S. R+D Accelerator, bringing it to the U.S. market later this year as a test-and-learn. The product is made with animal-free protein from Perfect Day.

10:55 EDT Zimmer Biomet committed to growing earnings faster than revenue

10:53 EDT Zimmer Biomet has 'pretty nice runway' for topline growth - Sees ability to grow operating margins into 2023. Comments taken from Morgan Stanley Healthcare Conference.

10:47 EDT NuCana: NUC-7738 showed 'encouraging' anti-tumor activity in Phase 1 trial - NuCana plc announced data from the ongoing NuTide:701 study of NUC-7738 in an oral presentation at the European Society for Medical Oncology Annual Meeting. Data on NUC-7738 from the Phase 1 part of NuTide:701 showed "encouraging" signals of anti-tumor activity across a range of tumor types, particularly melanoma. Promising data were observed in a variety of solid tumors with numerous patients staying on treatment for extended periods, including one patient with metastatic melanoma who became eligible for complete surgical resection following eleven months of treatment with NUC-7738. NUC-7738 also had a favorable safety profile with low rates of treatment-related AEs, very few Grade 3 TRAEs and no patients experiencing Grade 4 or 5 TRAEs. Dr. Stefan Symeonides, Senior Lecturer in Experimental Cancer Medicine at the Edinburgh Cancer Research Centre and lead author of the ESMO presentation, said: "NUC-7738 has shown an excellent safety profile and encouraging signals of anti-tumor activity in this study which is enrolling patients who have exhausted all standard therapies. We are excited to further investigate the activity of NUC-7738 in melanoma and other tumor types."

10:36 EDT BofA Securities fined $5M by FINRA for large options position reporting failures - FINRA announced that it has fined BofA Securities $5M for failing to report over-the-counter options positions to the Large Options Positions Reporting system in more than 7.4 million instances, including 26 positions that were over the applicable OTC position limit, and related supervisory failures. In settling this matter, BofAS consented to the entry of FINRA's findings, without admitting or denying the charges. In addition to the fine, the firm agreed to a penalty of a censure and a requirement that an officer and principal of the firm certify by Oct. 31, 2022, that BofAS has established, maintains and enforces supervisory procedures reasonably designed to achieve compliance with FINRA Rule 2360.

10:21 EDT BioMarin reports phase 3 BMN 270 study participant diagnosed with B-ALL - In a regulatory filing earlier, BioMarin Pharmaceutical disclosed information "due to the number of individuals required to be notified of the following matter consistent with BioMarin's regulatory obligations and to ensure consistent notification to security holders." In its filing, BioMarin stated: "On August 19, 2022, BioMarin was notified that a participant in its valoctocogene roxaparvovec, "BMN 270," phase 3 study was diagnosed with B-cell acute lymphoblastic leukemia, or B-ALL. Based on BioMarin's assessment of the case to date, including initial genetic testing of the leukemic cells, BioMarin believes at this time that this cancer is unrelated to BMN 270. The overall rate of all cancers observed in all BMN 270 trial patients - 2 in approximately 400 patient years of observation - appears consistent with expected rates of cancer in persons with Hemophilia. Consistent with the company's commitment to investigate any report of cancer in its BMN 270 trial, BioMarin promptly began a comprehensive assessment of the case. The preliminary results of genetic testing performed at the site revealed that 85% of leukemic cells carried a Philadelphia-like chromosomal translocation, which is a well-known driver-mutation in leukemic cells. Further, testing on leukemic cells enriched to 90% purity from peripheral blood carried negligible levels of BMN 270 vector DNA - less than 1 copy per 500 cells. These negligible, near background levels of BMN 270 indicate that BMN 270 is not clonally expanding in these leukemic cells. Additional genomic analyses are underway, which BioMarin expects to confirm the absence of BMN 270 vector integration events contributing to leukemic growth, as well as to provide further insights into the underlying genetic etiology of this case. Consistent with the company's commitments to regulatory authorities, BioMarin submitted an IND safety report to the U.S. Food and Drug Agency and communicated these findings to international health authorities on September 2, 2022. No authority has requested a hold on any trial at this time. Currently, all trials of BMN 270 are ongoing, including additional enrollments, with no modifications, and BioMarin does not expect to make any modifications in the future due to this event. The company's independent Data Safety Monitoring Board agreed that this case did not require any modification to BioMarin's ongoing trials at this time. BioMarin remains on track to resubmit the Biologics License Application for BMN 270 to the FDA by the end of this month."

10:10 EDT Arqit Quantum trading halted, volatility trading pause

10:08 EDT Splunk up after agreeing to provide non-public information to Hellman & Friedman - Shares of Splunk are up $4.51, or 5%, to $98.96 in early Monday trading after the company disclosed in a filing after the close on Friday that on September 7, Hellman & Friedman Advisors entered into a letter agreement with the company in connection with being provided certain non-public information by the company for the purposes of evaluating its investment in the company and enabling H&F to provide its perspectives and insights on the company's business, strategy and finances to the company. Among other things, H&F agreed that it and its affiliates will (i) abide by certain customary standstill restrictions for a minimum of six months following execution of the letter agreement, (ii) vote all beneficially owned securities of the company as recommended by the board of directors of the company in certain circumstances and (iii) abide by certain trading policies and windows of the company, the filing stated.

10:02 EDT Titan Aircraft, Ethiopian Airlines announce deal for three Boeing 767 freighters - Titan Aircraft Investments, the joint venture between Titan Aviation Holdings, Inc. and Bain Capital Credit, announced the placement of three 767-300ER converted freighters on long-term dry leases with Ethiopian Airlines Group. Ethiopian Airlines is expected to take delivery of the first of these aircraft later this month, with the second delivery planned for later this year, and the third aircraft planned for 2023. The addition of these three aircraft brings Titan Aircraft Investments' freighter fleet to 10 aircraft, five of which are Boeing 767 converted freighters. Titan Aviation Holdings is a subsidiary of Atlas Air Worldwide.

10:00 EDT Livent falls -6.6% - Livent is down -6.6%, or -$2.28 to $32.17.

10:00 EDT Carvana rises 10.3% - Carvana is up 10.3%, or $3.76 to $40.38.

10:00 EDT Allego rises 18.8% - Allego is up 18.8%, or 83c to $5.25.

09:52 EDT U.S. Bancorp sees Q3 mortgage revenue down 30%-35% from Q2 - Comments taken from the Barclays Global Financial Services Conference.

09:47 EDT Townsquare Media falls -7.0% - Townsquare Media is down -7.0%, or -61c to $8.05.

09:47 EDT Eve Holding rises 9.7% - Eve Holding is up 9.7%, or 75c to $8.46.

09:47 EDT Carvana rises 11.7% - Carvana is up 11.7%, or $4.28 to $40.90.

09:40 EDT GT Biopharma announces highlights from GTB-5550 study - GT Biopharma announced highlights of an accepted abstract titled, "B7H3-Targeted Tri-specific Killer Engagers deliver IL-15 to NK cells but not T cells, and specifically targets solid tumors as a pan-tumor antigen strategy mediated through NK cells," for poster presentation both virtually at the European Society for Medical Oncology Congress 2022. GTB-5550 product candidate is in development for the treatment of B7H3 positive solid tumor cancers and multiple myeloma. GTB-5550 TriKE is a tri-specific molecule composed of a dual camelid nanobody that binds the CD16 receptor on NK cells, the single chain variable fragment of an anti-B7H3 antibody, and human IL-15. Highlights of the abstract poster and mini-oral session include: GTB-5550 gives a robust and NK cell specific proliferation signal compared to IL-15 alone; GTB-5550 specifically targets B7-H3+ cells; GTB-5550 effectively induced NK cell degranulation and interferon gamma production in response to various prostate, brain tumor, HNSCC, multiple myeloma, sarcoma, ovarian, and myeloid malignancies; GTB-5550 TriKE In vivo activity in xenogeneic models of human tumor is underway and already validating in vitro studies.

09:35 EDT Perrigo says joint FDA advisory committee to review Opill for OTC use - Perrigo announced that the U.S. Food and Drug Administration has scheduled a joint meeting of the Nonprescription Drugs Advisory Committee, or NDAC, and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, or ORUDAC, on November 18 to review the company's application for Opill daily oral contraceptive for OTC use. The company previously announced its affiliate, HRA Pharma, filed its application with the FDA for an Rx-to-OTC switch of Opill, a progestin-only daily birth control pill. "If approved, Opill has the potential to be the first ever daily birth control pill available OTC without a prescription in the U.S.," the company stated.

09:33 EDT Forward Air reports QTD revenue per shipment up 16% - Forward Air Corporation provided the following key Expedited Freight Operating Statistics for the quarter-to-date period through August 2022. Revenue per shipment increased 16.0%, weight per shipment decreased 3.2%, pounds per day increased 3.1% and shipments per day increased 6.5% over the same period last year. Tom Schmitt, Chairman, President, and CEO of Forward, commented, "In July of the prior year, we completed a process to cleanse inefficient freight from our network. We have more than fully replaced the inefficient freight with higher quality freight in the network as evidenced by the positive trend in August with an increase of 5.2% pounds per day and 13.8% shipments per day. As we replaced lower quality freight with higher quality freight in our network, we executed upon our strategy to penetrate the highly profitable, more traditional air freight, which by nature has a lighter weight per shipment. Throughout the third quarter, we continued with our pricing initiative to work more closely with our customers to appropriately price the freight in our network as reflected by our strong revenue per shipment and revenue per hundredweight, which increased 19.8% for the quarter-to-date period through August 2022."

09:29 EDT Department of Labor announces settlement with Wells Fargo - The U.S. Department of Labor announced a settlement with Wells Fargo and Company and Wells Fargo Bank and GreatBanc Trust Company - a plan trustee - that recovers more than $131.8M for the retirement plan's participants after a department investigation found that, from 2013 through 2018, the fund overpaid for company stock purchased for the plan. Wells Fargo also agreed to pay a penalty of nearly $13.2 million as part of the settlement. Wells Fargo and GreatBanc entered into the settlement without admitting or denying the allegations made by the department, the DOL stated. Reference Link

09:21 EDT SunPower, IKEA U.S. launch home solar offering in California - IKEA U.S. has teamed up with SunPower to make home solar energy solutions easier to access in select California locations beginning September 12. Members of the IKEA Family customer loyalty program will be able to purchase home solar solutions, available through SunPower, to generate and store their own renewable energy and live more sustainably.

09:19 EDT Traeger CEO buys $203K in common stock - In a regulatory filing on Friday, Traeger disclosed that its CEO Jeremy Andrus bought 68.6K shares of common stock on September 7th in a total transaction size of $203K. Shares of Traeger are up 5.4% at $3.50 in pre-market trading.

09:16 EDT NeuroBo Pharmaceuticals announces 1-for-30 reverse stock split - NeuroBo Pharmaceuticals announced a 1-for-30 reverse split of its common stock, effective at 5:00 pm Eastern time on September 12. Beginning on September 13, the company's common stock will trade on The Nasdaq Capital Market on a split adjusted basis. The company's common stock will continue to trade on The Nasdaq Capital Market under the symbol "NRBO". The new CUSIP number for the common stock following the reverse split is 64132R 206.

09:14 EDT Amsylyx: Data shows synergistic effect of AMX0035 versus individual compounds - Amylyx Pharmaceuticals announced the publication of preclinical data showing the effect of sodium phenylbutyrate and taurursodiol on the transcriptomic and metabolomic profiles of primary skin fibroblasts from adults with sporadic amyotrophic lateral sclerosis ALS and adults without ALS. These results, which showed that AMX0035 had a greater and distinct effect on genes and metabolites involved in ALS-relevant pathways as compared to either PB or TURSO alone, are published in the peer-reviewed medical journal, Annals of Clinical and Translational Neurology...Data analyses from twelve primary fibroblast lines from healthy donors and twelve lines derived from people with ALS demonstrated that treatment with AMX0035 changed more genes and metabolites than treatment with either PB or TURSO individually. The majority of changes in genes and metabolites were unique to treatment with AMX0035 versus PB or TURSO alone, suggesting that the combination of PB and TURSO has certain distinct effects that are not exclusively additive effects of PB and TURSO. Further, most changes affected the expression of genes involved in ALS-relevant pathways, including nucleocytoplasmic transport, unfolded protein response, mitochondrial function, RNA metabolism, and innate immunity. These studies add new learnings regarding the mechanistic activity of PB and TURSO and supplement our preclinical work that has shown synergistic reduction in neuronal death through the hypothesized mechanism of combined inhibition of endoplasmic reticulum and mitochondrial stress.

09:10 EDT Bill.com announces Loren Padelford joins company as CCO - Bill.com announced that Loren Padelford has joined the company as Chief Commercial Officer responsible for sales and strategic partnerships, reporting to CEO and Founder, Rene Lacerte. "Loren has proven leadership experience scaling a world-class software platform serving SMBs across the globe. His strong expertise building sales and go-to-market capabilities that drive adoption and engage millions of SMBs around the world will be critical for us as we continue to scale," said Rene Lacerte, Bill.com CEO and Founder. "I look forward to working with him and leveraging his passion for helping SMBs flourish."

09:09 EDT Summit Materials CFO Brian Harris to retire - Summit Materials announced that Brian Harris, executive VP and CFO plans to retire after a decade with the company. As part of a planned transition, Harris will continue in the CFO role until a successor is installed, after which time he will take on a non-executive role until his retirement date in the fourth quarter of 2023. To ensure a transition, Harris will then continue to be engaged as a consultant to Summit for a period of time. Harris joined Summit Materials as EVP and CFO in October 2013. Harris played a central role in Summit's 2015 IPO, as well as the establishment and leadership of the company's finance, information technology, investor relations and procurement functions. Summit's board of directors has embarked upon a search for Harris's successor, which is expected to include both external and internal candidates.

09:05 EDT Skillz appoints Vassily Filippov to CTO - Skillz (SKLZ) announced the appointment of Vassily Filippov to the role of CTO. Most recently served as the director of engineering at Meta (META), Filippov joins the Skillz C-suite, further bolstering the company's executive team and product leadership bench.

09:05 EDT Embark Technology appoints Hescher as new board chair - Embark Trucks (EMBK) announced the appointment of Penny Herscher as independent chair of its board of directors and chair of its compensation committee. Herscher currently serves as chair of the board of directors at SGH-SMART Global, Lumentum Holdings (LITE), and as a director at Faurecia SA and several private companies.

09:04 EDT Xponential Fitness announces exclusive licensing agreement with Princess Cruises - Xponential Fitness (XPOF) announced an exclusive five-year licensing agreement with Princess Cruises. With this unique partnership, Xponential Fitness becomes the first cross-modality fitness franchise to put its curated brands on a major cruise line. Over the term of the agreement, a minimum of eight Xponential brands will be made available onboard each of Princess' 15-ship fleet, resulting in a minimum total of 120 licensed studio experiences across the Princess fleet all operated by OneSpaWorld (OSW).

09:02 EDT Rambus initiates $100M share repurchase plan - Rambus announced that it initiated an accelerated share repurchase program with Wells Fargo Bank, to repurchase an aggregate of approximately $100M of its common stock, with an initial delivery of approximately 3.1M shares.

08:58 EDT Astellas Pharma, Seagen, Merck report results from phase 1b/2 EV-103 trial - Astellas Pharma (ALPMY), Seagen (SGEN) and Merck (MRK) announced results from the phase 1b/2 EV-103 clinical trial Cohort K investigating PADCEV in combination with Merck's anti-PD-1 therapy KEYTRUDA and PADCEV alone as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. The findings were presented at the European Society for Medical Oncology Congress as part of a late-breaking abstract presentation. In patients treated with enfortumab vedotin and pembrolizumab, results demonstrated a 64.5% confirmed objective response rate per RECIST v1.1 by blinded independent central review, the primary endpoint of Cohort K, with 10.5% of patients experiencing a complete response and 53.9% of patients experiencing a partial response. The median duration of response per BICR was not reached. All-grade treatment-related adverse events of special interest for enfortumab vedotin in combination with pembrolizumab were skin reactions (67.1%), peripheral neuropathy (60.5%), ocular disorders (26.3%), hyperglycemia (14.5%), and infusion-related reactions (3.9%). Pembrolizumab adverse events of special interest were consistent with previously observed safety data from monotherapy with the exception of severe skin reactions. Overall, the results were generally consistent with previously reported efficacy and safety results of the EV-103/KEYNOTE-869 dose-escalation cohort and expansion Cohort A.

08:52 EDT Yum! Brands announces $2B share repurchase authorization - Yum! Brands board of directors approved a new share repurchase authorization which authorizes repurchases of up to $2B in shares of common stock through June 30, 2024. The new authorization will take effect upon the exhaustion of the current authorization approved in May 2021, of which $236M remained available as of September 12.

08:48 EDT Enlivex announces new preclinical data in murine mesothelioma model - Enlivex Therapeutics announced new preclinical data in a murine mesothelioma model showing a substantial and statistically significant survival benefit when Allocetra is combined with the chemotherapeutic agent, cisplatin. The data are featured in a poster being presented at the European Society for Medical Oncology, ESMO, Congress 2022, which is taking place both virtually and in-person at the Paris Expo Porte de Versailles in Paris, France from September 9, 2022 through September 13, 2022. Data featured in the ESMO poster are from preclinical studies in mice implanted with AB12 mesothelioma cells. Following implantation, mice were given vehicle, intravenous cisplatin monotherapy, Allocetra monotherapy administered intraperitoneally, or IV cisplatin in combination with IP Allocetra. On day-57 post-implantation, the survival rate in the untreated group was 0%, and the mean survival duration was 31.7 +/- 2.6 days. These were similar to the survival rate of 0% and slightly superior mean survival duration of 36.2 +/- 5.0 days in the cisplatin monotherapy group. The survival rate and mean duration in the Allocetra monotherapy group were 14.2%, and 40.4 +/- 10.9 days, respectively. When Allocetra was combined with cisplatin, a synergistic anti-cancer effect was observed, as the survival rate and mean duration in the combination therapy group were 55% and 49.3 +/- 10.6 days, respectively. Notably, the increase in survival duration observed in the combination therapy group was statistically significant compared to the untreated group, cisplatin monotherapy group, and Allocetra monotherapy group. Also featured in the ESMO poster are preclinical mesothelioma data showing a substantial survival benefit when Allocetra is combined with an anti-PD1 checkpoint inhibitor, and previously presented preclinical data in mesothelioma showing a substantial survival benefit when Allocetra is combined with a commercially approved anti-CTLA4 checkpoint inhibitor. Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, commented, "We are very pleased with the results of these preclinical studies, which support our ongoing Phase I/II trial evaluating Allocetra(TM) plus chemotherapy in patients with peritoneal metastases. This trial has been carefully designed to clinically demonstrate Allocetra's novel mechanism of action and further our understanding of its safety profile and anti-cancer activity. Successfully achieving these goals would represent a key milestone, as it would bring us substantially closer to providing cancer patients with a novel and highly scalable next-generation cell therapy."

08:46 EDT Origin Agritech to be added to two FTSE Russell equity indices - Origin Agritech announced that effective September 16, Origin Agritech will be added two new equity indices, the FTSE Micro Cap Index and the FTSE Total Cap Index.

08:45 EDT Agenus makes senior regulatory, clinical appointments - Agenus (AGEN) announced the appointment of Patricia Carlos as Chief Regulatory, Quality, and Safety Officer; Todd Yancey, MD as Global Clinical Development, Medical Affairs and Commercial Development Advisor. Patricia Carlos has more than 20 years of regulatory affairs leadership experience, directing programs from investigational new drug application to commercialization. Prior to joining Agenus, Carlos served as Senior Vice President of Regulatory and Quality at Arcus Biosciences (RCUS). Todd Yancey, MD, has 40 years of combined clinical and industry experience. Prior to joining Agenus, Dr. Yancey served as Senior Vice President, Global Medical Affairs and New Market Development at BeiGene (BGNE).

08:41 EDT Kiniksa closes global license agreement with Genentech for vixarelimab - Kiniksa Pharmaceuticals (KNSA) announced the closing of the global license agreement with Roche (RHHBY) and Genentech, a member of the Roche Group, for the rights to develop and commercialize vixarelimab, a fully human monoclonal antibody targeting oncostatin M receptor beta. Closing of the transaction was subject to customary closing conditions and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the license agreement, Kiniksa will receive $100M in upfront and near-term payments, which include $80M within 30 days of the closing of the transaction and $20M within 30 days after Kiniksa's delivery of certain drug supplies to Genentech. In addition, Kiniksa is eligible to receive up to approximately $600M in certain clinical, regulatory, and sales-based milestones, before fulfilling upstream financial obligations. Kiniksa is also eligible to receive royalties on annual net sales. Genentech obtains rights for the global development and commercialization of vixarelimab. Kiniksa expects that its cash and cash equivalents, including the proceeds received from the vixarelimab global license agreement with Genentech, will fund its current operating plan into at least 2025.

08:38 EDT Jeffs' Brands allocates up to $1M for launch of brands in Sweden, Belgium - Jeffs' Brands announced the launch of its stores and brands in Sweden and Belgium, after completing the required regulatory processes. To date, the Company has received Amazon's approval for sale of its brands in the United States, the United Kingdom, Germany, France, Spain and Italy. Viki Hakmon, Chief Executive Officer of the Company, commented "We are excited to launch our brands in additional European countries and extend our global reach. One of the ways we plan to achieve organic growth is by expanding our products offerings in new territories, in order to support these efforts, we have allocated up to $1 million for the launch of our stores in Belgium and Sweden."

08:38 EDT Yamana Gold announces completion of technical reports on mines, projects - Yamana Gold provides notice that it has completed technical reports under National Instrument 43-101 for the balance of its major mines and projects for which technical reports were not previously available. With the completion of technical reports for the Minera Florida gold mine in central Chile, the Cerro Moro gold and silver mine in Santa Cruz, Argentina, the Wasamac gold project in Quebec, Canada, and the MARA copper and gold project in Catamarca, Argentina, Yamana has now made public technical reports for all of its major mines and projects. Technical reports on the core material operations at the Canadian Malartic gold mine, the Jacobina gold mine and the El Penon gold and silver mine were previously filed with Canadian securities regulators and remain current.

08:37 EDT Onconova announces updated data from Phase 1/2 a trial of rigosertib - Onconova Therapeutics announced updated data from an investigator-sponsored Phase 1/2a trial of oral rigosertib plus the anti-PD-1 immune checkpoint inhibitor nivolumab in advanced KRAS-mutated non-small cell lung cancer, NSCLC. The data, which are featured in a poster at the European Society for Medical Oncology, ESMO, Congress 2022, show an early and encouraging signal of efficacy in the trial's extensively pre-treated population. The studied doublet has been well tolerated to-date. Key data from the presentation include: Response results: 3 of 14 evaluable patients achieved an objective response; 1 patient achieved a complete response as per RECIST Criteria, with complete resolution of the primary lung tumor as well as sites of metastatic disease; 2 patients achieved a partial response; Responses were achieved in patients with 3 distinct KRAS mutations; The mean duration of response is 6.75 months; 4 of 14 evaluable patients achieved disease control. Safety results: The studied doublet has been generally well tolerated. Treatment-related adverse events have been mostly mild and manageable; One dose limiting toxicity of grade 3 hyponatremia has been observed; Urinary toxicities well documented with rigosertib are the most common TRAE; No unexpected safety events or synergistic toxicities have been observed. Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, "The evidence of efficacy observed in the trial's highly challenging population suggests rigosertib may synergize with ICI and potentially provide clinical benefit to patients with limited therapeutic options. This hypothesis is supported both by these latest clinical data and the results of preclinical studies in multiple indications. Looking forward, we expect the maturation of the trial's current results, as well as the new data we expect to collect by enrolling additional patients, to provide key insights that will inform the next steps for rigosertib's current investigator-sponsored study program."

08:34 EDT ReWalk announces German Federal Social Court hearing on exoskeleton device - ReWalk Robotics announced the German Federal Social Court has scheduled a hearing to review the decision of whether an exoskeleton medical device should be classified as directly or indirectly compensating for the lost function of individuals with spinal cord injuries or paraplegia. The hearing is scheduled for November 10, 2022. The court's decision will establish a new national policy for exoskeleton medical aids and will apply nationally to all Germans covered by Statutory Health Insurance. Establishing a legal classification for exoskeletons will provide guidance for both patients and insurance companies, setting a reliable legal basis for the application process for the provision of exoskeletons. "The multitude of benefits that patients experience from regaining the ability to stand and walk again with the use of a ReWalk exoskeleton have made it clear that restoring walking function after spinal cord injury is a basic need," says Larry Jasinski, CEO of ReWalk Robotics. "The German healthcare system has led the way in its adoption of exoskeletons for spinal cord injured individuals. By establishing a clear classification for exoskeleton medical aids, the court will provide important, national guidance to payers and patients in the application process for care and create a pathway to providing access to this innovative technology for all eligible users in Germany through an established supply process. We look forward to the upcoming decision."

08:33 EDT SuperCom launches $33M national electronic monitoring project in Romania - SuperCom is pleased to announcethat, together with its local partner, it has executed the contract and launched the over $33M project with Romania's Ministry of Interior, following the award announced on August 24th. The project will include the deployment of SuperCom's PureSecurity Electronic Monitoring Suite for Domestic Violence monitoring, GPS Tracking of offenders, and a home detention monitoring program.

08:31 EDT CME Group announces launch of ether options - CME Group announced the launch of options on Ether futures. These new contracts deliver one Ether futures, sized at 50 ether per contract, and based on the CME CF Ether-Dollar Reference Rate, which serves as a once-a-day reference rate of the U.S. dollar price of ether.

08:30 EDT AmerisourceBergen to acquire PharmaLex, sees accretion - AmerisourceBergen announced that it has signed a definitive agreement to acquire PharmaLex Holding from funds advised by Auctus Capital Partners AG for EUR 1.28B in cash, subject to certain customary adjustments. The transaction will advance AmerisourceBergen's role as partner of choice for biopharmaceutical manufacturers by enhancing AmerisourceBergen's global portfolio of solutions to support manufacturer partners across the pharmaceutical development and commercialization journey. PharmaLex is a global team of scientific, regulatory, and safety and compliance, or GxP, experts that provide strategic guidance and regulatory support to biopharma companies throughout a product's lifecycle. The company provides tech-enabled services ranging from clinical development consulting to marketing authorization, enabling clients to efficiently bring products to global markets and diverse patient populations. The transaction is expected to close by March 2023 and is subject to the satisfaction of customary closing conditions, including receipt of required regulatory approvals. Upon closing, the acquisition of PharmaLex is expected to be approximately 15c accretive to AmerisourceBergen's adjusted diluted EPS for the last seven months of its fiscal year 2023, which would contribute to AmerisourceBergen's previously disclosed fiscal year 2023 growth target from capital deployment.

08:29 EDT Ascendis Pharma announces new Week 110 data from Phase 2 PaTH Forward Trial - Ascendis Pharma announced new Week 110 data from the Phase 2 PaTH Forward Trial showing that long-term therapy with TransCon PTH, an investigational prodrug designed to provide sustained release of active parathyroid hormone at stable levels in the physiological range for 24 hours/day, provided a durable response in adults with hypoparathyroidism, as seen in continued normalization of mean serum calcium levels and 93% of patients achieving independence from conventional therapy with active vitamin D and therapeutic levels of calcium. The data also showed continued restoration of skeletal bone mineral density toward sex- and age-expected norms for study participants treated with TransCon PTH, which augments turnover of stagnant bone. Participants with more years of hypoparathyroidism duration had higher mean baseline bone mineral density Z-scores and larger decreases in BMD Z-scores through Week 110, trending toward age- and sex-matched norms. PTH replacement therapy with TransCon PTH was well-tolerated through Week 110, with continued normalization of mean urine calcium and no discontinuations from the trial due to adverse events. Aimee Shu, M.D. Vice President of Clinical Development, Endocrine Medical Sciences at Ascendis Pharma said, "These and our Phase 3 data, which demonstrated improvements in health and quality of life, with well-tolerated safety profile, point to the importance of TransCon PTH as a potential new treatment option for hypoparathyroidism regardless of disease etiologies studied, and we will continue our work to deliver it to patients facing an urgent unmet need."

08:26 EDT Land's End announces CEO succession plan - Lands' End (LE) announced that Andrew McLean, President, International of American Eagle Outfitters (AEO) will join Lands' End as CEO-Designate and as a member of the Board of Directors on November 1, 2022. McLean, 53, will assume the role of CEO following the planned retirement of Jerome Griffith, 64, at the conclusion of Lands' End's 2022 fiscal year ending January 27, 2023. After the CEO transition, Griffith will continue to serve as a Director and is expected to be nominated for re-election to the Board at the Company's 2023 Annual Meeting of Stockholders. As part of this transition, he will become Executive Vice Chair after he retires as CEO.

08:23 EDT Hepion announces initiation of dosing in Phase 2 ALTITUDE-NASH trial - Hepion Pharmaceuticals announced that it has dosed the first NASH stage 3 subject with rencofilstat in a Phase 2 clinical trial designed to measure hepatic function. The trial is being conducted in collaboration with HepQuant, and Summit Clinical Research, at up to 20 sites within Summit's Integrated Research Organization. ALTITUDE-NASH is a Phase 2, randomized, multi-center, open-label study to evaluate the safety and efficacy of rencofilstat in 60 adult subjects. Subjects included in the trial will be presumed F3, based on either historical biopsy or by using the AGILE 3+ criteria as defined by a screening Fibroscan score alongside common clinical and laboratory parameters. Subjects will be randomized to receive a once daily, oral dose of 75, 150, or 225 mg rencofilstat soft gelatin capsules over a period of four months. The HepQuant 'SHUNT' test, a measure of hepatic function, will be performed at baseline, and changes in Disease Severity Index relative to baseline measurements will be determined at days 60 and 120. Other NASH biomarkers will be collected throughout the study duration. "When evaluating hepatic drug efficacy, clinicians and regulatory agencies rely on the assessment of many parameters, including liver fat content, inflammation, ballooning, and fibrosis, which require an invasive liver biopsy," stated Greg Everson, MD, CEO and Chief Medical Officer of HepQuant. "Although biopsy is the gold standard, it measures only surrogates to liver function and does not truly determine the extent of hepatic impairment or improvement with clinical interventions. HepQuant's non-invasive, blood-based technology determines a DSI score that relies on liver-specific uptake of cholate to measure hepatic and portal blood flow; and portal-systemic shunt in patients with chronic liver disease, providing a direct assessment of liver function and physiology. To date, HepQuant's procedure has been successfully utilized in 26 studies with over 1,100 subjects."

08:19 EDT Ocuphire Pharma receives PDFUA fee waiver for Nyxol NDA from FDA - Ocuphire Pharma announced that the U.S. Food and Drug Administration, FDA, has granted a small business waiver of the Prescription Drug User Fee Act, PDUFA, fee of $3.1M for the 505(b)(2) New Drug Application, NDA, for Nyxol, the Company's late stage product candidate. Ocuphire remains on track to file the NDA for Nyxol in its first indication, reversal of mydriasis, in late 2022. "We are pleased to receive this meaningful NDA fee waiver for Nyxol and look forward to continuing to work with the FDA throughout the submission and review process," said Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma. "NDA submission in late 2022 is a high priority. In parallel, we are ramping up our pre-commercial activities and continue discussions with commercial partners in preparation for the anticipated approval and launch of Nyxol in 2023 as potentially the only dilation reversal drops."

08:17 EDT Mereo BioPharma reports clinical update, biomarker data from ACTIVATE - Mereo BioPharma Group reported updated clinical data and biomarker data from ACTIVATE, a Phase 1b/ 2 study of anti-TIGIT antibody, etigilimab, in combination with nivolumab, in select recurrent advanced / metastatic solid tumors. These biomarker data were presented at a poster session at the 2022 European Society of Medical Oncology, ESMO, Annual Meeting on September 10, 2022. The multicenter ACTIVATE study is designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab, Mereo's proprietary anti-TIGIT antibody, in combination with a PD-1 inhibitor, nivolumab, with dosing every two weeks. Biomarker analyses were included as exploratory endpoints. As of September 12, 2022, there were 63 efficacy-evaluable checkpoint inhibitor-naive subjects with a minimum of 1 staging scan at 8 weeks and RECIST 1.1 response assessment or documented clinical progression. Key updates: Cervical cancer: 3/7 PD-L1 combined positive score CPSgreater than1%, CPI-naive cervical cancer subjects with confirmed complete responses ORR of 43%, 2 ongoing at greater than284 days and greater than142 days, and 1 withdrew consent with ongoing cCR at 163 days. Two additional patients had stable disease for a DCR rate of 71%. Of interest, biomarker analysis showed that the 2 cervical subjects with complete responses exhibited higher levels of PVR, TIGIT as well as high CD226+CD8+ co-expression. No evaluable tissue for biomarker analysis was available for the third patent with a complete response. Uveal melanoma: 1/6 evaluable subjects, with confirmed partial response at greater than347 days, ORR 17% and 2 patients were SD, for 175 and 294 days DCR 50%. The subject with cPR was noted to have high CD226+CD8+ co-expression, and was PVR positive and PD-L1 negative. Biomarker data presented at ESMO 2022 evaluated tumors for baseline expression of PVR, TIGIT, PD-L1 and CD226 by multiple modalities including validated IHC assays. Consistent with Mereo's previously reported data, high PVR expression was observed in subjects with decreases in target lesions from baseline and RECIST 1.1 responses. Additional noteworthy responses observed in subjects with cancer types not typically responsive to CPI monotherapy, with tumors that had high PVR expression and were either PD-L1 negative, or PD-L1 low include, an ovarian PR, an endometrial PR, a dedifferentiated liposarcoma PR, and a recurrent/metastatic testicular GCT patient with stable, near normalization of elevated tumor marker alpha feto protein, PD-L1 negative. The presentation at ESMO 2022 demonstrated robust target engagement in patients as evidenced by significant decreases in peripheral T regulatory cells while maintaining circulation levels of CD8 cells. Increases in proliferating T-cells subsets, proliferating NK cells, and intracellular cytokines were observed and sustained longitudinally. Additionally, etigilimab plus nivolumab reduced TPEX cells, progenitor cells believed to be committed to an exhausted-like fate. Further data was reported showing reductions in circulating tumor DNA measured at ~5-6 weeks post-treatment correlated with clinical benefit.

08:14 EDT The Oncology Institute becomes certified as a Patient Safety Organization - The Oncology Institute announced an important step in maximizing patient safety by becoming an Agency for Healthcare Research and Quality accredited Patient Safety Organization, PSO. The TOI PSO is a newly formed component entity whose purpose is to maintain the highest standards in patients' safety and quality by analyzing patient safety data to provide feedback, guidance, and training of TOI clinicians. "At TOI, the quality of our patient care is our highest priority. We believe this certification will further demonstrate to our patients that we offer them the highest quality care," said Dr. Yale Podnos, Chief Medical Officer of The Oncology Institute. "For our health professionals, this means we are creating a culture of safety at our organization where our teammates feel empowered to report incidences and provide input to continue to elevate patient quality and care."

08:11 EDT Mersana Therapeutics announces FDA Fast Track designation to XMT-1660 - Mersana Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer, TNBC. XMT-1660 is a B7-H4-directed Dolasynthen antibody drug conjugate with a precise, target-optimized drug-to-antibody ratio and Mersana's clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. "While breast cancer remains an area of high unmet need, TNBC is associated with particularly poor outcomes and very limited treatment options," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "XMT-1660 has demonstrated promising anti-tumor effects in preclinical studies, and we are excited to have recently initiated our Phase 1 trial to investigate its safety and clinical activity. This Fast Track designation allows for a potentially accelerated regulatory review of XMT-1660 as we seek to offer a new therapy for patients living with a range of B7-H4 expressing tumors." Mersana's ongoing multicenter Phase 1 trial is investigating the safety, tolerability and anti-tumor activity of XMT-1660 in patients with solid tumors, including in breast, endometrial and ovarian cancers. The initial dose escalation portion of this trial will evaluate the safety and tolerability of XMT-1660. The dose expansion portion of the trial will evaluate the safety, tolerability and efficacy of XMT-1660

08:08 EDT NortonLifeLock completes merger with Avast - NortonLifeLock (NLOK) announced it has completed its previously announced acquisition of Avast (AVASF). With the completion of the transaction, trading in Avast shares was suspended at 7:30 a.m. BST on September 12, 2022, and the Avast shares will be delisted from the London Stock Exchange effective as of September 13, 2022, at 8:00 a.m. BST. The combined company will operate as NortonLifeLock and discuss its shared financials and metrics during the fiscal year 2023 second quarter earnings release call. As it starts merging its operations, the combined company will soon announce a new name that reflects the forward-thinking vision and scale of its comprehensive Cyber Safety platform and trust-based solutions for consumers around the world. It will also begin trading under a new stock ticker under the new company name on NASDAQ. Until that time, the combined company will operate as NortonLifeLock and continue trading on NASDAQ under its current "NLOK" ticker symbol.

08:07 EDT Nocera to acquire 229 acres of land in Alabama for $865,000 - Nocera announced it entered into a purchase agreement to acquire 229 acres of agricultural land for U.S. land based fish farms in Montgomery, Alabama. The purchase agreement was executed on September 8 and the acquisition is anticipated to close by October 31. The purchase price for the parcel is $865,000. The company in the process of obtaining up to 85% financing from local banking institutions. The 229 acres of land is in the city limits of Montgomery, Alabama. It comes with a house, a manufactured home and a building site with sewer and power which the company will develop into an office and dormitory for Nocera's employees. The closing of the purchase agreement is contingent on the company satisfying the terms and conditions of the purchase agreement, including, but not limited, obtaining the necessary financing.

08:06 EDT Arko Corp. announces agreement to acquire all assets of TEG for $375M - ARKO announced that GPM Investment, a wholly owned subsidiary of ARKO, and certain of GPM's subsidiaries have agreed to acquire from Transit Energy Group, TEG, approximately 150 convenience stores, fuel supply rights to approximately 200 dealers, commercial, government, and industrial customers, as well as TEG's bulk storage, distribution and transportation assets, all in the Southeastern United States. The purchase price is approximately $375M plus the value of inventory, of which $50M is deferred and payable in two annual payments of $25M, which ARKO may elect to pay in either cash or, subject to certain conditions, shares of ARKO's common stock, on the first and second anniversaries of the closing. At closing, ARKO intends to finance from its own sources approximately $60M of the cash consideration plus the value of inventory and other closing adjustments. The remaining approximately $265 million is expected to be funded by Oak Street Real Estate Capital, a Division of Blue Owl Capital as part of the previously announced existing $1.15B agreement with the Company, according to which Oak Street is expected to acquire the real estate assets to be acquired from TEG as part of the transaction and the Company expects to lease the real estate assets from Oak Street. "We believe this significant, accretive acquisition will drive strategic growth with the addition of an exceptional team, well-known stores and other assets to our Family of Community Brands," said Arie Kotler, President, Chairman and Chief Executive Officer of ARKO. "A deal of this magnitude complements our core capabilities and will create long-term value for ARKO stockholders and valuable synergies given our existing footprint and proven strategy of adding value to strong local brands while keeping jobs in place." The closing of the transaction is subject to fulfillment of conditions precedent. There is no certainty that the transaction will close.

08:04 EDT Regulus announces 'positive' results from Phase 1 trial of RGLS8429 - Regulus Therapeutics announced positive topline safety and PK data from its Phase 1 SAD clinical trial of RGLS8429. Additionally, the company announced the initiation of its Phase 1b MAD clinical trial of RGLS8429. The Phase 1 SAD study demonstrated that RGLS8429 has a favorable safety and PK profile. RGLS8429 was well-tolerated with no serious adverse events reported. Among the 32 subjects treated with RGLS8429 or placebo, there were nine adverse events all of which were mild, except one (sinus infection) which was graded moderate in severity. Preliminary results suggest plasma exposure is dose proportional across the four doses tested and compare favorably to the PK data from the first-generation compound, RGLS4326.

08:01 EDT Patriot One Technologies selected by SAP Center as San Jose - Patriot One Technologies announced that SAP Center at San Jose, home of the NHL's San Jose Sharks, has signed an agreement to deploy the Company's SmartGateway patron screening solution and artificial intelligence-powered Platform to secure all entrances to the nearly 18,000-seat facility for all non-NHL events. In addition, Patriot One's solutions will be deployed to protect all entrances at Tech CU Arena, the new 4,200-seat home of the San Jose Barracuda at Sharks Ice at San Jose. "Partnering with forward-thinking organizations like Sharks Sports & Entertainment makes complete sense - they require next-gen technology to secure their state-of-the-art facilities, which is exactly what Patriot One can provide, along with customization to fit their unique security standards and requirements," said Peter Evans, CEO of Patriot One. "Working together with them, and the leadership at the NHL throughout the year to define a best-in-class experience, has opened new opportunities for Patriot One. Most importantly, our solution uniquely meets, and has been certified to meet, the DOJ NIJ standard for large and medium weapons, and therefore also the NHL's requirements for prohibited items."

08:00 EDT BIO-key announces distribution partnership with Multipoint Group - BIO-key International announced a distribution partnership with Israel-based Multipoint GROUP in Southern and Central Europe and the Middle East. Multipoint has joined BIO-key's Channel Alliance Partner program designed to leverage the expertise, reach and onsite presence of a range of leading IT service providers that deliver security solutions to their customers. The Multipoint partnership provides BIO-key with a strategic value-added distributor of cybersecurity with solid technical experience and a knowledgeable commercial sales team. Multipoint offers not only distribution but also pre-sales analysis, training, and full support to resellers and customers interested in security and identity solutions. BIO-key's Channel Alliance Partner program allows its partners to represent BIO-key's full line of biometric authentication solutions and large-scale identity management security products that provide robust Single Sign-on and Multi-factor authentication capabilities.

07:58 EDT Shawcor to rebrand, focus on infrastructure tech, explore strategic alternative - Shawcory announced that it will seek to change its name to Mattr. The Name Change is expected to occur during the first half of 2023, conditional on regulatory and shareholder approvals, and it is anticipated that trading of the Company's common shares will commence under a new ticker symbol. Further details regarding the Name Change, including the effective date of the Name Change and the new ticker symbol of the Company, will be announced over the coming months. Concurrently, the Company has commenced a review of strategic alternatives for its Pipeline Performance Group, Shaw Pipeline Services and Oilfield Asset Management operating units. A range of options are under consideration, including the potential sale of all three operating units. Shawcor's PPG and SPS operating units currently form the entirety of the Company's Pipeline & Pipe Services reporting segment, while the OAM operating unit is a component of the Composites Systems reporting segment. "The steps announced here are important elements in our ongoing strategy to unlock long-term profitable growth and demonstrate our commitment to continuing the transformation of our Company; by simplifying our portfolio, lowering volatility and elevating full-cycle margins and free cash flow," said Mike Reeves, President and CEO of Shawcor. "Since early 2020, Shawcor has successfully divested multiple non-core businesses and other assets, generating nearly $200 million of cash proceeds. Once completed, the additional actions shared today will enable Shawcor to tightly focus capital on the core elements of our Composite Systems and Automotive & Industrial segments, businesses which align closely with our materials technology competencies, are best positioned to benefit from favorable long-term macroeconomic trends and consistently offer high returns on invested capital. To many, the Shawcor name is synonymous with pipeline related products or services. As we look to the future, rebranding our Company is an important step to better reflect the energy, creativity and innovation of this organization, and our leadership in providing high value, materials-based products to industrial and critical infrastructure markets."

07:56 EDT Faraday Future up 9% as FF Top demands resignation of Executive Chair Swenson - Shares of Faraday Future are up 9% in pre-market trading at $1.21. On Friday, the company's shareholder FF Top filed a 13D/A, stating: "On September 6, 2022, FF Top delivered a Notice of Removal of FF Top Designee to the Board of Directors pursuant to Section 2.1(c) of the Shareholder Agreement, dated as of July 21, 2021, by and between FF Top and the Issuer, stating that FF Top was exercising FF Top's right to remove Ms. Susan Swenson, an FF Top Designee, from the Board of Directors. In the Second Removal Notice, FF Top also required that the Issuer "no later than 4:05 p.m., New York time, on Wednesday, September 7, 2022, either (i) cause Ms. Swenson and Mr. Krolicki to resign from the Board, and all other positions they may hold with the [Issuer], with immediate effect and disclose the same under Item 5.02 of Form 8-K by such same deadline or (ii) (A) remove Ms. Swenson and Mr. Krolicki from all management, Board, and Board committee positions with immediate effect (disclosing the same on Form 8-K by such same deadline), (B) request via public announcement the immediate resignation of Ms. Swenson and Mr. Krolicki in the best interests of the [Issuer] and (C) file a revised Special Meeting proxy statement, adding the Swenson [r]emoval [p]roposal to the items to be voted on and including the meeting and record dates for the Special Meeting." FF Top also more generally required in the Second Removal Notice that, among other things, the Issuer take all "Necessary Action" in connection with the subject matter of the Second Removal Notice."

07:50 EDT ContraFect announces multiple publications for each of the company's lysins - ContraFect Corporation announces the publication of an editorial in the Journal of Bone and Joint Infection discussing the potential for each of the Company's lysins, exebacase and CF-296, as additional agents in the treatment armamentarium against bone and joint infections due to their in vitro activity against coagulase-negative staphylococci, the bacteria most frequently involved in implant-associated BJIs, and their potential for both local and systemic anti-biofilm activity. The authors conclude that these advantages could compensate for the treatment challenges with current antibiotic treatments against staphylococcal BJIs alone. A second publication in Antimicrobial Agents and Chemotherapy presents the results from a study evaluating the in vitro activity of exebacase against biofilms formed by clinical strains of Staphylococcus epidermidis, a CoNS species, commonly isolated from patients with prosthetic joint infections. Exebacase displayed significant anti-biomass and bactericidal activity against S. epidermidis biofilms, as well as synergistic effects in addition to rifampicin, vancomycin, and daptomycin. "The activity we have seen with exebacase in vitro, in vivo, and in compassionate use cases as recently presented by Dr. Tristan Ferry of Hospices Civils de Lyon in Lyon, France at the 40th Annual Meeting of the European Bone and Joint Infection Society, provides a complete picture of the potential impact exebacase could have for patients suffering from osteomyelitis and prosthetic joint infections, which are particularly difficult-to-treat with current standard of care antibiotic agents," stated Roger Pomerantz, M.D., ContraFect's President, Chief Executive Officer, and Chairman. "Given the strength of the data we have accumulated to date, we believe a randomized clinical study of exebacase in patients with chronic or recurrent prosthetic joint infections caused by MRSA or S. epidermidis could be the first blinded and randomized trial in this field," added Dr. Pomerantz.

07:47 EDT AnaptysBio announces sale of Zejula Royalties for up to $45M - AnaptysBi announced that the company has sold its royalty interest on future global net sales of Zejula to a wholly-owned subsidiary of DRI Healthcare Trust for up to $45M. AnaptysBio has received a $35M upfront payment for the sale of its 1% royalty on global net sales of Zejula which, due to reductions relating to third party royalties, is paid at an effective rate of 0.5%. The company is also eligible to receive a further $10M from DRI upon FDA approval of Zejula for the treatment of endometrial cancer, for which the drug is currently in a fully-enrolled ongoing Phase 3 study, to the extent that such approval occurs on or before December 31, 2025.

07:45 EDT FTI Consulting announces appointment of Boetig as Senior Managing Director - FTI Consulting announced continued investment in the firm's Cybersecurity practice with the appointment of Brian Boetig as a Senior Managing Director, bringing more than 30 years of investigative, national security, crisis management and public safety expertise. Boetig joins after serving in senior leadership roles with the Federal Bureau of Investigation. In his role at FTI Consulting, Boetig will expand the firm's West Coast presence, establishing an official Cybersecurity practice footprint in Seattle.

07:43 EDT ContraFect announces presentation of data from study using LysinDAIR - ContraFect Corporation announces the presentation at the 40th Annual Meeting of the European Bone and Joint Infection Society, held in Graz, Austria from September 8-10, 2022, of data from a single center, exploratory, open-label prospective study using a minimally invasive LysinDAIR procedure in patients with chronic knee prosthetic joint infection , due to coagulase-negative staphylococci, with two different clinical presentations and treatment paradigms. "The positive clinical data demonstrated in these patients underpins the potential to prosecute exebacase in a blinded clinical study of patients with chronic or recurrent prosthetic joint infections caused by MRSA or coagulase-negative Staph," stated Roger Pomerantz, M.D., ContraFect's President, Chief Executive Officer, and Chairman. "I am particularly impressed with the durability of patient responses to therapy, in some cases out to 36 months, allowing patients to avoid expensive and potentially debilitating joint removal and reimplantation," added Dr. Pomerantz. The first cohort included patients suffering their first episode of CoNS knee PJI. The Lysin DAIR procedure was followed by three months of clindamycin and levofloxacin. Exebacase was well tolerated by all patients. No local or systemic serious adverse events related to exebacase were reported. The patients, through follow up periods of up to 36 months, have experienced no relapse of infection, no recurrence of the joint effusion and no loosening of the prostheses. The second cohort included patients suffering from a complex episode of multi-drug resistant CoNS knee PJI. The LysinDAIR procedure was followed by three months of antibiotics plus additional suppressive antimicrobial therapy. Exebacase was well tolerated by all patients. No local or systemic SAEs related to exebacase were reported. Two patients, through follow up periods of up to 12 months, have experienced no relapse of infection, no recurrence of the joint effusion and no loosening of the prostheses. One patient experienced a relapse of infection of Staphylococcus caprae after six months. One patient died from an unrelated COVID-19 infection.

07:41 EDT Orezone Gold pours first gold at Bombore mine - Orezone Gold Corporation announce that the Company has poured first gold from its Bombore Mine, located in Burkina Faso. The construction of the Bombore Mine was completed under budget, on time, and with no lost time injuries. Commissioning of the process plant commenced in late July with ore introduced into the circuit near the end of August. Mining operations are performing as planned and will ramp up as the mine enters commercial production expected in early Q4-2022. Patrick Downey, President and CEO stated: "I want to give recognition and thanks to the entire Bombore team for their extraordinary efforts in achieving this important milestone of first gold. The team exceeded expectations by delivering the plant construction under budget in a period marked by rapid inflation and COVID-related disruptions. This team includes our employees, communities, consultants, contractors, and local businesses under the guidance and direction of the Bombore site leadership in conjunction with Lycopodium, our EPCM contractor. In a short span of twenty months, we have successfully financed and constructed this greenfield project, mined over 15.7 million tonnes of material, including 5.8 million tonnes of ore, while maintaining the health and safety of our workforce."

07:38 EDT Theratechnologies announces publication of preclinical study of TH1902 - Theratechnologies announced the publication of a preclinical study demonstrating the in vitro and in vivo efficacy of TH1902, an investigational sortilin-targeted peptide-drug conjugate, in inhibiting ovarian cancer and triple-negative breast cancer, TNBC, stem-like cells', CSCs, tumor growth. The study, published as part of the special issue of Pharmaceutics "Targeting Drug Resistance and Metastatic Pathways for Cancer Therapy", reports that TH1902 appears to exert anticancer activity that is superior to unconjugated docetaxel in preclinical models, in part by circumventing the chemoresistance phenotype that is often responsible for treatment failure and cancer recurrence. SORT1 is a scavenger receptor protein that binds to circulating proteins and peptides prior to their intracellular internalization. It is upregulated in several types of cancer. TH1902, now being investigated across at least eight solid tumor types in a Phase 1 clinical trial, has been shown in preclinical models to recognize and exploit SORT1 function, to efficiently trigger in vitro cell death through apoptosis, to inhibit in vitro cell cycling by trapping cells into the G2/M phase, and to inhibit in vivo growth of CSCs from gynecological cancers including ovarian cancer and TNBC. The Pharmaceutics paper provides the first evidence for TH1902 targeting of human breast and ovarian CSCs, both in vitro and in vivo. The limited ability of docetaxel, a widely used cancer chemotherapeutic agent, to inhibit the growth of CSCs from TNBC and ovarian cancer may be one mechanism of resistance and limit the effectiveness of the drug in controlling tumor growth and spread. In the Pharmaceutics paper, researchers at Theratechnologies and the Molecular Oncology Laboratory at Universite du Quebec a Montreal describe the activity of TH1902 against CSCs and its ability to circumvent some of the known resistance phenotypes associated with CSCs. Their findings suggest that TH1902 targets cancer cells overexpressing the sortilin receptor - an effect that is absent in healthy cells. Additionally, at doses equivalent to docetaxel, single-agent TH1902 exhibited superior efficacy against breast and ovarian CSCs, compared to docetaxel alone. Finally, when combined with carboplatin in an ovarian tumor model, the efficacy of TH1902 was also superior to that of paclitaxel- or docetaxel-carboplatin combinations. In TNBC and ovarian CSCs animal models, TH1902 decreased tumor growth by 80%, compared to roughly 35% in docetaxel-treated mouse models.

07:36 EDT Energy Focus names Lesley Matt CEO - Energy Focus announced that Lesley Matt will join the company as its new CEO, effective September 12. Matt spent over twelve years at TCP Lighting.

07:35 EDT Bluebird Bio says Jason Cole, Chief Strategy and Financial Officer, to leave - bluebird bio announced that Jason Cole, Chief Strategy and Financial Officer, plans to leave bluebird bio to pursue new career opportunities. In March 2022, Mr. Cole was appointed Chief Strategy and Financial Officer at a critical juncture for the company. He led changes to stabilize the Company's financial position and strengthen its balance sheet. Since that time, he has also served as Principal Financial Officer and Principal Accounting Officer. Over the coming weeks, Mr. Cole intends to transition finance responsibilities to Katherine Breedis, an experienced business and financial executive from Danforth Advisors, who is expected to serve as interim CFO. bluebird has initiated an external search for its next CFO, with a focus on experience with commercial stage companies. Mr. Cole's management responsibilities for strategy, external affairs and operations will be transitioned to Andrew Obenshain. Mr. Cole's last day will be October 14; he expects to continue to consult with bluebird on corporate strategy through April.

07:33 EDT Columbia Financial appoints Rickert as EVP, Chief Credit Officer - Columbia Bank appoints Matthew Rickert as Executive Vice President, EVP, Chief Credit Officer, effective immediately. In his role, Rickert is responsible for the Bank's credit policies including all aspects of Commercial Credit and Special Assets. Rickert has over 20 years of diversified experience at premier institutions including senior leadership roles for JPMorgan Chase Bank.

07:32 EDT Acadia Pharmaceuticals files trofinetide NDA - Acadia Pharmaceuticals announced that the FDA has accepted for filing its new drug application, or NDA, of trofinetide for the treatment of Rett syndrome. The FDA has granted a priority review and assigned a PDUFA action date of March 12, 2023. The FDA has also informed the company that at this time they are not planning to hold an Advisory Committee meeting.

07:30 EDT Invitae announces collaboration with Simons Searchlight - Invitae announced a collaboration with Simons Searchlight, an international research program with a goal of accelerating research and improving lives for people with rare genetic neurodevelopmental disorders. This partnership will connect two sets of data - the longitudinal clinical data extracted from medical records through Invitae's Ciitizen, a patient-consented, digital natural history data platform and patient reported outcomes and biospecimens collected by Simons Searchlight. The partnership breaks down data silos and provides a rich and deep dataset that will help accelerate research for rare neurodevelopmental diseases.

07:24 EDT Invivyd announces multiple next generation COVID-19 antibody candidates - Invivyd (IVVD), formerly Adagio Therapeutics (ADGI), announced that the Company has generated multiple next-generation candidate antibodies for the prevention and treatment of COVID-19, including two molecules designated for near-term clinical development in combination as NVD200. NVD200 is expected to enter the clinic in the first quarter of 2023. "COVID-19 continues to impose a significant and unacceptable burden on humanity, which is why I am pleased that our integrated discovery platform has been so productive at identifying novel candidates with potential to transcend the limitations of the human immune response," said David Hering, CEO of Invivyd. "Our approach is designed to find unique molecules that target the validated SARS-CoV-2 spike protein at sites under limited immune pressure, which we expect to translate into a high barrier to viral escape. We are rapidly advancing NVD200, our novel combination candidate, toward the clinic with a Phase 1 clinical trial expected to start in the first quarter of next year. At the same time, we are diligently monitoring emerging variants to inform our development plans for the multiple additional discovery candidates in our pipeline, as well as innovating to provide a steady stream of new candidates to address the continuously evolving viral threat." NVD200 is a combination of two monoclonal antibodies which demonstrated potent in vitro neutralizing activity against prior and current SARS-CoV-2 variants of concern, including Omicron BA.1, BA.2, BA.4, BA.5, and BA.2.75 sublineages, as well as the more antigenically divergent SARS-CoV-1. This antibody combination has been selected for neutralization potency, breadth of coverage, and non-dominant epitope recognition. The antibodies in the combination target non-overlapping epitopes that are rarely targeted by endogenous neutralizing antibodies, which limits immune pressure on these sites and increases the probability of sustained utility in an evolving viral landscape. One of the antibodies in the combination is a re-engineered version of adintrevimab, the company's most advanced product candidate, which met all primary endpoints with statistical significance in a pre-Omicron setting in global Phase 3 clinical trials for the prevention and treatment of COVID-19.

07:19 EDT Else Nutrition launches in over 500 Winn-Dixie supermarket stores - Else Nutrition announces that it has started its rollout of Else Plant-Based Complete Nutrition products for toddlers at Winn-Dixie's and by the end of September will be fully available in its 515 locations. "Winn-Dixie marks a significant distribution addition for the Else brand, strategically strengthening our retailer presence across the South and making our Plant-Based, Clean-Label Nutrition products more accessible to millions of Americans," said Hamutal Yitzhak, CEO, and Co-Founder of Else Nutrition.

07:18 EDT Dyne Therapeutics highlights DM1, DMD clinical programs - Dyne Therapeutics hosts a virtual event, "Spotlight on the Clinic," highlighting its clinical programs, DYNE-101 in myotonic dystrophy type 1 and DYNE-251 in Duchenne muscular dystrophy from 7:30-9:00 a.m. ET. "With our DYNE-251 and DYNE-101 clinical trials now underway, this is a very exciting time for Dyne and people living with DMD and DM1. DELIVER and ACHIEVE, which are both designed to be registrational trials, are expected to report data in the second half of 2023, including evaluating important biomarkers of dystrophin in DMD and splicing in DM1," said Joshua Brumm, president and chief executive officer of Dyne. "We are extremely grateful to Drs. Sansone and Finkel for sharing their insights today, including on the unmet needs of their patients and where new therapies have the potential to address diseases with no or limited treatment options." In addition to remarks and discussion with the neuromuscular disease experts, the event includes a review of Dyne's clinical programs and pipeline: DELIVER Trial in DMD: Patient dosing is underway in DELIVER, a Phase 1/2 global clinical trial evaluating DYNE-251 for the treatment of DMD mutations amenable to exon 51 skipping. The DELIVER trial consists of a 24-week multiple ascending dose randomized, placebo-controlled period, a 24-week open-label extension and a 96-week long-term extension. Data from the MAD placebo-controlled portion of the DELIVER trial on safety, tolerability and dystrophin are anticipated in the second half of 2023. ACHIEVE Trial in DM1 - Dyne has initiated its ACHIEVE trial evaluating DYNE-101 for the treatment of DM1. The ACHIEVE trial is a Phase 1/2 global clinical trial consisting of a 24-week MAD randomized, placebo-controlled period, a 24-week open-label extension and a 96-week long-term extension. The primary endpoints are safety and tolerability; secondary endpoints include pharmacokinetics and pharmacodynamics, including change from baseline in splicing, as well as measures of muscle strength and function. Data from the MAD placebo-controlled portion of the ACHIEVE trial on safety, tolerability and splicing are anticipated in the second half of 2023. Pipeline and Resources: Dyne is prioritizing its focus and resources on its clinical programs, DYNE-101 in DM1 and DYNE-251 in DMD. The Company remains committed to advancing its facioscapulohumeral muscular dystrophy program but is deferring the Investigational New Drug application submission for DYNE-301 originally targeted for the second half of 2022. As a result, Dyne expects its cash runway will be extended through 2024 and plans to provide an update on its FSHD program in 2023.

07:16 EDT Fury and Newmont finish JV interests consolidation, targets defined - Fury Gold Mines (FURY) is pleased to announce that the Company and Newmont Corporation (NEM, through their respective subsidiaries, have completed the previously announced buy-out of the remaining approximately 23.77% participating interest of Azimut Exploration Inc. in the Eleonore South Joint Venture ESJV, on a pro-rata basis. As a result of the transaction, the 100% ESJV participating interests are Fury 50.022% and Newmont 49.978% with Fury remaining operator under an amended and restated joint venture agreement. The cost to Fury of the 11.902% additional participating interest in the joint venture is C$1,202,663."We are excited to be moving forward with our valued partner and industry leader, Newmont, with an updated ESJV agreement. One of our favourite targets has been the five and a half kilometer anomaly that is hosted on the ESJV property, and we are eager to more readily advance this to drill stage next year," said Tim Clark, CEO of Fury. "The potential for a larger scale discovery within the land package, coupled with the excellent access to roads and hydro power in the James Bay region could represent significant value and upside for shareholders. The Company is also pleased to provide an update on targeting at the Eleonore South Joint Venture project located in the Eeyou Istchee Territory in the James Bay region of Quebec. The Company has defined nine gold targets through the completion of an infill till sampling program within a five and a half kilometer long undrilled historical gold-in-till anomaly Fury and its joint venture partner are currently following up on these targets to advance them to the drill stage and exploring to develop additional targets.

07:12 EDT Plus Therapeutics presents data from Phase 1 ReSPECT-GBM trial - Plus Therapeutics announced Phase 1 data from the ReSPECT-GBM Phase 1/2a dose escalation clinical trial evaluating the Company's lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome, in recurrent glioblastoma, GBM in an oral presentation at the European Society for Medical Oncology, ESMO, Congress 2022, being held September 9-13, 2022 in Paris, France. The oral presentation titled, The ReSPECT-GBM Phase 1/2a Dose Escalation Trial of Rhenium-186 NanoLiposome in Recurrent Glioma via Convection Enhanced Delivery & Planned Phase 2b Trial, reviews data from the Phase 1 ReSPECT-GBM trial which evaluated 23 adult patients with recurrent GBM across 8 cohorts of increasing dose and treated over a seven-year period. Key findings include: No dose-limiting toxicities have been observed and the procedure is very well tolerated with a strong safety profile. Improved median overall survival rates correlated with the absorbed tumor radiation dose. Feasibility to deliver up to at least 20 times more radiation to the tumor than the standard of care, external beam radiation therapy. Average absorbed radiation dose to the tumor increased in latter dosing cohorts with greater administered doses of Re-186 beta-particle radiation, larger drug convection enhanced delivery infusate volumes, more catheters used, and higher convection flow rates. In cohorts 5 and later, 82% of patients received a therapeutic radiation dose of greater than100Gray. Single-photon emission computerized tomography and CT scanning were used during treatment to compute tumor coverage and dosimetry. Post treatment imaging analyses, including MRI, relative cerebral blood volume analysis and treatment response assessment maps correlated with a positive tumor response and confirmed the presence of pseudoprogression in patients with positive tumor responses. ReSPECT-GBM will proceed to an NIH and U.S. Food and Drug Administration approved Phase 2 trial in the U.S. at the current non-DLT 186RNL dose and will expand exploring higher radiation doses in larger volumes to treat larger tumors. Additionally, two or more 186RNL administrations, if indicated, will be evaluated and reviewed with the FDA, as well as expanded safety, imaging and efficacy data to support a planned future registrational trial. Based upon feedback from a Type C meeting with the FDA, the Company plans to initiate the ReSPECT-GBM Phase 2 trial in the second half of 2022, funded principally by the NIH. The Company intends to begin the ReSPECT-GBM Phase 2 trial utilizing cGMP 186RNL drug, which will be available in the second half of 2022.

07:11 EDT Moderna receives MHLW approval for mRNA-1273.214 NDA change - Moderna announced that it has received approval from the Ministry of Health, Labour and Welfare, or MHLW, in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.214. Spikevax Bivalent Original/Omicron contains mRNA-1273 and a vaccine candidate targeting the Omicron variant BA.

07:08 EDT Great Southern Homes to become public through DiamondHead Holdings merger - Great Southern Homes announced that it has entered into a definitive merger agreement with DiamondHead Holdings, a special purpose acquisition company. Upon closing of the transaction, GSH will become a publicly traded company, and DiamondHead Holdings will be renamed United Homes Group. Great Southern Homes is expected to remain listed on the Nasdaq Capital Market and is expected to trade under the new ticker symbol (UHG). GSH is currently one of the largest homebuilders in the Southeast. The company builds homes in South Carolina and Georgia, focusing on the entry level and first time move up home buyer segments. GSH plans to employ a capital efficient "land-light" operating model that is expected to generate higher returns with lower cyclical risk compared to a traditional homebuilding operating model. Through organic growth, GSH has become the 25th ranked starter-home builder and the 41st ranked single-family detached home builder in the United States, respectively, based on 2021 home closings according to Pro Builder's 2022 Housing Giants Report. DiamondHead is a special purpose acquisition company led by co-CEO and chairman David Hamamoto, who has over 40 years of experience in real estate investing, as well as operating both private and publicly held real estate businesses. David Hamamoto was the founder and Chairman of the previously publicly-traded NorthStar real estate related companies: NorthStar Realty Finance Corp., NorthStar Asset Management Group, Inc. and NorthStar Realty Europe Corp. In addition, David Hamamoto was a former partner at Goldman, Sachs & Co. and the co-founder of its Real Estate Principal Investment Group and Whitehall funds. DiamondHead is co-sponsored by Antara Capital, which is an event-driven hedge fund founded by Himanshu Gulati in 2018 that invests across a wide variety of financial instruments, including loans, bonds, convertible bonds, stressed/distressed credit and special situation equity investments. The transaction values the combined company at a pro forma enterprise value of approximately $572M, as of December 31. As part of the transaction, all of GSH's existing shareholders will roll 100% of their shares into shares of the combined company and, assuming no redemptions from DHHC public shareholders, will hold approximately 51% of the shares of the combined company on closing. Assuming no redemptions from DHHC shareholders, the transaction will deliver approximately $320M in cash proceeds, net of estimated transaction costs, to the combined company including a $25M commitment to purchase and not redeem DHHC public shares from the DHHC sponsor group, including David Hamamoto and Antara Capital. The transaction includes an earn-out provision pursuant to which GSH stockholders are entitled to receive up to an aggregate maximum of 20 million additional shares, over a five year period, as and when the share price of the combined company reaches certain thresholds. In addition, approximately 2.1M shares owned by the sponsor currently will be subject to the earn-out. The transaction also provides that additional sponsor shares will become subject to the earn-out to the extent there is not $100M of common stock at closing. The board of directors of GSH and DHHC have approved the transaction. The obligation of GSH to complete the transaction is subject to a minimum cash condition of $125M. For purposes of the minimum cash condition, cash includes cash in the DiamondHead trust account after giving effect to redemptions and any other permitted financings obtained in connection with the completion of the transaction. There can be no assurances that the minimum cash condition, which may be waived by GSH, will be satisfied. The transaction will also require the consent of GSH's lenders and the approval of DHHC stockholders, and is subject to customary closing conditions. The transaction is expected to close during the first quarter of 2023.

07:07 EDT XPO Logistics promotes Silberkleit to Chief Information Officer - XPO Logistics announced that Jay Silberkleit has been appointed chief information officer, effective upon the spin-off of XPO's brokered transportation platform. Silberkleit will succeed Mario Harik, XPO's current CIO and president, less-than-truckload - North America. As previously announced, Harik will become chief executive officer of XPO once the planned spin-off is complete. Silberkleit joined XPO as vice president, enterprise architecture in 2012. In 2021, he was named senior vice president, technology, with responsibility for the company's LTL optimization initiatives.

07:07 EDT Can-Fite : New psoriasis data showing "superior' safety & efficacy presented - Can-Fite BioPharma announced that Dr. Kim A. Papp, MD, PhD, presented new data from the Company's recently completed Phase III COMFORT study at the late-breaking news session of the 31st European Academy of Dermatology and Venerology or EADV Congress. Can-Fite previously reported the COMFORT study met its primary endpoint with Piclidenoson showing a statistically significant improvement over placebo in psoriasis patients. Piclidenoson is advancing into a pivotal Phase III psoriasis registration trial. The protocol, which is being designed by Dr. Papp, will be submitted to the U.S. Food and Drug Administration and the European Medicines Agency for market clearance of Piclidenoson in the treatment of moderate to severe psoriasis... Dr. Papp commented, "The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options especially given the chronic nature of psoriasis which can necessitate long-term treatment." Dr. Papps's presentation was based on a study co-performed by numerous dermatology investigators, in Europe, Israel, and Canada. Based in Waterloo, Ontario, Canada, Dr. Papp has over 25 years' experience as a Principal Investigator. Internationally renowned as a Key Opinion Leader in clinical research, Dr. Papp has conducted over 70 international dermatology studies on a wide range of dermatological disorders. The K. Papp Clinical Research center is considered one of the top clinical research centers in the world. Instrumental in improving and refining study designs, Dr. Papp has completed over 150 research studies on 50 compounds and has worked on new treatments that are now available and helping tens to hundreds of thousands of patients with their condition.

07:04 EDT Cara Therapeutics appoints Maynard as Chief Financial Officer - Cara Therapeutics announced the appointment of Ryan Maynard as Chief Financial Officer, CFO, effective immediately. As a member of the Executive Leadership Team, Maynard will lead the Company's financial operations. Maynard was most recently the CFO of LetsGetChecked, a global healthcare solutions company.

07:03 EDT Zentalis appoints Skvarka to board of directors - Zentalis Pharmaceuticals announced the appointment of Jan Skvarka, PhD, MBA to its Board of Directors. Dr. Skvarka currently serves as the Executive Chairman of GentiBio and DEM BioPharma.

07:01 EDT Compugen names Alberto Sessa as CFO - Compugen announced that Alberto Sessa has been appointed CFO and member of the management team. Alberto will join Compugen on November 1. He most recently served as acting CFO at several startup companies in the high-tech industry.

06:54 EDT ANI Pharmaceuticals names Krista Davis as Chief Human Resources Officer - ANI Pharmaceuticals (ANIP) announced that Krista Davis will join the company as Chief Human Resources Officer, effective September 12. Davis brings to the company over 20 years of executive leadership experience in human resources, talent management, and organizational development. Davis previously served as a global Head of People & Organization for the Novartis (NVS) Technical Operations Division, where she led P&O for the Global Cell & Gene platforms, supporting growth and the strategic transformation of the organization.

06:47 EDT Vista Gold provides update on strategic process on Mt Todd gold project - Vista Gold announced the following update regarding the company's process to seek a partner or other form of transaction to maximize shareholder value from the company's 100% owned Mt Todd gold project. "The company has advanced its strategic process for Mt Todd over the past year and, more formally, since announcing the appointment of CIBC Capital Markets as the company's strategic advisor in March 2022. During this period, a number of interested parties have engaged in reviews of the company's data, carried out independent testing and analyses, and completed site visits. We continue to engage in constructive discussions with a number of groups identified through the strategic process and to pursue additional interest from others." Frederick Earnest, President and CEO of Vista Gold, commented, "Our process has generated interest from a broad range of prospective parties, including high-quality gold producers of varying scale. These groups conducted extensive due diligence on Mt Todd. Based on the feedback received, we are pleased that the technical merits of the Project have stood up to the rigorous scrutiny of those who have evaluated Mt Todd. Additionally, engagement with other parties during the process is providing insights into alternative development and operating strategies which we continue to evaluate."

06:44 EDT Twitter says Musk's third purported termination invalid, intends to enforce deal - On September 9, Twitter received another notice of purported termination of the merger agreement with Elon Musk and disclosed its response to that third notice of termination in a regulatory filing, in which the lawyers for Twitter stated in part: "As was the case with both your July 8, 2022 and August 29, 2022 purported notices of termination, the purported termination set forth in your September 9, 2022 letter is invalid and wrongful under the Agreement, including under Section 8.1(d) thereof. Twitter has breached none of its representations or obligations under the Agreement, and following the receipt of the approval of Twitter's stockholders at its September 13, 2022 special meeting, all of the conditions precedent to the closing of the Merger will be satisfied (other than those conditions that by their nature are to be satisfied at Closing). Twitter intends to enforce the Agreement and close the transaction on the price and terms agreed upon with the Musk Parties... The Agreement is not terminated, the Bank Debt Commitment Letter and the Equity Commitment Letter remain in effect, and Twitter again demands that Mr. Musk and the other Musk Parties comply with their obligations under the Agreement, including their obligations to use their respective reasonable best efforts to consummate and make effective the transactions contemplated by the Agreement, the Bank Debt Commitment Letter, and the Equity Commitment Letter. Twitter will continue to pursue its right to specifically enforce all of the Musk Parties' obligations under the Agreement. Twitter reserves all contractual, legal, and other rights."

06:36 EDT Essential Properties Realty Trust announces partnership with Budderfly - Essential Properties Realty Trust announced, as part of its Essential Sustainability strategy, a partnership with Budderfly, the fastest growing Energy-Efficiency-as-a-Service provider in the United States. The company's first sustainability partnership aims to deliver operating savings to its tenants by deploying sustainability upgrades that are estimated to reduce the carbon footprint of the upgraded properties by up to 30%. Under the program, EPRT plans to invest capital in more efficient technologies and equipment upgrades that Budderfly will install and manage. The sustainability upgrades will include, but are not limited to: the installation of LED lighting and lighting controls, higher efficiency HVAC units along with HVAC controls and monitoring, refrigeration controls and monitoring, solar solutions, and net metering and controls. Budderfly's established methodologies as a leading EEaaS provider include identifying the optimum sustainability upgrades to deploy, completing the installation, maintaining the upgrades, and monitoring utilization. Tenants will receive an immediate reduction in their monthly utility costs and will have access to valuable data about their energy consumption, monthly savings, and carbon footprint reduction- all with Budderfly's Facility Smart Grid.

06:33 EDT Entera Bio reports results from Phase 2 study of EB613 - Entera Bio announced the details of "A Six-month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass - Dose Proportional Absorption and Effect on Lumbar Spine BMD (SUN-591)" poster presentation at the American Society for Bone and Mineral Research Annual Meeting 2022, being held from September 9-12th in Austin, Texas. The correlation results were derived from Entera's six-month phase 2 Study of lead clinical candidate, EB613, the first daily oral hPTH (1-34) teriparatide formulation in 161 post-menopausal women with low bone mass. The primary endpoint of change in P1NP at 3 months and secondary endpoints of change in lumbar spine, total hip and femoral neck Bone Mineral Density were met, as previously reported. The current abstract and poster presentation reveals excellent correlations between the dose of the oral formulation of EB613 and teriparatide hPTH plasma concentrations at the 15 min time point and a linear dose response for the change in lumbar spine BMD after 6 months of treatment. "These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken. This finding is consistent with excellent correlation between change in lumbar spine BMD and dose of EB613 after 6 months of treatment," Said Dr. Arthur Santora, Chief Medical Officer at Entera. "We are encouraged by this important correlation analysis from our positive phase 2 study of EB613. Recent debates at the ASBMR annual conference highlight the importance of potentially earlier intervention with osteoanabolic agents capable of repairing bone structure and increasing mass; versus initial treatment with anti-resorptive drugs that mostly stop bone loss. EB613 has unique potential in the osteoporosis treatment paradigm as the first convenient, daily tablets form of osteoanabolic treatment," said Miranda Toledano, CEO of Entera.

06:12 EDT AstraZeneca's Phase III trial of Imfinzi shows meaningful benefit in BTC - The company states: "Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca's Imfinzi, in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced biliary tract cancer, or BTC. These results from TOPAZ-1, the first Phase III trial to show improved OS with an immunotherapy combination in this setting, will be presented today at the European Society for Medical Oncology Congress 2022 in Paris. The updated results for Imfinzi plus chemotherapy showed enhanced clinical efficacy after an additional 6.5 months of follow-up, demonstrating a 24% reduction in the risk of death versus chemotherapy alone (based on a hazard ratio of 0.76; 95% confidence interval. Updated median OS was 12.9 months versus 11.3 with chemotherapy. More than two times as many patients were estimated to be alive at two years versus chemotherapy alone - 23.6% versus 11.5%. Results were seen across all prespecified subgroups, regardless of disease status, tumour location or PD-L1 expression. In addition, OS benefit was observed in patients whose tumours stayed the same size as well as in patients whose tumours got smaller or disappeared." Reference Link

06:06 EDT Vertex provides update on Alabama Refinery renewable diesel conversion project - Vertex Energy provided an update on the company's Mobile, Alabama Refinery renewable diesel conversion project, including a strategic extension of the planned construction timeline. As previously disclosed, Vertex is currently working on completing a $90M-$100M capital project designed to modify the Mobile Refinery's existing hydrocracking unit to produce renewable diesel fuel on a standalone basis. Upon completion of the conversion project, the refinery is expected to commence production of approximately 8,000-10,000 barrels per day of renewable diesel, with production volumes anticipated to subsequently ramp up to approximately 14,000 bpd. This project seeks to capitalize on the rapidly growing demand for advanced sustainable fuels, while further expanding upon Vertex's commitment to supply lower carbon fuels solutions. After a thorough review of project execution risk by the company, mechanical completion of the Mobile Refinery's renewable diesel conversion project has been proactively extended from its initial target of year-end 2022, to the first quarter of 2023. These risk considerations are the result of recent COVID-19 induced product delays and global supply chain shortages in several previously unimpacted markets, including common pipes, valves and fittings, and certain base bulk materials. Limited visibility into a solution for these challenges, combined with the notable financial benefits associated with reduced downtime and extending current operations, have allowed the Company to respond by extending the project timeline to ensure all necessary parts and materials are ready and on-site prior to shutting the hydrocracker unit down. Management now expects mechanical completion to occur in the first quarter of 2023, with production anticipated to begin in the second quarter of 2023, an extension of the previously communicated timeline of approximately one quarter. Management estimates that its decision to extend the project timeline will result in a positive impact to fourth quarter 2022 gross margin of approximately $15M to $17M, by maintaining current operations through year end 2022, assuming current refining spreads at the time of this announcement.

06:03 EDT China Yuchai announces dissolution of Vietnam subsidiary - China Yuchai announced that its subsidiary, Guangxi Yuchai Machinery Monopoly Development has deregistered and ceased operations of the Vietnam Yuchai Machinery Services Co due to the restructuring of the company's overseas business through resource optimization. Sales into the Vietnamese market are being conducted through the GYMCL headquarters.

06:02 EDT SQZ Biotechnologies presents preclinical SQZ TIL data at ESMO - SQZ Biotechnologies presented preclinical data supporting that tumor infiltrating lymphocytes engineered with membrane-bound cytokines IL-2 and IL-12 may eliminate the need for the high-dose, systemic IL-2 and lymphodepleting preconditioning used with current TIL therapies. SQZ TILs showed the ability to induce desirable cytokine signaling for more than 48 hours, which is comparable to the duration of exogenous IL-2 support in current TIL therapies. SQZ TILs also demonstrated improved killing of donor-matched tumor cells, upregulated markers associated with central memory T cells, and persistence in vivo. The data was presented today at the European Society for Medical Oncology Congress 2022.

05:54 EDT Ra Medical Systems enters merger agreement with Catheter Precision - Ra Medical Systems announced it has entered into an agreement and plan of merger with privately held Catheter Precision, a medical device and technology company focused in the field of cardiac electrophysiology. Under the terms of the agreement, Catheter Precision will become a wholly owned subsidiary of Ra Medical in a stock for stock reverse merger transaction. If completed, the merger will result in a combined publicly traded company that will focus on the cardiac electrophysiology market, one of the most robust and growing areas of medical devices. Medtech veteran David Jenkins, who has extensive experience growing medical device start-ups, will act as CEO of the combined company. Before taking the role as CEO of Catheter Precision, Jenkins was in several medical device start-ups, including Transneuronix. The merger is structured as a stock for stock reverse merger whereby all of Catheter Precision's outstanding convertible promissory notes and equity interests are to be exchanged for shares of Ra Medical common stock and Catheter Precision options assumed by the company. Catheter Precision stakeholders are expected to own approximately 80% of the combined company, and pre-merger Ra Medical equity holders are expected to own approximately 20% of the combined company, on a fully diluted basis calculated using the treasury stock method, subject to certain adjustments provided for in the Merger Agreement and further described in our Form 8-K filed today, including adjustment based on the amount of Ra Medical's net cash at closing. The boards of directors of both companies have approved the definitive merger agreement. The merger is expected to close before the end of 2022, subject to satisfying certain closing conditions, including the receipt of shareholder approval by both companies. The definitive merger agreement follows the signing by Ra Medical and Catheter Precision of a non-binding summary of proposed terms on June 18, which was publicly disclosed on July 22. Investors in Ra Medical are encouraged to review the definitive merger agreement, which contains the definitive terms of the merger. The descriptions of the merger, the Ra Medical special meeting of stockholders, Catheter Precision, and the other transactions and matters contemplated thereby or referenced herein do not purport to be complete and are qualified in their entirety by reference to the company's Current Report on Form 8-K filed on the date hereof, the company's Quarterly Report on Form 10-Q for the period ended June 30, and any prior or subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the Securities and Exchange Commission from time to time and available on the SEC website. The company also intends to file a proxy statement with the SEC. Ladenburg Thalmann & Co. Inc. is acting as the exclusive financial advisor to Ra Medical in connection with the proposed merger with Catheter Precision. Immediately following the closing of the merger, the combined company's board of directors will consist of five directors, with David Jenkins joining the board of directors as the executive chair and a to-be-determined current director of Ra Medical resigning at the closing of the merger.

05:27 EDT JPMorgan to acquire Renovite Technologies, terms undisclosed - J.P. Morgan announced that it has signed an agreement to acquire Renovite Technologies, a cloud-native payments technology company. Upon closing of the transaction, Renovite will become part of J.P. Morgan Payments, which combines corporate treasury services, trade finance, card and merchant services capabilities at the firm, delivering an integrated payments experience to clients across the economy. This acquisition complements the firm's proposed strategic investment in Viva Wallet and the strategic partnership with Volkswagen Financial Services. Final transaction execution is subject to customary closing conditions.

05:21 EDT Elbit Systems awarded $10M contract by Sossec - Elbit Systems announced that its U.S. subsidiary, Elbit Systems of America, was awarded a $10M contract by Sossec, Inc. to begin phase II of the development of an Advanced Low Light Level Sensor, or ALLLS, that is intended to be used to support the U.S. Army's Integrated Visual Augmentation System, or IVAS, 2.0 for soldiers. The contract will be executed through 2025 and the work will be conducted in Roanoke, Virginia.

05:16 EDT Amgen announces 30% ORR in CodeBreaK 101 study at ESMO - Amgen announced updated data from its Phase 1b CodeBreaK 101 study, one of the most comprehensive global clinical development programs in patients with KRAS G12C-mutated colorectal cancer, or CRC. These data show that combining Lumakras/Lumykras with Vectibix, Amgen's monoclonal anti-epidermal growth factor receptor antibody, demonstrated efficacy and safety. Overall, the confirmed objective response rate, or ORR, was 30% in patients with chemo-refractory metastatic colorectal cancer, or mCRC. These data were presented during an oral session at the European Society for Medical Oncology, or ESMO, annual meeting in Paris, France. In total, 40 patients with heavily pre-treated KRAS G12C-mutated chemo-refractory mCRC were enrolled in the dose expansion cohort for the combination of Lumakras and Vectibix. Disease control was seen in 37 patients for a total of 92.5% with a median progression free survival, or PFS, of 5.7 months. There were no apparent differences found in the efficacy between left-sided and right-sided tumors. Tumor shrinkage of any magnitude was observed in 88% of patients, based on Response Evaluation Criteria in Solid Tumors, or RECIST, version 1.1, and the median Duration of Treatment, or DoT, was 5.9 months with 25% of patients remaining on treatment at the time of data cutoff. With a median follow up of 8.8 months, median overall survival, or OS, was not yet reached. Treatment-related adverse events, or TRAEs, reported with the combination were consistent with known safety profiles of the individual medicines, and no TRAEs resulted in discontinuation of either drug.

05:06 EDT Ideanomics subsidiary expands partnership with GEP - Ideanomics announced that its subsidiary U.S. Hybrid is supplying Global Environmental Products, or GEP, with its proprietary electric and hybrid electric propulsion kits for use in the construction of 62 zero emission street sweepers. Once complete, GEP will provide the sweepers to New York City, California, the City of Helena, Montana, and Washington D.C.