Stockwinners Market Radar for September 27, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:37 EDT Eisai jumps 17% in early Tokyo trading after lecanemab data

19:35 EDT Biogen/Eisai's phase 3 trial of lecanemab in MCI meet primary endpoint - Eisai (ESALY) and Biogen (BIIB) "announced positive topline results from Eisai's large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer's disease, AD, and mild AD with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai's FY2022, which ends March 31, 2023. Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer's Congress, and publish the findings in a peer-reviewed medical journal. Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 in the analysis of Intent-to-treat population. Starting as early as six months, across all time points, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo. All key secondary endpoints were also met with highly statistically significant results compared with placebo. Key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography, the AD Assessment Scale-cognitive subscale14, AD Composite Score and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment."

19:25 EDT Biogen trading halted, news pending

18:24 EDT SpartanNash CEO: We're concerned about spiraling inflation - In an interview on CNBC's Mad Money, Tony Sarsam said the cause and effect of recent inflation is different from what the company has previously experienced. He attributed it to supply chain disruptions and upward pressure on labor costs. "We need to find the right pricing and balance of promotions," he noted.

17:25 EDT Sandstorm Gold falls 9% afterhours to $5.08 after announcing $60M financing

17:23 EDT Hain Celestial to replace Hanger in S&P 600 at open on 10/3 - Patient Square Capital, LP. is acquiring Hanger in a deal expected to be completed soon pending final closing conditions.

17:22 EDT Frontier Communications to replace Hain Celestial in S&P 400 at open on 10/3

16:46 EDT Canopy Growth to divest Canadian Retail Operations - Canopy Growth "announced that the Company has entered into agreements to divest its retail business across Canada which includes the stores operating under the Tweed and Tokyo Smoke retail banners. The announcement reinforces the Company's focus on advancing its path to profitability as a premium brand-focused cannabis and consumer packaged goods company. The Company has reached an agreement with OEG Retail Cannabis, an existing Canopy Growth licensee partner that currently owns and operates the Company's franchised Tokyo Smoke stores in Ontario. As part of this agreement, OEGRC has agreed to acquire all of Canopy Growth's corporate stores outside of Alberta as well as all Tokyo Smoke-related intellectual property. The Company has also reached an agreement with 420 Investments Ltd. pursuant to which FOUR20 has agreed to acquire the ownership of five retail locations in Alberta. Closing of the OEGRC Transaction and the FOUR20 Transaction is subject to regulatory approvals and other customary closing conditions."

16:35 EDT Thermo Fisher announces FDA approval of Oncomine CDx target test - The U.S. Food and Drug Administration has granted approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer, RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly's Retevmo. This marks the Oncomine Dx Target Test's first approval as a CDx for a therapy targeting RET-positive thyroid cancer and second approval associated with RET-positive NSCLC. Initially approved in 2020, Retevmo is a selective RET kinase inhibitor and was the first therapy approved for patients with advanced RET-driven lung and thyroid cancers. RET alterations are found in approximately 2% of patients with NSCLC, which is the leading cause of adult cancer death in the United States, 60% of patients with MTC and 20% in other thyroid cancers. The Oncomine Dx Target test is a next-generation sequencing (NGS)-based test that can detect multiple alterations at once from a small sample size, helping to quickly match patients with the appropriate targeted therapy. It is also approved in Japan as a companion diagnostic for Retevmo in the same indications. The test is the only globally distributable NGS CDx solution that has received regulatory approval in 17 countries for 15 targeted therapies, covering more than 550 million lives globally.

16:09 EDT Cal-Maine Foods says increase in pricing, favorable volume drove profitability - CFO Max Bowman says: "The significant increase in pricing and favorable volume trends in specialty egg sales, along with efficient expense management, led to improved profitability with a gross profit margin of 33.0% for the first quarter of fiscal 2023. Egg prices continued to move higher during the quarter as supply tightened due to the impact of the highly pathogenic avian influenza outbreak and good customer demand for conventional eggs. Conventional egg net average selling price per dozen increased to $2.368 compared with $0.990 a year ago, and both conventional and specialty egg revenue reached record levels for the first quarter of fiscal 2023. Net average selling price for specialty eggs rose 12.2% to $2.101 per dozen, compared with $1.872 per dozen for the first quarter of 2022. We saw our highest ever quarterly sales of specialty eggs of $200.8 million, or 31.8 % of total shell egg revenue. Specialty dozens sold were 34.7% of total dozens sold compared with 27.8% in the prior-year period."

16:08 EDT Tyson Foods names John Tyson CFO - Tyson Foods announced three changes to the company's enterprise leadership team as "part of its continuing effort to focus on the future while delivering operational excellence for its customers and consumers across the world." Stewart Glendinning will transition from his current role as Executive Vice President & Chief Financial Officer at Tyson to take on the position of Group President, Prepared Foods. John Tyson has been named Chief Financial Officer for Tyson Foods. John Tyson will continue to lead enterprise strategy and sustainability activities as part of the company's commitment to developing a more sustainable protein system. Prior to joining the company in 2019, he held various roles in investment banking, private equity, and venture capital, including at J.P. Morgan. Amy Tu has been named President, International & Chief Administrative Officer, expanding her current enterprise leadership role as Executive Vice President, Chief Legal Officer & Secretary, Global Governance & Corporate Affairs. "These shifts draw on the individual strengths of these leaders and the broad expertise that exists within the company's management team," said Donnie King, Tyson Foods President and CEO. "Stewart has the financial and operational background, as well as the proven organizational management skills, needed to help unlock the full potential of our iconic consumer brands within Tyson's Prepared Foods business. John R. Tyson is a dynamic next-generation company leader, and this combined role will enable him to further develop and drive the company's future strategy. Amy has extensive international experience and is a proven enterprise leader who builds high performing teams. Her global mindset will help us continue to grow our international business." These changes are effective October 2. Noelle O'Mara, formerly Group President, Prepared Foods, has decided to pursue other opportunities and is no longer with the company. We appreciate her contributions to the organization over the last six years."

16:06 EDT Consolidated Water says no damage to property, equipment following Hurricane Ian - Consolidated Water reported that its property and equipment sustained no damage after Hurricane Ian passed within 95 miles of Grand Cayman yesterday morning. Grand Cayman experienced some minor coastal flooding and wave damage. However, the National Emergency Operations Centre issued an "all clear" for the Cayman Islands yesterday afternoon and the hurricane has since moved out of the area.

16:05 EDT Ascent Solar announces Jeffrey Max to succeed Victor Lee as CEO - Ascent Solar announced that the company has named Jeffrey Max as Ascent Solar's new CEO. As part of Ascent's ongoing leadership transition, Jeffrey Max, a technology CEO with more than three decades of experience in scaling technology organizations, has succeeded Victor Lee as the company's CEO, effective immediately. From 2019 to 2022, Max was chairman and CEO of Agile Space Industries. Additionally, David Peterson is the newly appointed board chair of the company.

14:59 EDT Ryder up 13% after report of Apollo acquisition interest - Ryder (R) shares are up $8.70, or 13%, to $75.21 after Bloomberg's Gillian Tan and Kiel Porter reported that Apollo Global (APO) is weighing a takeover of the equipment rental, logistics and transportation company.

14:55 EDT Equinor, Tallgrass enter MOU to pursue low-carbon hydrogen and ammonia projects - Tallgrass and Equinor have announced a collaborative effort to pursue opportunities for development of large-scale, low-carbon hydrogen and ammonia projects in North America. The partners will assess the production and market potential for hydrogen and ammonia, and associated distribution infrastructure to help facilitate broad decarbonization. Under the memorandum of understanding, Tallgrass and Equinor have agreed to initial co-development activities, including the joint funding of a front-end engineering and design, or FEED, study. The study will be focused on large-scale hydrogen production, incorporating the capture of a minimum of 95% of the CO2 for permanent sequestration, coupled with ammonia for efficient transportation and storage. As part of the study, Tallgrass and Equinor are evaluating multiple regional energy centers across the U.S.

14:51 EDT Sterling Bancorp enters consent order with OCC - Sterling Bancorp, the thrift holding company for Sterling Bank and Trust, F.S.B., Southfield, Michigan, announced that the bank has entered into a consent order with the Office of the Comptroller of the Currency, or OCC, dated September 27, resolving the OCC's formal investigation relating to the bank's former residential loan product, marketed as the Advantage Loan Program, and related matters. Under the consent order, the bank has agreed to pay a civil money penalty of $6M. The civil money penalty will be applied against the previously accrued liability for contingent losses reflected on the company's consolidated balance sheet, which amounted to $15M as of June 30. The consent order represents a full and final settlement of the OCC's investigation with respect to the bank. Concurrent with the consent order, the OCC notified the bank that the formal agreement between the bank and the OCC entered on June 18, 2019, has been terminated. The OCC agreement primarily related to certain aspects of the bank's Bank Secrecy Act/Anti-Money Laundering compliance program and the bank's credit administration. "Today's announcement from the OCC represents a painful resolution of the long running regulatory fallout from the ill-fated Advantage Loan Program. The level of cooperation that we have provided and the comprehensive internal investigation have been critical to our building a reputation with our regulators that had been absent previously. In my tenure as CEO, the board of directors, management and staff have placed this extensive cooperation along with the remediation of all of the critical findings in the OCC Agreement and elsewhere as our primary focus. Our commitment and the ultimate success are evidenced by the termination of the OCC Agreement. As regulatory enforcement orders go, our remediation was all accomplished in very quick order especially given the severity of the findings and rebuilding required. I feel it is recognition of the extraordinary efforts by the entire Sterling team. The $6 million civil money penalty, while significant, is a clear reflection of our extraordinary cooperation and remediation efforts and represents another significant milestone in putting these legacy issues behind us. Notwithstanding these achievements and as noted above, we remain engaged with the DOJ on the criminal aspects arising from the Advantage Loan Program. At this point in time, we have no visibility into the potential terms or timing of any settlement with the DOJ. We will continue to provide full cooperation and hope resolution with Sterling will be forthcoming. Both the Bank and the Company remain eager to put this entire episode behind them as expeditiously as possible. It is, however, possible that the issues surrounding multiple individuals regarding their involvement with the fraud will continue well into the future," said Thomas O'Brien, Chairman, President and CEO.

14:34 EDT Netflix rolls out ability to create game handles - Netflix said that it is rolling out the ability to create game handles for a more personalized gameplay experience. "With game handles, members will be able to create a unique public username that can be used across all Netflix games," the company said. "In multiplayer games like Rival Pirates, an adventure game where you set sail, fire cannonballs and strive to be the last boat afloat or within leaderboards in games like Dominoes Cafe and Lucky Luna, game handles help players discover, make friends and play with each other." Reference Link

14:20 EDT Harrow Health trading resumes

13:51 EDT Harrow, Sintetica announce FDA approval of IHEEZO - Harrow and Sintetica jointly announced the U.S. Food and Drug Administration approval of IHEEZO 3% for ocular surface anesthesia. IHEEZO is a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038. "On behalf of all our ophthalmic physician partners and the patients they serve, we and our partners at Sintetica are grateful to the FDA for a New Drug Application review process that resulted in the approval of IHEEZO in advance of our PDUFA target action date," said Mark L. Baum, Harrow Chairman and Chief Executive Officer. "We have always believed in the unique clinical value of IHEEZO, and now that IHEEZO is approved for use in the U.S. market, it has the potential to become an indispensable premium tool for eyecare professionals and their patients requiring ocular surface anesthesia."

13:07 EDT Larkspur Health Acquisition, ZyVersa announce business combination update - ZyVersa Therapeutics and Larkspur Health Acquisition Corp., a blank-check special purpose acquisition company, annonced that Larkspur has refiled with the U.S. SEC their proxy/registration statement on Form S-4 in connection with the business combination agreement between Larkspur and ZyVersa previously announced on July 20, 2022. Larkspur and ZyVersa also announced commitments of approximately $8.5M, exceeding the previously announced $7M, contingent financing that provides for the purchase of Convertible Preferred Stock of Larkspur. ZyVersa has also announced an additional closing of an interim finance round of approximately $1.5M from an offering of Series A Convertible Preferred Stock of ZyVersa that will convert into ZyVersa common stock in connection with the Transaction. The aggregate committed capital between the PIPE Investment and the Bridge is now $10M. Capital raised in the Bridge will support the advancement of research and development programs and ongoing ZyVersa operations and, along with funds from the PIPE Investment, will be used by the combined company following the Transaction for similar business purposes. The PIPE Investment is anticipated to close simultaneously with the closing of the Transaction, which is expected to take place in the fourth quarter of 2022. Upon closing of the Transaction, Larkspur is expected to be renamed ZyVersa Therapeutics, Inc. and will continue to operate under the ZyVersa management team, led by Stephen C. Glover, Co-Founder, Chief Executive Officer, and Chairman of ZyVersa. The combined company's common stock is anticipated to be listed on NASDAQ under ticker symbol "ZVSA."

12:26 EDT RegeneRx partner submits Phase 3 protocol for neurotrophic keratopathy - RegeneRx Biopharmaceuticals announced that its U.S. joint venture partner and licensee, HLB Therapeutics, has announced that it submitted a protocol for its second phase 3 clinical trial to the U.S. FDA on September 26th, evaluating RGN-259 as a treatment for neurotrophic keratopathy. NK is being developed by ReGenTree, a U.S. joint venture company between RegeneRx Biopharmaceuticals, Inc. and HLB Therapeutics. The clinical study design of SEER-2 and SEER-3 is based on the results of the first phase 3 clinical trial, where the number of subjects was relatively small, but good results were obtained. In the SEER-2 and SEER-3 studies, approximately 70 patients will be recruited in each study to evaluate efficacy, in particular complete healing after 4 weeks treatment. For the SEER-3 clinical trial, which will be conducted simultaneously in the U.S. and Europe, the study site selection process is ongoing by ReGenTree among 80 candidate sites in six European countries, and preparation of applications to be filed through CTIS is also underway. The company plans to drastically shorten the development period of RGN-259 by conducting the two phase 3 clinical trials in the U.S. and Europe simultaneously. Therefore, HLB Therapeutics is focusing all of its capabilities to achieve the possibility of applying for FDA BLA application in 2025 as an ultimate goal in its NK project.

12:21 EDT Intel unveils 13th Gen Intel Core Processor family - Intel revealed the 13th Gen Intel Core processor family, led by the 13th Gen Intel Core i9-13900K - the world's fastest desktop processor. The new 13th Gen Intel Core family includes six new unlocked desktop processors with up to 24 cores and 32 threads and blazing clock speeds up to 5.8 GHz for the best gaming, streaming and recording experience. Led by the launch of the Intel Core "K" processors, the 13th Gen Intel Core desktop family will consist of 22 processors and more than 125 partner system designs - providing an uncompromising experience in both application performance and platform compatibility. "Enthusiasts can take advantage of 13th Gen Intel Core processors' performance improvements with existing Intel(R) 600 or new Intel 700 series chipset motherboards," the company said. "Combined with both the latest DDR5 memory support and continued DDR4 memory support, users can enjoy the benefits of 13th Gen Intel Core while customizing their setup based on their own feature and budget preferences." 13th Gen Intel Core desktop "K" processors and the Intel Z790 chipset will be available starting Oct. 20, 2022, including boxed processors, motherboards and desktop system sales.

12:00 EDT Daily S&P Biotech Bear 3x Shares falls -9.8% - Daily S&P Biotech Bear 3x Shares is down -9.8%, or -$2.85 to $26.26.

12:00 EDT Provident Financial falls -11.4% - Provident Financial is down -11.4%, or -$2.63 to $20.52.

12:00 EDT CVR Energy rises 9.0% - CVR Energy is up 9.0%, or $2.31 to $27.87.

12:00 EDT Grove Collaborative rises 25.7% - Grove Collaborative is up 25.7%, or 76c to $3.72.

11:51 EDT Statera BioPharma to have hearing on Nasdaq listing non-compliance on Oct. 6 - In a regulatory filing, Statera Biopharma announced that it received notice from the Listing Qualifications Staff of The Nasdaq Stock Market indicating that the company's continued non-compliance with the minimum bid price requirement, as set forth in Nasdaq Listing Rule 5550(a)(1), could serve as an additional basis for the delisting of the company's securities from Nasdaq. The company requested and was granted a hearing before the Nasdaq Hearings Panel, which hearing will be held on October 6, with the Panel subsequently granting a further stay of any suspension or delisting action by the Staff at least pending completion of the hearing and the expiration of any extension that may be granted to the company by the Panel following the hearing. "At the hearing, the company will present its plan to regain compliance with the minimum bid price requirement and all other applicable requirements for continued listing on Nasdaq along with its request for a specific period of time to do so. There can be no assurance, however, that the Panel will determine to continue the company's listing or that the company will be able to evidence compliance with the applicable listing criteria within any extension period that may be granted by the Panel," the filing stated.

11:24 EDT Neogen CFO Steve Quinlan to retire, David Naemura to succeed - Neogen Corporation (NEOG) announced that Steve Quinlan, the company's CFO, has announced his intent to retire effective May 31, 2023, at the conclusion of the company's fiscal year. Neogen also announced the naming of David Naemura as CFO, effective January 2, 2023. During the five-month overlapping period, he and Quinlan will work together to ensure a smooth transition of responsibilities. Naemura was previously the CFO of Vontier Corporation (VNT).

11:00 EDT Bulbs.com enters distribution agreement with SemaConnect - Bulbs.com announces a distribution agreement with SemaConnect. The company said, "Bulbs.com sought a partner that could afford them an opportunity to better service their customers and connect them with the right EV products. SemaConnect is that complete EV solutions partner that provides innovative, elegantly designed charging stations, a robust and open network platform, and an unparalleled charging experience for both drivers and station owners."

10:03 EDT NTT Data to acquire Umvel, terms not disclosed - NTT DATA announced it has signed a definitive agreement to acquire Umvel, a digital design and engineering firm. Headquartered in Mexico City, Umvel provides high-end design and digital product development services and brings a strong culture of talented and in-demand designers and engineers. Once the transaction is closed, Umvel will build on NTT DATA's successful acquisitions in the digital design and engineering space including Nexient, Vectorform and Postlight. More than 140 team members will join NTT DATA. The transaction is subject to customary closing conditions and is expected to close in the following weeks.

10:01 EDT Lincoln Financial Distributors, Modern Life enter partnership - Lincoln Financial Group announced a new partnership between Lincoln Financial Distributors and Modern Life, a tech-enabled life insurance brokerage. The partnership will enable Lincoln's life insurance product portfolio to be delivered on Modern Life's digital platform, providing an improved digital end-to-end experience - an important pillar of both companies' shared commitment to innovation and support for financial professionals and their clients.

10:00 EDT Provident Financial falls -7.9% - Provident Financial is down -7.9%, or -$1.82 to $21.34.

10:00 EDT Energy Vault rises 8.6% - Energy Vault is up 8.6%, or 42c to $5.33.

10:00 EDT Grove Collaborative rises 16.6% - Grove Collaborative is up 16.6%, or 49c to $3.45.

09:51 EDT Tecogen receives 250 kW microgrid system order - Tecogen announced an order for two 125 kilowatt InVerde microgrid enabled cogeneration systems to a high school in Connecticut. The units will provide a significant reduction in the electricity costs for the school, with the free waste heat used to reduce the operational cost of the school's existing heating system. The systems are anticipated to be serviced from Tecogen's Connecticut service center in East Hartford, Connecticut.

09:47 EDT Direxion Daily Semiconductor Bear 3X Shares falls -6.3% - Direxion Daily Semiconductor Bear 3X Shares is down -6.3%, or -$4.17 to $61.60.

09:47 EDT Blue Apron rises 6.6% - Blue Apron is up 6.6%, or 29c to $4.76.

09:47 EDT Grove Collaborative rises 10.1% - Grove Collaborative is up 10.1%, or 30c to $3.26.

09:35 EDT Hertz, BP sign memorandum of understanding for EV charger network - Hertz (HTZ) and bp (BP) announced the signing of a memorandum of understanding, or MOU, for the development of a national network of EV charging stations powered by bp pulse, bp's global electrification and charging solution brand. "The MOU sets the foundation for Hertz and bp to drive the future of mobility and accelerate EV consumer adoption. The agreement also involves the management of Hertz's charging infrastructure by bp pulse and the customization of its Omega software to ensure Hertz's growing fleet of electric rental cars are recharged quickly and efficiently between rentals. Omega supports fleet operations by automating charging when the power price is low, while providing real-time visibility to EVs, chargers, power usage, and more," the companies stated. Stephen Scherr, Hertz CEO, said: "Hertz is accelerating the adoption of electrification by investing in the largest rental fleet of electric vehicles in North America and expanding the availability of charging stations. We are excited to partner with bp pulse to create a national charging infrastructure for the Hertz EV fleet, thereby growing the number of charging options available to our customers and providing them with a premium electric experience and lower emission travel options."

09:30 EDT Wildpack Beverage reports August throughput of 18.9M cans - Wildpack Beverage entered into a senior secured revolving credit facility with Transportation Alliance Bank, for up to $5,000,000 in asset backed financing. The Facility provides for a senior secured revolving credit facility, with a 2-year term, and interest only payments at the variable 30-day Secured Overnight Financing Rate plus 4.85%. TAB Bank holds a first position security interest in the Company's assets, as well as a guarantee from the Company. The Company has completed an initial draw of $1,545,000 to repay, in full, existing credit obligations with Fulton Bank. The Company intends to use available proceeds for general working capital purposes. In August 2022, Wildpack achieved 18.9 million can throughput. Wildpack's throughput results, which include cans and can equivalents, were led by a 5% month-over-month increase in cans brokered and an 11% MoM increase in tertiary packaging sales. Can decorating achieved 3.4 million units, can filling achieved 789 thousand Units, and Printing operations achieved 2.3 million units produced. Wildpack's total sales orders for the month of August were 138, with 25 customers making their first purchase with Wildpack. Plant utilization was 20% for the month of August, with production yields for both can decorating and can filling above 90%.

09:27 EDT 3M establishes new 3M Verify platform to report potential counterfeit products - 3M has established the new 3M Verify platform to report potential counterfeit 3M products, building on the success of its anti-counterfeit efforts during the COVID-19 pandemic by expanding its counterfeit reporting process to include all products made by 3M. 3M.com/3MVerify provides resources and information to help customers, distributors, employees and the general public avoid purchasing counterfeit 3M products and allows customers to contact 3M to report potential counterfeit products.Reports of suspected counterfeit 3M products will be reviewed and investigated by anti-counterfeit response teams globally.

09:21 EDT Varonis announces new data discovery capabilities - Varonis Systems announced powerful new data discovery capabilities that uncover exposed secrets that unlock access to mission-critical resources. Exposed secrets are increasingly responsible for devastating data breaches. With soaring cloud adoption and rapid app development, secrets can end up almost anywhere, exposing intellectual property, source code, and critical infrastructure. Varonis can now accurately and automatically discover secrets where you least expect them, remediate exposure, and detect anomalous access behavior. It works by continually scanning source code files and other locations where an organization's secrets can spread - places like Windows, Microsoft 365, Box, AWS, Google Drive, Salesforce, and other leading apps and services.

09:18 EDT Boston Scientific, Truveta collaborate to advance post-procedure patient insight - Truveta announced a strategic collaborative agreement with Boston Scientific to improve long-term patient care and gain insights into healthcare disparities. Through this collaboration, Boston Scientific researchers will be able to access data from Truveta, which contains de-identified medical records from more than 65 million U.S. patients.

09:16 EDT SAITECH to receive UL listing certification for SAIHUB CAB 025M - SAI.TECH Global announced that it received the notice from UL that it has completed the investigation and confirmed compliance of SAI.TECH's core product SAIHUB CAB 025M with UL standards and to receive the certification after the first IPI.

09:14 EDT Statera BioPharma trading halted, news pending

09:13 EDT Jamf Holding kicks off Jamf Nation User Conference - Jamf will kick off its 13th annual Jamf Nation User Conference (JNUC) both virtually and in-person in San Diego, California.This year's keynote is centered around simplifying device management and security - while maintaining the intended end user experience Apple users expect. Dean Hager, Jamf CEO, will be joined by Jamf customers and partners, some of the biggest names in technology, to walk through how Jamf is innovating to help organizations succeed with Apple at work.

09:07 EDT Siemens obtains UL listing for 120-volt, single pole solid-state circuit breaker - Siemens is the first company to successfully receive UL listing for a 120-volt, single pole solid-state circuit breaker. The solid-state breaker concept replaces the traditional moving parts of an electromechanical circuit breaker with semiconductors and advanced software algorithms that control the power and can interrupt extreme currents faster than ever before.

09:07 EDT FIH Mobile, Azumo partner for LCD 2.0 displays - Azumo announced a partnership with FIH Mobile to design and manufacture the next generation of frontlit LCD 2.0 reflective displays.

09:05 EDT Oncternal initiates global registrational Phase 3 study of zilovertamab - Oncternal Therapeutics announced the initiation of its Phase 3 global registrational study of zilovertamab, ZILO-301, for the treatment of patients with relapsed/refractory mantle cell lymphoma, MCL. The Company obtained its first Institutional Review Board, IRB, approval for the study and expects to promptly begin patient screening and enrollment. "The initiation of the first Phase 3 study of zilovertamab, ZILO-301, represents a key milestone for Oncternal, our partners, investors and patients with R/R MCL," said James Breitmeyer, M.D., Ph.D., Oncternal's President and CEO. "We are looking forward to opening between 50-100 sites across the globe to support what we expect to be the first BLA approval of zilovertamab. ZILO-301 also represents the first registrational study for a therapeutic targeting the novel ROR1 pathway, which we believe can help address significant unmet needs in multiple hematological malignancies and other solid tumors."

09:04 EDT Creative Realities announces enhancements, global expansion of platformStellantis - Creative Realities (CREX) announced significant enhancements and updates to the automotive sales assistant product platform, as well as plans to further internationalize the product. Already being used in more than 2,600 Stellantis (STLA) dealerships in the US, the industry-leading platform -known internally as iShowroom -- is available in nine countries in the Middle East and will launch in 440 dealership locations in Canada in Q4 of this year. "Given our extensive, unparalleled work in the automotive industry, Creative Realities was uniquely positioned to meet a growing need to provide exceptional shopping experiences for dealerships' prospective buyers," said Rick Mills, CEO at Creative Realties. "The iShowroom platform has already been the industry standard for creating efficient, highly customized buying journeys for those in the market to purchase a vehicle. With these new enhancements and global expansion, we're now able to bring this next-generation platform to previously untapped markets and OEM dealerships around the world."

09:03 EDT SEC says Oracle to pay $23M to settle charges of violating FCPA - The Securities and Exchange Commission announced settled charges requiring Oracle Corporation to pay over $23M to resolve charges that it violated provisions of the Foreign Corrupt Practices Act, or FCPA, when subsidiaries in Turkey, the United Arab Emirates, and India created and used slush funds to bribe foreign officials in return for business between 2016 and 2019. The SEC previously sanctioned Oracle in connection with the creation of slush funds. In 2012, Oracle resolved charges relating to the creation of millions of dollars of side funds by Oracle India, which created the risk that those funds could be used for illicit purposes, the SEC stated. Reference Link

09:02 EDT Sintx Technologies announces receipt of Phase II award of $1.1M by U.S. DOE - SINTX Technologies announces the receipt of a Phase II award of $1.1M, issued by the U.S. Department of Energy, DOE, to develop, design and characterize 3D-printed alumina ceramic heat exchangers for heating, ventilation, and air conditioning systems, HVAC. The proposal was originally submitted by Technology Assessment and Transfer, TA&T, now a wholly owned subsidiary of SINTX. The Phase II award follows the successful completion of the Phase I effort by TA&T. The award aligns with the DOE's interest in supporting unique technologies for next-generation non-metallic heat exchanger systems to improve the energy efficiency of heat pumps and air conditioners over a broad range of operating conditions for building and industrial applications. "In order to meet the objectives of the original Phase I effort, SINTX - in collaboration with the University of Cincinnati and industrial partner Carrier - proposed the development, demonstration and potential commercialization of highly efficient, light weight, compact additive manufactured alumina ceramic heat exchangers for a broad spectrum of residential and industrial air to refrigerant HVAC applications.," said Dr. Larry Fehrenbacher, Vice President of Technology, SINTX Technologies. "We believe that this concept has strong merit, and this new Phase II award will allow SINTX to advance the technology towards scale-up and commercialization."

08:49 EDT Meta removes coordinated inauthentic behavior from China, Russia - Meta on Tuesday shared the company's findings into two covert influence operations - from China and Russia - "that we took down for violating our policy against Coordinated Inauthentic Behavior. We shared information with our peers at tech companies, security researchers, governments and law enforcement so they too can take appropriate action." Ben Nimmo, Global Threat Intelligence Lead and David Agranovich, Director, Threat Disruption, said the Chinese-origin influence operation ran across multiple social media platforms, and was the first one to target US domestic politics ahead of the 2022 midterms and Czechia's foreign policy toward China and Ukraine. Meanwhile, the Russian network targeted primarily Germany, France, Italy, Ukraine and the UK with narratives focused on the war and its impact through a sprawling network of over 60 websites impersonating legitimate news organizations. Reference Link

08:47 EDT BK Technologies receives $7.8M follow-on purchase order - BK Technologies announced that it has received a purchase order valued at $7.8M from the United States Department of Agriculture Forest Service for its BKR 5000 portable communications technology. The purchase order is part of the Company's 5-year Blanket Purchase Agreement with the U.S. Department of Agriculture, announced in May 2021, and is a follow-on to the recently announced USFS group of purchase orders totaling $8.9M.

08:46 EDT Sabre announces strategic agreement in East Africa with Sabron Tech - Sabre announced a new, long-term strategic agreement with Nairobi-based travel technology distribution company SABRON Tech to boost its presence across key markets in East Africa. The relationship combines SABRON's strong market knowledge with Sabre's innovative technology. It will enable Sabre to strengthen its geographic reach and bring world-class solutions and services to new markets through SABRON. Under the agreement, SABRON is now licensed to represent and distribute the Sabre brand to travel agencies in Kenya, Tanzania and Uganda. The alliance will promote access to important Sabre solutions and services to travel agencies in East Africa. The Sabre solutions and services cut across retailing, fulfillment and distribution, and include the intuitive Sabre Red 360 interface which enables travel agents to deliver highly personalized offers to travelers.

08:44 EDT BK Technologies receives $78M follow-on purchase order - BK Technologies announced that it has received a purchase order valued at $7.8M from the United States Department of Agriculture Forest Service for its BKR 5000 portable communications technology. The purchase order is part of the Company's 5-year Blanket Purchase Agreement with the U.S. Department of Agriculture, announced in May 2021, and is a follow-on to the recently announced USFS group of purchase orders totaling $8.9M.

08:42 EDT Gaucho Group receives notice of allowance on trademark application - Gaucho Group Holdings announced its trademark application for MAISON GAUCHO has received its Notice of Allowance for the categories of Class 41 - Casinos; Night club services; Dance club services, and Class 43 - Hotel accommodation services; Restaurant services; Bar services; Bar and cocktail lounge services. In addition, Gaucho Holdings announced last year its commitment of $35 million to LVH Holdings LLC for a 40% ownership in a project located in Las Vegas, Nevada, that would include opportunities in lodging, hospitality, retail and gaming. Gaucho Holdings' brands are intended to be featured prominently in the project, including the development of a Gaucho-branded boutique hotel, hospitality lodging with residential leasing, a well-appointed Gaucho retail store featuring Gaucho's fine leather goods & accessories, as well as an Argentinian steakhouse with the potential curation of a tango show. Additionally intended is a wine bodega featuring Gaucho Holdings' high end wine brand Algodon Fines Wines, which are produced at its 4,138 acres winery in San Rafael, Mendoza, Argentina.

08:40 EDT Yoshiharu unveils new menu items for all locations - Yoshiharu Global announced the launch of brand new menu items for all restaurant locations starting October 1, 2022. To complement the ongoing success of core items such as the Tonkotsu Black and Tonkotsu Shoyu Ramens, the latest offerings feature new appetizers, sushi rolls, plates, and a ramen bowl that will further provide customers with an authentic Japanese dining experience. Debuting the refreshed menu through a soft launch at two locations, Yoshiharu received positive customer feedback and, on average, generated a 10% increase in overall sales at these locations. In particular, the featured St. Louis Pork Rib Spicy Miso Ramen using Yoshiharu's popular pork bone broth and the addition of several new sushi rolls have been deemed as customer favorites.

08:39 EDT ArcelorMittal holds investor meeting in India - ArcelorMittal hosted an investor and analyst event at AM/NS India's flagship plant at Hazira, Gujarat, the first such meeting since ArcelorMittal and Nippon Steel jointly acquired the Indian asset in December 2019. The event focused on the progress AM/NS India has achieved since the acquisition completed and the strategic initiatives being undertaken to transform AM/NS India into a best-in-class, integrated steel producer capable of producing high-added value products, grow its domestic market share and play a leading role in the growth of the Indian steel industry. Presentations given by Aditya Mittal, ArcelorMittal CEO and Chairman of AM/NS India and members of the AM/NS India management committee, focussed on: AM/NS India's commitment to reaching levels of industry excellence in all aspects of ESG performance, with a specific focus on health and safety, diversity and inclusion and decarbonisation. The scope and scale of AM/NS India's steelmaking business and its leading position in the Indian steel industry. The improvement achieved in AM/NS India's financial and operational performance since acquisition, with significant growth in its steel production and Ebitda generation, and strong progress in reducing net debt and strengthening its balance sheet. Efforts to secure the company's supply chain and enhance profitability through several strategic acquisitions of a range of assets including slurry pipelines, iron ore mines, ports, power plants and land. How AM/NS India intends to lead the decarbonisation of the Indian steel industry by integrating renewables into its energy supply chain and exploring the use of a range of decarbonisation technologies over the next decade. The significant market growth opportunity India presents and AM/NS India's strategy to play a leading role in the development of the Indian steel industry by expanding the capacity of its Hazira plant, initially to c. 15 million tonnes by early 2026 in the first phase of its expansion. The planned expansion of the Hazira facility comes almost three years since the asset was acquired and renamed AM/NS India. Since then, AM/NS India has made strong progress on performance and debottlenecking at Hazira by applying the global best practices of its parent companies and investing in technology and R&D. The company is now a self-sustaining, free cash-flow generating business, strongly positioned in a rising market to deliver long-term value to its employees, its communities, the Indian steel industry, and its shareholders. Hazira's planned expansion reflects ArcelorMittal and Nippon Steel's confidence in the long-term prospects for the Indian economy, which is forecast to grow strongly for the next two decades. Addressing the group of ArcelorMittal's investors and analysts, Aditya Mittal cited as strengths the scale, strategic location, and secure supply chain that make AM/NS India well-positioned to capture the growth opportunities presented by a domestic steel market which has the potential to grow to 300 million tonnes per annum by 2030. In addition to volume growth, AM/NS India is focussed on leading the decarbonisation of the Indian steel industry and will also increase its production of high grade, speciality steels in key growth sectors such as automotive and infrastructure, aligned with India's national steel policy and key policy initiatives such as Atmanirbhar Bharat.

08:37 EDT Real Brands to acquire assets of Boulder Botanical for $12M - Real Brands announced that it has signed the definitive agreement for the acquisition of substantially all the assets of Boulder Botanical & Biosciences Laboratories, a manufacturer of white-label and private-label wellness and sports medicine herbal supplements and CBD products, from Frankens Investment Fund, which had acquired Boulder Botanical in April 2022. The acquisition will include Boulder Botanical's brands for human and pet markets, IP, and distribution at the 27,000 sq. ft. R&D and production facility in Golden, Colorado. The value of the transaction is $12M, with a $1M operating capital commitment. Boulder Botanical will retain its name and operate as a division of Real Brands. Real Brands has contracted to retain key Boulder Botanical employees for a seamless transition, with no interruption in supply to customers.

08:37 EDT Moleculin Biotech to evaluate WP1096 molecule in animal studies - Moleculin Biotech announced its WP1096 molecule will be evaluated in animal studies through the preclinical services offered by the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health. WP1096 is being studied by Moleculin as a novel potential therapy for a broad spectrum of viruses, including arenaviruses. WP1096 is a compound within the WP1122 portfolio, which is designed to exploit, amongst other uses, the potential uses of monosaccharide decoys as a means to inhibit glycolysis and alter glycosylation. As an example, the Company's WP1122 molecule is a prodrug of 2-deoxy-D-glucose, or 2-DG, and 2-DG has been approved outside the US for use as a treatment for COVID-19. The Company believes WP1096 may target and therapeutically impact glycolysis and glycosylation processes in host cells and viruses. Moleculin is currently conducting a Phase 1 trial of analog WP1122 in healthy volunteers in preparation for a Phase 2 trial in COVID-19 patients. Between its antiviral effort with WP1122 and a range of oncology focused initiatives, Moleculin is not currently able to allocate significant resources to the development of WP1096.

08:36 EDT Loop Media expands distribution and content with new 'HyperLoop' - Loop Media announced both expanded distribution to NBC Universal's Peacock streaming service, and new channels for its SONIFI in-room partnership and its Loop for Business service...Loop also announced that earlier this year they began producing four new music video channels for Peacock, NBC Universal's streaming service and one of Loop's newest distribution partners. Peacock's audience now has access to music video channels designed and programmed by Loop dedicated to Country, Pop, Latin and Classics.

08:33 EDT Porch Group announces new business unit leadership appointments - Porch Group (PRCH) announced key business unit leadership appointments designed to support growth across multiple market sectors. Nick Graham has been appointed Senior Vice President and Group General Manager of Porch Group's Moving Division, effective September 26, 2022. In his new role, Graham will be responsible for Porch Group's moving division. Most recently, Graham served as the general manager of Hotwire, a subsidiary brand of Expedia Group (EXPE). Mindy Barker has been appointed as Chief Financial Officer of Homeowners of America, a property and casualty insurance provider and subsidiary of Porch Group, effective September 26, 2022. Barker has been serving as interim CFO since November 5, 2021.

08:32 EDT TTEC Holdings raises semi-annual dividend to 52c per share - The dividend is to be paid on October 26 to shareholders of record as of October 11. This semi-annual dividend represents a 10.6% increase over the dividend paid in October 2021 and 4% increase over the dividend paid in April 2021.

08:29 EDT Viveve launches company-wide rebranding initiative - Viveve Medical announced the launch of a company-wide rebranding initiative that will include content and new graphic elements related to the treatment of SUI in women. The rebranding is being completed in advance of the planned reporting of topline results from Viveve's pivotal U.S. PURSUIT clinical trial in early 2023. The Viveve rebranding effort premiers a new corporate website that includes content addressing the prevalence of SUI in women and the current unmet need for a noninvasive treatment option. Stylish new design elements include vibrant color palettes, updated graphic elements and new layout for easy access to information for clinicians, investors, patients, and other audiences. The new brand designs will be carried through all customer and public-facing communications from Viveve including presentations, educational materials in both print and digital media, and the Company's social media channels.

08:27 EDT Zentek announces Canadian Patent Office allowance of ZenGuard application - Zentek announced that on September 16, 2022, it's Canadian patent application directed to its ZenGUARD technology, for use on personal protective equipment, and heating, ventilation, and air conditioning, has been allowed by the Canadian Intellectual Property Office including all 54 claims made in the application. Zentek is now working with its IP counsel to map out the strategy to extend patent protection of its commercial rights in all global jurisdictions of interest.

08:26 EDT NLS Pharmaceutics announces results from Phase 2a trial of Quilience - NLS Pharmaceutics announce top-line results from its Phase 2a clinical trial evaluating its lead product candidate, Quilience, in the treatment of narcolepsy. The trial met its primary endpoint with high statistical significance. Treatment with Quilience 3mg per day resulted in a 7.1 point mean reduction from baseline in excessive daytime sleepiness over the 4-week treatment period based on the Epworth Sleepiness Scale, compared to a 3.2 point reduction for placebo. The two treatment groups separated early and consistently throughout the study period confirming Mazindol ER's rapid onset of action and durable benefit. For the ESS score, the least squares means change from baseline to each visit and the standard error of Quilience versus placebo were all statistically significant at week 1 -4.3 versus -1.1, at week 2 -4.7 versus -1.3, at week 3 -5.0 versus -1.6, and at week 4 -5.8 versus -2.1. The treatment arms were balanced in terms of patient demographics, baseline levels, and disease characteristics. Quilience was well-tolerated and no safety concerns were identified. No serious adverse events were reported. With regard to the reduction in cataplexy attacks in narcolepsy Type 1 patients, a key secondary endpoint, Quilience consistently outperformed placebo at all time points. In the trial's open label extension study, 85% of patients including those with NT1, elected to rollover and receive Quilience for up to 6 months as a monotherapy. NLS plans to release interim results from the OLE study before year-end and announce final results in the first quarter of 2023. NLS will host a Key Opinion Leader Event on September 30, 2022 to review the top-line Phase 2a results. The KOL Event will also feature study investigators and an independent practitioner that will discuss the clinical results and offer perspectives on the potential for Quilience to treat patients with both NT1 and narcolepsy type 2.

08:22 EDT Emerson Electric to divest Russian business - Emerson announced an agreement to sell its Russia business, including Metran, its Russia-based manufacturing subsidiary, and Emerson in Russia, the sales and service organization for Metran, to the local management team. This announcement follows the company's May statement to exit its Russia business and explore strategic options to divest Metran. For FY21, Russia represented approximately 1.5% of total Emerson sales. As part of the previously announced Russia exit, Emerson included a pre-tax loss of $162M in the third quarter. The transaction will be subject to regulatory and government approvals, and other customary closing conditions. Emerson will work closely with the local Russia management team to help ensure a smooth transition for employees through the process.

08:19 EDT Good Works II and Direct Biologics sign LOI for potential SPAC combination - Good Works II Acquisition (GWII) and Direct Biologics, a late-stage biotechnology company, announced the signing of a letter of intent for a potential business combination. The letter of intent is non-binding except with respect to certain specified provisions relating to, among other things, exclusivity, expenses and other customary provisions. The letter of intent provides that, until November 21, Good Works II and Direct Biologics will negotiate exclusively with each other to achieve a definitive agreement whereby Good Works II would combine with Direct Biologics, resulting in a combined publicly traded company. Completion of the proposed transaction is subject to the negotiation of a definitive agreement and the satisfaction of conditions contained therein. Accordingly, there can be no assurance that a definitive agreement will be entered into or that the proposed transaction will be consummated or, if a transaction is consummated, as to its terms, structure or timing...Commencing in the fourth quarter of 2022 and the first quarter of 2023, the company intends to initiate clinical trials with ExoFlo in all-cause ARDS, ulcerative colitis, Crohn's disease and abdominal solid organ transplant. In addition, there are numerous investigator-initiated trials underway with ExoFlo at leading research institutions addressing other applications as Direct Biologics believes ExoFlo holds potential in a wide range of other medical indications involving inflammation and tissue repair, including mild-to-moderate and long COVID.

08:18 EDT PaxMedica provides corporate update following IPO - PaxMedica provided a corporate update after the Company's initial public offering, which closed on August 26, 2022. Most recently, PaxMedica appointed Stephen Sheldon as CFO in July 2022. In May 2022, Dr. John Coelho was appointed to the Company's Board of Directors. Prior to joining PaxMedica, Mr. Sheldon served as the CEO of privately held Indochina Healthcare. Coelho has served in leadership roles, including most recently as Senior Vice President of Medical Affairs for Sanofi,

08:17 EDT Seagen, Zai Lab enter regional collaboration, license agreement for TIVDAK - Zai Lab (ZLAB) and Seagen (SGEN) announced an exclusive collaboration and license agreement for the development and commercialization of TIVDAK in mainland China, Hong Kong, Macau, and Taiwan. TIVDAK is the first and only ADC approved in the U.S. for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the terms of the agreement, Seagen will receive an upfront payment of $30M, as well as development, regulatory, and commercial milestone payments, and tiered royalties on net sales of TIVDAK in the Zai Lab territory. Based on the existing TIVDAK co-development and co-commercialization collaboration between Seagen and Genmab (GMAB), all upfront, milestone payments, and royalties will be shared 50/50 with Genmab. "Zai Lab has a significant presence treating women's cancers in China, and TIVDAK is an important addition to our oncology commercial portfolio. Treatments for cervical cancer remain a significant unmet need in China with approximately 110,000 new cases annually 1, and currently there are few effective therapeutic options available," said William Liang, Chief Commercial Officer, President of Greater China at Zai Lab. "We look forward to this collaboration with Seagen to make TIVDAK available for patients in China as we expand our oncology portfolio."

08:14 EDT Oatly Group debuts YouTube cooking show 'Will it Swap?' - Oatly Group announced the global launch of its original YouTube cooking show, "Will It Swap?" Produced and created by Oatly, the four-episode series convenes a group of eccentric and charming characters and challenges them to swap Oatly for dairy in their time-honored and favorite recipes.

08:13 EDT SAIC gets $170M NASA contract for IV&V of space systems and software - Science Applications International has been awarded a $170M contract by the National Aeronautics and Space Administration NASA to continue performing independent verification and validation of space systems and software. This Systems and Software Assurance Services 2 or SAS2, contract will support all of NASA's current human space exploration programs as well as numerous Earth science and planetary science missions. "The SAS2 contract enables SAIC to continue providing critical engineering expertise to NASA," said Michael LaRouche, president National Security and Space sector at SAIC. "When missions such as the Perseverance Mars Rover or the Artemis Program take flight, SAIC performs critical system and software verification and validation that helps to ensure mission success." Under the five-year contract, SAIC will deliver services including Software Systems IV&V, Safety & Mission Assurance, Software Assurance and Mission Protection services.

08:11 EDT Kinder Morgan sells 25.5% equity interest in ELC for $565M - Kinder Morgan announced that it has closed on the sale of a 25.5% equity interest out of its membership interest in Elba Liquefaction, or ELC, to an undisclosed financial buyer for approximately $565M, subject to customary purchase price adjustments to reflect an economic effective date of July 1. These proceeds will reduce short-term debt and create additional capacity for investments, including share repurchases. The value of the equity interest implies an enterprise value of approximately $2.3B for ELC, which is approximately 13 times 2022E EBITDA. Upon closing, KMI and the undisclosed financial buyer will each hold a 25.5% interest and Blackstone Credit will continue to hold a 49% interest in ELC. The ELC joint venture was formed in 2017 to construct and own the 10 modular liquefaction units in operation at Elba Island. KMI will continue to operate the facility. The Elba Liquefaction facility located on Elba Island in Chatham County, Georgia, is owned by ELC and includes 10 modular liquefaction units for a total capacity of approximately 2.5M tons per year of LNG, which is equivalent to approximately 0.35B cubic feet per day of natural gas. The facility is supported by a 20-year contract with Shell LNG, who is subscribed to 100% of the liquefaction capacity.

08:10 EDT Chipotle begins piloting two new technologies in its restaurants - Chipotle Mexican Grill announced it is piloting advanced technologies to enhance its employee and guest experience by streamlining operations and reducing friction. The company recently began piloting two new technologies in its restaurants to deliver precise forecasting, optimal quality, and increased convenience for digital guests. In select Southern California restaurants, Chipotle is piloting a cook to needs kitchen management system that provides demand-based cooking and ingredient preparation forecasts to optimize throughput and freshness while minimizing food waste. Leveraging AI and machine learning, the system monitors ingredient levels in real time and notifies the crew how much to prep, cook and when to start cooking, while automatically populating real time production planning for each restaurant. The company is simultaneously piloting advanced location-based technology to enhance its app functionality and provide a seamless, convenient experience for guests. For guests who opt-in, the program can engage with Chipotle App users upon arrival and utilizes real time data to enhance their experience with order readiness messaging, wrong pick-up location detection, reminders to scan the Chipotle Rewards QR code at checkout, and more. Chipotle's contextual restaurant program, utilizing Radius Networks' technology platform, Flybuy, is currently being tested at 73 restaurants in Cleveland, Ohio. Early results indicate positive performance with improved in-store rewards engagement, order alert notifications, and efficiencies with earlier assignments for marketplace delivery drivers.

08:10 EDT TransUnion launches TruValidate Device Risk with Behavioral Analytics - TransUnion announced the launch of TruValidate Device Risk with Behavioral Analytics. The solution is newly fortified by NeuroID's behavioral analytics and aims to help businesses stop fraud - not good customers - based on device recognition, context, device and user behavior. The solution builds trusted connections by allowing users to join a global network of 6,000 fraud and security analysts, over 10 billion known devices and 100 million+ detailed known fraud reports. TransUnion's TruValidate Device Risk with Behavioral Analytics is configurable, enabling users to measure the risk of a device and user by combining device intelligence and applicant behavior signals powered by NeuroID to their unique fraud challenges.

08:09 EDT Harley-Davidson, AEA-Bridges Impact Corp. complete business combination - Harley-Davidson (HOG) and AEA-Bridges Impact Corp. (IMPX) announced the completion of their previously announced business combination under which LiveWire EV, LLC, Harley-Davidson's electric motorcycle division, combined with ABIC, to create a new public company. The business combination was officially approved at an extraordinary general meeting by ABIC stockholders on September 16, 2022. Upon completion of the business combination, the combined public company will operate as LiveWire Group (LVWR) and its common stock and warrants will begin trading on the New York Stock Exchange under the symbols "LVWR" and "LVWR WS," respectively, on September 27. Through this combination, LiveWire will become the first and only EV motorcycle company in the U.S. to list on the NYSE.

08:08 EDT Synthetic Biologics: DSMC recommends Phase 1b/2a trial proceed with enrollment - Synthetic Biologics announced the outcome from the Data and Safety Monitoring Committee review of results from the first Cohort of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 in allogeneic hematopoietic cell transplant recipients for the prevention of acute graft-versus-host-disease. Cohort 1 enrolled 19 patients who received at least 1 dose of study drug. Sixteen patients received at least one dose of intravenous meropenem and 12 of these patients completed sufficient doses of IV meropenem to be evaluable towards the study endpoints. The study is on-going and remains blinded; however, key findings from blinded data for Cohort 1 are included below: Adverse events and serious adverse events observed in Cohort 1 were typical of those observed in allo-HCT patients and no AEs or SAEs were determined to be related to study drug treatment by the investigators. A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations including sepsis. One patient died 14 days after the last dose of study drug due to sepsis that was not related to study drug. Consistent with previous studies of SYN-004 in healthy volunteers, SYN-004 was not observed in blood samples from the majority of the evaluable patients. A total of three plasma samples had low but quantifiable levels of SYN-004 using a sensitive ECL assay. None of the three ECL positive plasma samples were found to contain active SYN-004 using a functional enzyme activity assay. Meropenem pharmacokinetics were as expected for this patient population. Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study may proceed to enroll Cohort 2 in which study drug will be administered in combination with the IV beta-lactam antibiotic piperacillin/tazobactam.

08:05 EDT Atai Life Sciences announces initiation of Phase 1 trial of EMP-01 - atai Life Science, which is developing EMP-01, announced its Phase 1 study has received regulatory and ethics approvals required from Medsafe and HDEC, respectively, to initiate participant enrollment. The Phase 1 randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of single-ascending doses of EMP-01 in healthy adult participants, as well as assess the usability and acceptability of the IDEA-1 app in delivering "set and setting" content to participants in preparation for their EMP-01 administration. This study also includes a range of behavioral assessments that, in conjunction with the PK and safety readouts, are expected to inform the design of and doses tested in future Phase 2 clinical trials of EMP-01. The need for new interventions for PTSD is critical given the current lack of effective treatments for those suffering from this debilitating mental health disorder," said Florian Brand, CEO of atai Life Sciences. "We are thrilled to have received the necessary approvals for the initiation of the Phase 1 trial for EMP-01 in order to further progress the potential development of this promising new therapy." atai anticipates topline results in H2 2023 for this Phase 1 study.

08:05 EDT Nikola extends exchange offer to acquire shares of Romeo Power - Nikola (NKLA) announced that Nikola has extended its exchange offer to purchase all outstanding shares of common stock of Romeo Power (RMO) until midnight, Eastern Time, at the end of October 12. Nikola and Romeo jointly announced that the companies entered into a definitive agreement for this all-stock transaction on August 1. Under the terms of the merger agreement, Romeo stockholders will receive 0.1186 of a share of Nikola common stock for each Romeo share, representing an equity value of approximately 4.5% pro forma ownership of Nikola. On August 29, Nikola commenced, through a wholly-owned subsidiary, an exchange offer to purchase all outstanding shares of common stock of Romeo. The deadline to tender shares is midnight, Eastern Time, at the end of October 12 unless extended further. If less than a majority of the outstanding shares of Romeo common stock are tendered, the Offer cannot be completed by Nikola.

08:04 EDT Ayala Pharmaceuticals announces Fast Track designation for AL102 - Ayala Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Fast Track designation for AL102 for the treatment of progressing desmoid tumors. AL102 is a potent, selective, oral gamma-secretase inhibitor. AL102 is being evaluated in the ongoing RINGSIDE pivotal Phase 2/3 clinical trial in desmoid tumors. Positive interim results from Part A, the Phase 2 segment of this study, were presented at ESMO 2022, showing efficacy across all cohorts, with early tumor responses that deepened over time. AL102 was well tolerated. The company has initiated Part B of RINGSIDE, and is enrolling patients in an open label extension study.

08:02 EDT Quantum and Atempo expand partnership - Quantum announced an expanded partnership with Atempo, a leading European software vendor. As part of the expanded partnership, the companies are introducing validated solution bundles that combine Atempo Tina software, a Quantum media server, and Quantum secondary storage solutions. As part of a new worldwide reseller agreement, Quantum will resell Atempo Tina software with an all-inclusive, capacity-based subscription licensing model that is only available through Quantum.

08:01 EDT Genasys announces multi-year contract from global automaker - Genasys announced a Genasys Emergency Management, GEM, software-as-a-service, SaaS, contract from the North American group of a global auto manufacturer, the Company's second customer in the Automotive sector. The Company's enterprise software services are replacing a competitor's system. "GEM software will facilitate the delivery of life safety alerts and other critical event notifications to the automaker's employees in the U.S., Canada and Mexico," said Richard Danforth, Chief Executive Officer, Genasys Inc. "GEM will provide best-in-class capabilities under the multi-year SaaS agreement, including a custom-branded mobile staff application with tracking, automated weather warnings, polling, enterprise-level reporting and analytics, as well as FEMA IPAWS monitoring for local situational awareness."

07:48 EDT Iris Energy increases operating capacity to over 3.7 EH/s - Iris Energy announced it has increased its operating capacity to exceed 3.7 EH/s. The full energization of 1.4 EH/s at Prince George, BC was on schedule and marks delivery of the Company's third operating site, increasing the Company's operating capacity by greater than60% to 3.7 EH/s. This follows the recent full energization of 1.5 EH/s at the Company's second operating site in Mackenzie, BC less than two months ago. Phase three expansion of a further 1.0 EH/s at Mackenzie also remains on track to be energized by the end of Q4 2022, increasing the Company's expected near-term operating capacity to 4.7 EH/s. As previously announced, an initial 1.3 EH/s development is currently planned at Childress, Texas, to reach total expected Company operating capacity of 6.0 EH/s in 2023.

07:42 EDT Avidity Biosciences drops 20% after FDA partial clinical hold on MARINA trial - In pre-market trading, shares are down about 20% to $15.05.

07:40 EDT Energem announces confidential submission of draft registration statement - Energem and Graphjet Technology announced the submission of a confidential draft Registration Statement on Form F-4 to the U.S. Securities and Exchange Commission with respect to their previously announced proposed business combination. The proposed business combination, which has been approved by the boards of directors of Energem and Graphjet, is expected to be completed in early 2023, subject to, among other things, the approval by Energem's shareholder, satisfaction of the conditions stated in the definitive agreement and other customary closing conditions, including a registration statement being declared effective by the SEC and approval by The Nasdaq Stock Market to list the securities of the combined entity. Upon the closing of the business combination between Energem and Graphjet, Energem expects to be renamed Graphjet Technology and, as a publicly listed holding company, with Graphjet as its wholly-owned subsidiary, be listed on the Nasdaq Global Market under the ticker symbol "GTI."

07:39 EDT Blade Air Mobility and Eve Holding announce partnership - FlyBlade India, a joint venture between Hunch Ventures and Blade Air Mobility (BLDE), and Eve Air Mobility (EVEX) announced a strategic partnership which includes a non-binding order of up to 200 electric vertical take-off and landing vehicles, service and support, and Eve's Urban Air Traffic Management, or UATM, software solution. The companies also plan to collaborate on a three-month pilot project connecting passengers using helicopters. India is a unique market with its vast expanse, accessibility concerns, traffic congestion and regulations.

07:34 EDT Cognition Therapeutics awarded $2.14M in grant funding from NIA - Cognition Therapeutics announced that the company has received a $2.14M grant award from the National Institute on Aging, NIA, a division of the National Institutes of Health, NIH, to support completion of the ongoing SEQUEL Study of CT1812 in adults with mild-to-moderate Alzheimer's disease. The aim of the SEQUEL trial is to investigate whether treatment with CT1812 results in a normalization of the EEG patterns, as measured by quantitative electroencephalogram. "Although the Covid 19 pandemic slowed down the progression of the SEQUEL trial, receipt of this grant award puts us in a position to propel this study forward to its conclusion," explained Lisa Ricciardi, Cognition's president and CEO. "The NIA has been tremendously supportive of our research to date, and we look forward to a continued collaboration with the Institute as we advance CT1812 through the clinic. We also want to extend our gratitude to the patients who enrolled in SEQUEL and the team at Amsterdam UMC who remained engaged through the pandemic." The SEQUEL study is enrolling 16 adults with mild-to-moderate Alzheimer's disease, each of whom are randomized to receive either CT1812 or placebo once daily for 28 days. After a 14-day wash-out period, participants cross over into the other treatment arm for an additional 28 days. The purpose of this study is to assess the safety and efficacy of CT1812 and to determine how well a once-a-day oral dose is tolerated. The study will also measure the impact of CT1812 on the electrical activity in the brain, specifically those electrical impulses in the theta band.

07:34 EDT Mitsui & Co makes $10M investment in FourKites - FourKites announced a $10M investment from Mitsui & Co., Ltd. to expand FourKites' offerings across the APAC region. This investment encompasses the first phase in an ongoing strategic relationship between FourKites and Mitsui, which the two companies intend to formalize by the end of the year. Mitsui's investment in FourKites is the culmination of a yearlong effort between the two companies, which included Mitsui's extensive due diligence of the supply chain visibility landscape. Given FourKites' market-leading offerings and proven track record in the region, Mitsui is planning to invest significant resources to expand FourKites' coverage in APAC, including sales, customer service, operations and product localization, which will result in a hyper-localized solution for the APAC market. The strategic partnership will initially focus on Japan, with plans to jointly expand throughout APAC.

07:33 EDT Emergent completes acquisition of rights to TEMBEXA smallpox oral antiviral - Emergent BioSolutions announced last night that it has completed its acquisition of exclusive worldwide rights to TEMBEXA, which it calls "the first oral antiviral approved by the U.S. Food and Drug Administration for all age groups for the treatment of smallpox," from Chimerix (CMRX). TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority, or BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent. The 10-year contract, valued at up to $680M, to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA to the U.S. government, was awarded to Chimerix on August 29. The contract includes an initial product procurement valued at approximately $115M, with optional future procurement, valued at up to approximately $551M, exercisable at the sole discretion of BARDA. In addition to product procurement, the contract includes reimbursed post marketing activities of approximately $12M. Based on the terms of the final BARDA agreement, Emergent is expected to pay Chimerix an upfront payment of $238M; Potential milestone payments of up to $124M contingent on the potential exercise by the U.S. government of procurement options following the base period; 15% royalty on gross profit from sales of TEMBEXA outside the U.S.; 20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of the 1.7 million treatment courses as contemplated in the existing BARDA contract; and up to an additional $12.5M upon achievement of certain development-based milestones.

07:31 EDT Axon appoints Andrea James as Chief Communications Officer - Axon announced the appointment of Andrea James to the role of Chief Communications Officer. In this role, James will be responsible for global corporate communications, including investor, media and public relations. James was most recently SVP Corporate Strategy and Investor Relations. She joined Axon in 2017 and established a strong track record of driving clear and concise communication with the investment community regarding Axon's strategy, products and financial health. She also established and served as an integral leader of Axon's corporate strategy function, which includes mergers and acquisitions, strategic partnerships and investments. James will report to Axon's incoming CFO & Chief Business Officer, Brittany Bagley, who was announced in August and starts at Axon this week.

07:19 EDT Provident Financial, Lakeland Bancorp to combine in $1.3B all-stock merger - Provident Financial Services (PFS) and Lakeland Bancorp (LBAI) entered into a definitive merger agreement pursuant to which the companies will combine in an all-stock merger, valued at approximately $1.3B. The merger combines two complementary banking platforms to create New Jersey's preeminent super-community bank. The combined company will have more than $25B in assets and $20B in total deposits. Pro forma calculations with respect to the combined company indicate 2024 GAAP earnings per share accretion of approximately 24% or 9% with and without purchase accounting interest rate marks, respectively. The transaction is approximately 17% or 4% dilutive to tangible book value with and without purchase accounting interest rate marks, respectively. Management believes that conservative and achievable cost savings, projected to be approximately 35% of Lakeland's expense base, will drive strong financial metrics, material capital generation and tangible book value per share growth. The transaction results in an internal rate of return of approximately 20%. Under the terms of the merger agreement, which was unanimously approved by the boards of directors of both companies, Lakeland will merge with and into Provident, with Provident as the surviving corporation, and Lakeland Bank will merge with and into Provident Bank, with Provident Bank as the surviving bank. Following the closing of the transaction, Lakeland shareholders will receive 0.8319 shares of Provident common stock for each share of Lakeland common stock they own. Upon completion of the transaction, which is subject to both Provident and Lakeland shareholder approval, Provident shareholders will own 58% and Lakeland shareholders will own 42% of the combined company. The combined company will operate under the "Provident Financial Services, Inc." name and the combined bank will operate under the "Provident Bank" name. The administrative headquarters of the combined company will be located in Iselin, New Jersey. The combined company will trade under the Provident ticker symbol "PFS" on the New York Stock Exchange. The combined company's board of directors will have sixteen directors, consisting of nine directors from Provident and seven directors from Lakeland. Christopher Martin, Provident's current Executive Chairman, will continue to serve as Executive Chairman of the combined company board of directors. Thomas Shara Jr., Lakeland's current President, CEO and director, will serve as Executive Vice Chairman of the combined company board of directors. Anthony Labozzetta, a current director of Provident, will continue to serve as a director of the combined company. A Provident board representative will serve as the independent lead director of the combined company. board of directors. The combined company will be led by a well-respected management team that is comprised of individuals with significant financial services and M&A integration experience. Anthony Labozzetta, Provident's current President and CEO, will continue to serve in that role in the combined company Thomas Lyons, Provident's current Senior Executive Vice President and CFO, will continue to serve in that role in the combined company. The remainder of the executive team will draw from both Provident and Lakeland. The merger is expected to close in the second quarter of 2023, subject to satisfaction of customary closing conditions, including receipt of customary regulatory approvals and approval by the shareholders of each company.

07:15 EDT Autodesk begins its annual design and make conference - Autodesk kicks off Autodesk University, or AU, 2022, the company's annual design and make conference and premier learning experience. After two years as a digital experience, the event returns in person this year in New Orleans and runs September 27-29. AU brings together thousands of industry experts and thought leaders at the forefront of architecture, engineering, and construction, product design and manufacturing, and media and entertainment. Live in New Orleans and online, Autodesk University 2022 includes mainstage sessions, panel discussions, thought leadership presentations, and industry case studies, along with Autodesk product briefings and trainings.

07:11 EDT Aclaris Therapeutics appoints Doody as VP, Investor Relations - Aclaris Therapeutics (ACRS) announced that it has appointed Robert Doody Jr. as Vice President, VP, Investor Relations. Doody has nearly 20 years of biotechnology industry experience leading investor relations programs, most recently serving as Vice President of Investor Relations at Provention Bio (PRVB).

07:10 EDT Clearside Biomedical to present corporate review, upcoming catalysts - Clearside Biomedical announced that Thomas Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer, will present a corporate overview at the Eyecelerator conference on September 29, 2022, as part of the Annual Meeting of the American Academy of Ophthalmology. "We are pleased to highlight the breadth of our suprachoroidal space platform across ophthalmic indications," said Thomas Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "There are multiple upcoming catalysts related to our internal CLS-AX program and from our development and commercialization partners. In November of this year, we plan to report data from all four cohorts of our OASIS Phase 1/2a clinical trial of CLS-AX in patients with neovascular age-related macular degeneration. We believe this data will provide more insight into the potential benefits of combining pan-VEGF inhibition from the highly potent tyrosine kinase inhibitor, axitinib, with targeted delivery to affected chorioretinal tissues utilizing our proprietary SCS Microinjector."

07:09 EDT SES AI advances plans to make next-gen batteries amid South Korea support - SES AI significantly advanced its plans to produce next-generation batteries, securing support from the government of South Korea toward SES's development of Li-Metal batteries that are designed to greatly increase the range of electric vehicles at a time when global demand for emission-free transport is skyrocketing. In a meeting with South Korean President Yoon Suk-yeol at the North America Investors Roundtable in New York on September 22, SES founder and CEO Qichao Hu committed to advancing research and development for Li-Metal batteries in South Korea. SES was the only North American battery company to participate in the event, where South Korea announced a total of $1.15B of planned investment for batteries, semiconductors, and other industries. "South Korea is the world leader in EV battery, it plays a key role in global and in particular, North American EV battery industry by bridging the upstream global supply chain with downstream North American EV market. This is why we are investing in development in Korea," said Dr. Hu. "We are proud that we have been recognized by the Government of South Korea for our innovation in Li-Metal technology and our commitment to supporting the future of the electric vehicle and urban air mobility ecosystem that can benefit us all."

07:08 EDT BioLineRx announces U.S. commercialization plan for Aphexda - BioLineRx announced its U.S. commercialization plan for APHEXDA in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients. If approved, the company intends to commercialize APHEXDA in the U.S. independently in order to accelerate its availability to patients and to maximize the value of this innovative therapeutic candidate. To lead its U.S. operations and drive commercial strategy, the company has appointed commercial product veteran Holly May to the role of President, BioLineRx USA. "We are excited to announce our plan to commercialize Motixafortide, now known by its FDA approved trade name APHEXDA, independently in the U.S., assuming FDA approval next year," said Philip Serlin, Chief Executive Officer of BioLineRx. "Our approach ensures focused outreach to transplant centers and enhanced value for the Company over other potential commercialization approaches examined. Since the beginning of 2022, we have been advancing key pre-launch activities. Our progress, together with our recent financings, puts us in an ideal position to efficiently build the additional infrastructure and targeted sales team to ensure the rapid uptake of APHEXDA."

07:06 EDT Waldencast Acquisition appoints Gautier as CFO, COO - Waldencast (WALD) announced that Philippe Gautier will join the company as Chief Financial Officer, CFO, and Chief Operating Officer, COO, on October 19, 2022. In this role, Gautier will also serve as the principal financial officer of the Company. Most recently, Gautier served as Group Chief Financial Officer at Selecta - a KKR (KKR) portfolio company.

07:06 EDT Avidity: Partial clinical hold due to SAE reported in single participant

07:04 EDT Equillium gives data on the EQUALISE study evaluating itolizumab for LN - Equillium announced interim results from the Type B portion of the EQUALISE study evaluating itolizumab, a first-in-class anti-CD6 monoclonal antibody selectively targeting the CD6-ALCAM pathway, in patients with lupus nephritis. "Despite recently approved therapies, 60% of lupus nephritis patients are failing to achieve a complete response at 12 months, highlighting the need for new medicines with differentiated mechanisms," said Bruce Steel, chief executive officer at Equillium. "We are very encouraged by the interim data from the LN portion of the EQUALISE study as we observed compelling responses in a patient population with significantly greater baseline proteinuria than recent studies, with a mean baseline UPCR of 5.8 grams. At end of study, 83% of patients achieved a complete or partial clinical response, with 67% reaching a greater than 80% reduction in UPCR. The interim data adds to our conviction in the clinical activity of itolizumab and the potential to be an impactful therapy for patients with lupus nephritis. We look forward to continuing to enroll patients in the Type B portion of the EQUALISE study and anticipate sharing topline data in mid-2023. In parallel, we are engaged with key opinion leaders to prepare for later stage development that we expect can support potential product registration."

07:04 EDT Nuwellis announces activation of sites for REVERSE-HF trial - Nuwellis announced the activation of three additional sites for its pivotal REVERSE-HF clinical study. Jefferson Abington Hospital in Pennsylvania, the University of California San Francisco, and Baycare Morton Plant Hospital in Florida are now eligible to enroll patients and evaluate the clinical outcomes and economic value of the Aquadex ultrafiltration therapy in comparison to intravenous diuretics for the treatment of fluid overload in patients unresponsive to diuretics with worsening heart failure. REVERSE-HF is a multicenter, open-label, randomized controlled trial that is being conducted across the United States. The study is led by Sean Pinney, M.D., Professor of Medicine and Co-Director of the Heart and Vascular Center at The University of Chicago Medicine, and Maria V. DeVita, M.D., Professor of Medicine at Hofstra School of Medicine/Northwell and Chief of the Division of Nephrology at Lenox Hill Hospital. In addition to Jefferson Abington, USCF, and BayCare Morton Plant, Nuwellis is currently partnering with other clinical institutions that will soon be enrolling patients for the REVERSE-HF study as well. The Company anticipates at least 12 clinical institutions will participate in the study.

07:02 EDT GXO Logistics expands warehouse services for Bayer - GXO Logistics (GXO) celebrated the opening of a new warehouse facility with Bayer (BAYRT) expanding the companies' 25-year partnership. Through its shared-space distribution network GXO Direct, GXO will manage warehouse support, including all shipping and receiving activities, for Bayer's Crop Science division at the new 350,000-square-foot facility in Kearney, Nebraska. The new facility features GXO's warehouse management system and cold storage space. With the addition of the facility in Kearney, GXO now manages more than 1 million square feet of warehouse space for Bayer's Crop Science division and a total of nearly 2.3 million square feet across seven sites that support the company's agriculture business.

06:56 EDT Aecom awarded contract by Greater Orlando Aviation Authority - AECOM announced it has been awarded a contract by the Greater Orlando Aviation Authority, or GOAA, to provide ongoing program and project management services, continuing a decades-long partnership with the Authority. In this role, AECOM expects to support the enhancement of GOAA's assets in line with the agency's primary goals of excellent customer service, fostering economic development through expansion, leveraging federal and state funding, facilitating safety and security, and being fiscally responsible. AECOM's scope is expected to encompass program, project, and construction management, including program controls, development of master program schedules, budget review, funding support, design management, project monitoring, quality assurance, risk management, design scopes, and contract administration.

06:49 EDT Velodyne Lidar signs multi-year agreement with Stanley Robotics - Velodyne Lidar announced a multi-year agreement to provide its lidar sensors to Stanley Robotics for an automated valet parking solution. The innovative service uses autonomous handling robots to help car parks to improve the customer experience and increase the number of vehicles that can be stored. Stanley Robotics is working with Velodyne's Puck and Velarray M1600 lidar sensors to provide perception and navigation capabilities that enable its all-electric Stan robot to operate autonomously and safely. The sensors provide real-time 3D perception data for localization, mapping, object classification and object tracking. Velodyne's power-efficient sensors support Stan robots in a wide range of challenging environmental conditions, including varied temperature, lighting and precipitation. The Stanley Robotics automated valet parking solution equipped with Velodyne sensors is already in operation in airports and finished vehicle logistics in Europe and Japan, with further deployments expected in 2023, including North America.

06:32 EDT Welsbach Technology Metals Acquisition extends combination deadline - Welsbach Technology Metals Acquisition Corp. announced that it has approved an extension of the time period to consummate a Business Combination, in accordance with Article G of the company's amended and restated certificate of incorporation, to and including December 30, 2022. In connection therewith, the company has also approved the issuance and sale of, to Welsbach Acquisition Holdings LLC a non-interest bearing, unsecured promissory note equal to $772,768.60 that will not be repaid in the event that the company is unable to close a Business Combination unless there are funds available outside the trust account to do so. Such note would either be paid upon consummation of the Business Combination out of the proceeds of the Trust Account released to the company or, at the Sponsor's discretion, converted, in full or in part, upon consummation of the Business Combination into additional private units at a price of $10.00 per unit.

06:09 EDT AstraZeneca's Tezspire approved in Japan for severe asthma treatment - The company states: "AstraZeneca's Tezspire, tezepelumab, has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies. The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety results from the PATHFINDER clinical trial programme. The application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy." Reference Link

06:03 EDT Ocular Therapeutix reports interim data form Phase 1 clinical trial of OTX-TKI - Ocular Therapeutix announced interim 7-month data from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the Company's axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration, or wet AMD, and other retinal diseases. The data will be presented in more detail at the upcoming American Academy of Ophthalmology 2022 Annual Meeting Subspecialty Day being held in Chicago by Dilsher Dhoot, MD on Friday, September 30th and can be accessed approximately two hours after the presentation's conclusion. "These interim results from our U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet AMD represent a significant milestone for Ocular," said Antony Mattessich, President and CEO. "Wet AMD is a leading cause of blindness affecting approximately 14 million individuals globally and approximately 2 million in the U.S. alone. The data presented today highlights the potential of OTX-TKI to become a highly-differentiated product capable of providing a durable anti-VEGF response that improves upon today's standard of care in the management of wet AMD and with potential in other retinal diseases. We look forward to discussing our future development plans with the FDA and, subject to those discussions, plan to initiate a Phase 2 clinical trial in the third quarter of 2023." Based on the data cutoff of August 24, 2022, interim data from the U.S.-based Phase 1 clinical trial showed that the single OTX-TKI implant was generally well tolerated with a favorable safety profile. There were no drug-related ocular or systemic serious adverse events observed.

06:00 EDT Meta testing single interface to switch between Facebook, Instagram accounts - Meta has begun testing a single interface to manage Facebook and Instagram accounts and is streamlining registration to help users create accounts on both services, the company said in a statement. Robert d'Apice, Director of Product Management, commented: "People can get notifications for both Facebook and Instagram profiles in one place if they choose to add them to the same Accounts Center. People can now create an account with their existing Facebook or Instagram login, and use it to sign up for additional accounts and profiles... We know that many people use more than one of our apps to pursue different interests, reach a broader audience or share different aspects of who they are with different groups of people. With that in mind, we're simplifying the process of creating and switching between accounts and profiles." The executive added: "While these changes are currently limited to Facebook and Instagram, we'll continue to explore how to improve connected experiences across all of our technologies." Reference Link

05:31 EDT GSI Technology announces SAR approved for use by IAI/Elta System - GSI Technology announced that its Synthetic Aperture Radar, or SAR, image processing acceleration system using GSI's APU technology has been approved for use by IAI/Elta System Ltd, a subsidiary of Israeli Aerospace Industries.

05:20 EDT IBM and SDAIA team up drive adoption of carbon capture, industrial domain AI - Saudi Data and Artificial Intelligence Authority, or SDAIA, and IBM announced the signing of a strategic agreement to drive adoption of artificial intelligence in the carbon capture and industrial domains across the Kingdom of Saudi Arabia. Announced at the second Global AI summit in the Kingdom, the first use case under this agreement will be in collaboration with the Ministry of Energy in Saudi Arabia. SDAIA, Ministry of Energy and IBM will use artificial intelligence technology to detect, map, and eventually reduce carbon emissions across the country. As part of the overall agreement, IBM will work with SDAIA to identify high value applications of artificial intelligence and machine learning to solve challenges in public and private sector organizations in the Kingdom, with a focus on supporting the Kingdom's sustainability and industrialization objectives.

05:12 EDT Babylon Holdings, Bupa announce extended partnership - Babylon and Bupa have announced that they have extended their partnership agreement for a further three years to deliver digital health services to 2.3M Bupa UK health insurance customers. Bupa, a leading health insurer, and Babylon have been in partnership since 2015, when access to the Babylon app for Bupa UK customers was launched. Since launch, there have been over 360,000 Babylon app downloads by Bupa UK Insurance customers. Babylon provides digital services within Bupa including Symptom Checker, 24/7 virtual consultations and My Health. These products help users to better understand their health symptoms, access relevant health information and gain insights into their current and future health risks. These products are available to all UK Bupa customers.

05:05 EDT Pros Holdings services selected by Qatar Airways Cargo - With the addition of Qatar Airways Cargo, Pros is powering nearly 40% of the top air cargo providers. Together, Pros Smart Price Optimization and Management and Pros Smart Configure Price Quote deliver impactful results to air cargo customers-up to 3% profit improvement and up to 5% win rate improvement-by optimizing prices across online platforms in real-time. With the addition of Qatar Airways Cargo, Pros powers three of the top six international cargo carriers.