Stockwinners Market Radar for June 09, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:50 EDT Eisai, Biogen: FDA panel votes unanimously to confirm benefit of Leqembi - Eisai (ESALY) and Biogen (BIIB) announced that the U.S. FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai's Phase 3 Clarity AD clinical trial confirms the clinical benefit of Leqembi 100 mg/mL injection for intravenous use for the treatment of Alzheimer's disease. Additionally, the committee members confirmed the overall benefit-risk profile of Leqembi, the clinical meaningfulness of the data and discussed its use in specific subgroups, including Apolipoprotein E 4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents, and patients with cerebral amyloid angiopathy.

18:02 EDT Kymera Therapeutics announces updated clinical data form Phase 1 trials - Kymera Therapeutics announced new data demonstrating that its oncology programs KT-333 and KT-413 continue to demonstrate substantial target knockdown in ongoing Phase 1a dose escalation clinical trials, with no dose limiting toxicities (DLTs) observed. The data were shared in the online abstract book of the International Conference on Malignant Lymphoma (ICML), taking place from June 13-17, 2023, in Lugano, Switzerland, and reflect a data cut-off date of February 3, 2023. On June 14, a KT-333 poster will be released at ICML and presented on June 16. Kymera will share updated results from both programs in conjunction with the poster release on June 14.

17:50 EDT Walmart director Walton sells 170,587 common shares - In a regulatory filing, Walmart director S. Robson Walton disclosed the sale of 170,587 common shares of the company on June 8 at a price of $150.1244 per share.

17:24 EDT Artemis Strategic Investment Corp trading halted, news pending

17:17 EDT Theravance Biopharma announces Pfizer terminates license agreement - In December 2019, Theravance Biopharma Ireland Limited, an affiliate of Theravance Biopharma (YBPH), entered into a global license agreement with Pfizer (PFE) for its preclinical skin-selective, locally acting pan-JAK inhibitor program. On June 9, 2023, the company received notice from Pfizer terminating the Pfizer Agreement, effective as of October 7, 2023.

17:08 EDT ON Semiconductor CEO El-Khoury sells 22,500 common shares - In a regulatory filing, ON Semiconductor president and CEO Hassane El-Khoury disclosed the sale of 22,500 common shares of the company on June 7 at a price of $90.01 per share.

16:45 EDT NextPlay Technologies receives Nasdaq notice regarding delayed annual report - NextPlay Technologies announced that the Company received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") stating the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1), as a result of not having timely filed its Annual Report on Form 10-K for the fiscal year ended February 28, 2023. The Nasdaq notification letter has no immediate effect on the listing of the Company's common stock on The Nasdaq Capital Market. The Nasdaq notification letter provides the Company 60 calendar days from the date of the notification, or until August 7, 2023, to submit a plan to Nasdaq to regain compliance with Nasdaq Listing Rule 5250(c)(1). If the plan is accepted, Nasdaq may grant an exception of up to 180 calendar days, or until November 27, 2023, for the Company to regain compliance. If the Company does not regain compliance within the allotted compliance period, including any exception period that may be granted by Nasdaq after submission of a plan to regain compliance, if applicable, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel under Nasdaq Listing Rule 5815(a).

16:17 EDT Artisan Partners reports preliminary AUM $136.4B at May 31

16:14 EDT Century Aluminum expands board to seven members - Century Aluminum announced that the company's stockholders voted to increase the size of Century's board of directors from six to seven members, and elected Tamla Olivier to join Century's six incumbent directors, as an independent director with a term expiring at the company's annual meeting of stockholders in 2024.

16:06 EDT Rail Vision receives Nasdaq notification regarding minimum bid requirements - Rail Vision announced that on June 8, 2023, the company received a written notice from the Nasdaq Stock Market LLC indicating that the company was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the company's closing bid price for its Ordinary Shares was below $1.00 per share for the last 30 consecutive business days. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day compliance period, or until December 4, 2023, to regain compliance with the minimum bid price requirement. During the compliance period, the company's Ordinary Shares will continue to be listed and traded on the Nasdaq Stock Market. To regain compliance, the closing bid price of the company's Ordinary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the 180-calendar day compliance period. If the company is not in compliance by December 4, 2023, the company may be afforded a second 180-calendar day compliance period. To qualify for this additional time, the company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market with the exception of the minimum bid price requirement and will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the company does not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the company's Ordinary Shares will be subject to delisting.

16:00 EDT OFS Credit estimates NAV per share $8.04-$8.14 as of May 31 - OFS Credit Company announced the following net asset value estimate as of May 31, 2023. Management's unaudited estimate of the range of our NAV per share of our common stock as of May 31, 2023 is between $8.04 and $8.14. This estimate is not a comprehensive statement of our financial condition or results for the month ended May 31, 2023. This estimate did not undergo the company's typical quarter-end financial closing procedures.

15:21 EDT Oil-Dri CEO says will be 'opportunistic' with stock buybacks - Daniel Jaffee, Oil-Dri Corporation's Chairman and CEO, stated earlier on the company's Q3 call, according to a transcript of the event: "It was a great quarter, and we believe even if -- I'm looking at the stock price is doing and it's running up. And I'll let you guys do your own math, but whatever kind of EPS you want to apply for a year and any kind of multiple you want to do, you can see that we should have a lot of upward pressure on the stock price. So the Board has authorized us to be opportunistic. We're generating a lot of cash and to restart our stock buyback program. So we will be opportunistic with it. We will abide by all the training rules that we need to do, but we see our stock as a good buy at this level."

13:56 EDT Telecom Italia says two offers received as part of bidding process for Netco - Telecom Italia issued the following notice to the market: "TIM announces that, as part of the competitive bidding process relating to Netco, two new non-binding offers have been received today, respectively submitted by the consortium formed by CdP Equity S.p.A. and Macquarie Infrastructure and Real Assets Limited, acting on behalf of a group of investment funds managed or advised by the Macquarie Group, and by Kohlberg Kravis Roberts & Co. L.P. The two non-binding offers will be examined by TIM's Board of Directors at the meeting scheduled for 19 and 22 June, after preliminary investigation by the Related Parties Committee." Reference Link

13:42 EDT 3M says Aearo assessing options for appeal after bankruptcy dismissed - Today, the United States Bankruptcy Court in the Southern District of Indiana granted plaintiffs' motion to dismiss Aearo's bankruptcy filing, 3M confirmed. "Aearo is assessing its options for appeal of this decision, and 3M and Aearo will continue to pursue appeals raising evidentiary and legal issues from previous multi-district litigation, or MDL, bellwether trials. 3M and Aearo are prepared to continue to defend the product in litigation. The Eleventh Circuit Court of Appeals recently heard the appeals of initial trial verdicts, during which 3M and Aearo argued for the correction of the important legal and evidentiary issues that have kept information from jurors, allowed improper evidence and arguments to be part of the trial records, and resulted in the flawed outcome of the bellwether process to-date. These appeals have the potential to fundamentally change the trajectory of this litigation," the company stated.

13:26 EDT Global Indemnity trading resumes

13:02 EDT Allegiant Travel reaches tenative agreement for flight attendants - Allegiant and The Transport Workers Union of America, AFL-CIO Local 577 announced they have reached a tentative agreement on all remaining open issues for the successor to the parties' first collective bargaining agreement. The parties' first collective bargaining agreement became amendable on December 21, 2022, and Allegiant and the TWU were able to secure the new five-year tentative agreement after just over 10 months of bargaining. The Tentative Agreement covering Allegiant's nearly 1,900 flight attendants includes significant increases to wages and deadhead pay, and includes improvements to retirement benefits, sick accrual, bonus flight hour calculations, vacation pay, annual vacation allocation and flex time. Additionally, there are meaningful quality of life improvements in scheduling, hours of service and leave of absence, and the parties have agreed to introduce a minimum day pay and the ability for flight attendants to earn commission from sales of buy on board items. The deal still requires a ratification vote by the union's full membership, which is expected to open later this month.

13:01 EDT Baker Hughes reports U.S. rig count down 1 to 695 rigs

12:31 EDT Creative Medical Technology announces 1-for-10 reverse stock split - Creative Medical Technology Holdings announced that the company's Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1 for 10. The Reverse Stock Split will become effective at 9:00 a.m. Eastern time on June 12, 2023, and the company's common stock will open for trading on The Nasdaq Capital Market on a post-split basis on June 12, 2023 under the company's existing trading symbol "CELZ". At such time, the company's common stock will also commence trading under new CUSIP number 22529Y 408. "We expect that the Reverse Stock Split will increase the market price per share of the Company's common stock, bringing the Company into compliance with the $1.00 minimum bid price requirement for maintaining its listing on The Nasdaq Capital Market," the company said.

12:22 EDT Blue Apron jumps 70% to $9.26 after FreshRealm deal eliminates debt

12:00 EDT Argan falls -13.5% - Argan is down -13.5%, or -$5.98 to $38.26.

12:00 EDT Farfetch rises 9.1% - Farfetch is up 9.1%, or 50c to $5.98.

12:00 EDT Oil-Dri Corporation of America rises 10.0% - Oil-Dri Corporation of America is up 10.0%, or $4.06 to $44.61.

11:39 EDT Blue Apron sees reduced headcount, hitting profitability 'quicker' - The company said in a statement, "In moving to an asset-light model, Blue Apron plans to execute further streamlining of its business, which includes reduced headcount and administrative costs, and drive additional cost savings and continued year-over-year cash burn reduction beyond the initiatives disclosed in December 2022. With the ability to focus on the brand, marketing, product and consumer experience, Blue Apron expects to be more agile, which will facilitate faster decision making, enhance its balance sheet and reduce PTG&A costs. The Company believes this will allow it to get to profitability quicker. Blue Apron plans to provide an update on its profitability goals and future plans on its second quarter 2023 earnings call. "

11:38 EDT Blue Apron says 'asset-light company' after FreshRealm closing - Blue Apron closed its previously announced transaction with FreshRealm. Under the definitive agreements entered into today, Blue Apron transferred its operational infrastructure to FreshRealm, including fulfillment centers, equipment, know-how and related personnel. Blue Apron received approximately $25M of upfront cash, subject to certain adjustments, and is eligible to receive up to $25M of value upon the achievement of certain milestones. "Blue Apron is now an asset-light company, focused on the growth of its direct-to-consumer business. The Company plans to continue to build its strong brand and deliver the high-quality products its customers have come to love. In addition, Blue Apron expects to accelerate the expansion of its product offerings, including the addition of new convenient options. With a portion of the proceeds of the transaction, Blue Apron also completed the repayment of all its outstanding senior secured notes. With this payment, Blue Apron eliminated its debt," the company said in a statement.

11:06 EDT Vertex Pharmaceuticals presents data on CFTR modulators at ECFS Conference - Vertex Pharmaceuticals announced that 12 scientific abstracts on the company's portfolio of cystic fibrosis medicines were presented at this year's European Cystic Fibrosis Society's 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria. Together, the data presented show the long-term benefits of treatment with CFTR modulators as well as the importance of treating the underlying cause of CF as early in life as possible. Key data presented at this year's conference are highlighted below. Vertex presented an interim analysis of a registry-based study of real-world data collected from people with CF and treated with TRIKAFTA, also known in the European Union and in the U.K. as KAFTRIO in combination with ivacaftor, including over 16,000 people with CF from the Cystic Fibrosis Foundation Patient Registry and nearly 3,000 from the German CF Registry. This ongoing five-year post-authorization study is the largest real-world study of people with CF treated with TRIKAFTA to date. The IA showed clinically significant disease-modifying benefits for TRIKAFTA, including improved lung function and a 79% reduction of pulmonary exacerbations in the U.S. and 83% in Germany overall compared to pre-TRIKAFTA baseline. The rate of death was 72% lower in the U.S. and 82% lower in Germany, the rate of lung transplant was 85% lower in the U.S. and 100% lower in Germany, compared to 2019 U.S. CFFPR and German CF Registry populations. No new safety concerns were identified. Vertex also presented final results of the nearly four-year TRIKAFTA open-label follow-up study of the Phase 3 pivotal trials in people with CF ages 12 years and older with at least one F508del mutation in the CFTR gene. The results of this study are unprecedented, showing for the first time that treatment with TRIKAFTA resulted in no decline in lung function over a four-year period.

10:16 EDT Nuvei appoints Laura Miller as chief revenue officer, global head of ecommerce - Nuvei Corporation announced the appointment of Laura Miller to a newly created role of Chief Revenue Officer and Global Head of eCommerce, reporting directly to Nuvei President Yuval Ziv. Her primary responsibilities will include developing Nuvei's strengthening relationships with the enterprises in global eCommerce, as well as heading up its eCommerce commercial organization in North America, Europe, MEA, APAC and LATAM, Nuvei said in a statement.

10:00 EDT ChargePoint falls -8.6% - ChargePoint is down -8.6%, or -83c to $8.78.

10:00 EDT Planet Labs falls -20.2% - Planet Labs is down -20.2%, or -99c to $3.91.

10:00 EDT Samsara rises 10.4% - Samsara is up 10.4%, or $2.90 to $30.67.

09:49 EDT Rite Aid announces Thomas Sabatino as chief legal officer - Rite Aid announced that Thomas Sabatino has joined the company as executive VP and chief legal officer. Sabatino will play a pivotal role in the company's growth strategy to help create meaningful customer, client, and member experiences for millions of Americans. As CLO, he will oversee the organization's legal affairs, including enterprise risk management, compliance, regulatory affairs, and privacy.

09:47 EDT ChargePoint falls -9.2% - ChargePoint is down -9.2%, or -88c to $8.73.

09:47 EDT Teekay Corp. rises 6.4% - Teekay Corp. is up 6.4%, or 37c to $6.15.

09:47 EDT MagnaChip rises 9.0% - MagnaChip is up 9.0%, or 96c to $11.63.

09:44 EDT Robinhood to end support for Cardano, Polygon and Solana coins - Robinhood Markets said in a statement, "We regularly review the crypto we offer on Robinhood. Based on our latest review, we've decided to end support for Cardano (ADA), Polygon (MATIC), and Solana (SOL) on June 27th, 2023 at 6:59 PM ET. No other coins are affected and your crypto is still safe on Robinhood...After the deadline, any ADA, MATIC, and SOL still in your Robinhood Crypto account will be sold for market value and the proceeds will be credited to your Robinhood buying power." Reference Link

09:26 EDT VirnetX signs non-exclusive agreement with Envoy Data - VirnetX announced that it has signed a non-exclusive agreement with Envoy Data Corporation to sell VirnetX's family of products, including VirnetX Matrix, to their 500 small-to-medium-size business customers in Healthcare, Manufacturing, Banking and Agriculture. They will also sell VirnetX Matrix to their 400+ existing channel partners ranging from System Integrators, VARS, MSPs and MSSPs.

09:04 EDT Exela Technologies closes sale of high-speed scanner business - Exela Technologies completed the sale of its high-speed scanner manufacturing and maintenance business, including the Intelliscan family of products, to Imaging Business Machines. Exela customers will continue to receive the technology and best in class solutions as part of the transaction. The Business generated revenue of $20.5 million in 2022 and is included in the ITPS reporting segment. This transaction is part of the strategic initiatives previously announced. The Company plans to use the incremental liquidity for general corporate purposes, debt obligations and transactions expenses. Under ibml's ownership, the Business will continue to provide the complete suite of scanning products and services for our customers, providing a seamless transition.

08:56 EDT Victory Capital reports AUM of $154.8B as of May 31 vs. $157.6B last month - Victory Capital reported assets under management of $154.8 billion as of May 31, 2023, and average assets under management for May of $155.8 billion.

08:54 EDT EVe Mobility Acquisition transfers listing to NYSE - EVe Mobility Acquisition, a special purpose acquisition company, announced that it will transfer its listing from The New York Stock Exchange to the NYSE American LLC, where it has been approved to list. Following the transfer, it will continue to file the same types of periodic reports and other information it currently files with the Securities and Exchange Commission. EVe anticipates the transfer to the NYSE American to occur on or about June 12, 2023.

08:51 EDT Jones Soda names David Knight as new CEO - Jones Soda is pleased to announce that David Knight was appointed by the Company's board of directors (the "Board") to serve as the Company's President and Chief Executive Officer, effective June 23, 2023, to replace Mark Murray who announced his intention to retire on that date. Mr. Knight has previously served as Vice President of Marketing Gatorade International for PepsiCo International, Vice President of Marketing Asia Pacific for Quaker Oats, Vice President of Internal Communications for eBay Inc., and most recently was CEO and Co-founder of SX Latin Liquors.

08:47 EDT Metals Company director buys $3.0M in common stock - In a regulatory filing, Metals Company disclosed that its director Andrei Karkar bought 4M shares of common stock on June 8th in a total transaction size of $3.0M. TMC shares are up 12% in pre-market trading.

08:34 EDT Cineverse, TCL announce content and technology partnership - TCL and Cineverse announced a new content and technology partnership. Through this deal, Cineverse's proprietary Matchpoint technology platform has been selected to provide content services for new TCL televisions in North America. Cineverse will be one of a select few, content aggregators to provide key ad-supported video-on-demand programming as well as provide key content aggregation services. Cineverse will offer its full portfolio of free, ad-supported streaming television channels to TCL users. In addition, Cineverse will also serve as a key demand partner with TCL by providing programmatic ad and direct ad sales expertise for the breadth of content provided by company.

08:32 EDT FirstEnergy names Abigail Phillips as chief risk officer - FirstEnergy announced that Abigail Phillips has been named vice president and chief risk officer, effective July 10. In this role, she will execute a risk program that reflects FirstEnergy's core values and behaviors; implement robust processes, procedures and standards to identify, mitigate and prevent risks across the company; and support efforts by the Board of Directors and senior leadership to implement, review and approve the company's enterprise-wide risk governance and compliance framework.

08:31 EDT Color Star Technology unit, Hua Yu Sheng Shi Group enter partnership - Color Star Technology Co., announces that its subsidiary, Color Metaverse Pte. Ltd., recently entered into a strategic cooperation framework agreement with Hua Yu Sheng Shi Group to work together on developing new entertainment and sports IPs in the future, with terms to be set forth in a definitive written agreement. The partnership will involve co-organizing large-scale events, talent cultivation programs, variety shows, agency operations and commercial rights management.

08:19 EDT Kaival to seek third-party licensing opportunities to monetize new patents - Kaival Brands Innovations provided additional details of its recently-acquired extensive patent portfolio from GoFire, Inc. as it looks to expand its current product offerings to explore near and long-term revenue opportunities. In the near term, Kaival Brands expects to seek third-party licensing opportunities in the cannabis, hemp/CBD, nicotine and nutraceutical markets, as a means of monetizing its new patents. Longer term, the Company believes it can utilize the acquired patents to create innovative and market-disruptive products for its growing base of adult consumers, including patent protected vaporizer devices and related hardware and software applications. The consideration for the purchased patents consisted primarily of Kaival Brands equity securities, consisting of common stock, newly designated Series B Preferred Stock and a warrant to purchase common stock. Importantly, in certain key aspects, the equity consideration was structured in a forward-looking manner with valuations or exercise prices struck at premiums to the current market price of Kaival Brands' common stock. The weighted price per share of the common stock issued and the common stock underlying the Series B Preferred Stock was $1.53 per share on the May 30 closing date, accompanied by warrants with exercise prices ranging from $3.00 and $6.00. Included in the acquired technologies are patented systems and methods that are designed to overcome common issues regarding reliability and consistent dispensing over the entire life of a cartridge or reservoir, as well as improvements to the vaporizing chamber to ensure complete vaporization with minimum residue. The acquired patent portfolio includes the following: Bluetooth Child Safety App and Mechanical Cartridge Protection- A dual lockout system including a child safety lockout via Bluetooth app and child safety measures built mechanically into the cartridge design to prevent accidental consumption by minors. Controlled Delivery- Patented Twist-to-Dose technology utilizes a micro-threaded piston that provides consistent and precise delivery of consumables. There is an audible "click" so the consumer knows exactly how much is inhaled with each use. Flavor Delivery and Experience to Last Puff- Patented technology eliminates the bad taste that is associated with oil and e-liquid degradation. The RefreshFlavor technology is designed in a novel way to keep the vaporized solution safely away from the heating chamber until the moment it is consumed. Leak Proof Design and Removal of Cutting Agents- Patented sealed reservoir prevents leaks from occurring. Ordinary cartridges rely on dangerous thinning agents and wicks to deliver the oil and e-liquid to the heating chamber. The Twist-to-Dose technology with micro-threaded piston system can directly extrude oil into the heating chamber decreasing carbonyl and analyte formation. Authentication System/Counterfeit Protection- The acquired patents also include novel cartridge/pod identification and authentication/counterfeit protection capabilities. Dry Puff Protection- Certain elements of the acquired technologies design mitigate "dry puffs" which can occur when the consumable reservoir in a vaping/inhalation device is depleted, allowing the coil or wick to burn dry and emit potentially harmful toxins. 510 and Pod Compatibility- The technology included in the acquired patents is compatible with both the universal 510 thread format as well as pod based systems, the dominant formats of vaporizer and inhalation technologies. Product Remaining Indicators- The acquired technology provides indicators allowing for consumer insight into remaining product supply. MHRA Requirements- Technology is designed to meet all Medicines and Healthcare products Regulatory Agency requirements in the United Kingdom.

08:09 EDT Avinger announces presentations at NCVH annual conference - Avinger announced two podium presentations featuring the company's Lumivascular technology at the New Cardiovascular Horizons annual conference, which took place May 30 through June 2 in New Orleans. Key opinion leaders in the fields of interventional cardiology and endovascular interventions highlighted Avinger's Lumivascular technology in the following sessions: Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart in Little Rock, highlighted the entire portfolio of Avinger's proprietary OCT-guided atherectomy technologies in his session, "OCT-Guided Atherectomy of ATK and BTK Lesions." Dr. Jon George, Director of Complex Interventions, and interventional cardiologist and endovascular medicine specialist at Pennsylvania Hospital, University of Pennsylvania Health System in Philadelphia, featured Avinger's Pantheris SV OCT-guided atherectomy system in his session, "Utility of the Pantheris Atherectomy Device with OCT Imaging in Treating BTK Lesions," and presented updated interim data from the IMAGE-BTK clinical study. Dr. Cawich commented, "Performing atherectomy with onboard image-guidance provides a number of benefits to both physicians and patients, and results in safer and more effective outcomes than other technologies. A growing amount of published peer-reviewed data supports Avinger's OCT-guided atherectomy as a frontline option for interventionalists treating peripheral vascular disease above and below the knee, as well as in-stent restenosis. The 89% freedom from target lesion revascularization at 12 months in Avinger's INSIGHT study represents best-in-class results for in-stent restenosis patients." Dr. George noted, "Due to safety concerns and lack of long-term durability with most interventional technologies in the below-the-knee space, standalone balloon angioplasty has represented the primary therapy despite the high risk of dissection and low patency rates. With the introduction of Pantheris SV, interventionalists have a new option available that safely and effectively addresses these complex lesions due its onboard image-guidance system and targeted excision mechanism. The interim findings of IMAGE-BTK, a post-market study designed to evaluate the safety and efficacy of Pantheris SV in treating below-the-knee lesions, show a great deal of promise in this area of significant clinical need, with 94% patency in treated vessels at 12 months and 100% freedom from major adverse events. These types of outcomes, if maintained throughout this trial, would validate Pantheris as a standard of care for below-the-knee vascular disease."

08:06 EDT Gentex equips Peugeot Hybrid Hypercar with digital vision system - Gentex Corporation has equipped Peugeot's all-new 9X8 Hybrid Hypercar with an intelligent rear vision system designed to optimize the vehicle's rearward view during the upcoming 24 Hours of Le Mans and for the FIA World Endurance Championship. With a focus on performance and safety, Peugeot Sport and Gentex partnered to implement a digital rearview mirror that will enhance the driver's visibility and situational awareness during the race. The system is an enhanced racing version of Gentex's Full Display Mirror, a digital rearview mirror available on more than 90 passenger vehicles around the world. The technology captures video from a rearward-facing camera and streams it to a mirror-integrated LCD display, providing drivers with a wide, unobstructed view behind the vehicle.

08:03 EDT Shift says strategic alternatives review 'ongoing' - The strategic alternatives review by the Shift Board of Directors is ongoing and includes the evaluation of options regarding the Company's debt.

08:02 EDT Inspire Medical announces FDA approval for AHI expanded indication - Inspire Medical Systems has received approval from the Food and Drug Administration on an expanded indication. The update includes an increase on the upper limit of the Apnea Hypopnea Index to 100 events per hour from 65, and raises the Body Mass Index warning in the labeling to 40 from 32.

07:38 EDT Zomedica launches TRUVIEW digital microscopy platform - Zomedica announced the launch of the revolutionary TRUVIEW digital microscopy platform, featuring the proprietary TRUprep system that automatically prepares slides, along with LiquiViewTM liquid lens technology that provides best-in-class images. Microscopic examination of blood and cytology fluids is the standard of care in the veterinary industry and is utilized by essentially every veterinary practice. The groundbreaking all-in-one TRUVIEW system combines LiquiView advanced optics, TRUprep automated slide preparation and tele-pathology with an easy-to-use interface to ensure consistent quality to boost veterinarian diagnostic confidence. The LiquiView advanced optics system will provide the highest quality slide images on the market, leading to better diagnostics for the pet.

07:36 EDT Vor Bio announces FDA clearance for VCAR33 IND application - The Company announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for VCAR33, a T-cell therapy derived from allogeneic healthy donors using a chimeric antigen receptor specifically binding to CD33. VCAR33 is planned to be studied in the VBP301 clinical trial, which will focus on patients who have relapsed following allogeneic stem cell transplant where T cells harvested from the original donor are used as starting material for the drug product.

07:33 EDT Abeona Therapeutics says FDA requests additional assay data for EB-101 - Abeona Therapeutics received feedback from the U.S. Food and Drug Administration on June 8, 2023, in which the Company gained the Agency's alignment on the data required to establish retroviral vector comparability, a critical Chemistry, Manufacturing and Controls component for the EB-101 Biologics License Application. As part of the package, the FDA requested additional assay data to establish comparability between RVV sourced from Indiana University and RVV manufactured in-house at Abeona, both of which have been used in the EB-101 clinical studies. The Company has the necessary reagents in-house to promptly generate the requested data. To allow the FDA the necessary time to review the requested RVV data, Abeona has requested that its pre-BLA meeting date for EB-101 be rescheduled for August 2023. The Company expects to file its BLA for EB-101 in the third quarter of 2023.

07:18 EDT ADC Therapeutics announces updated LOTIS-2 results of ZYNLONTA - ADC Therapeutics announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA in patients with relapsed/refractory diffuse large B-cell lymphoma. The data are being presented in a poster today at the European Hematology Association 2023 Hybrid Congress and will also be featured in an oral presentation at the 17th International Conference on Malignant Lymphoma being held in Lugano, Switzerland from June 13-17, 2023.The multicenter, open-label, single-arm Phase 2 LOTIS-2 study that evaluated ZYNLONTA in patients with relapsed or refractory DLBCL after greater than or equal to2 prior systemic therapies resulted in an overall response rate of 48.3%, with a complete response rate of 24.8%. The median time to response was 41.0 days for all responders and 42.0 days for patients with a CR. All-grade treatment-emergent adverse events occurring in greater than or equal to30% of all patients were increased gamma-glutamyltransferase, neutropenia, and thrombocytopenia. Key data from 145 evaluable patients as of the data cutoff of September 15, 2022 include the following: The median duration of response was not reached for patients with a CR and was 13.37 months among all responding patients; Of the 36 patients with a CR, 11 were event-free for greater than or equal to2 years with no evidence of disease and no new anticancer therapy; In the subsets of patients who were event-free for greater than or equal to1 year and greater than or equal to2 years, the median duration of time patients remained treatment-free post-ZYNLONTA was 24.8 months and 27.7 months, respectively; No new safety signals were identified.

07:15 EDT Aura Minerals declares semi-annual dividend of 14c per share - Aura Minerals announced that the Company's Board of Directors has declared and approved the payment of a dividend of 14c per common share. In accordance with the Company's dividend policy, the Dividend is in respect of and is based on Aura's expected financial results for the six months ending June 30, 2023.

07:12 EDT Praxis Precision Medicines to begin ulixacaltamide Phase 3 by year-end - Praxis Precision Medicines announced the outcomes from a recent end-of-Phase 2 meeting with the U. S. Food and Drug Administration regarding plans to advance ulixacaltamide into Phase 3 for essential tremor. Key elements of the registration plan: Use of the modified Activities of Daily Living 11 as the primary endpoint is acceptable. In the Phase 2 Essential1 study, mADL11 was nominally significant; Agreement to use a single dose of 60 mg for the Phase 3 trials; Base case assumption confirmed for two Phase 3 trials, one of which will be a 12-week, parallel design study and one of which will be a 12-week randomized withdrawal study for stable responders; Safety database required for a New Drug Application at the minimum required by ICH guidelines: 300 patients with six-months of exposure and 100 patients with one-year of exposure; Agreement that the completed and planned clinical pharmacology and toxicology studies would be sufficient for submission of an NDA. The protocols for the Phase 3 trials are being finalized and Praxis intends to submit to the current Investigational New Drug Application shortly.

07:07 EDT Finch Therapeutics will effect 1-for-30 reverse stock split - Finch Therapeutics will effect a one-for-30 reverse stock split of its issued and outstanding common stock. Finch stockholders approved an amendment to its Amended and Restated Certificate of Incorporation to effect the reverse stock split at Finch's Annual Meeting of Stockholders held on June 8, 2023. The reverse stock split is intended to increase the per share trading price of Finch's common stock to enable Finch to satisfy the minimum price requirement for continued listing on the Nasdaq Global Select Market. Finch expects that, upon the opening of trading on June 12, 2023, its common stock will trade on the Nasdaq Global Select Market on a split-adjusted basis under the current trading symbol "FNCH" and the CUSIP number 31773D200. The reverse stock split affects all issued and outstanding shares of Finch's common stock uniformly and will not alter any stockholder's percentage interest in Finch's equity, except to the extent that the reverse stock split results in some stockholders receiving cash in lieu of any fractional shares. No fractional shares will be issued in connection with the reverse split. Stockholders who would otherwise be entitled to receive a fractional share will instead receive a cash payment in lieu of such fractional shares equal to the fair market value of such fractional shares, as determined in good faith by Finch's Board of Directors. The par value of Finch's common stock will remain unchanged at $0.001 per share after the reverse stock split. There will be no change in the authorized number of shares of common stock or preferred stock after the reverse stock split.

07:06 EDT QuantaSing board authorizes $20M share repurchase program - QuantaSing Group announced that its board of directors has authorized a share repurchase program under which the Company may repurchase up to $20M of its Class A ordinary shares in the form of American depositary shares during a twelve-month period commencing on June 9, 2023.

07:03 EDT ChipMOS reports May revenue $59.7M, down 23.5% y/y - Revenue for the month of May 2023 was $59.7M, representing an increase of 0.7% from April 2023, and a decrease of 23.5% from May 2022.

07:01 EDT OTC Markets Group welcomes Pine Cliff Energy to OTCQX - OTC Markets Group announced Pine Cliff Energy has qualified to trade on the OTCQX Best Market. Pine Cliff Energy Ltd. upgraded to OTCQX from the Pink market.

06:40 EDT AstraZeneca reports danicopan met primary endpoint in Phase 3 ALPHA trial - Results from the pivotal Phase III ALPHA trial showed that investigational, first-in-class oral Factor D inhibitor danicopan as add-on to standard of care C5 inhibitor therapy Ultomiris or Soliris demonstrated a statistically significant and clinically meaningful increase in haemoglobin levels and maintained disease control in patients with paroxysmal nocturnal haemoglobinuria, or PNH, who experience clinically significant extravascular haemolysis, or EVH, compared to placebo plus established C5 inhibitor therapy, AstraZeneca reported. At the prespecified interim analysis for the ALPHA trial - occurring after 63 study participants either completed or discontinued from the primary treatment period of 12 weeks - danicopan met the primary efficacy endpoint. In patients managing PNH with Ultomiris or Soliris, add-on treatment with danicopan was superior to placebo plus Ultomiris or Soliris based on change in haemoglobin from baseline to week 12, reported as least squares mean change from baseline and standard error of the mean. Further, significant improvements in haemoglobin were observed with danicopan by week 2 and maintained through week 12. All key secondary endpoints also met statistical superiority in favour of danicopan plus Ultomiris or Soliris, compared to placebo plus C5 inhibition. Results showed significantly more patients treated with danicopan 59.5% versus placebo 0% experienced an improvement in haemoglobin of greater than or equal to2 g/dL at week 12 in the absence of transfusion. Gianluca Pirozzi, Senior Vice President, Head of Development, Regulatory and Safety, Alexion, said: "As a leader in PNH for decades, Alexion has transformed the treatment landscape by developing the first approved medicine for this rare disease and establishing C5 complement inhibition as standard of care. These promising results presented at the EHA Annual Meeting underscore the potential for targeted Factor D inhibition with danicopan as an add-on to Ultomiris or Soliris to address clinically significant EVH while allowing patients to maintain disease control with established C5 complement inhibitors."

06:34 EDT Hut 8 Mining mined 147 Bitcoin in May - Hut 8 Mining mined 147 Bitcoin in the period ending May 31. Overall, 179 Bitcoin were sold in May for proceeds totaling $6.8M. Total balance of unencumbered Bitcoin held in reserve as of May 31 is 9,233.

06:04 EDT AppTech Payments signs partnership, channel partner agreements with Broadnet - AppTech Payments announced the execution of definitive Strategic Partnership and Channel Partner Agreements with Broadnet Technologies, a business messaging solutions company. Broadnet has over 60,000 customers internationally, making the company an ideal partner to penetrate the U.S. marketplace for Text-to-Pay, 2-way SMS and a suite of SMS tools. The Partnership will strengthen AppTech's sales and distribution efforts and expand the company's market share domestically by enabling AppTech to offer competitive SMS rates and innovative new solutions. In addition, the Partnership will allow AppTech to embed its Text-to-Pay solution into Broadnet's Easy Paperless solution. Easy Paperless enables businesses to print, scan, and send documents to a mobile phone by SMS link.

05:30 EDT TuSimple awarded fully driverless test license by Pudong New Area of Shanghai - TuSimple announced it has been awarded a fully driverless test license by the Pudong New Area of Shanghai in China. TuSimple is among the first batch of companies to be awarded, thus enabling the company to conduct SAE Level 4 fully autonomous Driver Out testing in the designated test areas of Yangshan Deep-water Port and Donghai Bridge. Shanghai is also set to become the first city in China to pass legislation to allow Level 4 fully driverless testing of autonomous trucks.

05:22 EDT ASE Technology reports May revenue $1.51B, down 17.3% - Reports May ATM revenue $856M.

05:13 EDT Vertex, Crispr announce both exagamglogene autotemcel trials met endpoints - Vertex Pharmaceuticals (VRTX) and Crispr Therapeutics (CRSP) announced that both pivotal trials for exagamglogene autotemcel in patients with transfusion-dependent beta thalassemia, or TDT, or severe sickle cell disease, or SCD, met primary and key secondary endpoints at pre-specified interim analyses. The results are being presented at the Annual European Hematology Association, or EHA, Congress. Both CLIMB-111 and CLIMB-121 met their primary endpoint and key secondary endpoint at the pre-specified interim analysis for each trial. These analyses evaluated the efficacy and safety of exa-cel in patients with TDT or SCD in the ongoing Phase 3 trials as well as in the long-term follow up trial CLIMB-131. The data shared are from 83 patients dosed with exa-cel with follow-up up to 43.7 months. All patients treated with exa-cel demonstrated clinical benefit, and these data continue to demonstrate the potentially transformative profile of exa-cel. Of the 35 patients with SCD who had received exa-cel at the time of the analysis, 17 patients were evaluable for the primary and key secondary endpoint at the time of the data cut. Overall, 16/17 achieved the primary endpoint of freedom from vaso-occlusive crises for at least 12 consecutive months. Mean duration of VOC-free was 18.7 months, with a maximum of 36.5 months. 17/17 achieved the key secondary endpoint of being free from hospitalizations related to VOCs for at least 12 consecutive months. The one patient who did not achieve VF12 did achieve HF12 and has a complex set of comorbidities, including a history of chronic pain. One patient who achieved VF12 had a VOC 22.8 months following exa-cel infusion in the setting of a parvovirus infection. This patient has since fully recovered from the infection and been VOC-free. Increases in fetal hemoglobin and total hemoglobin occurred early, within the first few months, and were maintained over time. In the analysis of all patients who received exa-cel, mean fetal hemoglobin was more than 30% of total hemoglobin by Month 3 and was then maintained at approximately 40.0% through follow-up, with pancellular distribution. Mean proportion of edited BCL11A alleles was stable over time in bone marrow and peripheral blood, indicating successful permanent editing in the long-term hematopoietic stem cells. The safety profile of exa-cel was generally consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant. All patients engrafted neutrophils and platelets after exa-cel infusion. As previously reported, two TDT patients had serious adverse events, or SAEs, considered related to exa-cel. One patient had three SAEs considered related to exa-cel: hemophagocytic lymphohistiocytosis, acute respiratory distress syndrome and headache, and one SAE of idiopathic pneumonia syndrome that was considered related to both exa-cel and busulfan. All four SAEs occurred in the context of HLH in the peri-engraftment period and have resolved. One patient had SAEs of delayed neutrophil engraftment and thrombocytopenia, both of which were considered related to exa-cel and busulfan, and both SAEs have resolved. Among the 35 patients with SCD, there were no SAEs considered related to exa-cel. Also as previously reported, one adult patient with SCD developed pneumonia and respiratory failure following SARS-CoV-2 infection, resulting in death. The investigator assessed the events as not related to exa-cel. There were no other deaths or discontinuations, and there have been no malignancies in either study. Patients also had clinically significant improvements in patient-reported outcomes.