Stockwinners Market Radar for June 23, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:02 EDT Vertex Pharmaceuticals reports 'positive' Phase 1/2 VX-880 results - Vertex Pharmaceuticals presented data on all patients dosed in Parts A and B of its Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemic events. All six patients treated with VX-880 had undetectable fasting C-peptide at baseline, a history of recurrent SHEs in the year prior to treatment and required an average of 34.0 units of insulin per day. Following treatment, all six patients demonstrated endogenous insulin secretion, improved glycemic control as measured by HbA1c, improved time-in-range on continuous glucose monitoring, and reduction or elimination of exogenous insulin use. Patients with greater than 90 days of follow-up had elimination of SHEs in the evaluation period. One patient in Part A received a half-target dose of VX-880 and was followed for approximately nine months, at which time this patient received a second half dose. This patient subsequently withdrew consent and was therefore not evaluable for the primary endpoint. Two patients treated with VX-880 had at least 12 months of follow-up after the last infusion and were therefore evaluable for the study's primary efficacy endpoint of elimination of SHEs between Day 90 and Month 12 with a reduction of HbA1c. Both of these patients met the criteria for the primary endpoint of the study. In addition, these two patients are insulin independent. Patient A1 had HbA1c of 5.3% at Month 21, compared to 8.6% at baseline, and Patient B1 had HbA1c of 6.0% at Month 12, compared to 7.6% at baseline. Both patients showed over 95% time-in-range based on continuous glucose monitoring. The ADA recommended target is greater than or equal to70%. The three additional patients in Part B, each administered the full target dose of VX-880 given as a single infusion, have follow-up between 29 and 90 days and have shown endogenous insulin secretion, reduction in HbA1c, improvements in glucose time-in-range, and reductions in daily exogenous insulin use. Their trajectory is consistent with that observed in the two patients with more than one year of follow-up at equivalent periods of follow-up after VX-880 infusion. VX-880 has been generally well tolerated in all patients dosed to date. The majority of AEs were mild or moderate, and there were no serious AEs related to VX-880 treatment. The most common AEs were dehydration, diarrhea, hypomagnesemia and rash. As previously reported, one subject had SHEs in the perioperative period. As a result of these safety and efficacy data in Parts A and B, the independent data review committee has recommended moving to Part C of the trial, which allows for concurrent dosing of patients at the full target dose of VX-880.

17:52 EDT FDA approves Pfizer's Litfulo for treatment of severe alopecia areata - Pfizer announced that the U.S. Food and Drug Administration has approved LITFULO, a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents with severe alopecia areata. "While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs in their teens, twenties, or thirties," said Dr. Brittany Craiglow, Associate Professor Adjunct - Dermatology at Yale School of Medicine. "LITFULO is a particularly important treatment option for younger patients with substantial hair loss, who often struggle with such a visible disease." LITFULO is a kinase inhibitor which inhibits Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases. "LITFULO is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults," said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. "With today's approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth."

17:30 EDT HII awarded contract modification for John F. Kennedy aircraft carrier - HII announced that its Newport News Shipbuilding division has received contract modifications totaling $393.3 million from the U.S. Navy to shift the delivery strategy for the aircraft carrier John F. Kennedy (CVN 79). The contract action announced today revises the delivery approach for the second Gerald R. Ford-class aircraft carrier, shifting work previously planned for Post-Shakedown Availability (PSA) completion at NNS into the baseline construction contract. Under the new delivery strategy, John F. Kennedy will now deliver to the Navy July 31, 2025. "The contract modification reflects extensive collaboration with the Navy, as we have supported their decision to change the delivery strategy," said Lucas Hicks, NNS vice president for John F. Kennedy (CVN 79) new construction aircraft carrier program. "This strategy will decrease post-delivery work required and increase ship capability and readiness at delivery. We understand the importance of Kennedy and look forward to delivering this mission-ready capability to the Navy."

17:15 EDT Huntington Ingalls awarded $274.04M, $119.21M Navy contract modifications - Huntington Ingalls was awarded a $274.04M mixed-price incentive and a $119.21M cost-plus-fixed-fee and cost-plus-incentive-fee modification to the previously awarded contracts respectively, to improve capability at ship delivery, define unpriced change orders, and for additional engineering and integrated logistics support for Pre-Commissioning Unit John F. Kennedy. Work will be performed in Newport News, Virginia, and is scheduled to be complete by July 31, 2025. No funding is being obligated at time of award. The Naval Sea Systems Command is the contracting activity.

16:16 EDT Hagerty raises $105M in capital from existing strategic investors - Hagerty announced that the company is raising $105M in capital from existing strategic investors including State Farm, Markel Group and the Hagerty family. This capital raise is comprised of $80M of convertible preferred equity, which closed on June 23rd, 2023, as well as a $25M commitment of long-term debt financing for Hagerty Reinsurance Limited. The funds will help support the company's profitable growth initiatives focused on serving the car enthusiast community. This includes evolving the company's risk appetite and core product to augment its offerings to current members and reach new members who represent 33M enthusiast vehicles in the United States which is expected to drive meaningful written premium and operating profit growth over the coming years. The capital will also allow Hagerty to make ongoing technology investments that should drive operating efficiencies while improving customer facing interactions.

16:15 EDT Alpha Metallurgical announces two separate operational challenges - Alpha Metallurgical Resources announced two separate operational challenges. While both issues have been substantially resolved, they are expected to delay certain shipments that would have otherwise occurred within the second quarter of 2023. Due to a ventilation issue likely stemming from a previously mined and worked-out area, the Road Fork 52 mine in Wyoming County, West Virginia temporarily halted production as a safety precaution while the issue was analyzed and addressed. Ventilation adjustments were made, and acceptable air quality levels were reestablished in the mine, which is now back in operation. Currently, the mine is running at roughly one-third capacity and is expected to ramp back towards full capacity in the next several days as technical inspections are performed and system functions are verified. Operations teams coordinated with the applicable regulatory agencies, as required, and no injuries or citations were incurred. The temporary shutdown of production at Road Fork 52 lasted approximately six days, which will result in the delayed shipment of coal to customers who have received force majeure letters notifying them of these circumstances. Alpha expects to be able to make up these delayed tons in the third quarter. An unrelated issue at the Dominion Terminal Associates (DTA) facility in Newport News, Virginia, in which Alpha has a sixty-five percent ownership interest, has also contributed to an expected delay in Alpha shipments. At DTA, one of the stacker/reclaimer machines experienced a mechanical failure that caused it to be inoperable for a period of approximately three days while it was repaired. This timeframe of inoperability hampered train unloading capability and created related vessel loading delays for roughly 250,000 short tons of Alpha shipments for export customers. These customers have received force majeure letters, and Alpha expects to be able to fulfill these shipments in early July. With the repairs complete and all systems operating as normal, the stacker/reclaimer is now back to full capacity. "Our teams safely and quickly addressed the separate issues at our Road Fork 52 mine and at DTA, bringing each unfortunate interruption to a positive conclusion in a relatively short period of time," said Andy Eidson, Alpha's chief executive officer. "We have been in communication with our customers to explain these circumstances and reiterate our commitment to serving them. Now that we are working back towards full productive capacity at Road Fork 52, we expect to swiftly make up lost time with some extra shifts, and we are already rescheduling vessels at DTA in the early days of July."

16:10 EDT Mercury Systems CEO Mark Aslett resigns, Bill Ballhaus named interim CEO - Mercury Systems announced that following a comprehensive review of strategic alternatives, the board of directors of Mercury has determined that execution of the company's strategic plan under a refreshed leadership team represents the best path forward. In connection with this determination, the company also announced a series of leadership and board changes, including the initiation of a president and CEO transition, the appointment of a new independent director, and the identification of a second new independent director and a permanent CFO. Bill Ballhaus, a member of the board, has been appointed Interim president and CEO, effective June 24 and will serve in this role until a permanent successor is named. Ballhaus succeeds Mark Aslett, who has resigned from his role as president and CEO of the company. His resignation is effective June 24. The Board has commenced a comprehensive search process, which will include external and internal candidates, to identify a permanent CEO with the assistance of a leading executive search firm.

16:02 EDT iMedia Brands receives second Nasdaq notice of non-compliance - iMedia Brands announced that the company received a second notice of non-compliance from the Listing Qualifications Department of the Nasdaq Stock Market on June 16, 2023, related to Nasdaq Listing Rule 5250(c)(1) as a result of its failure to file its Form 10-Q for the period ended April 29, 2023, with the SEC. As previously disclosed, the company received an initial notice from Nasdaq on May 3, 2023, regarding its non-compliance with the Rule following the company's delay in the filing of its Annual Report on Form 10-K for the year ended January 28, 2023.

15:17 EDT Designer Brands amending previously announced $100M 'Dutch auction' tender offer - Designer Brands announced that it is amending its previously announced modified "Dutch auction" tender offer to purchase for cash up to $100M in value of its Class A common shares. The offer originally was set at a price per share not greater than $8.00 nor less than $7.00, less any applicable withholding taxes and without interest. Additionally, the offer originally was conditioned on the company entering into a term loan agreement for $135M to be used principally to fund the offer. As amended, the offer is now set at a price per share not greater than $10.00 nor less than $8.75, less any applicable withholding taxes and without interest. Furthermore, as amended, the offer is no longer subject to the financing contingency, as the company has satisfied such condition through its entry into a senior secured term loan in the maximum aggregate principal amount of $135M, effective June 23. The offer will expire at 12:00 Midnight, ET, at the end of the day on July 7, the company noted.

13:25 EDT FDA approves Bayer's Ultravist injection for contrast-enhanced mammography - Bayer announced that Ultravist-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration for contrast-enhanced mammography, "making it the only contrast agent approved for this indication." Bayer stated: "The product can be used to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to help identify breast lesions. The new FDA approved indication aligns with the recent increased focus on supplemental imaging needs for women at a higher risk for breast cancer, which may include the 40-50% of U.S. women older than 40 with dense breasts."

13:02 EDT Baker Hughes reports U.S. rig count down 5 to 682 rigs - Baker Hughes reports that the U.S. rig count is down 5 from last week to 682 with oil rigs down 6 to 546, gas rigs unchanged at 130 and miscellaneous rigs up 1 to 6. The U.S. Rig Count is down 71 rigs from last year's count of 753 with oil rigs down 48, gas rigs down 27 and miscellaneous up 4. The U.S. Offshore Rig Count is down 1 to 19, up 3 year-over-year. The Canada Rig Count is up 10 from last week to 169, with oil rigs up 7 to 110, gas rigs up 3 to 59. The Canada Rig Count is up 15 rigs from last year's count of 154 with oil rigs up 6, and gas rigs up 9.

12:12 EDT Mirum Pharmaceuticals presents data on LIVMARLI at EASL Congress - Mirum Pharmaceuticals announced data presented during the European Association for the Study of the Liver Congress 2023, taking place in Vienna, Austria. The congress presentations feature new analyses from the LIVMARLI oral solution MARCH-PFIC study as well as the long-term extension study, MARCH-ON. MARCH-PFIC is the largest Phase 3 trial in progressive familial intrahepatic cholestasis, evaluating all types, including genetic types that had not previously been studied. The data underscore long-term maintenance of effect, markers of improved liver health, impact on sleep improvement and long-term safety data. Additionally, data showing LIVMARLI's benefit in adult patients with Alagille syndrome was presented during EASL. Data from Mirum's studies of LIVMARLI include oral and poster presentations: Abstract OS-072: Maralixibat leads to significant reductions in bilirubin for patients with Progressive Familial Intrahepatic Cholestasis: Data from MARCH-PFIC: The goal of the analysis was to characterize the impact of maralixibat on bilirubin in patients with PFIC as part of the MARCH Phase 3 study, specifically evaluating the mean change in baseline in total and direct bilirubin. Clinical evidence suggests that elevated serum bilirubin levels may indicate poorer outcomes in patients with PFIC. The data demonstrated: Maralixibat resulted in statistically significant improvements in total and direct bilirubin in the All-PFIC cohort versus placebo. Of the patients with abnormal total bilirubin values at baseline, 40% of maralixibat-treated patients achieved normalization, versus none in the placebo group. Reductions in bilirubin corresponded with reductions in serum bile acids. Data suggest that maralixibat may yield clinical improvements in liver health in patients with PFIC. Maralixibat is the only IBAT inhibitor to demonstrate significant decreases in total and direct bilirubin compared with placebo in patients with PFIC. LBP-35: Long-term maintenance of response and improved liver health with maralixibat in patients with progressive familial intrahepatic cholestasis: Data from the MARCH-ON study: The analysis evaluated the long-term maintenance response to maralixibat in patients who were randomized to receive maralixibat or placebo in MARCH and continued treatment with maralixibat in MARCH-ON. Eighty-five patients from MARCH enrolled in MARCH-ON. Baseline was defined as the start of maralixibat treatment for each group. The results showed: Significant improvements observed in the first 26 weeks of the MARCH study were sustained from Baseline to Week 52 in MARCH-ON for pruritus severity, sBA levels, total bilirubin, height -score and weight Z-score in the MRX-MRX group. Newly gained statistically significant reductions in pruritus severity and sBA levels were observed in the key efficacy endpoints from Baseline to Week 26 in the MRX-PBO group, in line with observations from the initial MARCH maralixibat group. No new safety signals were identified. The most frequent treatment emergent adverse events were gastrointestinal-related, in line with the mechanism of action of IBAT inhibition, mostly mild and transient. Patients who previously received maralixibat in MARCH were less likely to have events in MARCH-ON compared to MARCH. The data suggest overall improved liver health following maralixibat treatment in patients with PFIC, which are maintained over time. WED-257: Impact of maralixibat on cholestatic pruritus in adults aged 16 years and older with Alagille syndrome: Previous data in ALGS has been largely focused on pediatric populations; however, 24-40.3% of patients with ALGS reach 18 years of age with their native liver and may require treatment for cholestasis and pruritus. This analysis reported, for the first time, the efficacy and safety of maralixibat in adult patients with ALGS; greater than or equal to16 years transitioning to adult care and participants aged greater than16 years who initiated treatment in the ALGS clinical program. Results demonstrated that: Patients receiving maralixibat during childhood had significant improvements in pruritus that were maintained into adulthood. Maralixibat was generally well-tolerated and demonstrated a safety and tolerability profile consistent with previously reported data. The observations in this analysis support the potential for maralixibat to have a positive impact on the treatment for adults with ALGS who survive with their native liver into adulthood. WED-252: Maralixibat leads to significant reductions in pruritus and improvements in sleep for children with Progressive Familial Intrahepatic Cholestasis: Data from MARCH-PFIC: The analysis evaluated data from the Phase 3 MARCH-PFIC study and assessed pruritus response, as well as the relationship between a reduction in pruritus and an improvement in sleep. The proportion of patients with an itch score of less than or equal to1 during treatment, the measurement of pruritus at different times throughout the day, the physician's assessment of pruritus, and the overall impact of pruritus on sleep were assessed. The data demonstrated that: Maralixibat was associated with complete or near-complete resolution of pruritus in the majority of patients with PFIC; the median proportion of days with pruritus scores of 0-1 was 95% for maralixibat and only 9% for placebo. The effect of maralixibat on pruritus was independent of when or how it was measured, or who made the assessments. Absolute values of pruritus as well as changes in pruritus were strongly correlated with improvements in sleep; spearman r=0.93; pless than0.000 for both analyses, suggesting that maralixibat may result in meaningful improvements in this aspect of quality of life. WED-282: Analysis of safety in maralixibat-treated participants with Progressive Familial Intrahepatic Cholestasis: Data from MARCH-PFIC: The poster provided a detailed safety analysis from the MARCH-PFIC clinical trial, the largest and most genetically inclusive study of PFIC to date and included participants with variants not known. The analysis showed that maralixibat was overall well-tolerated with no new safety signals observed. The most frequent treatment-emergent adverse events were gastrointestinal and were generally mild with only 5.5 days duration. Fat soluble vitamin deficiency and increased bilirubin occurred more frequently in the placebo group compared with maralixibat. No changes in liver enzymes were observed over the duration of the study and individual elevations were mild and transient; there were no discontinuations. All serious adverse events resolved without any dose reductions. Overall, dosing with maralixibat was shown to be well-tolerated with an acceptable safety profile for chronic dosing.

12:00 EDT Carvana falls -12.3% - Carvana is down -12.3%, or -$3.13 to $22.41.

12:00 EDT Virgin Galactic falls -21.0% - Virgin Galactic is down -21.0%, or -$1.11 to $4.21.

12:00 EDT Big Lots rises 7.3% - Big Lots is up 7.3%, or 57c to $8.35.

11:31 EDT Security Federal board adopts stock repurchase program up to 3% of shares - Security Federal Corporation announced that its Board of Directors has adopted a stock repurchase program. Under the repurchase program, the Company may repurchase up to approximately 3% of the current outstanding shares.

10:18 EDT Supreme Court rules for Coinbase, says district court must stay its proceedings - In a ruling published on the court's website, Supreme Court Justice Kavanaugh wrote: "When a federal district court denies a motion to compel arbitration, the losing party has a statutory right to an interlocutory appeal. See 9 U. S. C. Section16(a). The sole question here is whether the district court must stay its pre-trial and trial proceedings while the interlocutory appeal is ongoing. The answer is yes: The district court must stay its proceedings." The court explains in its decision: "Abraham Bielski filed a putative class action on behalf of Coinbase users alleging that Coinbase, an online currency platform, failed to replace funds fraudulently taken from the users' accounts. Because Coinbase's User Agreement provides for dispute resolution through binding arbitration, Coinbase filed a motion to compel arbitration. The District Court denied the motion. Coinbase then filed an interlocutory appeal to the Ninth Circuit under the Federal Arbitration Act, 9 U. S. C. Section16(a), which authorizes an interlocutory appeal from the denial of a motion to compel arbitration. Coinbase also moved the District Court to stay its proceedings pending resolution of the interlocutory appeal. The District Court denied Coinbase's stay motion, and the Ninth Circuit likewise declined to stay the District Court's proceedings pending appeal." Reference Link

10:00 EDT C3.ai falls -7.9% - C3.ai is down -7.9%, or -$2.97 to $34.47.

10:00 EDT Virgin Galactic falls -15.4% - Virgin Galactic is down -15.4%, or -82c to $4.50.

10:00 EDT CarMax rises 8.4% - CarMax is up 8.4%, or $6.61 to $84.93.

09:52 EDT IonQ raises 2023 bookings view to $45M-$55M from $38M-$42M - IonQ announced that the company is increasing its 2023 bookings expectations by 25% to a range of $45M-$55M. At the midpoint, IonQ is now expecting more than 100% growth in bookings compared to last year's record bookings performance of $24.5M. IonQ's increased bookings expectation comes on the heels of a recent $28M commercial transaction that will see IonQ install two future quantum systems in Europe, including an anticipated future #AQ1 64 system. Such a quantum computer would be capable of considering more than 18 quintillion different possibilities simultaneously, and is anticipated to demonstrate quantum advantage over the very best supercomputers across a variety of applications. This transaction will also allow IonQ to service its European customers out of a joint data center, with IonQ and its partner each managing 50% of the IonQ systems. IonQ currently anticipates delivering the first quantum system in Europe after 2023 and, as such, the company is not increasing its expectations for 2023 recognized revenue.

09:47 EDT Sasol falls -6.0% - Sasol is down -6.0%, or -78c to $12.29.

09:47 EDT IonQ rises 6.9% - IonQ is up 6.9%, or 65c to $10.08.

09:47 EDT CarMax rises 10.9% - CarMax is up 10.9%, or $8.54 to $86.86.

09:42 EDT California, others join FTC challenge of Amgen deal to buy Horizon Therapeutics - California Attorney General Rob Bonta announced joining the Biden Administration in a legal effort to block Amgen (AMGN) from purchasing Horizon Therapeutics (HZNP). "In challenging the $28 billion acquisition, the Federal Trade Commission (FTC) alleges that the proposed acquisition raises significant anti-competitive concerns. This is the FTC's first ever challenge of a pharmaceutical merger. Today, the California Department of Justice, which has for years called on the federal government to enforce competition laws more aggressively, welcomed and joined the lawsuit. DOJ believes that the proposed merger would allow Amgen to virtually monopolize the market for certain crucial medications, and would reduce affordability, access, and choice of drugs for California's most vulnerable patients," the AG stated. In addition to California, New York, Illinois, Wisconsin, Minnesota and Washington state also joined the FTC's lawsuit to block the combination on antitrust grounds. Reference Link

09:38 EDT Trxade Health Inc trading resumes

09:33 EDT Trxade Health Inc trading halted, volatility trading pause

09:21 EDT Nikola says 'foul play is suspected' after fire at Phoenix HQ - Nikola Motor tweeted: "Early this morning behind our Phoenix headquarters, a fire occurred which affected multiple battery electric trucks. No one has been injured. Foul play is suspected as a vehicle was seen in the area of the affected trucks just prior to the incident and an investigation is underway. Our team applauds the Phoenix and Tempe Fire Departments for taking quick action and staying on top of the situation. We will release additional information as it becomes available." Reference Link

09:09 EDT FuboTV partners with Seattle Mariners - FuboTV announced that it is now a proud partner of the Seattle Mariners. Fubo's marketing partnership with the Mariners marks its fourth with a Major League Baseball team following recent agreements with the Boston Red Sox, Cleveland Guardians and St. Louis Cardinals. The partnership includes the display of Fubo branding at select Mariners home games as well as fan engagement opportunities. Additionally, Mariners season ticket holders will receive an invite from the club inviting them to join Fubo through a free 30 day trial.

09:07 EDT EnWave announces option trade program, additional option grant for employees - EnWave has adopted a value-for-value option trade program for non-insider employees whose current stock options are significantly "out of the money". The Program is designed to incentivize and retain key employees. Non-insider employees will have the option to elect to exchange their previously awarded stock options for up to 905,515 new stock options with equivalent value. The Traded Options will have a five-year term and an exercise price of $0.75, which is a premium to the current market price of the Company's common shares. As a result of the Program, the total number of outstanding stock options will be materially reduced. The Company will also grant a total of 500,000 additional stock options under its current share option plan to certain employees of the Company on the same terms as the Traded Options which vest over 18 months.

09:05 EDT Motorsport Games releases NASCAR Heat 5 - Next Gen Car Update - Motorsport Games have released the NASCAR Heat 5 - Next Gen Car Update offering fans the exhilarating opportunity to experience the debut of the 2022 NASCAR Cup Series Chevrolet Camaro ZL1, Ford Mustang GT, and Toyota Camry TRD Next Gen cars.

09:04 EDT Bright Green to be added to the Russell 3000 Index - Bright Green Corporation announced that it is set to join the broad-market Russell 3000 Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the US market opens on June 26, 2023. "We believe that inclusion in the widely referenced Russell U.S. Indexes is another milestone in Bright Green's progress, which includes our recent DEA approval making us the only publicly traded, federally authorised company in the United States," said Seamus McAuley, Bright Green's Chief Executive Officer. "We look forward to continued progress on our strategic path as we now shift our focus to producing high quality API and botanical raw material for sale to researchers across the U.S. and internationally, as well as producing API for candidates, and so, inclusion in the Russell Index in the healthcare category is continued demonstration of our progress and of the development of the Company and its capabilities."

09:03 EDT Finward Bancorp appoints Kwait as SVP, General Counsel, CRO - Finward Bancorp announced the appointment of David Kwait as the Senior Vice President, SVP, General Counsel, Corporate Secretary, and Chief Risk Officer, CRO, of the Bancorp and the Bank, with the appointment to be effective as of June 30, 2023. Kwait joined the Bank in 2011, when he was hired as an Assistant Vice President, Staff Attorney, Legal Counsel, and Wealth Management Officer. In his new role as Chief Risk Officer, General Counsel and Corporate Secretary, Kwait will lead the Risk Management and Compliance teams in fostering and advancing a culture of compliance, as well as coordinating with the Bank's operational and administrative functions to effectively manage risk.

09:02 EDT Digerati terminates combination agreement with Minority Equality Opportunities - Digerati Technologies (DTGI) has terminated its Business Combination Agreement with Minority Equality Opportunities Acquisition (MEOA). Arthur Smith, CEO of Digerati, commented, "Due to the circumstances created by the trading halt of MEOA's stock and related Nasdaq listing application approval issues, we determined it was in the best interest of Digerati and its shareholders to terminate the BCA. Although we pursued this transaction for all the right reasons, including meeting certain corporate objectives, we reached a point where we had to do what was best for the Company and its shareholders. We need to move on, put this transaction and the associated resources and costs behind us, and continue building on the solid foundation we have constructed to date via our disciplined acquisition strategy. Our foundation consists of a great business built by an exceptional team that has executed almost flawlessly over the last six years by sourcing, qualifying, and closing on six acquisitions and subsequently delivering on fundamental ROI and EBITDA objectives upon integration. We have a solid and proven business model that has taken us from $200,000 in annual revenue to over $32 million since its launch in FY2017. During the current 2023 fiscal year, we optimized our acquisition platform that was built for scaling organically and via mergers and acquisitions. At this point, we are eager to return to acquisition mode and pursue strategic opportunities that have been on hold pending the closing of the business combination with MEOA."

08:59 EDT Indus Realty Trust receives CFIUS clearance for merger - Indus Realty Trust announced that it has received written notice from the Committee on Foreign Investment in the United States, or CFIUS, that it has concluded its review and cleared the transaction contemplated by the previously announced agreement and plan of merger, dated as of February 22 by and among the company, IR Parent, a Delaware limited liability company and IR Merger Sub. All regulatory approvals required to close the merger pursuant to the merger agreement have now been received. The parties currently expect to close the merger on June 29, subject to the satisfaction or waiver of the remaining closing conditions set forth in the merger agreement.

08:55 EDT Vistagen regains compliance with Nasdaq - Vistagen announced that it received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market indicating that Vistagen has regained full compliance with the minimum $1.00 bid price per share or greater requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Vistagen is now in full compliance with all applicable Nasdaq listing requirements, and Nasdaq considers the matter closed.

08:35 EDT Navitas, GravaStar roll out charger customized to Transformers movie characters - Navitas Semiconductor announced that GravaStar's new Alpha65 Transformers-branded fast chargers use the next-generation GaNSense Control power IC. These custom chargers celebrate the world-wide release of the action-packed movie "Transformers: Rise of the Beasts." Each '2C1A' 65 W charger has two USB Type C and one USB Type A output, to fast-charge three devices simultaneously, including laptops, cellphones, tablets, earbuds, etc.

08:33 EDT Exela Technologies announces satisfaction of requisite consents condition - Exela Technologies it has extended the early tender time from 5:00 p.m., New York City time, on June 22, 2023 until 5:00 p.m., New York City time, on June 29, 2023, with respect to the previously announced exchange offer by certain of its subsidiaries for Old Notes as described in the Offering Memorandum. As of the Original Early Tender Time, approximately $955.5 million of outstanding Old Notes were tendered for exchange pursuant to the Exchange Offer and the Requisite Consents condition had been satisfied. The Company expects the Initial Settlement Date for the Exchange Offer to occur promptly after the Extended Early Tender Time. Upon settlement, Old Notes validly tendered at or prior to the Extended Early Tender Time and not validly withdrawn in accordance with the terms of the Exchange Offer will be exchanged into the Issuers' new 11.500% First-Priority Senior Secured Notes due 2026 on the basis of $800 principal amount of the New Notes for each $1,000 principal amount of outstanding Old Notes. The deadline to validly withdraw tenders of the Old Notes was not extended and expired at 5:00 p.m., New York City time, on June 22, 2023. The Exchange Offer and the Consent Solicitation will expire at 11:59 p.m. New York City Time on July 7, 2023, unless extended or terminated. The Exchange Offer and the Consent Solicitation are being made upon the terms and conditions set forth in the confidential offering memorandum and consent solicitation statement, dated June 8, 2023. Capitalized terms used but not defined in this press release have the respective meanings ascribed to such terms in the Offering Memorandum.

08:32 EDT Surgalign receives Nasdaq delisting notice following Chapter 11 filing - Surgalign received a letter from the Listing Qualifications Department of the Nasdaq Stock Market. Nasdaq has determined that due to the Company's voluntary petition for relief under chapter 11 of the U.S. Bankruptcy Code, the Company's securities will be delisted from The Nasdaq Stock Market. The Company does not intend to appeal Nasdaq's determination. As previously announced, Surgalign entered into an asset purchase agreement to sell substantially all its global hardware and biomaterials assets and filed voluntary petitions for relief under chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas, Houston Division. The Company intends to pursue an auction and sale process under section 363 of the U.S. Bankruptcy Code for its Digital Health business and has a stalking horse bidder in place for its hardware and biomaterials assets. The Company intends to continue to operate its business in the normal course while in chapter 11. Trading of the Company's common stock will be suspended at the opening of business on July 3, 2023, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's securities from listing and registration on The Nasdaq Stock Market. Once the delisting from Nasdaq takes effect, the Company's common stock is expected to begin trading on the OTC under the symbol SRGAQ.

08:23 EDT Amylyx gets negative CHMP opinion on marketing authorization of AMX0035 - Amylyx announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a negative opinion on the application for conditional marketing authorisation of AMX0035, for the treatment of adults with amyotrophic lateral sclerosis in the European Union. This update follows the company's May announcement that the CHMP was trending toward a negative opinion.

08:17 EDT Bird Global expands operations in Vienna - Bird Global announced the expansion of its operations in Vienna, Austria. Bird, which pioneered e-scooters in Vienna in 2018, was awarded a new three-year permit that includes expansion of its services throughout the city including outer districts. As a result, Bird is doubling its fleet size in Vienna, increasing its operational area by 250% and population served by 120%. Following a rigorous review process by the City of Vienna, Bird was selected on the basis of its mobility concept, which places a special focus on safety, sustainability and technical innovation.

08:12 EDT Aldeyra to be added to Russell 2000, Russell 3000 indexes - Aldeyra announced that it will be added to the Russell 2000 and the Russell 3000 indexes, effective after the U.S. equity markets close on June 23.

08:09 EDT Ramaco Resources provides dual-class structure update - The shares of the Class B Common Stock of Ramaco Resources began trading on June 22nd, 2023 on Nasdaq under the ticker symbol "METCB." The Class B common stock provides holders of METCB with direct participation in the financial performance of what the Company calls the "CORE" assets, which is an abbreviation of "Carbon Ore-Rare Earth." The company views the CORE assets as a unique group of assets which are distinct from its metallurgical coal mining operations. By creating a separate stock that will participate in the financial performance of these assets we feel it will unlock additional value to both the company and its shareholders. It is important to note that, effective at the commencement of trading on June 22nd, 2023, NASDAQ made a decision, independent of the company, to adjust downward the reported historical prices of METC by approximately 18.2%. That NASDAQ change has given rise to substantial questions from investors, particularly those holding the Class A Common Stock. Investors should note that the addition of the Class B common stock does not cause a reduction in the company's net income, Adjusted EBITDA, or impact any potential future dividends for holders of the Class A Common Stock of the company. Indeed, the company believes this new structure will create new additional value for shareholders of both classes of stock.

08:07 EDT AbbVie receives positive CHMP opinion for atogepant - AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide receptor antagonist treatment spanning both episodic and chronic migraine in the European Union.

08:05 EDT Abcam to explore strategic alternatives, including sale of company - Abcam announces that, having listened to and extensively engaged with shareholders, the Board of Directors has unanimously decided to initiate a process to explore strategic alternatives for the company. The comprehensive process will begin immediately and will evaluate a broad range of options to maximize shareholder value, including a potential sale of the company. As previously disclosed, Abcam has received strategic inquiries from multiple parties over the past few weeks. The Board of Directors has retained Lazard and Morgan Stanley as financial advisors to assist in its review of strategic alternatives. Latham & Watkins has been appointed as legal advisor in connection with the review process.

08:04 EDT Ocean extends patent rights for idiopathic pulmonary fibrosis discovery - Ocean Biomedical announced that Scientific Co-founder Dr. Jack Elias, MD received notice from the European Patent Office of its intention to grant European patent rights for Methods and Compositions relating to the treatment of fibrosis using Ocean's anti-Chitinase 1 small molecule candidate, a new target discovered by Dr. Elias that appears to be a major factor in controlling-and inhibiting-fibrosis progression. Ocean's approach has shown an 85%-90% reduction in collagen accumulation in four "gold standard" IPF and HPS pulmonary fibrosis animal models. This treatment approach is anticipated to be well-tolerated based on data from original clinical studies and recent EPA data. "Combining innovative science with a great management team has potential for great impact," said Dr. Chirinjeev Kathuria, Ocean Biomedical's co-founder and Executive Chairman. "We are pleased to receive this patent extension and look forward to getting new drugs to patients in Europe and the world."

08:03 EDT Rezolve AI Limited announces filing of registration statement on Form F-4 - Rezolve AI Limited and Armada Acquisition Corp. I announced the filing of a registration statement on Form F-4, which contains a preliminary proxy statement/prospectus, with the U.S. SEC in connection with their proposed business combination. On December 17, 2021, Rezolve AI entered into a definitive Business Combination Agreement with Armada, which is expected to close in the latter part of 2023, subject to approval by Armada's shareholders, the Registration Statement being declared effective by the SEC, and other customary closing conditions. Upon closing of the transaction, the combined company's shares are expected to trade on the Nasdaq under the ticker symbol "ZONE".

08:01 EDT scPharmaceuticals expects to be added to Russell 2000, Russell 3000 - scPharmaceuticals announced that it expects to be added to the small cap Russell 2000 and broad market Russell 3000 Indexes at the conclusion of the Russell US Indexes annual reconstitution, effective when the US market opens on June 26, 2023, according to a preliminary list of additions posted on May 19, 2023.

08:00 EDT Brown & Brown appoints Paul Krump, Bronislaw Masojada to board - Brown & Brown (BRO) announces the addition of Paul Krump and Bronislaw Masojada to Brown & Brown's board of directors. Krump retired from Chubb (CB), effective January 1, 2023, most recently serving as vice chairman, global underwriting and claims from September 2020 until his retirement. Masojada served as chief executive officer of Hiscox Group from 2000 until his retirement in 2021. He first joined Hiscox in 1993 as group managing director.

07:34 EDT Glencore makes strategic equity investment in Stillwater Critical Minerals - Stillwater Critical Minerals executed a definitive agreement for a strategic equity investment by Glencore Canada Corporation in the form of a non-brokered private placement financing for exploration and development activities at the Company's North American nickel projects, as well as for working capital and general and administrative expenses. Pursuant to the Placement, Glencore has agreed to purchase 19,758,861 units of Stillwater at a price of $0.25 per unit for gross proceeds of $4.94 million, with each unit comprising one common share and 0.70 of a common share purchase warrant. Each full warrant shall entitle Glencore to purchase one common share at an exercise price of $0.375, providing up to approximately $5.2 million additional funding, if exercised in full. The warrants shall be exercisable for three years from the date of issue and contain a customary acceleration provision, which shall be effective if the volume weighted average trading price of the common shares on the TSX-V is greater than $0.5625 for a period of 20 consecutive trading days. Following closing of the investment, Glencore will have ownership and control of 9.99% of the outstanding common shares of Stillwater on a non-diluted basis and, including the warrants, 15.87% of the outstanding common shares on a partially diluted basis. Glencore does not currently own or control any securities of the Company. In connection with the Placement, Stillwater and Glencore have agreed to enter into an investor rights agreement, pursuant to which Glencore will be entitled to certain customary rights including participation in future equity issuances and a right to maintain its pro-rata position in Stillwater. In addition, a technical committee will be formed with representatives from each company. Net proceeds of the private placement are intended to be used for exploration and development activities at the Company's North American nickel projects, as well as for working capital and general and administrative expenses. The Placement is expected to close, subject to customary conditions, upon acceptance by the TSX Venture Exchange. All securities issued pursuant to the Placement will be subject to a four-month hold period from the date of issuance in accordance with applicable securities laws.

07:33 EDT Miami-Dade Transit awards contract to NFI for 100 New Flyer buses - NFI Group announced that Miami-Dade Transit, operated by Miami-Dade County Transportation and Public Works, awarded its subsidiary New Flyer of America with a firm order for 100 zero-emission, battery-electric Xcelsior CHARGE NG 60-foot, heavy-duty transit buses. The new order also includes two on-route Heliox 450 kW chargers and 50 Heliox Flex 180 kW depot power cabinets by NFI Infrastructure Solutions to support zero-emission bus deployment in Miami County. These buses were added to NFI's backlog in the first quarter of 2023.

07:23 EDT Intercept jumps 8% to $12.45 after announcing restructuring, workforce reduction

07:13 EDT Pinstripes to go public via Banyan Acquisition Corp. combination - Pinstripes announced its plan to go public via a business combination with Banyan Acquisition Corp. (BYN), that would result in Pinstripes becoming a publicly-listed company. Upon the closing of the transaction, Pinstripes' common stock and warrants are expected to be listed on the NYSE under the ticker symbol (PNST). The transaction values the combined company at a pro forma enterprise value of approximately $520M, at $10.00 per share. Including the more than $20M from Middleton Partners, the closing of the transaction is conditioned upon the delivery of at least $75M in gross cash proceeds to the combined company, which will be used to support its growth strategy and the continued opening of additional locations. The boards of directors of Pinstripes and Banyan have each approved the transaction, the consummation of which is subject to various customary closing conditions, including the filing and effectiveness of an S-4 registration statement with the SEC, approval of the stockholders of Banyan and Pinstripes and delivery of the minimum gross cash proceeds referenced above. The transaction is expected to close in the fourth quarter of 2023.

07:07 EDT Nutriband receives notice of allowance for U.S. patent covering Aversa - Nutriband received a Notice of Allowance from the United States Patent and Trademark Office on June 15, 2023 for patent application 17/568,999, "Abuse and Misuse Deterrent Transdermal Systems" which covers its Aversa abuse deterrent technology. The receipt of a Notice of Allowance means that the USPTO is expected to issue a U.S. patent for this application after administrative processes have been completed. The expected issuance of this patent further expands Nutriband's intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband's lead product under development is Aversa Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first abuse deterrent pain patch on the market.

07:03 EDT View Smart Windows selected by Sterling Bay's Atlanta building - View announced its Smart Windows will enclose 1050 Brickworks, a 14-story, Class-A office building under construction at 1050 Marietta Street NW in the trendy West Midtown region of Atlanta, GA. Developed by Sterling Bay and Asana Partners, the 225,000 square-foot creative office building will be enclosed by View Smart Windows and will serve as a premium amenity for tenants at 1050 Brickworks. "We're thrilled that Sterling Bay, a leader in real estate development, has chosen View Smart Windows as a key amenity for 1050 Brickworks. Sterling Bay's mission to 'create lasting impact and make life better for everyone' aligns perfectly with View's mission. We look forward to working together with Sterling Bay to create sustainable, experiential, healthier and smarter buildings," said Dr. Rao Mulpuri, CEO of View, Inc.

07:03 EDT Necessity Retail REIT says 'Go-Shop' period expires for proposed GNL merger - The Necessity Retail REIT (RTL) announced the expiration of the 30-day "Go-Shop" period set forth in the previously announced definitive merger agreement with Global Net Lease (GNL). Under the terms of the merger agreement, RTL stockholders will receive 0.670 shares of GNL for each common share of RTL, which represents a total consideration of $7.08 per share based on share prices as of May 23, 2023 and a 35% premium to RTL's 30-day volume-weighted average price for the 30 days prior to May 23, 2023. During the Go-Shop, at the direction of the Special Committee, representatives of Truist Securities, the financial advisor to the Special Committee, actively solicited over 70 potentially interested third parties. To date, none of the third parties contacted by the company or its financial advisors, or any other third parties, have made a superior acquisition proposal following the execution of the merger agreement. Upon expiration of the Go-Shop period, the company became subject to the "no-shop" provisions contained in the merger agreement limiting the company's ability to negotiate acquisition proposals with, or provide non-public information to, third parties, subject to exceptions specified in the merger agreement. The transaction is anticipated to close in the third quarter of 2023, subject to approval by the company's stockholders, GNL's stockholders and the satisfaction of other customary closing conditions.

06:55 EDT 3M sees pre-tax charge of $10.3B for broad class resolution of PFAS claims - 3M announced last night that it has entered into a broad class resolution to support PFAS remediation for public water suppliers that detect PFAS at any level or may do so in the future. "This agreement will benefit U.S.-based PWS nationwide that provide drinking water to a vast majority of Americans," the company stated. Subject to court approval, the agreement provides funding for PWS across the country for PFAS treatment technologies without the need for further litigation; Provides funding for eligible PWS that may detect PFAS in the future; Resolves current and future drinking water claims by PWS related to PFOA, PFOS, and all other PFAS, including those that are included as a portion of the Aqueous Film Forming Foam, or AFFF, multi-district litigation based in Charleston, South Carolina; Provides funding for PWS nationwide to conduct testing for PFAS. Under the terms of the settlement, 3M has agreed to contribute up to a present value of $10.3B, payable over 13 years. 3M expects to record a pre-tax charge of approximately $10.3B in the second quarter of 2023 and to reflect it as an adjustment in arriving at results, adjusted for special items. Additional details will be included in 3M's filings with the Securities and Exchange Commission. "The strength and stability of 3M's business model and strong free cash flow capability, together with proven capital markets access, provide financial flexibility to deploy capital to meet its cash flow needs under this agreement and other contractual commitments and obligations. This agreement is not an admission of liability. If the agreement is not approved by the court or certain agreed terms are not fulfilled, 3M is prepared to continue to defend itself in the litigation. 3M also will continue to address other PFAS litigation by defending itself in court or through negotiated resolutions, all as appropriate," the company said. "This is an important step forward for 3M, which builds on our actions that include our announced exit of PFOA and PFOS manufacturing more than 20 years ago, our more recent investments in state-of-the-art water filtration technology in our chemical manufacturing operations, and our announcement that we will exit all PFAS manufacturing by the end of 2025," added 3M chairman and CEO Mike Roman.

06:53 EDT CarMax plans to open five new stores in FY24 - "During the first quarter of fiscal 2024, we opened one new retail location in Winchester, Virginia. In fiscal year 2024, we plan to open a total of five new stores across the country and our first offsite production location in the Atlanta metro market."

06:47 EDT Tenet Healthcare says Sun Park to succeed Dan Cancelmi as CFO - Tenet Healthcare (THC) announced the appointment of Sun Park as Executive Vice President & CFO of the company, effective January 1, 2024, as part of the company's planned CFO transition. Park will serve as an Executive Vice President of the company from July 11, 2023 through December 31, 2023. As previously announced, Dan Cancelmi, Executive Vice President & CFO, will retire at the end of 2023. Park will succeed Cancelmi in that capacity and report to Saum Sutaria, M.D., CEO of Tenet. Most recently, Park served as Executive Vice President and Group CFO for Pharmaceutical Distribution and Strategic Global Sourcing of AmerisourceBergen (ABC).

06:41 EDT Intercept anticipates achieving profitability in 2024 - "We are taking decisive actions that we believe will improve our ability to drive long-term growth and maintain leadership with our PBC business, continue to develop innovative new medicines, and achieve profitability beginning in 2024," said Jerry Durso, President and CEO of Intercept. "We will move quickly to make a strategic shift that puts Intercept in the best position to create value for shareholders while fully supporting our patient-driven mission." Durso added, "We understand the implications of these changes on our employees and are committed to supporting them throughout this process."

06:36 EDT Intercept lowers FY23 adjusted operating expense view to $350M-$370M - The company has lowered 2023 non-GAAP adjusted operating expense guidance to $350 million to $370 million. This guidance includes expenses to wind down the REGENERATE study and stop all other NASH-related activity, as well as estimated charges of approximately $16 million relating to the planned workforce reduction in 2023. The company expects the majority of restructuring costs to be incurred during the third quarter of 2023. Intercept reiterated its full-year 2023 Ocaliva net sales guidance of $310 million to $340 million, as compared to 2022 Ocaliva U.S. net sales of $285.7 million. As of March 31, 2023, Intercept had cash, cash equivalents, restricted cash, and investment debt securities available for sale of $435.2 million. As previously disclosed, the company will use available cash to settle $110 million of convertible notes on or around July 1, 2023.

06:31 EDT Starbucks union says 3,500 workers to strike this week - The Starbucks Workers United union said via Twitter: "STRIKE WITH PRIDE! Seattle Roastery leads nationwide Starbucks strike over Starbucks' hypocritical treatment of LGBTQIA+ workers. Over 150+ stores and 3,500 workers will be on strike over the course of the next week."

06:01 EDT Babylon Holdings provides update on take private proposal - After a thorough exploration of strategic alternatives, Babylon Holdings is pleased to provide an update on the recapitalization transaction, previously announced on May 10, following receipt of a proposal from AlbaCore Capital LLP on behalf of certain of its affiliates and MindMaze Group SA, and share that Babylon has selected the previously announced take private proposal from the options considered. The proposal strongly positions Babylon to accelerate its core mission - to make high quality healthcare more accessible and affordable by combining the most cutting-edge technology with the best medical expertise. In combination with MindMaze, a global leader in brain technology and digital neurotherapeutic solutions for brain health and recovery, the pro forma business is positioned to uniquely address patient and member needs across the continuum-of-care, from healthcare through sick care. Collectively, the new organization is positioned to become a leading value-based care platform with cutting edge technological, clinical and operational ability to both provide holistic primary care and effectively diagnose, manage and treat major episodic and chronic diseases. Babylon and MindMaze believe that the combined entity will form a powerful digital-first global AI-driven healthcare business that will help transform the industry from sick care to predictive and preventative healthcare. Babylon and MindMaze will be dedicated to improving patient engagement and access to high quality optimized healthcare by tackling a broad range of chronic conditions, including but not limited to neurological conditions. In the coming weeks and months, while Babylon and MindMaze come together, they will both continue delivering on their missions, executing on day-to-day operations, and pursuing strategic objectives including a relentless commitment to patient and member care, client satisfaction and employee engagement. Babylon and its management will continue to operate and deliver on its existing business plan. Over the mid-to-long term Babylon and MindMaze intend to align the strengths of their organizations to deliver a truly novel care paradigm and deliver exceptional outcomes for all stakeholders. The transaction provides for a new capital structure with a significant reduction of pro forma company debt, resulting in a substantially strengthened and more flexible financial profile. In addition, the transaction will include immediate material funding for current business operations as well as a commitment to fund the combined business, allowing the pro forma company to focus on its strategy of delivering concurrent growth and profitability over the near to mid-term. The transaction is expected to close in July 2023. Completion of the transaction will be subject to agreed documentation, various conditions and appropriate regulatory approvals if required. As previously stated, the transaction will not provide for any payment to Babylon Holdings Limited's Class A ordinary shareholders or other equity instrument holders, as AlbaCore will be exercising rights under its debt agreements with Babylon, and the go-forward private business will be transferred to private ownership. Therefore, the transaction would transfer core operating subsidiaries of Babylon to MindMaze, and Babylon Holdings Limited's Class A ordinary shares will cease trading on the NYSE under the ticker symbol 'BBLN'.

05:35 EDT Benchmark Electronics reopens, expands Netherlands facility - Benchmark Electronics celebrated the grand reopening of its facility in Almelo, Netherlands serving customers across the aerospace and defense, industrial, medical and semiconductor capital equipment industries. While the facility was never closed during the renovations, Benchmark is calling it a grand reopening due to a complete revitalization of the facility with extensive expansions and upgrades throughout. To facilitate a rapid increase in customer projects and production over the last five years, Benchmark Almelo has had to grow its talent by 25% - expanding from 480 employees in 2018, to 650. The renovations are highlighted by the site's 4,000 m2 expansion, which includes a 3,000 m2 increase to the production floor and a new Design Center of Innovation to host interactive concept and design projects with customers. Benchmark also reorganized to enable a more efficient material and production flow. Technology investments include a new 3D rapid prototyping printing lab, prototyping lab enhancements, installation of a major EMC pre-compliance test lab, improvements to the site's ISO Class 6 and 7 cleanrooms.

05:17 EDT Gilead announces Week 96 results from MYR301 clinical trial - Gilead announced Week 96 results from the pivotal MYR301 Phase 3 clinical trial evaluating the entry inhibitor Hepcludex for the treatment of adults with chronic hepatitis delta, or HDV, infection. These new data presented at the European Association for the Study of the Liver, or EASL, Congress 2023 reinforce the role of bulevirtide as an efficacious and well-tolerated treatment for the management of chronic HDV. Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S. The new findings presented reinforce the efficacy and safety of bulevirtide and demonstrate that additional improvements in combined response are observed at Week 96 compared with Week 48, with no signs of treatment resistance. An additional analysis from the MYR301 Phase 3 trial presented in a late-breaker showed that study participants who appeared to not respond or only partially respond to bulevirtide treatment at Week 24, went on to achieve a virologic response at 96 Weeks with continued bulevirtide monotherapy. The MYR301 Phase 3 data assessing the efficacy and safety of bulevirtide at 96 weeks, builds on the Week 48 data shared at EASL's ILC 2022 and was published yesterday in the New England Journal of Medicine. Study participants receiving either 2 mg or 10 mg bulevirtide achieved similar combined responses at Week 96. The combined virological and biochemical response rates continued to increase through Week 96 compared to Week 48, with response rates of 55% and 56% with 2 mg and 10 mg bulevirtide respectively. The safety profile at Week 96 is consistent with what was observed at Week 48, with no resistance observed and no serious adverse events attributed to bulevirtide treatment. Increases in bile acids without a correlation to pruritus or other symptoms were noted with bulevirtide treatment. Injection site reactions occurred in a higher proportion of study participants receiving 10 mg of bulevirtide. In a new analysis, study participants treated with bulevirtide monotherapy who experienced suboptimal virological response at Week 24 were continued on treatment through Week 96. Among study participants who had no response or a partial-response at Week 24, 43% and 82% respectively achieved virological response by Week 96. Virologic response was defined as undetectable HDV RNA or a decrease by greater than or equal to 2 log10 IU/mL from baseline; non-response and partial virologic response was defined as HDV RNA decline of less than1-log10 IU/mL and greater than or equal to1 but less than2-log10 IU/mL respectively. The data also showed that ALT improvements at Week 96 could be seen in participants treated with bulevirtide with the earlier defined suboptimal virologic response. These results highlight that even in patients who have a suboptimal virologic response initially, prolonged treatment with bulevirtide led to virological and/or biochemical response in the majority of study participants.

05:03 EDT Smart Share Global receives noncompliance notification from Nasdaq - Smart Share Global announced that it has received a written notification from the staff of the Listing Qualifications Department of Nasdaq, indicating that for the last 30 consecutive business days, the closing bid price of the Company's American depositary shares was below the minimum bid price of $1.00 per share requirement set forth in Nasdaq Listing Rule 5450. The Nasdaq notification letter has no current effect on the listing or trading of the company's ADSs on Nasdaq.