Stockwinners Market Radar for May 25, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:36 EDT C3.ai director sells $726K in common stock - In a regulatory filing, C3.ai discloses that its director Richard Levin sold 24 shares of common stock on May 25th in a total transaction size of $726K.

20:14 EDT Cathie Wood's ARK Investment bought 304K Adaptive Biotechnologies shares today

19:04 EDT Invitae CFO Wen resigning to pursue other opportunities - Invitae announced that Chief Financial Officer Yafei Wen is resigning to pursue other opportunities, effective June 30, 2023. The Company has initiated a search for a new CFO. Ms. Wen will continue in her role through the end of the second quarter. Christine Gorjanc, the Company's longtime Chair of the Audit Committee of the Board of Directors, will assist during the transition and will assume the role of interim CFO, effective July 1, 2023. Ms. Wen will work closely with Ms. Gorjanc and the executive team to ensure a smooth transition. Ms. Wen's resignation is not the result of any disagreement with the Company on any matter related to the Company's operations, policies or procedures. "We are immensely grateful for Roxi's significant contributions to the Company over the past two years, and appreciate her assistance during the transition. We wish her only the best in her future endeavors," said Ken Knight, president and chief executive officer of Invitae. "We are also fortunate that Christine is stepping in at this time. Christine's prior CFO experience with publicly-traded companies, her deep and relevant expertise in finance and accounting, along with her long-time tenure as the Chair of our Audit Committee with the Invitae Board of Directors, make her a great resource for Invitae while we conduct the search for our next CFO."

18:24 EDT Splunk CEO: We drove efficiency across the business in Q1 - In an interview on CNBC's Mad Money, Gary Steele said Splunk is seeing great benefits across the platform from A.I. "There are going to be great opportunities in the segments we serve with A.I.," he noted. Splunk signed the largest public sector agreement in company history in Q1. The macro environment has impacted some of the company's cloud migrations, he added. Steele said Splunk will continue to look at tuck-in acquisitions.

18:10 EDT Zentalis presents phase 1b data for Azenosertib at ASCO - Zentalis "announced positive data from the Phase 1b trial of azenosertib, the Company's potentially first-in-class WEE1 inhibitor, in combination with chemotherapy in patients with platinum-resistant ovarian cancer. Azenosertib was well tolerated in combination with multiple types of chemotherapy and demonstrated encouraging clinical activity, with noteworthy improvements in objective response rates (ORRs) and median progression free survival (mPFS) in all patients, especially those with Cyclin E1+ tumors, a subgroup recognized to have a poor prognosis and be refractory to chemotherapy. Results will be presented in a poster discussion session at the 2023 ASCO Annual Meeting on June 5th (Abstract #5513). A total of 115 patients were enrolled in the study across all chemotherapy combination groups. At the data cut-off of April 10, 2023, 94 were efficacy evaluable. Across all dosing schedules, azenosertib plus paclitaxel demonstrated the highest ORR of 50.0% (mPFS of 7.4m), followed by an ORR of 38.5% (mPFS of 8.3m) for azenosertib plus gemcitabine. Azenosertib plus carboplatin demonstrated an ORR of 35.7% (mPFS of 10.4m), and azenosertib plus PLD demonstrated an ORR of 19.4% (mPFS of 6.3m). A total of 82 response-evaluable patients had available Cyclin E1 expression data by immunohistochemistry (IHC). Cyclin E1+ status (H-score greater than50) was associated with a superior ORR and a longer mPFS across the total patient population (ORR of 40.0% vs 8.3%; mPFS of 9.86 vs 3.25 months, HR = 0.37; P = 0.0078), showcasing the potential synergy of WEE1 inhibition with chemotherapy in this patient population. Overall, the tolerability of azenosertib dosed intermittently in combination with either paclitaxel or carboplatin compares favorably to historical data from standard of care chemotherapy doublets of either paclitaxel-carboplatin or PLD-carboplatin. Frequent Grade greater than or equal to3 treatment-related adverse events (%) across all azenosertib intermittent dosing groups were thrombocytopenia (27.5%), neutropenia (25.5%), anemia (15.7%), and fatigue (9.8%). A recommended Phase 2 dose was determined for each of the azenosertib combinations with paclitaxel, carboplatin, and PLD. Based on these results, the Company is planning to initiate a Phase 3 study comparing azenosertib dosed intermittently in combination with either carboplatin or paclitaxel in patients with Cyclin E1+ platinum-sensitive ovarian cancer. The Company expects to initiate the Phase 3 study in the first quarter of 2024."

17:49 EDT Redfin: Mortgage rates over '7.1% for first time since November' - "Redfin Housing payments hit a new high this week as mortgage rates jumped due to progress on a possible debt-ceiling deal. That's according to a new report from Redfin the technology-powered real estate brokerage. Daily average rates hit 7.12% on May 25, reaching their highest level since November. The typical U.S. homebuyer's monthly mortgage payment hit a record-high $2,614 at a 6.57% mortgage rate, the current weekly average. The rate increase dampened homebuying demand. Pending home sales dropped 17.4% nationwide from a year earlier during the four weeks ending May 21, the second-biggest dip since January, the biggest was a 17.5% decline in early April. Mortgage-purchase applications declined too, dropping 4% from the week before. Potential sellers continued backing off, with new listings of homes for sale dropping 24%, one of the biggest declines since May 2020. That's because homeowners continue to hang onto their homes, locked in by comparatively low rates. Even though demand is down, it's still outpacing supply as the new-listing drought has caused the total number of homes for sale to post an annual decline for the first time in nearly a year. Despite rates jumping past 7% and a lack of new listings, many early-stage homebuyers remain committed. Redfin's Homebuyer Demand Index, which measures requests for tours and other services from Redfin agents, increased from a week earlier and is essentially flat from a year earlier. Some of these house hunters are likely to continue moving forward, while others may wait for rates to decline before securing loans. We may see a burst of pent-up demand when and if rates dip again," said the company in a statement. Companies that may be impacted by this include: Redfin (RDFN), ReMax (RMAX), Zillow (Z), OPEN (OPEN), LEN (LEN), TOL)(TOL) and Ocwen (OCN). " Reference Link

17:47 EDT Leap Therapeutics to present updated data from DKN-01+Tislelizumab study - Leap Therapeutics "announced the Company will be presenting new long-term follow-up data in first-line patients with advanced gastric or gastroesophageal junction adenocarcinoma (GEA) from Part A of the DisTinGuish study, a Phase 2 clinical trial evaluating Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with BeiGene's tislelizumab and chemotherapy, at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL on June 2-6, 2023." "The long-term follow-up data for DKN-01 in combination with tislelizumab and chemotherapy indicates a novel and well-tolerated treatment with the potential for enhanced response rate, survival, and quality of life for advanced GEA patients," said Samuel Klempner, MD, Associate Professor at Harvard Medical School and principal investigator on the DisTinGuish study. "Median overall survival and progression-free survival for patients treated with DKN-01 plus tislelizumab and chemotherapy exceeded current PD-1 combination benchmarks, especially for those patients with low expression of PD-L1. Together with the previously reported data on the encouraging outcomes with DKN-01 for patients with high DKK1 expression, these results provide strong support for the ongoing randomized controlled clinical trial in first-line GEA patients."

17:42 EDT Bristol-Myers to present first results from Phase 3 COMMANDS study of Reblozyl - Bristol Myers Squibb "announced first results from the Phase 3 COMMANDS study, an open-label, randomized trial evaluating Reblozyl versus epoetin alfa, an erythropoiesis-stimulating agent, for the treatment of anemia in adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes who require red blood celltransfusions and are ESA-naive. Results from the study will be featured as part of the press program at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 3 p.m. EDT, and in an oral presentation of select abstracts during a plenary session at the European Hematology Association Congress on June 10, 2:45 p.m. "Chronic anemia, low hemoglobin levels and transfusion dependency are the primary clinical challenges for patients with lower-risk MDS, increasing the risk of death by more than half compared to those who do not require transfusions," said Guillermo Garcia-Manero, M.D., lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center. "Results from the COMMANDS study showed treatment with Reblozyl compared to epoetin alfa led to superior and statistically significant improvements in red blood cell transfusion independence and hemoglobin increase, improvements in response durability, and equal or better outcomes across all subgroups, with acceptable safety and tolerability for patients with ESA-naive, lower-risk MDS."

17:33 EDT Ford EV customers to gain access to 12,000 Tesla superchargers - Ford (F) said it reached an agreement with Tesla (TSLA) that will provide Ford electric vehicle customers access to more than 12,000 Tesla Superchargers across the U.S. and Canada, doubling the number of fast-chargers available to Ford EV customers starting Spring 2024. Starting early next year, Ford EV customers will have access to more than 12,000 Tesla Superchargers across the U.S. and Canada, in addition to the over 10,000 DC fast-chargers that are already part of the BlueOval Charge Network. This will give Ford EV customers unprecedented access to fast-charging. Mustang Mach-E, F-150 Lightning and E-Transit customers will be able to access the Superchargers via an adapter and software integration along with activation and payment via FordPass or Ford Pro Intelligence. In 2025, Ford will offer next-generation electric vehicles with the North American Charging Standard connector built-in, eliminating the need for an adapter to access Tesla Superchargers. The reliable Tesla Supercharger network has already established charging corridors across the U.S. and Canada. Additionally, Ford dealers are adding roughly 1,800 public-facing fast-chargers and locations to the BlueOval Charge Network by early 2024.

17:30 EDT Alaunos Therapeutics to present TCR-T Library Phase 1/2 trial data at ASCO - Alaunos Therapeutics "announced that the Company will present early translational data from the first three patients treated in its ongoing TCR-T Library Phase 1/2 trial at the 2023 American Society of Clinical Oncology Annual Meeting taking place June 2-6, 2023, at the McCormick Place Convention Center in Chicago. The poster will highlight early clinical and translational data on the first three patients with refractory solid tumors expressing KRAS or TP53 mutations who received Sleeping Beauty TCR-T cells at one of two dose levels, DL1 (0.9 x 1010 TCR-T cells) and DL2 (6.4 x 1010 TCR-T cells and 5.8 x 1010 TCR-T cells). Manufactured TCR-T cells exhibited greater than 90% TCR positivity, viability and purity, underscoring the ability of the Company's non-viral, universal manufacturing process to create TCR-T cells in multiple indications with different TCRs. Overall, the TCR-T cell therapy was observed to be well-tolerated and presented a manageable safety profile, with no dose-limiting toxicities or immune effector cell-associated neurotoxicity syndrome observed and only one instance of grade three cytokine release syndrome, which was resolved with administration of tocilizumab. "Demonstrating our first objective clinical response in solid tumors using non-viral TCR-T cell therapy establishes proof-of-concept of our Sleeping Beauty cell engineering platform's potential to generate safe, persistent and effective TCR-T therapies," said Kevin S. Boyle, CEO of Alaunos. "We believe our innovative non-viral approach targeting high-frequency driver mutations is the most promising approach for treating solid tumors. We are encouraged by our ability to manufacture cell products with high viability, purity and TCR positivity that have exhibited persistence and tumor infiltration in patients. We remain confident in the promise of our TCR-T platform to weaponize the immune system and revolutionize the treatment of solid tumors."

17:21 EDT Bank of Hawaii to replace HomeStreet in S&P 600 at open on 6/2

17:20 EDT Knife River to be added to S&P 400 at open on 6/1 - Knife River (KNF) will be added to the S&P MidCap 400 prior to the open of trading on Thursday, June 1 following its spin-off from MDU Resources Group (MDU).

17:17 EDT Geron: Data support NDA submission for imetelstat on track for June 2023 - Geron announced acceptance of its IMerge Phase 3 abstract as an oral presentation at the upcoming 2023 American Society of Clinical Oncology ASCO Annual Meeting. This abstract describes statistically significant positive efficacy and safety data from the pivotal IMerge Phase 3 clinical trial evaluating the Company's first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes MDS . These data support the Company's planned New Drug Application NDA submission to the U.S. FDA which is on track for June 2023, to support a potential U.S. commercial launch of IMerge in lower risk MDS in the first half of 2024. "We believe that imetelstat has the potential to be practice-changing in lower risk MDS based on the unprecedented durability of transfusion independence, as well as broad activity across a range of disease subtypes in IMerge Phase 3," said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. "We are thrilled that these data will be featured in an oral presentation at ASCO, where we will have a significant medical affairs presence to bring more awareness to the continuing unmet need in lower risk MDS and very much look forward to meaningful engagement with the medical community."

17:16 EDT Evaxion Biotech unveils technology to boost effect of DNA and mRNA vaccines - Evaxion Biotech unveils the technology behind its novel, proprietary genetic adjuvant developed to enhance the effectiveness of DNA and mRNA vaccines for infectious diseases and cancer. Latest data from the adjuvant program were presented at Evaxion's live stream R&D Day, May 25, 2023. "We are excited to present this novel genetic adjuvant technology to the global scientific community. It boosts Evaxion's own DNA technology and has the potential to improve the effect of virtually any vaccine. We foresee a great market potential in that this technology appears to be highly effective in both DNA and mRNA based vaccines against cancer as well as infectious diseases," said Per Norlen, CEO at Evaxion.

17:15 EDT Evaxion Biotech to present Phase 1 data for personalized cancer vaccine - Evaxion Biotech to present promising clinical data from its EVX-01 Phase 1 clinical trial in metastatic melanoma on June 3, at the 2023 ASCO annual meeting, in Chicago, Illinois. "We are excited to report that the EVX-01 Phase 1 trial achieved its primary objectives. EVX-01 was well tolerated and induced a higher objective response rate than previously reported for standard of care treatment. Importantly, EVX-01 induced a broad immune response that correlated with clinical outcome, which is very encouraging for the further development of Evaxion's personalized cancer vaccine programs," said Per Norlen, CEO at Evaxion.

17:10 EDT Verastem's vutometinib shows 45% response rate in recurrent ovarian cancer - Verastem announced updated data from Part A of the ongoing registration-directed RAMP 201 trial evaluating the safety and efficacy of avutometinib alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer - LGSOC -. In the RAMP 201 study, treatment with the combination of avutometinib and defactinib resulted in an objective response rate of 45% - 13/29 - and tumor shrinkage in 86% of evaluable patients. Safety and tolerability continued to be favorable and consistent with previously reported data. These data build on the Breakthrough Therapy Designation granted by the FDA for the combination in recurrent LGSOC. The safety profile was consistent with previously reported safety data. The discontinuation rate, due to greater than or equal to 1 adverse event, was 12% in the trial overall to date. The company plans to include data to support filing for accelerated approval. The company is finalizing the design of a randomized confirmatory trial with the FDA, which is planned to begin in the second half of 2023.

17:08 EDT I-Mab announces results from CD73 antibody combination study - I-Mab announced results from the Phase 1b/2 study evaluating uliledlimab, the company's proprietary CD73 antibody, in combination with toripalimab, a PD-1 antibody, in patients with treatment-naive advanced non-small cell lung cancer, or NSCLC, and exploring the potential value of CD73 expression as a predictive biomarker. The results will be reported in a poster presentation on June 3 at the 2023 American Society of Clinical Oncology, or ASCO, annual meeting. The study is a dose expansion portion of a Phase 1b/2 trial evaluating the safety and efficacy of the combination therapy and investigating the potential correlation between tumor CD73 expression and clinical response for patients with treatment-naive advanced NSCLC. As of April 14, a total of 70 patients were enrolled in the study. Uliledlimab demonstrated a favorable safety profile up to 30mg/kg Q3W in combination with toripalimab with most treatment-related adverse events, or TRAEs, being Grade 1 or Grade 2 in severity. In the efficacy evaluable population, the objective response rate was 31.3% regardless of PD-L1 and CD73 expression. CD73High was established as less than 40% of tumor or immune cells with less than or equal to 1+ staining intensity identified by immunohistochemistry, or IHC. The cutoff was determined through receiver operating characteristic, or ROC, analysis. Notably, patients with CD73High exhibited a higher ORR compared with those with CD73Low. The ORR further increased to 63% in patients with both CD73High and PD-L1 tumor proportion score greater than or equal to 1%, whereas patients with CD73Low had an ORR of 20%. At the time of data cutoff, with a median follow-up of 10.4 months, 18 out of 21 responders remained on treatment, and the median duration of response, or DOR, was not reached. Progression-free survival (PFS) and overall survival (OS) data will be analyzed when the data are fully mature.

17:07 EDT Affimed to present AFM24-101 data on NSCLC and CRC trial cohorts at ASCO - Affimed N.V. "announced the publication of two abstracts with its innate cell engager AFM24 in advance of the American Society of Clinical Oncology Annual Meeting, taking place on June 2 - 6, 2023 in Chicago, IL. As of the December cut-off data for the abstract, 14 patients were enrolled in the EGFR mutant NSCLC cohort and the best objective response in 10 evaluable patients was a confirmed partial response in 1 patient (change from baseline -45%); 4 patients exhibited stable disease of which two had tumor shrinkage. AFM24 exhibited a well-managed safety profile and the most common treatment-related adverse events observed were mild to moderate infusion-related reactions. Updated data with a cut-off date of mid-April 2023 will be presented by Dr. Anthony El-Khoueiry, Associate Director of Clinical Research at USC Norris Comprehensive Cancer Center, at ASCO on June 3, 2023 during the poster session on Developmental Therapeutics - Immunotherapy. Dr. El-Khoueiry's presentation will include data from 15 evaluable patients."

17:05 EDT Relay Therapeutics announces full dose escalation data for RLY-4008 - Relay Therapeutics announced complete first-in-human dose escalation data for RLY-4008, an investigational, potent, selective and oral small molecule inhibitor of fibroblast growth factor receptor 2. These data, from the global Phase 1/2 ReFocus study in patients with FGFR2-altered cholangiocarcinoma and multiple other solid tumors, will be presented at the 2023 American Society of Clinical Oncology Annual Meeting on June 4, 2023. The data being presented at ASCO are generally consistent with those previously reported at the European Society for Medical Oncology Congress in September 2022. Among the 91 CCA patients in the dose escalation portion of the study, 25 had FGFR2 fusions and had not previously received an FGFR inhibitor. This represents a subset of the interim data reported at ESMO in September 2022, which also included some patients from the ongoing dose expansion cohorts. Eleven of these patients were treated at or above the pivotal dose of 70mg QD: All 11 patients experienced radiographic tumor reductions; Eight of the 11 patients (including all 4 patients receiving the pivotal dose) had a partial response (73% overall response rate (ORR)), and an additional three patients experienced a best response of stable disease; The median duration of response (DoR) was 11.2 months; Maximum treatment duration is from a patient who remains on treatment at 27 months as of the data cut-off date of January 30, 2023; Fourteen patients were treated at doses below the 70mg QD pivotal dose; Twelve of 14 patients experienced radiographic tumor reductions; Five patients experienced a partial response (36% ORR), and six patients experienced a best response of stable disease; Median DoR was 5.6 months. The dose escalation portion of the study also included 50 CCA patients with FGFR2 fusions who were previously treated with a non-selective FGFR inhibitor: In patients treated at or above the pivotal dose of 70mg QD (n=14), the ORR was 21 percent, and in patients treated at doses below the 70mg QD pivotal dose (n=36), the ORR was 11 percent; Multiple partial responses occurred in patients with detected V565 and/or N550 mutations. In addition, across all doses, there were early signs of activity in the 14 CCA patients with FGFR2 mutations: Nine patients experienced radiographic tumor reductions and four patients experienced a partial response (29% ORR). The safety analysis from the complete dose escalation portion of the study was generally consistent with the analysis from the 2022 ESMO data disclosure, which also included patients treated at the 70mg QD dose in the expansion cohorts: Most treatment-related adverse events were expected FGFR2 on-target, low-grade, monitorable, generally manageable and largely reversible; There were no observed Grade 4 or 5 adverse events; Off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant.

17:04 EDT Aravive to present 'promising' update from phase 2 trial of Batiraxcept at ASCO - Aravive announced the presentation of updated results from its ongoing Phase 2 trial of batiraxcept in clear cell renal cell carcinoma at the 2023 American Society of Clinical Oncology annual meeting, taking place June 2-6, 2023 in Chicago, IL and virtually. The poster presentation will highlight updated results from the Phase 2 portion of the trial in patients with advanced or metastatic ccRCC with or without prior line(s) of therapy, including immuno-oncology (IO)- and vascular endothelial growth factor tyrosine kinase inhibitor based therapies. In addition, an abstract highlighting batiraxcept data in pancreatic adenocarcinoma will be published in the 2023 ASCO Annual Meeting Proceedings.

17:02 EDT Erasca to present HERKULES-3 phase 1b data for ERAS-007 at ASCO - Erasca announced preliminary Phase 1b data for ERAS-007 combinations in patients with GI malignancies from two poster presentations at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. The posters will be available online at Erasca.com/science/presentations. "Early clinical data from HERKULES-3 continue to reinforce the potential to combine ERAS-007 with multiple agents and its potential as a backbone therapy to treat patients with GI malignancies. Importantly, these preliminary findings support a data-driven approach to refine the focus of our initial clinical development efforts on indications holding significant promise," said Jonathan E. Lim, M.D., Erasca's chairman, CEO, and co-founder. "Our initial evaluation of the ERAS-007 + EC combination in patients with BRAF-mutated metastatic CRC will focus on EC-naive patients based on the preliminary activity observed in HERKULES-3. By evaluating efficacy and safety in a larger sample size of patients treated at the 100 mg BID-QW dose of ERAS-007 with EC, we believe we will be able to better assess whether the promising response rate and duration of treatment observed with the triplet can be maintained."

16:57 EDT eFfector Therapeutics' zotatifin shows positive Phase 2 breast cancer results - eFFECTOR Therapeutics announced positive interim data updates from a Phase 2 expansion cohort evaluating zotatifin combined with fulvestrant and abemaciclib - ZFA triplet - in patients with ER+ metastatic breast cancer. These data, as well as initial data from further dose escalation, will be presented as a poster at the American Society of Clinical Oncology Annual Meeting June 2-6 in Chicago. "The activity observed with the ZFA triplet, with partial responses seen in 26% of patients, is substantially higher than we would expect for treating such heavily pretreated patients with just fulvestrant and abemaciclib," said Steve Worland, CEO. "...The partial response observed at a higher dose of zotatifin in combination with only fulvestrant is encouraging and we look forward to reporting data from the completed dose escalation in the second half of 2023." Five out of 19 -26% - RECIST-evaluable patients achieved a partial response, including four confirmed and one unconfirmed. The disease control rate, reflecting patients with at least one on-treatment scan showing PR or stable disease, was 14 of 19. The ZFA triplet was generally well tolerated, with 3 patients discontinuing due to adverse events of any cause, and the large majority of AEs being Grade 1 or 2. New data were also reported for patients in resumed dose escalation cohorts utilizing the ZF doublet. In the one fully enrolled cohort, wherein patients received zotatifin dosed at 0.1 mg/kg every other week combined with fulvestrant, 1 of 3 patients achieved a PR. Data on changes in circulating tumor DNA were also updated. In the new data set, 9 patients who received the ZFA triplet at 0.07 mg/kg zotatifin had both pre- and on-treatment samples available for ctDNA analysis. Eight patients had decreases in ctDNA of greater than 50%, representing 89% of the patients with on-treatment samples available for analysis, and 62% of patients who either had available on-treatment samples or who had discontinued prior to collection of on-treatment samples.

16:49 EDT VMware names Karen Dykstra as new CFO - VMware announced that Karen Dykstra will take on the role as CFO and executive vice president in addition to her current role as a member of the VMware Board of Directors. Current VMware CFO and EVP Zane Rowe will be leaving the company, effective June 9, 2023.

16:31 EDT Takeda, Hutchmed say Fruquintinib NDA granted priority review by FDA - Takeda (TAK) and Hutchmed (HCM) announced that the U.S. Food and Drug Administration has granted priority review of the New Drug Application for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer. If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC. The Prescription Drug User Fee Act goal date assigned by the FDA for this NDA is November 30, 2023. "We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile," said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. "There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients' biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible."

16:25 EDT Houlihan Lokey reports certain revised financial information - Houlihan Lokey reported certain revised financial information for the fiscal year and fourth fiscal quarter ended March 31, 2023. On May 9, 2023, Houlihan Lokey announced financial results for the fiscal year and fourth fiscal quarter ended March 31, 2023. Subsequent to this announcement, staff of the Securities and Exchange Commission's Division of Enforcement proposed a potential settlement with Houlihan Lokey to resolve an investigation of Houlihan Lokey's compliance with records preservation requirements related to business communications sent over off-channel electronic messaging platforms. The SEC has conducted similar investigations of other financial institutions as part of a widely publicized industry sweep that has already included publicly announced settlements with 14 firms to date, with civil penalties ranging from $7.5 million to $125 million each, and aggregating over $1.2 billion. Houlihan Lokey has notified the SEC's Division of Enforcement of its present intention to agree to a settlement to resolve the investigation that includes a $15 million civil penalty. The potential settlement is subject to the negotiation of definitive documentation, which is expected to include terms consistent with previously announced settlements between other firms and the SEC, and any formal offer, proposed civil penalty, and additional terms submitted by the Company would be subject to approval by the Commission. As a result of the foregoing, while finalizing its financial statements for inclusion in its Annual Report on Form 10-K for the fiscal year ended March 31, 2023, Houlihan Lokey determined that it should recognize a $15 million accrual in other (income)/expense, net for the fourth fiscal quarter and fiscal year ended March 31, 2023 relating to the anticipated settlement with the SEC. The effect of the accrual reduced net income, as originally reported on May 9, 2023, of $75 million and $269 million to $60 million and $254 million for the fourth fiscal quarter and fiscal year ended March 31, 2023, respectively, and reduced earnings per fully diluted share as originally reported of $1.10 and $3.98 to $ 0.88 and $3.76 for the fourth fiscal quarter and fiscal year ended March 31, 2023, respectively, in each case as calculated in accordance with generally accepted accounting principles in the U.S. The accrual had no impact on the amounts of revenue, as reported in the previously released financial results. The full amount of the $15 million accrual recorded in other (income)/expense, net has been added back to adjusted earnings per fully diluted share such that the amounts of adjusted earnings per fully diluted share of $1.11 and $4.54 for the fourth fiscal quarter and fiscal year ended March 31, 2023, respectively, included in the previously released financial results remain unchanged.

16:24 EDT Gap jumps 14% to $8.50 after Q1 results, FY23 guidance

16:22 EDT Fox Factory to appoint Dennis Schemm as CFO - Fox Factory Holding announced that it will appoint Dennis Schemm to the role of Chief Financial Officer effective June 12. Mr. Schemm will succeed Interim CFO, Maggie Torres, who will retire upon his arrival.

16:20 EDT Stryve Foods names Katie Grady Chief Customer Officer - Stryve Foods announces that Ms. Katie Grady has been named the Company's Chief Customer Officer, effective May 30. Jerry Goldner is assuming the role of Senior Vice President / General Manager to lead marketing, the e-commerce channel and the innovation agenda for Stryve.

16:17 EDT Embark Technology to be acquired by Intuition for $71M - Embark Technology and Applied Intuition, a tooling and software provider for autonomous vehicle development, have entered into a definitive merger agreement. Under the agreement, Applied will acquire Embark in an all-cash transaction with an equity value of approximately $71M. Founded in 2016, Embark has built a autonomous software stack that uses machine learning methodologies for perception while relying on a safety-redundant compute system. Applied aims to integrate Embark's internal tools, data, and software assets to further improve its offerings for customers in the trucking and automotive industries. Embark plans to retire its fleet of test vehicles as part of the transaction. Key Embark employees are expected to remain to support Applied. Under the terms of the agreement, which has been approved unanimously by the boards of directors of both companies, Embark shareholders will receive $2.88 per share in cash. The transaction is expected to close in Q3 and is subject to approval by Embark shareholders and other customary closing conditions. Upon completion of the transaction, Embark shares and warrants will cease trading on NASDAQ, and Embark will become a privately held company.

16:16 EDT TechnipFMC awarded significant contract by Shell for Dover development - TechnipFMC (FTI) has been awarded a significant integrated Engineering, Procurement, Construction, and Installation contract by Shell plc (SHEL) for its Dover development in the Gulf of Mexico. TechnipFMC will supply the subsea tree systems in addition to the engineering, procurement, construction and installation of the umbilical, riser, and flowline systems. The Dover development will tie back to the Appomattox platform, where TechnipFMC previously supplied and installed the subsea production systems. Jonathan Landes, President, Subsea at TechnipFMC, commented: "Dover represents a continuation of our decades-long relationship with Shell. We look forward to helping extend production in this prolific basin." For TechnipFMC, a "significant" contract is between $75M and $250M. This award will be included in inbound orders in the second quarter of 2023.

16:15 EDT Ulta Beauty falls 8% to $446.50 after Q1 results and guidance

16:14 EDT Workday jumps 8% to $213.00 after Q1 results beat estimates - The company also raised the bottom end of its FY24 subscription revenue view.

16:12 EDT Marvell jumps 18% to $58.37 after Q1 results, Q2 guidance beat estimates

16:11 EDT Genelux publishes data on VIRO-15 Trial evaluating Olvi-Vec in PRROC - Genelux announced the publication of positive topline results from its Phase 2 VIRO-15 trial of Olvi-Vec-primed immunochemotherapy in heavily pretreated patients with platinum-resistant or -refractory ovarian cancer in JAMA Oncology. The article by Holloway et al. was published in print and online and is available here. "We are incredibly pleased to have the Phase 2 trial data featured as an Original Investigation in such a prominent peer-reviewed journal. The results published in JAMA Oncology add to the body of evidence supporting the clinically-meaningful efficacy and safety of Olvi-Vec," said Thomas Zindrick, President, Chairman and CEO of Genelux. "Furthermore, we were privileged to have a companion Editorial of our Phase 2 data which we believe further validates the use of our proprietary oncolytic virus in the treatment paradigm of ovarian cancer."Patients with PRROC have limited therapeutic options, representing a considerable unmet medical need. In this Phase 2 clinical trial of 27 patients [platinum-resistant or platinum-refractory and median 4 prior lines of therapy, Olvi-Vec followed by platinum-based chemotherapy +/- bevacizumab as immunochemotherapy demonstrated objective response rate of 54% and a median progression-free survival of 11.0 months with a manageable safety profile.

16:10 EDT Virios Therapeutics regains compliance with Nasdaq - Virios Therapeutics announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

16:08 EDT Marvell reports Q1 adjusted gross margin 60%

16:04 EDT Workday names Zane Rowe as CFO succeeding Barbara Larson - Workday announced the appointment of Zane Rowe to CFO, effective June 12. Rowe will oversee the company's overall finance and accounting functions, internal audit, and investor relations, and advise on Workday's business strategy and product development. Workday's current CFO, Barbara Larson, will be stepping back to spend more time with her family, after a transition period. Rowe brings more than twenty years of experience scaling and leading fast-growing organizations, including most recently as CFO of VMware, where he oversaw the company's finance and accounting functions for seven years. Rowe also served as interim CEO of VMware from February 2021 to May 2021. Prior to his time at VMware, Rowe served as CFO at EMC, CFO at United Airlines, and led North America sales for Apple.

15:52 EDT Icahn's Teno says activism 'alive and well' after Illumina elects him to board - In a statement posted to Carl Icahn's Twitter account, Icahn Capital's (IEP) Andrew Teno said, "Thank you to all of the Illumina (ILMN) shareholders that voted for me. I look forward to serving on behalf of all shareholders and stakeholders. I am happy to say that activism is alive and well at Icahn." Reference Link

15:43 EDT Goldenbridge Acquisition Ltd trading resumes

15:23 EDT Goldenbridge Acquisition Ltd trading halted, volatility trading pause

14:47 EDT Google starts access to new generative AI capacity in Search - Google said in a blog posting: "We're starting to open up access to Search Labs, a new program to access early experiments from Google. If you've already signed up for the waitlist at labs.google.com/search, you'll be notified by email when you can start testing Labs experiments, like SGE (Search Generative Experience), Code Tips and Add to Sheets in the U.S. And if you want to opt-in to these experiments, simply tap the Labs icon in the latest version of the Google app (Android and iOS) or on Chrome desktop to sign up. You can also visit the Labs site to check your waitlist status. Once you're in, the new generative AI powered Search experience will help you take some of the work out of searching, so you can understand a topic faster, uncover new viewpoints and insights and get things done more easily. So instead of asking a series of questions and piecing together that information yourself, Search now can do some of that heavy lifting for you..." "Easily get up to speed on a new or complicated topic. Maybe you're starting to map out a decision that you'd typically need to break down into smaller parts, like "Learning ukulele vs guitar." Search will provide an AI-powered snapshot so you can get help understanding what factors to consider," said the company in part. Reference Link

14:45 EDT AeroVironment says JUMP 20 Medium UAS not selected by U.S. Army for FTUAS - AeroVironment announced that the company's JUMP 20 Medium UAS was not selected by the U.S. Army to proceed further within the Future Tactical Unmanned Aircraft System, or FTUAS, Program Increment 2, the next development phase of the FTUAS program. "Despite this news, the company had a strong close to its fiscal year 2023, ended April 30, 2023, achieving all key financial metrics. This outcome does not have a material impact on the company's near-term outlook and AeroVironment remains poised for at least 15% top-line and robust bottom-line growth in fiscal 2024... AeroVironment maintains a positive outlook for the group 2/3 UAS market going forward. International opportunities and engagements for JUMP 20 systems continue to grow, and the company remains well-positioned to pursue additional domestic programs... Given AeroVironment's broad portfolio of innovative unmanned solutions - and numerous contracts in the pipeline - the company expects to continue generating strong returns for shareholders," the company stated. "While we are extremely disappointed with the US Army's decision, we respect it. We are now fully assessing the US Army's evaluation process to determine our next steps. We remain convinced that our JUMP 20 system is the best-in-class Group 3 UAS on the market and we will continue investing in the platform to ensure it remains the top performing solution for our customers. Our JUMP 20 has an unmatched ability to carry multiple armed payloads, including our Switchblade loitering munitions. We also recently incorporated autonomy functionality and other upgrades to improve operations in highly contested environments," said Wahid Nawabi, AeroVironment chairman, president and CEO.

14:31 EDT Cleveland-Cliffs gains MN Executive Council approval of iron ore mineral leases - Cleveland-Cliffs issued a statement on Thursday regarding the Minnesota Executive Council's approval of state mineral leases for more than 2,600 acres of iron ore at the Nashwauk mine site in Itasca County, Minnesota. The approval is a final action and Cleveland-Cliffs has now assumed these leases. Cleveland-Cliffs' Chairman, President and Chief Executive Officer, Lourenco Goncalves, stated, "Today's approval of these leases by the Minnesota Executive Council resolves years of uncertainty regarding Hibbing Taconite's mine life. Cleveland-Cliffs will immediately begin the work necessary to develop this quality ore body as an extension of Hibbing Taconite. The state's mineral leases, combined with our own private mineral holdings at Nashwauk acquired by Cleveland-Cliffs in 2017, will provide more than two decades of additional ore reserves for Hibbing Taconite, preserving hundreds of good paying union jobs, and ensuring continued supply of iron ore pellets for Cleveland-Cliffs' steel mills."

14:26 EDT Illumina confirms Icahn Capital's Andrew Teno elected to board - Illumina announced that based on the preliminary results of its 2023 Annual Meeting, Illumina shareholders have voted to elect eight of nine Illumina director nominees - Francis deSouza, Robert Epstein, MD, Frances Arnold, PhD, Caroline Dorsa, Scott Gottlieb, MD, Gary Guthart, PhD, Philip Schiller, and Sue Siegel, as well as Andrew Teno, to the board of directors. Illumina issued the following statement: "Illumina thanks shareholders for their continued support of the company, which remains committed to its mission of improving human health by unlocking the power of the genome. We appreciate the constructive shareholder feedback throughout this process and are committed to delivering on our plan to accelerate shareholder value creation. We will continue to provide transparent and effective communication as we move forward together. We would like to welcome Andrew Teno, a portfolio manager at Icahn Capital LP, to the Board and look forward to productive and collaborative engagement. We also thank John Thompson for his years of service and contributions to Illumina as Chair of the Board. His deep executive experience and business knowledge were greatly valued during his tenure. John brought extensive technology leadership, including as a CEO at Symantec and Virtual Instruments, and Chairman of the Board at Microsoft, to Illumina. His depth and breadth of knowledge in technology and across a number of private and public sectors, as well as his financial expertise, greatly contributed to the Board's strategic leadership of the company."

13:58 EDT MoviePass launches nationwide with varied subscription plans - MoviePass announced it is opening up its subscription service for nationwide availability to kick off Memorial Day weekend. MoviePass was previously available only to those on the waitlist during its beta period. "The company has several subscription plans available at affordable price points starting at $10/month, providing film buffs with access to see a variety of their favorite films per month at a considerable savings. Members benefit from being able to use their subscription for tickets at any theater that accepts debit cards. With America's largest theater network, MoviePass members can choose from more than 4,000 locations. Publicly listed companies that may be impacted by this include: Cinemark (CNK), Imax (IMAX), National CineMedia (NCMI) and AMC Entertainment (AMC).Reference Link

13:31 EDT Nikola under pressure after receiving delisting notice - Shares of Nikola are under pressure on Thursday after the company disclosed notice of delisting or failure to satisfy a continued listing rule or standard. The company said in a filing that, On May 24, it received written notice from Nasdaq notifying Nikola that "it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on Nasdaq. Nasdaq Listing Rule 5450(a)(1) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the company's common stock for the 30 consecutive business days prior to the date of the Notification Letter, the company does not currently meet the minimum closing bid price requirement." The Notification Letter states that the Company has 180 calendar days, or until November 20, 2023, to regain compliance. In Thursday afternoon trading, shares of Nikola have dropped almost 23% to 60c.Reference Link

13:21 EDT CVS Health sees 2024 operating income hit of $800M-$1B due to 'star ratings' - In a regulatory filing, CVS Health stated: "On April 4, 2022, the U.S. Centers for Medicare & Medicaid Services, or 'CMS,' issued its final notice detailing final 2023 Medicare Advantage payment rates. Final 2023 Medicare Advantage rates resulted in an expected average increase in revenue for the Medicare Advantage industry of 5.00%, excluding the CMS estimate of Medicare Advantage risk score trend. On February 1, 2023, CMS issued an advance notice detailing proposed 2024 Medicare Advantage payment rates. The 2024 Medicare Advantage rates, if finalized as proposed, will result in an expected average decrease in revenue for the Medicare Advantage industry of 2.27%, excluding the CMS estimate of Medicare Advantage risk score trend. CMS intends to publish the final 2024 rate announcement no later than April 3, 2023. The ACA ties a portion of each Medicare Advantage plan's reimbursement to the plan's 'star ratings.' Plans must have a star rating of four or higher out of five to qualify for bonus payments. CMS released the company's 2023 star ratings in October 2022. The company's 2023 star ratings will be used to determine which of the company's Medicare Advantage plans have ratings of four stars or higher and qualify for bonus payments in 2024. Based on the company's membership at December 31, 2022, 21% of the company's Medicare Advantage members were in plans with 2023 star ratings of at least 4.0 stars, compared to 87% of the company's Medicare Advantage members being in plans with 2022 star ratings of at least 4.0 stars based on the company's membership at December 31, 2021. The estimated impact from the decline in the number of Medicare Advantage members in plans with star ratings of at least 4.0 stars, net of mitigating actions, is a reduction of the 2024 operating income of the Health Care Benefits segment of approximately $800M to $1.0B."

13:13 EDT Bunge up 7% after report on merger talks with Glencore's Viterra - Shares of Bunge are up $6.24, or 7%, to $96.70 following Bloomberg's report.

12:46 EDT Lufthansa confirms agreement on acquisition of 41% stake in ITA Airways - Deutsche Lufthansa confirmed that it has reached an agreement with the Italian Ministry of Economy and Finance to acquire a minority stake in the Italian national carrier ITA Airways. Lufthansa will obtain a 41% stake in ITA for EUR 325M through a capital increase, the company said in a statement, adding that as part of the agreement, the MEF has also committed to a capital increase of EUR 250M into ITA. In addition, the MEF and Lufthansa agreed on options to enable a potential acquisition of the remaining shares by Lufthansa at a later date. The purchase price for the remaining shares will be based on the business development of ITA Airways. The contractual finalization of the agreement is expected to be completed shortly. The acquisition of the minority stake is subject to approval by the relevant authorities. Upon closing of this transaction, ITA Airways and Lufthansa Group are expected to immediately start their cooperation at a commercial and operational level. Carsten Spohr, CEO of Deutsche Lufthansa AG says: "Today's agreement will lead to a win-win situation for Italy, ITA Airways and Lufthansa Group." Reference Link

12:29 EDT Virgin Galactic says VSS Unity has reached space - Virgin Galactic said via Twitter: "Release, release, release! VSS Unity is flying free, having separated cleanly from the mothership VMS Eve! Successful boost, WE HAVE REACHED SPACE!"

12:00 EDT Snowflake falls -19.2% - Snowflake is down -19.2%, or -$33.99 to $143.15.

12:00 EDT Genesco falls -32.5% - Genesco is down -32.5%, or -$9.69 to $20.09.

12:00 EDT VeriSign Inc rises 20.9% - VeriSign Inc is up 20.9%, or $5.98 to $34.56.

11:50 EDT Mobile Global Esports to acquire OrionsWave social challenge engine - Mobile Global Esports announced that the company has executed the definitive agreement to acquire, implement and relaunch the social challenge technology developed by Nils Lahr and OrionsWave. "Moving forward with OrionsWave's social challenge technology provides the robust technological backbone required for building out the capabilities, value and offering of our MOGO social platform. We're looking forward to working closely with Nils and his team to drive gamer engagement through offering users the ability to create challenges with which to motivate player and team unity and competitiveness," said Mobile Global Esports CEO Dave Pross.

11:28 EDT Cosmos Holdings announces binding LOI to acquire all outstanding Docpharm shares - Cosmos Health announced that it has executed a binding Letter of Intent, or LOI, to acquire all of the outstanding shares of Docpharm GmbH, which it calls "an established pharmaceutical distributor based in Germany." Greg Siokas, CEO of Cosmos Health, stated: "We are extremely excited to have successfully concluded this binding LOI for the acquisition of Docpharm. This transaction is a testament to our commitment to creating value for our shareholders and sustainably growing our business through M&A and organic growth. Docpharm is another important milestone that will help us significantly accelerate our international growth plans and is expected to contribute more than $32M annual revenue by the end of 2025, or approximately $35M based on today's exchange rate. In other words, this acquisition alone is expected to boost our annual revenue by approximately 70% compared to FY 2022."

11:11 EDT SmileDirectClub to file motion to vacate final award in Align arbitration - In a regulatory filing, SmileDirectClub (SDC) disclosed: "On August 27, 2020, Align Technology, (ALGN) filed an arbitration demand against the company alleging that the company breached the Amended and Restated Supply Agreement between the parties and the company, subsequently, filed counterclaims against Align alleging breaches by Align under the Align Agreement. The arbitration proceeded in two phases to address the parties' claims. The hearing on the initial phase addressing Align's claims and one of the company's counterclaims occurred in July 2022 and the second phase of the arbitration addressing the balance of the company's counter claims hearing occurred in February 2023. On October 27, 2022, the arbitrator issued an interim award against the company on certain of Align's claims, specifically stating that it was not final award, and that final award would be issued after the second phase of the arbitration and subsequent proceedings on attorneys' fees, interest, and costs. A final award was issued on May 18, 2023 against the company, which could be material to the company's financial statements and position. This final award must still be confirmed by a state court in California prior to becoming enforceable. In light of what the company views as the improper preclusion of critical evidence during the arbitration proceedings and other misconduct, among other things, the company plans to file a motion to vacate the final award, which the company believes will present the court with compelling grounds to overturn the award . The company intends to vigorously oppose any confirmation of the interim or final award."

11:02 EDT Jana Partners calls on Freshpet to rectify corporate governance 'failures' - JANA Partners, which along with its affiliates and partners, owns 9.3% of Freshpet, delivered the following letter to the legal counsel of the Freshpet Board of Directors regarding recent changes to the size and composition of the Board. By adopting such changes, which JANA believes are a desperate attempt to entrench Freshpet's incumbent directors and impede the free exercise of the shareholder franchise at the Company's 2023 Annual Meeting of Stockholders, the Board has breached its fiduciary duties. Barry Rosenstein and Scott Ostfeld, Managing Partners at JANA, commented, "The Freshpet Board has a track record of poor decision making, lax oversight and apparent disregard for corporate governance. The Board's latest stunt-reducing the number of directors up for election amid a contested Annual Meeting and abruptly accelerating its date-is an overt attempt to influence the shareholder vote, and underscores why Board change is desperately needed. The Board must immediately remedy its corporate governance failures and permit shareholders to participate in a fair and democratic election of directors."

10:59 EDT QuantaSing Group Ltd- ADR trading resumes

10:48 EDT American Airlines 'pleased' with this year's operating margins

10:42 EDT Icahn Enterprises 'reminds me somewhat of Archegos,' Ackman says - Investor Bill Ackman, the CEO Pershing Square, who has feuded publicly in the past with Carl Icahn, stated in a lengthy Twitter post last night: "I have been fascinated by the @HindenburgRes $IEP situation, and there are some interesting learnings here... The $IEP premium has been sustained by a large dividend yield, which is not supported by operating cash flows. The yield is generated by returning capital to outside shareholders, which is in turn funded by the company selling stock to investors. This system has worked for a considerable period of time, but it is highly dependent on the maintenance of the premium and the placidity of Icahn's margin lender(s)... The problem Icahn has is that his system has been outed by @HindenburgRes. Transparency is not the friend of $IEP having caused a more than 50% decline in the shares, which has caused Icahn to post more shares, now more than 65% of his holdings. Further declines over the last several days will likely require additional postings... Icahn's margin lender(s) must be extremely concerned with the situation, particularly in light of the recent involvement of the @TheJusticeDept, which will also likely be investigating the lenders' involvement in the situation... $IEP reminds me somewhat of Archegos where the swap counterparties were comforted by each having relatively smaller exposures to the situation. The problem is that multiple lenders make for a more chaotic situation. All it takes is for one lender to break ranks and liquidate shares or attempt to hedge, before the house comes falling down. Here, the patsy is the last lender to liquidate. I am surprised that Icahn has not disclosed the terms of his margin loans including who provided them... Over his storied career, Icahn has made many enemies. I don't know that he has any real friends. He could use one here. We are neither long or short. Just watching from a distance." In Wednesday morning trading, shares of Icahn Enterprises are down $5.05, or 21%, to $18.89. Reference Link

10:33 EDT American Airlines CFO: Pilot deal 'consistent' with current guidance

10:22 EDT ViaSat announces European approval of Inmarsat acquisition - Viasat announced that the European Commission unconditionally approved its acquisition of Inmarsat. This follows the recent U.K. Competition & Markets Authority's clearance on May 9, and that of the Federal Communications Commission on May 19, the company said in a statement. "The two companies will now work to expedite completion of the transaction, which is expected to close by the end of this month," it added.

10:10 EDT ViaSat's acquisition of Inmarsat cleared by EU - The European Commission has approved unconditionally, under the EU Merger Regulation, the proposed acquisition of Inmarsat (IMASF) by Viasat (VSAT). The Commission concluded that the merger would not raise competition concerns in the European Economic Area or any substantial part of it, it said in a statement. Reference Link

10:03 EDT FDA approves Paxlovid for mild-to-moderate COVID-19 in adults - The Food and Drug Administration approved the oral antiviral Paxlovid or the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug-and first oral antiviral pill-approved by the FDA to treat COVID-19 in adults, the agency said in a statement. Paxlovid manufactured and packaged under the emergency use authorization and distributed by the Department of Health and Human Services will continue to be available, it added. Pfizer is the maker of Paxlovid. Reference Link

10:01 EDT BAE Systems awarded $7M contract from DARPA - The Defense Advanced Research Projects Agency has awarded BAE Systems' FAST Labs research and development organization a $7M contract for the Oversight autonomous space-based target custody program. Work on the program, which is part of BAE Systems' autonomous technologies portfolio, includes collaboration with subcontractors OmniTeq and AIMdyn.

10:00 EDT UiPath falls -16.9% - UiPath is down -16.9%, or -$2.76 to $13.58.

10:00 EDT VeriSign Inc rises 17.8% - VeriSign Inc is up 17.8%, or $5.08 to $33.66.

10:00 EDT Alerian Midstream Energy Index rises 1240.5% - Alerian Midstream Energy Index is up 1240.5%, or $442.58 to $478.26.

09:47 EDT Direxion Daily Semiconductor Bear 3X Shares falls -13.7% - Direxion Daily Semiconductor Bear 3X Shares is down -13.7%, or -$2.40 to $15.17.

09:47 EDT UiPath falls -14.6% - UiPath is down -14.6%, or -$2.39 to $13.95.

09:47 EDT X Financial rises 24.5% - X Financial is up 24.5%, or 76c to $3.86.

09:43 EDT The Real Brokerage Inc. launches operations in South Dakota - The Real Brokerage has launched operations in South Dakota, expanding the company's presence to 47 states and four Canadian provinces. Josh Boschee, who serves as Real's Principal Broker in North Dakota, also will assume responsibility for South Dakota. Real opens for business in South Dakota with the Christians Team Real Estate. The 16-member team, which is led by Jeff Christians, includes six agents who serve the Rapid City/Spearfish metropolitan area and two agents who are based in Phoenix.

09:40 EDT Caravelle signs $25M supply agreement with Best Polystyrene - Caravelle International Group signed a supply agreement with South African company Best Polystyrene. Over the next two years, Caravelle will supply 50,000 cubic meters of wood from its processing facility in Gabon, West Africa, with an estimated revenue of $25M. Caravelle will ship the wood products from Gabon, and in line with its innovative practices, will use its proprietary CO-Tech system to dry the wood in transit, offering significant cost savings and reducing lead times. The wood will then be delivered directly to Best Polystyrene in South Africa.

09:36 EDT Vinco Ventures receives Nasdaq staff determination letter - Vinco Ventures announced receipt of a staff determination on May 18 stating that the company failed to meet its obligations under Nasdaq Listing Rule 5810(b) because it has not yet filed its Form 10-Q for the period ended March 31. The company is required to file updated information with the Hearings Panel no later than May 25, regarding its scheduled plans to file this delinquent Form 10-Q. The company notes, in the April 14 determination letter, which it received from the Panel, its agreement to file its 10-Q by July 7 was referenced, and that the company continues to remain confident that it will file its 10-Q by that date.

09:33 EDT CRE exposure may pressure ratings of regional banks, Fitch Ratings says - U.S. banks with less than $100B in assets are more susceptible to deteriorating commercial real estate, CRE fundamentals than larger banks, which could add to ratings pressure, given their higher relative exposure as a percentage of assets and total capital, Fitch Ratings says. "The tight monetary environment has placed pressure on most CRE properties' collateral values and transaction volumes while structural changes in demand for office space have adversely impacted occupancy for that asset class. These factors increase credit risk for banks that have CRE loan concentrations, and are expected to have an impact on asset quality in CRE loan portfolios of U.S. banks. While most rated banks' CRE exposures are diversified both across property type and geography, some have meaningful CRE concentrations, which are either currently an important constraint on ratings or could contribute to negative rating pressure if portfolios deteriorate. However, the majority of the CRE exposure is held on smaller bank balance sheets, which are not rated by Fitch, limiting our visibility into lender-level credit quality for the broader industry, which includes 4,700 FDIC-insured banks," wrote Fitch in a statement out earlier. Company's in the space include: Valley National (VLY), M&T Bank (MTB), East West Bancorp (EWBC),Western Alliance (WAL), Signature Bank, (SBNY) and First Republic Bank (FRCB). Reference Link

09:30 EDT Fiserv to transfer listing to NYSE, switch symbol - Fiserv announced that it is transferring the listing of its common stock to the NYSE from the Nasdaq Global Select Market. The company expects to begin trading on the NYSE June 7, under a new ticker (FI). The stock will continue to trade on Nasdaq until the transfer is complete.

09:28 EDT Boeing CFO: Parts of supply chain not where they need to be

09:27 EDT Dish jumps 20% after WSJ report on mobile plan talks with Amazon - Shares of Dish Network (DISH) are moving higher after the Wall Street Journal said the company is in talks to sell wireless plans for its mobile phone service through Amazon (AMZN). Details of the new phone plans sold through Amazon's U.S. website could be announced as soon as June, people familiar with the matter told the Journal. A Dish spokeswoman said the company does "not have any type of distribution plan or partnership with Amazon at this time." Dish shares in premarket trading are up 20%, or $1.24, to $7.47. Citi last night downgraded Dish to Neutral from Buy citing its "substantial capital needs."

09:23 EDT Eguana, Virtual Peaker have integrated their respective technologies - Eguana Technologies and Virtual Peaker have integrated their respective technologies to provide utilities and consumers with dynamic options to leverage batteries to benefit the grid and reduce energy costs. This partnership will allow utilities supported by Virtual Peaker's DERMS suite, Shift to connect with any internet-connected Eguana energy storage system. Utilities can enroll, deploy, and manage BYOD demand response programs through Virtual Peaker's simple-to-use, integrated enrollment management framework. Eguana owners can now easily participate in their local utility's demand response or TOU program and capture available consumer rebates. "Eguana is pleased to partner with Virtual Peaker to deliver value to energy users and the power grid transition," said Daljit Ghotra, Chief Technology Officer at Eguana. "Together, Eguana and Virtual Peaker are able to leverage advanced power systems and dynamic DER management to deliver reliable power and financial incentives to battery owners while supporting utility grid modernization."

09:22 EDT Boeing CFO: Demand environment 'favorable'

09:21 EDT ZyVersa Therapeutics announces publication of article in Frontiers in Medicine - ZyVersa Therapeutics announces publication of an article in the peer-reviewed journal, Frontiers in Medicine, demonstrating a role for innate inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, both of which are typically thought to be classical antigen-driven autoimmune conditions. In the paper titled, "Inflammasome activation and formation of ASC specks in patients with juvenile idiopathic arthritis," the authors reported the following: Higher numbers of ASC speck-positive monocytes were detected in peripheral blood of JIA patients compared to controls; ASC speck-positive monocytes were detected significantly more frequently in patients with oligo-articular JIA compared to those with poly-articular JIA; Serum IL-1beta was significantly higher in patients with JIA compared to controls; Higher numbers of ASC speck-positive monocytes were observed in JIA patients with an elevated titer of antinuclear antibodies, ANA; Il-1beta production from macrophages exposed to extracellular ASC specks was enhanced in serum of JIA patients with a high titer of ANA, suggesting that autoantibodies favor a secondary inflammatory response to ASC specks by macrophages. "The research published in Frontiers in Medicine demonstrates the role of inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, which were previously thought to be classical antigen-driven autoimmune conditions. This research provides support for the broad range of conditions that are impacted by activation of the innate immune response," commented Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO and President. "Additionally, the data demonstrating enhanced IL-1beta production from macrophages exposed to extracellular ASC specks in JIA patients with a high titer of ANA supports the potential of ASC speck inhibition in helping to control inflammation in this population."

09:21 EDT Telus to invest $5M in North Shore region - TELUS is pleased to announce a $5 million private investment in the North Shore region this year to deploy and update its PureFibre and 5G networks. This investment is paired with the financial contributions of $6.89 million from the Government of Quebec and $4.06 million from the CRTC to add nine new wireless sites in the La Manicouagan and La Minganie RCMs to improve connectivity along Route 389 in the north of Baie-Comeau, in Lac Walker, along stretches of road on Route 138 between Sept-Iles and Natashquan and the surrounding municipalities. Planning and preparatory work will begin in 2023 and TELUS plans for the first sites to be operational in 2024.

09:18 EDT BriaCell enters definitive arrangement agreement for spinout of BriaPro - BriaCell Therapeutics entered into an arrangement agreement dated May 24, 2023 with BriaPro Therapeutics, a wholly-owned subsidiary of the Company pursuant to which certain pre-clinical pipeline assets of the Company, including Bria-TILsRx and protein kinase C delta inhibitors for multiple indications including cancer, will be spun-out to SpinCo by way of a court approved statutory plan of arrangement under the Business Corporations Act. Pursuant to the Arrangement Agreement, SpinCo will acquire the entire right and interest in and to the SpinCo Assets in consideration for the issuance by SpinCo to the Company of SpinCo common shares. Under the terms of the Arrangement, for each BriaCell share held immediately prior to closing, BriaCell shareholders will receive one common share of SpinCo, and one new common share of BriaCell having the same terms and characteristics as the existing BriaCell common shares. SpinCo Shares issued to BriaCell shareholders will, in aggregate, represent 33.33% ownership of SpinCo Shares upon closing of the Arrangement, with BriaCell initially retaining a 66.67% ownership interest in SpinCo. BriaCell shareholders who receive SpinCo Shares will ultimately own shares in both companies: BriaCell, which will continue with its mission to develop targeted immunotherapies for cancer, and SpinCo, which will focus on the development of the SpinCo Assets. Under the terms of the Arrangement, existing holders of BriaCell warrants shall receive upon exercise of each BriaCell warrant, for the original exercise price: one BriaCell common share and one SpinCo Share for each BriaCell common share that was issuable upon exercise of the BriaCell warrant. Following the Arrangement, BriaCell will remain listed on both the NASDAQ Capital Market and Toronto Stock Exchange, and SpinCo will become an unlisted reporting issuer in Canada. The Arrangement requires approval by BriaCell shareholders at a special meeting of shareholders expected to be held in July 2023. Approval of the Arrangement must be obtained by a special resolution passed by a majority of not less than two-thirds of the votes cast by BriaCell shareholders who vote in respect of the resolution. The Arrangement must also be approved by the Supreme Court of British Columbia. An interim order of the Court will be applied for to prescribe certain procedural matters relating to the special meeting of shareholders, followed by an application for a final order to approve the Arrangement after the special meeting of shareholders. Subject to the satisfaction of all conditions to closing set out in the Arrangement Agreement, it is anticipated that the Arrangement will be completed by August 2023. Conditions to closing include, inter alia, shareholder approval, required court orders and TSX and NASDAQ approvals.

09:17 EDT Boeing still sees FY23 free cash flow $3B-$5B, says CFO

09:15 EDT Ralph Lauren: Global environment 'highly dynamic'

09:14 EDT LiveOne, PodcastOne to launch Adam Carolla debut pay-per-view event - PodcastOne, a subsidiary of LiveOne, announced the June 4, 2023 Pay-Per-View event with PodcastOne host and world famous comedian, Adam Carolla, entitled Adam Carolla & Friends. The evening will kick off at 9:30pm ET/6:30pm PT live from the Belly Up Tavern outside of San Diego, CA, featuring Carolla alongside comedians Brad Williams, Kimbles Hume and other special guests for 90 minutes of Carolla's signature on-topic, cutting edge comedy. "We are excited that PodcastOne and LiveOne have partnered with Adam to produce and distribute Adam's very first headlining pay-per-view event. Very few comedians are as entertaining in an intimate club environment as Adam. Each show he performs is unique and tailored and to be able to bring this to a worldwide audience exemplifies how we're able to create opportunities for our podcast hosts outside of the traditional audio driven mediums," said Kit Gray, President of PodcastOne.

09:13 EDT Ralph Lauren sees pressure on value-oriented consumers to persist near-term

09:09 EDT Patterson Companies promotes Bergeson to CHRO, hires Tonya Barber as DE&I - Patterson Companies announced two new additions to the organization's leadership team with the promotion of Samantha Bergeson to Chief Human Resources Officer or CHRO, and the hiring of Tonya Barber to the role of Director of Diversity, Equity and Inclusion or DE&I . Bergeson joined Patterson in 2013 and has held several human resources leadership roles within the company, most recently serving as Vice President of Human Resources. She will join the executive leadership team and report to Patterson Companies President and CEO Don Zurbay. Bergeson will be responsible for the company's human resources strategy, specifically focused on culture, compensation, talent management, organizational alignment, employee development, diversity, equity and inclusion. "Samantha is a proven and highly respected leader within Patterson," said Zurbay. "She has consistently demonstrated her ability to deliver results; she knows our business and deeply understands our culture and values. I am confident that she will further strengthen our team and business. I look forward to working with Samantha more closely as we seek to build momentum, advance our strategic priorities, and continue to create shareholder value."

09:07 EDT 22nd Century highlights recent TCORS Symposium findings - 22nd Century Group provided comments following the recent Tobacco Centers of Regulatory Science Symposium and attempts to use funding limitations to inhibit actions by the U.S. Food and Drug Administration to advance its top tobacco harm reduction policies. The FDA's proposed tobacco policies include a federal ban on menthol as a flavoring agent, slated for final rule status in August 2023, and a proposed national reduced nicotine content standard that would require all tobacco products sold be made minimally or non-addictive. Together, these policies are expected to dramatically reduce the rates of smoking in the U.S., saving millions of lives and countless healthcare dollars. A recent TCORS Symposium titled "Computational Modeling in Tobacco Regulatory Science: Nicotine Reduction and Flavor Restrictions" provided two days of sessions dedicated to modelling the substantial public health benefits of these proposed FDA policies, strong statements from public health researchers and policy makers in support of the health benefits to be won from implementation, and references to 22nd Century's leadership in bringing the first and only FDA authorized reduced nicotine content products to market, now in the first stages of commercial launch. Decades of clear and compelling research support both of FDA's proposed policies and underpin the importance of VLN products in supporting their implementation. In particular, research indicates that a nationwide menthol ban would not only reduce the harms of smoking, but also provide significant benefit to minority communities where the rate of menthol smoking is particularly prevalent. Specifically, a menthol ban in conjunction with the availability of a non-addictive off-ramp products, like the Company's VLN Menthol King cigarettes, will encourage adult smokers to reduce their smoking habit, or even quit all together through the use of appropriately labelled FDA authorized products. Off-ramp products have been clinically shown to be an important component in achieving a true reduction in smoking rates, rather than adult smokers merely switching to other addictive products. Extensive clinical research also documents that reduced nicotine content cigarettes increase cessation, decrease consumption, decrease dependence and reduce toxicants, leading to an overall reduction in population smoking activity. The FDA's proposed mandate to require only nonaddictive levels of nicotine in cigarettes is similar to the policy recently enacted by New Zealand. Reducing nicotine to nonaddictive levels is a groundbreaking public health mandate and perhaps the single most impactful policy to reduce the rates of smoking worldwide. In recognizing this important turning point in public health, the FDA also recently executed an agreement with the government of New Zealand enabling the governments to share confidential data as the policies advance. Additionally, 22nd Century opposes the tobacco industry's attempts to influence congress and interfere with the U.S. Food and Drug Administration's plans to advance these policies. Though unlikely to become law, if passed, specific language included in SEC. 768 and SEC. 769 of the proposed Agriculture Appropriations bill would seek to interfere with FDA's plans to remove menthol from cigarettes, presently expected to reach final rule status in August

09:05 EDT ResMed announces new evidence on OSA with PAP - Renowned medical experts at the American Thoracic Society International Conference unveiled new evidence that demonstrates treating obstructive sleep apnea, OSA, with positive airway pressure, PAP, therapy lowers all-cause mortality for patients. In addition, a late-breaking abstract showed treating central sleep apnea, CSA, caused a "significant and clinically relevant improvement" in their symptoms and quality of life. The studies were among 24 supported by ResMed. Treating OSA with PAP lowered all-cause mortality in France, Germany: Two headline studies presented at ATS showed an association between PAP treatment for OSA and lower all-cause mortality. One is an analysis of over 22,000 anonymized German patients diagnosed with OSA - roughly half using PAP, the other not. The study, led and presented by German sleep researcher Holger Woehrle, concluded PAP treatment for OSA is associated with a 13% lower mortality in the first four years of treatment. The other is an analysis of over 100,000 deidentified French patients who previously stopped but restarted PAP to treat OSA - roughly two-thirds were still using PAP one year later, the other one-third stopped a second time. The study, led and presented by French sleep researcher Jean-Louis Pepin and part of ResMed's broader landmark ALASKA study, found "the risk of all-cause death was 38% lower in individuals who continued using CPAP after therapy resumption." Treating CSA with ASV improved quality of life, symptoms over 1 year: A third major finding came out of READ-ASV, the largest prospective registry investigating the clinical use and effects of adaptive-servo ventilation in a real-world cohort with central sleep apnea. Led and presented by German sleep researcher Michael Arzt, this prospective, multicenter, and multinational study of 847 patients concluded that first-time ASV users with central sleep apnea "experienced a significant and clinically relevant improvement in disease-specific quality of life, daytime sleepiness, and quality of sleep."*

09:04 EDT GSE Systems announces recent wins totaling more than $1M - GSE Solutions announced that its GSE Engineering division showed positive momentum with several new customer service and support wins. These recent wins, totaling more than $1M, verify that customers continue to trust GSE to provide subject matter expertise and specialty engineering services critical to them to boost agility, reduce operation and maintenance costs, and maintain regulatory compliance.

09:04 EDT Digerati Technologies postpones special meeting of shareholders - Digerati Technologies filed a definitive proxy statement / final prospectus with respect to a special meeting of its stockholders to be held on Thursday, May 25, 2023 at 11:00 a.m. EDT to vote on, among other things, a proposal to adopt and approve that certain Business Combination Agreement by and among Digerati, Minority Equality Opportunities Acquisition Inc., a Delaware corporation and MEOA Merger Sub, Inc., and the business combination contemplated thereby. On May 24, 2023, Digerati determined to postpone the Special Meeting until 11:00 a.m. EDT on Friday, May 26, 2023.

09:03 EDT Emerson Electric joins Greentown Labs as a Terawatt Partner - Greentown Labs, the largest climatetech incubator in North America, announced Emerson as its newest Terawatt Partner, the highest level of engagement with the incubator. Through the agreement, Emerson's industry-leading automation portfolio of intelligent sensors, final control devices, software, and analytics, combined with deep domain expertise, are now available to Greentown members to help them commercialize and scale their innovations.

09:01 EDT Synopsys initiates $300M accelerated share repurchase agreement - Synopsys has entered into an accelerated share repurchase agreement with Mizuho Markets Americas LLC to repurchase an aggregate of $300M of Synopsys stock. Under the terms of the ASR, Synopsys will receive an aggregate initial share delivery of approximately 645,000 shares, with the remainder, if any, to be settled on or before August 11, 2023, upon completion of the repurchases. The specific number of shares that Synopsys ultimately repurchases under the ASR will be based on the average of Synopsys' daily volume-weighted average share prices during the repurchase period, less a discount.

08:46 EDT Wearable Devices announces preorder availability of Mudra Band for Apple Watch - Wearable Devicesannounced that its flagship consumer product, the Mudra Band for Apple Watch, is now available for preorder at www.mudra-band.com, as the Company prepares for its first volume manufacturing batch.

08:45 EDT Legend: Type II variation application submitted to EMA for CARVYKTI - Legend Biotech (LEGN) announced that a Type II variation application was submitted to the European Medicines Agency for CARVYKTI based on data from the CARTITUDE-4 study, which investigates the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. The submission was filed to the EMA by Janssen-Cilag International an affiliate of Janssen Biotech (JNJ), Legend Biotech's collaborator for the development and commercialization of cilta-cel. "We are committed to investigating the full potential of CARVYKTI across patient populations, including in earlier lines of treatment," said Ying Huang, Ph.D., CEO of Legend Biotech. "I am proud of the efforts that Legend Biotech and our collaborator, Janssen, continue to make to potentially bring CARVYKTI to a broader range of patients." The application is supported by data from the CARTITUDE-4 study, a randomized Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma.1,2.

08:41 EDT Jaguar Health announces over-enrollment in Phase 3 OnTarget trial - Jaguar Health has over-enrolled its global, pivotal, Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without chemotherapy. The OnTarget study is a first-of-its-kind prophylactic clinical trial with a primary endpoint based on patient reported outcomes that address the highly neglected and unmet burden of cancer therapy-related diarrhea. This study will evaluate the benefit of crofelemer to prevent or substantially reduce the number of weekly loose/watery stools as a continuous measurement over the 12-week treatment period compared to placebo. By completing the targeted enrollment, the OnTarget study has approximately 90% power to detect the difference in the incidence and severity of diarrhea between crofelemer and placebo. The Company's expectation is that the double-blind placebo controlled OnTarget trial will provide evidence that diarrhea associated with targeted cancer therapies is chronic, not acute, and impacts the patient's ability to perform activities of daily living as well as remain on their cancer therapy regimens at proven doses for better outcomes. The OnTarget trial is evaluating the effectiveness of crofelemer's novel mechanism of action - the modulation of two gastrointestinal chloride ion channels - to mitigate or substantially reduce chronic cancer therapy-related diarrhea.

08:39 EDT Columbia Financial announces sixth stock repurchase program - Columbia Financial announced that the Company's Board of Directors has authorized a new stock repurchase program to acquire up to 2,000,000 shares, or approximately 1.9% of the Company's currently issued and outstanding common stock and 6.8% of the Company's currently issued and outstanding common stock excluding shares held by Columbia Bank, MHC. Thomas Kemly, President and Chief Executive Officer of the Company, stated: "I am happy to announce a new stock repurchase program. Our continuation of our share repurchase program underscores our continued commitment to financial discipline and enhancing shareholder value."

08:38 EDT Clever Leaves enters five-year agreement with SOMAI Pharmaceuticals - Clever Leaves Holdings entered into a five-year agreement with SOMAI Pharmaceuticals, to supply its operations in Portugal with EU-GMP certified CBD extracts from Colombia. With the first shipments under the agreement already completed, Clever Leaves will continue to supply EU-GMP pharmaceutical-grade APIs and CBD extracts, produced in the Company's facility in Colombia, to SOMAI for further processing into finished products for patients across Europe. Positioned to be one of the largest players in Europe's medical cannabis market, SOMAI's goal is to design new dosage forms that deliver consistent quantities of active ingredients to patients by going beyond conventional drug delivery systems. These are the first commercial shipments Clever Leaves has sent to Portugal, adding to the more than 15 countries that Clever Leaves has exported to from its European Union Good Manufacturing Practices certified facility in Colombia.

08:36 EDT Smart for Life announces corporate video with Chef Manfred Schmidtke - Smart for Life released a video interview with Chef Manfred Schmidtke, the Company's master chef spearheading many of Smart for Life's R&D initiatives. "We are pleased to release our latest corporate video with Chelf Manfred Schmidtke," stated Darren Minton, Smart for Life's Chief Executive Officer. "Manfred has been an indispensable member of Smart for Life well before our company went public on Nasdaq. He has been working with Dr. Sasson Moulavi, founder of the Smart for Life brand, for over four years and has proven to be a tremendous asset to the company. Manfred has been a key driving force behind the R&D initiatives across all of our culinary creations at Smart for Life, including the most recent launch of our new high protein ice cream products, for which we expect to see significant demand. We are looking forward to leveraging Manfred's extensive culinary knowledge and expertise as we continue to expand our portfolio in the health and wellness space."

08:34 EDT RDE upgrades to new payment processor - RDE, Inc. announced an upgrade to a new payment processor, which significantly upgrades its payment processing capabilities, offering an enhanced, seamless, and secure checkout experience for its customers. The new partnership is with a globally renowned payment processor, known for its industry-leading technology, commitment to security, user-friendly interface, and their extensive experience in optimizing transaction processes. Through these improvements, Restaurant.com has greatly advanced its risk management capabilities, leading to a marked reduction in fraudulent transactions while ensuring the safety and security of the personal and payment information of its customers. The updated payment processing capabilities are already active, with Restaurant.com customers enjoying a smoother and more secure checkout experience. The new payment processing capabilities have led to substantial improvements in key performance indicators, whereby Restaurant.com has already seen an increase in conversion rates and a significant reduction in chargebacks, benefiting both customers and restaurant partners.

08:34 EDT Lightwave Logic begins commercialization of electro-optic polymer materials - Lightwave Logic announced the company's first commercial material supply license agreement for its Perkinamine chromophore materials. This initial commercial material supply license agreement will provide Perkinamine chromophore materials for polymer based photonic devices and photonic integrated circuits. The supply license agreement terms include supply of electro-optic polymer material, license initiation fee, per unit royalties, minimum royalty levels that increase annually, and minimum sales volume in units.

08:32 EDT Treasure Global signed a strategic partnership agreement with AmBank - Treasure Global announced it has signed a strategic partnership agreement with AmBank Group Berhad, allowing for a wider customer reach and supporting its future regional expansion by leveraging AmBank's customer base of credit card users. Under the partnership agreement, TGL will offer rewards through promotional campaigns for users on its proprietary application, ZCITY, when they use AmBank credit cards for payments on the app, driving additional users to ZCITY and increasing its brand exposure. "Through this strategic collaboration, TGL is able to expand its product portfolio while providing more rewards options for ZCITY registered users. This aligns with our ultimate goal of transforming and simplifying the e-payment experience for consumers with a one-stop digital ecosystem, while simultaneously allowing them to earn rewards," said Sam Teo, Chief Executive Officer of TGL.

08:18 EDT Laser Photonics receives second order from Caterpillar - Laser Photonics announced it received an order from Caterpillar Inc. for a MarkStar Pro Handheld Laser Marker.

08:17 EDT Fintech Ecosystem Development receives notice of noncompliance from Nasdaq - On May 23, 2023, Fintech Ecosystem Development received a notice from the Staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC, stating that the Company is not in compliance with the continued listing standards of Nasdaq Capital Markets under the timely filing criteria included in Listing Rule 5250(c)(1) because the Company failed to timely file with the Securities and Exchange Commission its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. On May 24, 2023, the Company filed the Form 10-Q to cure the delinquency.

08:13 EDT Singing Machine announces new CARE-eoke initiative - The Singing Machine Company announced the Company's new CARE-eoke by Singing Machine initiative, and a strategic focus on social impact for children and adults of all ages who would benefit from singing. Singing Machine intends to form a series of collaborative partnerships, to help amplify the diverse emotional and physical health and wellness benefits of karaoke, beginning with formalizing its CARE-eoke by Singing Machine initiative. "For over four decades Singing Machine has been bringing joy through music to millions of families around the world. But, recent scientific evidence suggests that karaoke is more than just joyful experiences; it also has strong links to health and mental wellbeing," said Gary Atkinson, CEO of Singing Machine. "We plan to align with like-minded partners who can help us reach different populations that would benefit from karaoke. We started during Autism Awareness Month with the announcement of a new licensing initiative with Sesame Workshop, and programming with the Center for Learning Unlimited, two groups creating community, acceptance, and normalizing neurodiversity. We intend to do more in this space, and with other populations."

08:11 EDT Ocean Biomedical announces addition to Russell 2000 Index - Ocean Biomedical announced that it is expected to be added to the Russell 2000 Index, effective after the U.S. market opens on June 26, 2023. This addition is part of the annual reconstitution of the Russell stock indexes. A preliminary list of index additions, including Ocean Biomedical, was posted by FTSE Russell on May 19, 2023. "Our company was founded to build better, more streamlined processes for bringing great discoveries to market," commented Dr. Chirinjeev Kathuria, Ocean Biomedical's co-founder and Executive Chairman. "We are pleased to be included in the Russell 2000(R) because we believe it will help us advance that goal."

08:10 EDT SES AI to be added broad-market Russell 3000 on June 26 - SES AI announced it is set to join the broad-market Russell 3000 Index. SES will be added at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the US market opens on June 26, according to a preliminary list of additions posted by FTSE Russell May 19. The annual Russell reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization. Membership in the US all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000(R) Index or small-cap Russell 2000(R) Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $12.1T in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell 3000 Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

08:09 EDT Cadma Capital Partners appoints Jon Beizer as CEO, Josh Brody as presiedne - Apollo announced that the recently established Cadma Capital Partners has named Jon Beizer and Josh Brody as its CEO and President, respectively. Cadma is a credit financing platform for the venture ecosystem, providing asset-backed financing to venture- and growth-lenders, high-growth companies and financial sponsors, and is backed by Apollo-affiliated entities. Beizer and Brody both join Cadma from Western Technology Investment. As CEO and President, they will be responsible for the continued build out of the Cadma franchise, which seeks to provide flexible, asset-backed capital solutions to venture- and growth-oriented lending platforms, growth companies as well as financial sponsors. By lending against assets and contracted cash flows, and in consultation with other Apollo related platforms, including ATLAS, Redding Ridge, and MidCap, Cadma can help its clients access cost-effective capital while providing investors downside protected opportunities.

08:07 EDT Stratasys to review unsolicited special tender offer from Nano Dimension - Stratasys (SSYS) confirmed that Nano Dimension (NNDM) has commenced an unsolicited special tender offer to acquire between 53% and 55% ownership of Stratasys' outstanding ordinary shares for $18 per share in cash. . Consistent with its fiduciary duties, and in consultation with its independent financial and legal advisors, the Stratasys Board of Directors will carefully review and evaluate the Offer to determine the course of action that it believes is in the best interests of the Company and Stratasys shareholders. Stratasys shareholders are advised to take no action at this time pending the Stratasys Board's review and evaluation of the Offer. Stratasys intends to advise shareholders of the Stratasys Board's position regarding the Offer within ten business days by making available to shareholders a Solicitation/Recommendation Statement on Schedule 14D-9, to be filed with the U.S. Securities and Exchange Commission. Earlier Stratasys announced it has entered into a definitive agreement with Desktop Metal (DM) to combine in an all-stock transaction valued at approximately $1.8B. The transaction, which is expected to be completed in the fourth quarter of 2023, is subject to customary closing conditions, including the approval of Stratasys' shareholders and Desktop Metal's stockholders and the receipt of certain governmental and regulatory approvals. .

08:06 EDT Immutep doses first patient in AIPAC-003 Phase II/III trial - Immutep Limited announces the first patient has been enrolled and safely dosed at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is evaluating eftilagimod alpha, Immutep's soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with standard-of-care paclitaxel for the treatment of metastatic HER2-neg/low breast cancer and triple-negative breast cancer. It will take place at approximately 17 clinical sites across Europe and the United States of America. Patients will receive same-day administration of efti + paclitaxel that can continue until disease progression. Immutep CSO, Prof Frederic Triebel said: "Commencing patient dosing for our AIPAC-003 trial of efti is a significant milestone for Immutep. Our aim is to improve clinical outcomes, focusing on a robust primary endpoint later in the phase III, overall survival, for patients with standard-of-care chemotherapy. Our previous trial, AIPAC, showed encouraging efficacy and safety results, including a 2.9-month median overall survival benefit and statistically significant median overall survival improvements of between 4.2 to 19.6 months across three pre-specified subgroups. We look forward to seeing how 90mg efti dosing, along with same-day administration of efti plus paclitaxel until disease progression, may build upon these prior results."

08:06 EDT Harmony Biosciences completes enrollment of Phase 3 study of pitolisant - Harmony Biosciences announced that its Phase 3 registrational INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia has completed enrollment nine months before its estimated enrollment completion date. Topline results are anticipated the fourth quarter of 2023.

08:05 EDT Ceridian announces Dayforce Career Explorer - Ceridian announced the launch of Dayforce Career Explorer, an AI-powered solution that helps improve engagement and retention by empowering employees to manage their careers. Dayforce Career Explorer provides employees with access to data-driven career pathing, opportunities for learning and development, and job notifications for open roles that match their skills and interests. Customers, including Jisc, are currently using Dayforce Career Explorer within their global workforce.

08:04 EDT Onconova doses first participant in Phase 2 trial of rigosertib w/ pembrolizumab - Onconova Therapeutics announced that the first participant has been dosed in an investigator-sponsored Phase 2 trial of oral rigosertib plus the PD-1 inhibitor pembrolizumab in patients with metastatic melanoma who have progressed on prior PD-1/L1 inhibitor therapy. The investigator-sponsored Phase 2 trial is an open-label, two-stage, single arm study. Stage 1 of the trial is expected to include ten patients. If a pre-specified response criteria is met, the study will then proceed to Stage 2, during which an additional 19 patients are expected to be enrolled. Patients in the study will receive 560 mg of oral rigosertib twice daily on days 1-21 of 28-day treatment cycles, plus 400 mg of pembrolizumab administered via intravenous infusion every six weeks. The primary endpoint of the trial is overall response rate, while key secondary endpoints include assessments of safety, tolerability, progression-free survival, and overall survival. Correlative biomarker assessments will also be conducted.

08:04 EDT Clene awarded grant from NMSS to advance development of CNM-Au8 - Clene announced that Clene has received a grant from the National Multiple Sclerosis Society, NMSS, via the organization's Fast Forward Program, a competitive, expert-reviewed funding opportunity to support commercial organizations that are developing new therapies for the treatment of multiple sclerosis, MS. The specific focus of this program is to identify and fund the development of promising new therapies that promote nervous system repair and regeneration in MS. Clene's lead drug candidate, CNM-Au8, a catalytically active gold nanocrystal suspension, has been shown to elicit robust remyelination and repair in multiple in vitro and animal models by enhancing energy metabolism in central nervous system cells. The one-year grant will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MS. Using non-invasive brain imaging, the study will enroll up to 15 individuals with primary progressive or non-active secondary progressive MS and determine the effects of 12 weeks of CNM-Au8 daily oral dosing on critical brain energy metabolites that have been shown to be compromised in individuals with MS. The study will be carried out at the University of Texas Southwestern Medical School under lead investigator Dr. Peter Sguigna and imaging expert Dr. Jimin Ren. Benjamin Greenberg, M.D., a Professor and Vice Chair of Clinical & Translational Research at UTSW, is not affiliated with this project.

08:02 EDT Aemetis resumes operations at 65 MGY California biofuel plant - Aemetis announced the re-start of production at the 65 million gallon per year capacity Keyes, California ethanol plant after completing the most extensive maintenance and system upgrades in the 12 years of facility operations. "The Keyes plant has a history of high uptime and consistent production, with only one scheduled maintenance day annually for nearly a decade. When natural gas prices reached historic highs several months ago, we made the strategic decision to idle operations and undertake an extensive cleanout, repair, and system upgrade cycle to install important technology upgrades," said Eric McAfee, Chairman and CEO of Aemetis, Inc. "The significant investments made at the plant include an entirely new Allen Bradley Decision Control System with more than 1,100 sensor connections installed across the facility to enhance the automation of operations and enable Artificial Intelligence management of energy use. The DCS system and other future mechanical upgrades will directly reduce the carbon intensity of biofuels produced by the Keyes plant, while reducing carbon pollution and improving local air quality in the Central Valley.

08:02 EDT Mesa Labs reports Q4 adjusted EPS $1.94, consensus 37c - Reports Q4 revenue $55.591M, consensus $57.4M. "Revenues of $55,591 in the quarter resulted in an organic revenues decline of 5.6% for the quarter. This was influenced by currency headwinds across the company, slower Biopharmaceutical spending primarily impacting our Biopharmaceutical Development Division, as well as a significant decrease in COVID related revenues and the previously disclosed closure of Sema4's expanded carrier screening business both of which impacted the Clinical Genomics division. Excluding currency and COVID related revenues, core organic revenues declined 1.6%. For the year, organic revenues growth was 0.6% and core organic revenues growth was 5.2%, within striking distance of our long-term core growth aspirations despite multiple headwinds faced throughout the year" said Gary Owens, Chief Executive Officer of Mesa Labs.

07:48 EDT Draganfly to showcase First Responder Drone technoloy at Texas conference - Draganfly announced that the Company will be featured at the 2023 Texas Emergency Management Conference. The conference will be held at the Fort Worth Convention Center in Fort Worth, Texas, from May 30 to June 2, 2023. The Texas Emergency Management Conference connects over 3,000 elected officials, first responders, emergency managers, and decision-makers from across the U.S. Attendees can participate in key workshops and check out innovative products and services from various organizations. Draganfly will showcase its Drone as First Responder, Heavy Lift, and Commander 3 XL Drone platforms and Vital Intelligence Smart Vital technology.

07:35 EDT NFI Group awarded new firm orders for six transit buses from Phoenix PTD - New Flyer of America, a subsidiary of NFI Group, announced that its subsidiary New Flyer Industries has received new firm orders for six zero-emission fuel cell-electric and 20 low-emission hybrid-electric transit buses from the Phoenix Public Transit Department, PTD. The two five-year contracts include options to purchase up to 160 fuel cell-electric and 160 hybrid-electric transit buses in 40-foot lengths. In total, NFI added up to 346 low- and zero-emission buses to its backlog in the first quarter of 2023 from firm and option orders. This purchase of low- and zero-emission buses will deliver on PTD's Transportation 2050 plan, focused on extending the bus service to enhance transit connectivity across Phoenix. "Today, PTD joins many other cities and transit agencies across North America in choosing advanced mobility solutions from NFI to enable its transition to a zero-emission fleet. Having delivered nearly 1,000 vehicles to PTD since 1994, we are honored to support its goal of transitioning to a 100% electric fleet by 2040," said Chris Stoddart, President, North American Bus and Coach, NFI. "With best-in-class features on board and one common platform to streamline training and maintenance, our high-performance fuel cell-electric and hybrid-electric buses will support a smooth transition to sustainable mobility through high operational performance, maintenance savings, and improved air quality."

07:34 EDT Syneos Health appoint Anson to Global Head, Patient Diversity and Health Equity - Syneos Health announced the appointment of Batisha Anson to the newly created role of Global Head of Patient Diversity and Health Equity. In this role, Anson will advance Syneos Health's goal to improve diverse representation of patient populations to provide more equitable access to therapies and innovative science. She will help inform diversity, equity and inclusion strategies for investigator sites, patient experience, access, launch and more, accelerating efforts to advance patient diversity in clinical trials and commercial programs. Most recently, she was Executive Vice President at Biosector 2 leading multiple DE&I initiatives.

07:31 EDT Dyne Therapeutics receives EMA orphan drug designation for DYNE-101 - Dyne Therapeutics announced that the European Medicines Agency, EMA, has granted orphan drug designation for DYNE-101. DYNE-101 is being evaluated in the Phase 1/2 ACHIEVE global clinical trial in adults with myotonic dystrophy type 1, DM1. "We are pleased to receive orphan drug designation from the EMA for DYNE-101, further supporting our efforts to develop a potentially transformative therapy for DM1," said Wildon Farwell, M.D., MPH, chief medical officer of Dyne. "The DM1 community has waited far too long for a therapy that addresses the underlying cause of this devastating rare muscle disease. We are committed to advancing DYNE-101 as quickly as possible and anticipate our first clinical data readout from our ACHIEVE trial later this year."

07:21 EDT Nvidia announces release of NVENC Video Codec SDK 12.1 - NVIDIA Corporation (NVDA) announced the release of Video Codec SDK 12.1, including new APIs to support Beamr Imaging Ltd.'s (BMR) Content Adaptive Bit Rate library, as part of the new Nvidia Encoder features enabling enhanced video processing use-cases on Nvidia GPUs. This collaborative effort aims to deliver fully standard compliant bitstreams with the lowest possible bit rate for a given perceptual quality, setting new benchmark in quality driven encoding. The integration of CABR with NVENC, utilizing the Iterative Encoding, Recon, and External look ahead features, enables a range of powerful use cases, unlocking new use cases offering significant benefits for video encoding. These use cases include reducing bitrate of a target encode while preserving quality, as well as codec modernization.

07:18 EDT Republic First Bancorp dedicates additional resources to SBA team - Republic First Bancorp announced that the Bank is dedicating additional resources to grow its Small Business Administration team, under the direction of Executive Vice President, SBA Director Arnie Horvath. Republic Bank will be adding staff to the SBA team and transitioning it under the Commercial Lending Business to increase deal flow and leverage synergies. The SBA team has extensive experience in the Bank's core markets extending into New Jersey and Eastern Pennsylvania. The additional resources being allocated to this group will allow for further expansion into these markets.

07:16 EDT Agios Pharmaceuticals appoints Owen to board of directors - Agios Pharmaceuticals (AGIO) announced that Catherine Owen has been appointed to its board of directors, effective June 13, 2023. Agios also announced that, following a collaborative succession planning process, John Maraganore, Ph.D., who has served as a valuable board member and advisor to the company since 2011, will step down from the board of directors, effective immediately, and that Kaye Foster, who has served as a member of the board of directors since 2014, will assume the role of lead independent director. In her current role as senior vice president and general manager, U.S. commercialization at Bristol Myers Squibb (BMY), Owen leads the company's cardiovascular, immunology and oncology U.S. commercialization efforts.

07:14 EDT Applied Therapeutics announces orphan medicinal product designation for AT-007 - Applied Therapeutics announced that AT-007 has been granted orphan medicinal product designation by the European Medicines Agency for treatment of Sorbitol Dehydrogenase Deficiency. Additionally, the Company announced that new data has been published in the Journal of Clinical Investigation on govorestat treatment in models of SORD Deficiency. Orphan medicinal product designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market. Applied Therapeutics has partnered govorestat for treatment of SORD Deficiency as well as Galactosemia in Europe with ADVANZ Pharma. Sorbitol reduction via govorestat ameliorates synaptic dysfunction and neurodegeneration in sorbitol dehydrogenase deficiency: The new data on govorestat treatment in models of SORD Deficiency was recently published in the Journal of Clinical Investigation. The molecular and cellular pathophysiology of SORD neuropathy was investigated through use of patient-derived cells and a drosophila model of disease, finding reduced adenosine triphosphate production and reactive oxygen species (ROS) accumulation in the central nervous system and muscle, indicating mitochondrial dysfunction as a result of increased sorbitol accumulation. Govorestat treatment significantly reduced sorbitol levels in patient-derived fibroblasts, patient iPSC-derived motor neurons, and SORD-deficient drosophila. Govorestat treatment in the SORD drosophila model mitigated synaptic degeneration and significantly improved synaptic transduction, locomotor activity, and mitochondrial function. Moreover, govorestat treatment significantly reduced ROS accumulation in patient derived cells and drosophila CNS and muscle. These findings uncover the molecular and cellular pathophysiology of sorbitol toxicity in SORD neuropathy, and govorestat provides a potential treatment strategy for patients with SORD Deficiency.

07:13 EDT BioXcel announces results from Part 1 SERENITY III trial of BXCL501 - BioXcel Therapeutics announced promising results for BXCL501, the Company's proprietary, orally dissolving film of dexmedetomidine under investigation for the treatment of agitation, in Part 1 of its Phase 3 SERENITY III trial conducted in institutional settings for acute treatment of bipolar disorders- or schizophrenia-associated agitation. These results are expected to enable the initiation of Part 2 for at-home use. BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved. SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use. Part 1 was similar to SERENITY I and II in design and assessed the efficacy and safety of a 60mcg dose using the same primary and secondary endpoints with patients in a monitored medical setting, as surrogates for the home setting. Patients enrolled in Part I were expected to have a relatively higher level of agitation than the home-based patient population expected to be enrolled in Part 2. Patients in Part 1 were evaluated with half of the already-approved 120mcg dose to enhance safety for the targeted at-home setting. "We are pleased with the outcome and progression of our land-and-expand strategy, which we believe moves us closer to addressing up to an additional 23 million annual agitation episodes in bipolar disorder and schizophrenia patients in the at-home setting. This would potentially more than double our current market opportunity, if approved. Treatment in the early stages of agitation at home could significantly benefit patients, caregivers, and hospital systems by reducing the need for emergency room visits and associated treatment costs," said Vimal Mehta, CEO of BioXcel Therapeutics. "We believe the entirety of BXCL501's clinical dataset generated, along with our upcoming Alzheimer's-related agitation milestones, could transform the agitation landscape for a broad spectrum of neuropsychiatric patients." Clinically meaningful efficacy results were observed with half of the lowest approved dose of IGALMI. In addition, greater than 50% PEC response rate was achieved, with responder rate dose-proportionally consistent with those observed in SERENITY I and II trials. Although the primary efficacy endpoint was not statistically significant at 2 hours, BXCL501 separated from placebo at 4 hours.

07:10 EDT LSB Industries in MOU for low-carbon ammonia as a marine fuel - LSB Industries jointly announced they have entered into a memorandum of understanding MOU aimed at promoting the adoption of low-carbon ammonia as a marine fuel, initially for the U.S. inland waterways transportation sector. Through joint efforts, the companies will focus on advancing the understanding, utilization, and advocacy of low-carbon ammonia as a sustainable fuel..."We're delighted by this opportunity to work with LSB to advance the development of a low-carbon ammonia supply chain primarily in the US," says Seonghoon Woo, CEO of Amogy. "The success of this collaboration will be a key step toward solidifying ammonia's position as a comprehensive solution for decarbonizing the commercial transportation sector across the entire value chain, from the upstream production to the downstream usage."

07:09 EDT Destination XL sees 2023 revenue at lower end of guidance - Based on our results for the first quarter of fiscal 2023 and considering the macro-economic challenges and uncertainties regarding consumer spending seen throughout the retail industry, we are currently trending toward the lower end of our previously reported guidance for fiscal 2023 sales, net income and adjusted EBITDA margin, based on a 53-week year.

07:07 EDT Agrify announces changes to executive leadership team - Agrify Corporation announced three leadership changes to support sustainable long-term growth initiatives: David Kessler, who joined Agrify in 2020 as Vice President of Horticulture & Customer Success, has been promoted to Executive Vice President, Chief Science Officer and General Manager -- Cultivation Division. Brian Towns, who joined Agrify with the acquisition of Precision Extraction Solutions in 2021, has been promoted to Executive Vice President and General Manager -- Extraction Division. Sheryl Elliott, who joined Agrify in 2020 as the Director of Human Resources, has been promoted to Senior Vice President of Human Resources. Stuart Wilcox, who joined Agrify as a Board Member in 2021, and then as Chief Operating Officer in 2022, has resigned to pursue other ventures.

07:04 EDT Ginkgo Bioworks, Centrient Pharmaceuticals expand partnership - Centrient Pharmaceuticals and Ginkgo Bioworks announced they are expanding their existing partnership aimed at broadening Centrient's portfolio of environmentally friendly active pharmaceutical ingredients, following the success of previous work together. Ginkgo's ongoing partnership with Centrient focuses on improving the sustainability of fermentation and enzymatic syntheses of beta-lactam antibiotic APIs. In the first phase of this project, Ginkgo delivered an enzyme with significantly improved efficiency, reducing the environmental footprint of enzymatic production of amoxicillin and cephalexin APIs. These semi-synthetic beta-lactam antibiotics are widely prescribed to both children and adults and are on the World Health Organization's List of Essential Medicines. Centrient aims to build on these improvements through ongoing strain projects on Ginkgo's platform which focus on reducing carbon emissions and waste production compared to traditional chemical routes.

07:03 EDT Medtronic to acquire EOFlow for $738M - Medtronic announced it has entered into a set of definitive agreements to acquire EOFlow, manufacturer of the EOPatch device. Pursuant to share purchase agreements, pr SPA, with Jesse J. Kim, CEO, and Luis Malave, Medtronic will acquire all of their shares in EOFlow at a price per share of KRW 30,000. Pursuant to a share subscription agreement, or SSA, with EOFlow, Medtronic will acquire new shares at a price per share of KRW 24,359 to fund EOFlow's ongoing operational and research and development requirements. Medtronic will also undertake a public tender offer to acquire up to all outstanding public shares at a price per share of KRW 30,000. The public tender offer will be subject to a minimum condition such that after the closings under the SPA, SSA and the public tender offer, which will occur on the same day, Medtronic will hold at least a majority of the shares outstanding on a fully diluted basis. With these transactions, Medtronic intends to acquire all outstanding shares in EOFlow and delist the company. To the extent that all the public shares participate in the tender offer, the total consideration for the acquisition of the shares in EOFlow would be KRW 971B, or $738M, at current exchange rates. The acquisition is expected to close in the second half of calendar year 2023 subject to the satisfaction of the minimum tender condition and certain customary closing conditions, including receipt of required regulatory clearances. Following close, the transaction is expected to be less than 1% dilutive to Medtronic's adjusted earnings per share in each of the first three years, and neutral to accretive thereafter. The anticipated partial year dilution was included in the fiscal year 2024 guidance Medtronic issued on May 25. In addition, EOFlow is expected to be accretive to Medtronic's weighted average market growth rate and meets Medtronic's long-term financial metrics for acquisitions.

07:02 EDT Palantir and Ukraine's Ministry of Digital Transformation partnering - Palantir Technologies and the Ministry of Digital Transformation of Ukraine have announced a partnership that will help enable the company's technology to support the defense and reconstruction of the country in the wake of the Russian invasion. The Memorandum of Understanding will pave the way for cooperation in critical areas such as the cataloging and assessment of damage to buildings and infrastructure, and harnessing software to optimize reconstruction. Some of the goals include: enhancing the digital capabilities for electronic public services providing the defense and reconstruction of Ukraine, supporting and coordinating a digitally-led reconstruction of Ukraine, consolidating the efforts in the field of digitalization, digital innovations and integration of Ukraine into the international market and promoting the implementation of projects with the support of the Armed Forces of Ukraine. Palantir's support for Ukraine includes the provision of software to Ukrainian forces and supporting the resettlement of Ukrainian refugees, including 110,000 in the UK.

06:58 EDT Brown & Brown names Pattysue Rauh as chief audit officer - Brown & Brown has announced the appointment of Pattysue Rauh as chief audit officer for Brown & Brown, effective July. Rauh will also serve on the senior leadership team. In this new role, Rauh will lead the company's internal audit and compliance operations, overseeing internal controls. She will transition from her current role as executive vice president of national employee benefits within Brown & Brown's Retail segment over the coming month. Before joining Brown & Brown, Rauh worked as an auditor for Price Waterhouse.

06:50 EDT Burlington Stores CEO says Q1 SSS growth 'came in just below guidance' - Michael O'Sullivan, CEO, stated, "Our first quarter comparable sales growth came in just below guidance. We had gotten off to a very strong start but then the trend fell off in March. We believe that this weakening in the trend was driven by two external and transitory factors - lower tax refunds and cooler weather leading up to Easter." O'Sullivan continued, "We have seen a nice pick-up in our trend since mid-April. We feel good about our underlying strategies and our focus on delivering value to the customer. We are encouraged by the recent trend but given the risks and uncertainties we think it is prudent to manage our business conservatively. We are ready to chase if this current trend is sustained." Looking to the full year, O'Sullivan said, "We are reiterating our full year sales and earnings guidance. We see plenty of uncertainty and we remain concerned about the economic health of the lower-income shopper, but we also see some potential tailwinds. The supply environment remains very strong and with our focus on value, we believe that we are well positioned to achieve this full year guidance." O'Sullivan concluded, "In addition to driving our near-term performance, we are continuing to make strong progress on our major Burlington 2.0 initiatives. We are particularly excited about some of the new processes and tools that we are rolling out to the merchant team this year. We believe that these will further enhance our ability to execute the off-price model and deliver tremendous value to the customer."

06:42 EDT Vista Gold extends agreement with Australia's Northern Territory Government - Vista Gold announced that the term of its agreement with the Northern Territory Government of Australia pertaining to the Mt Todd gold project has been extended to December 31, 2029, including the option for an additional three-year extension. The company holds the exclusive right to develop Mt Todd. The company also continues to have no present liability for the condition of the site prior to its involvement in 2006. Vista, at its sole option, may elect to proceed with the development of the Project by giving notice to the NT Government, which then results in the transfer of the NT Government-owned assets at Mt Todd and all pre-existing historical rehabilitation liabilities for the Project from the NT Government to the company.

06:38 EDT Nano Dimension launches $18.00 all-cash offer to increase Stratasys stake

06:36 EDT Adverum Biotechnologies announces new executive leadership roles - Adverum Biotechnologies announced new executive leadership roles that support the ongoing development of the investigational gene therapy ixoberogene soroparvovec - Ixo-vec -. Ixo-vec is currently being evaluated in the Phase 2 LUNA trial as a one-time intravitreal injection for patients in the treatment of neovascular or wet age-related macular degeneration, wet AMD. On June 1, 2023, Richard Beckman will transition to the new role of senior medical advisor. Star Seyedkazemi, chief development officer, is expanding her responsibilities to lead Adverum's clinical development, medical affairs and pharmacovigilance teams. Seyedkazemi brings extensive experience in clinical development and medical affairs from Tobira, Allergan, Gilead Sciences and Johnson & Johnson.

06:12 EDT Team secures stakeholder loans to refinance capital structure - Team, Inc. has secured committed financing from two of its largest current stakeholders for a series of transactions that, once completed, are expected to significantly improve its capital structure and extend maturities. Team entered into a commitment letter with Corre Management Partners for a new $57.5M million, 12% senior secured first lien term loan maturing in December 2026 and comprised of a $37.5 term loan tranche and a $20M delayed draw term loan tranche. Team expects to use the proceeds from the Corre Secured Term Loan to repay in full Team's remaining $41M of Convertible Notes due August 2023 and for general corporate purposes. Team also entered into a commitment letter with Eclipse Business for a new $27.4M term loan secured by certain real estate and machinery and equipment. The Eclipse Commitment Letter also provides for an amendment to the existing revolving credit facility to extend the maturity date of the revolving credit facility to August 2025, and to increase availability under the revolving credit facility by an additional $2.5M. Team expects to use the proceeds from the Eclipse Term Loan, together with advances under the company's revolving credit facility to repay in full the company's existing senior secured term loan with Atlantic Park Strategic Capital. The closing of the term loan facilities and related amendments to existing credit facilities is expected to occur in Q2.

06:08 EDT Planet Labs announces partnership with United Arab Emirates Space Agency - Planet Labs announced its partnership with the United Arab Emirates Space Agency, to build a regional satellite data-driven loss and damage atlas for climate change resilience. The initiative aims to provide data to a select country facing high degrees of climate risk to help build resilience, make informed policy decisions, and stimulate financial programs for climate adaptation and mitigation. The data facility plans to initially focus on compiling data for a select climate-vulnerable country for purposes of quantifying damages caused by extreme weather events, such as floods and drought and helping to establish early-warning systems.

06:06 EDT Stratasys to combine with Desktop Metal in $1.8B all-stock transaction - Stratasys (SSYS) and Desktop Metal (DM) announced that they have entered into a definitive agreement whereby the companies will combine in an all-stock transaction valued at approximately $1.8B. Stratasys and Desktop Metal are expected to generate $1.1B in 2025 revenue, with significant upside potential in a total addressable market of more than $100B by 2032. Under the terms of the agreement, which has been unanimously approved by the Boards of Directors of both companies, Desktop Metal stockholders will receive 0.123 ordinary shares of Stratasys for each share of Desktop Metal Class A common stock. This represents a value of approximately $1.88 per share of Desktop Metal Class A common stock based on the closing price of a Stratasys ordinary share of $15.26 on May 23, 2023. Following the closing of the transaction, which is expected to occur in the fourth quarter of 2023, existing Stratasys shareholders will own approximately 59% of the combined company, and legacy Desktop Metal stockholders will own approximately 41% of the combined company, in each case, on a fully diluted basis. Following the close of the transaction, Dr. Zeif will lead the combined company as CEO together with Fulop as Chairman of the Board. Upon completion of the transaction, the combined company's Board of Directors will be comprised of 11 members, five of whom will be selected by Stratasys, and five of whom will be selected by Desktop Metal, plus Dr. Zeif as CEO. Stratasys Chairman Dov Ofer will serve as lead independent director of the combined company.

06:04 EDT Air Products to acquire natural gas-to-syngas facility in Uzbekistan for $1B - Air Products announced it has signed an investment agreement with the Government of the Republic of Uzbekistan and Uzbekneftegaz, or UNG, to acquire, own and operate a natural gas-to-syngas processing facility in Qashqadaryo Province, Uzbekistan for $1B. The natural gas-to-syngas industrial complex is an integral part of state-owned energy company Uzbekneftegaz JSC's multi-billion gas-to-liquid facilityone of the most advanced energy plants in the world producing 1.5M tons per year of high value-add synthetic fuels for domestic use and potentially export. Under the purchase agreement, Air Products will acquire, own and operate two large-scale air separation units, two large-scale auto-thermal reforming units, and a hydrogen production unit within the Uzbekistan GTL complex and supply oxygen, nitrogen, hydrogen and syngas under a long-term, take-or-pay/fixed fee contract to UNG. UNG will supply the feedstock natural gas and utilities and offtake all products.

05:37 EDT Stratasys, Desktop Metal to combine in $1.8B an all-stock transaction - Stratasys (SSYS) and Desktop Metal (DM) announced that they have entered into a definitive agreement whereby the companies will combine in an all-stock transaction valued at approximately $1.8B. Stratasys and Desktop Metal are expected to generate $1.1B in 2025 revenue. Under the terms of the agreement, which has been unanimously approved by the boards of both companies, Desktop Metal stockholders will receive 0.123 ordinary shares of Stratasys for each share of Desktop Metal Class A common stock. This represents a value of approximately $1.88 per share of Desktop Metal Class A common stock based on the closing price of a Stratasys ordinary share of $15.26 on May 23. Following the closing of the transaction, which is expected to occur in the fourth quarter of 2023, existing Stratasys shareholders will own approximately 59% of the combined company, and legacy Desktop Metal stockholders will own approximately 41% of the combined company, in each case, on a fully diluted basis. Following the close of the transaction, Yoav Zeif will lead the combined company as CEO together with Ric Fulop as chairman of the board. Upon completion of the transaction, the combined company's board will be comprised of 11 members, five of whom will be selected by Stratasys, and five of whom will be selected by Desktop Metal, plus Zeif as CEO. Stratasys chairman Dov Ofer will serve as lead independent director of the combined company. The transaction, which is expected to be completed in the fourth quarter is subject to customary closing conditions, including the approval of Stratasys' shareholders and Desktop Metal's stockholders and the receipt of certain governmental and regulatory approvals.

05:10 EDT KKR to acquire 30 properties in Finland from Kruunuasunnot, terms undisclosed - KKR announced that KKR's European real estate platform has agreed to acquire a portfolio of thirty residential properties in Finland from Kruunuasunnot. The portfolio comprises over 1,200 residential units with two thirds of the portfolio located in the country's three largest cities of Helsinki, Turku and Tampere. This transaction is KKR's first in the Nordic region through its European Core Plus Real Estate strategy, which invests in high-quality, substantially stabilised assets with medium-term value growth potential.

05:06 EDT Jacobs, University of Manchester to create new international research center - Jacobs and the University of Manchester will create a new international research center to develop robotics and autonomous systems that will play a role in climate response. The Centre for Robotic Autonomy in Demanding and Long-lasting Environments, or CRADLE, will research new technologies for challenging and heavily regulated industry sectors such as space, nuclear decommissioning, energy generation and urban infrastructure. The center will be co-funded to a total value of $11M over five years by Jacobs, the University of Manchester and the U.K. Engineering and Physical Sciences Research Council's, or EPSRC, Prosperity Partnerships program, which fosters links between academia and industry.