Stockwinners Market Radar for May 26, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:13 EDT Avis Budget chairman buys $4.9M in common stock - In a regulatory filing, Avis Budget disclosed that Executive Chairman Bernardo Hees bought 28.3K shares of common stock on May 24th in a total transaction size of $4.9M.

19:00 EDT Biomea Fusion to present new preclinical data on BMF-219 at ASCO - Biomea Fusion "announced it will present new data at the American Society of Clinical Oncology Annual Meeting demonstrating BMF-219's activity in ex vivo preclinical models of CLL. In addition, the company will present a Trial In Progress poster presentation detailing the design of COVALENT-101. BMF-219 demonstrated potency across ex vivo CLL tumor models with varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in all of these models. Additionally, BMF-219 showed consistently strong activity compared to venetoclax (used as a positive control) and significantly greater activity than a clinical non-covalent menin inhibitor. Additionally, BMF-219 exhibited robust growth inhibition in patient samples that were less responsive to bendamustine and ibrutinib" CEO Thomas Butler states: "Given our leadership team's involvement with the discovery and development of ibrutinib and, thus, its demonstrated efficacy in CLL, we were highly encouraged to see BMF-219 demonstrate greater activity than ibrutinib ex vivo, especially in patient samples with TP53 alterations and NOTCH1 mutations. BMF-219's powerful cell-killing activity across ex vivo CLL models as a single agent, at similar concentrations as our prior experiments of BMF-219 in ex vivo models of other cancer types, is a very important finding. We are eager and very excited to fully explore the clinical potential of a covalent menin inhibitor across multiple liquid and solid tumor types."

18:55 EDT Affimed to present on three AFM24 clinical trial designs at ASCO 2022 - Affimed announced that three abstracts of clinical trial designs of its AFM24 innate cell engager have been published and will be presented at the ASCO Annual Meeting on June 3-7. The Trial in Progress posters provide background information and introduce the study designs of the three ongoing AFM24 studies in which patients with a variety of EGFR-positive solid tumors are treated with AFM24 monotherapy or in combinations with either Roche's checkpoint inhibitor, atezolizumab, or NKGen Biotech's autologous NK cell product, SNK01. The AFM24 monotherapy study abstract includes information about the dose-escalation phase of the study. An ongoing phase 1/2a, first-in-human study is evaluating AFM24 in patients with locally advanced or metastatic, treatment refractory solid tumors that are known to express EGFR. AFM24 had a well-managed safety profile and the RP2D was established at 480 mg. In parallel to the continuing dose escalation phase, a phase 2a dose expansion study was initiated, and the first patient was enrolled in January 2022. The trial will progress to the second stage unless the null hypothesis, that the true tumor response rate is below a specific value, is confirmed at the end of stage one. The AFM24 combination with atezolizumab study abstract details the trial design and rationale for the combination study of AFM24 and atezolizumab in patients with advanced EGFR-expressing solid tumors. An ongoing phase 1/2a open-label, non-randomized, multicenter, dose escalation and dose expansion study was initiated in November 2021 to evaluate the safety, tolerability and efficacy of AFM24 in combination with atezolizumab. The primary aim of the phase 1 study is to determine the maximum tolerated dose and the RP2D of AFM24. Escalating doses of AFM24 will be given to each cohort as weekly intravenous infusions. The phase 2a study will establish the overall response rate and safety of the combination therapy in patients with various types of cancer.

18:49 EDT Puma Biotechnology to present two abstracts on neratinib at ASCO Meeting - Puma Biotechnology announced the publication of two abstracts on neratinib to be presented at the 2022 ASCO Annual Meeting. The full posters will be available on the Puma website following the presentations. The first abstract's title is: Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: final results from the phase 2 SUMMIT 'basket' trial. The second abstract is titled "Neratinib plus fulvestrant plus trastuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): Outcomes and biomarker analysis from the SUMMIT trial".

18:47 EDT Arbutus Biopharma to present data from preclinical study of PD-L1 inhibitor - Arbutus Biopharma's abstract on a preclinical oncology study for one of Arbutus' oral PD-L1 inhibitor compounds, designed to reawaken the immune system, has been selected for publication at the ASCO Annual Meeting. The abstract's title is "Pre-clinical anti-tumor activity of small-molecule oral PD-L1 checkpoint inhibitors". Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation.

18:42 EDT PDS Biotechnology announces presentation of Phase 2 data on PDS0101 at ASCO - PDS Biotechnology "announced an upcoming poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology, ASCO, Annual Meeting taking place June 3-7, 2022 in Chicago and online. VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech's proprietary Versamune technology, in combination with Merck's anti-PD-1 therapy KEYTRUDA. The combination is being evaluated in checkpoint inhibitor-naive and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma. The data being presented at ASCO will detail preliminary safety and efficacy data for CPI-naive patients at a prespecified interim analysis point. In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA(R) 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles and again on Cycle 12; KEYTRUDA treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy."

18:39 EDT SpringsWorks Therapeutics presents Nirogacestat Clinical Data at 2022 ASCO - SpringWorks Therapeutics (SWTX) "announced initial clinical data from the Phase 1/2 study evaluating nirogacestat, SpringWorks' investigational gamma secretase inhibitor, in combination with BLENREP, GSK plc's (GSK) antibody drug conjugate targeting B-cell maturation agent, in patients with relapsed or refractory multiple myeloma. In addition, SpringWorks also highlighted long-term follow-up data from a Phase 2 study sponsored by the National Cancer Institute evaluating nirogacestat in patients with progressing desmoid tumors, which included follow-up on progression-free survival and long-term safety data.2 These data sets will be shared in poster sessions at the 2022 American Society of Clinical Oncology Annual Meeting, June 3-7, 2022 in Chicago. The objective of this sub-study of GSK's DREAMM-5 platform trial is to determine if low-dose BLENREP in combination with nirogacestat results in similar efficacy with an improved ocular toxicity profile compared to single-agent BLENREP at its approved dose and schedule. The study opened with a dose-exploration arm evaluating 0.95 mg/kg BLENREP Q3W combined with 100 mg BID nirogacestat dosed continuously, and subsequently moved into a cohort expansion arm. The target enrollment for the CE arm of the study is 70 patients randomized either to BLENREP 2.5mg/kg Q3W monotherapy or low-dose BLENREP plus nirogacestat combination using the same dose as the DE arm cohort. The study enrolled patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody. The poster being presented at ASCO includes data from a total of 24 patients treated with low-dose BLENREP + nirogacestat across the DE and CE cohorts and 14 patients treated with monotherapy BLENREP in the CE cohort. At the time of the March 4, 2022 data cut-off, the median of follow-up in the low-dose BLENREP plus nirogacestat DE cohort was 34.5 weeks (5-88 weeks), with durations of response exceeding one year in some patients. Data from the CE cohorts are not yet mature with a median duration of follow-up of 12 weeks available at the time of data cut-off. The CE cohorts utilized the KVA ocular toxicity grading scale; Grade 3 ocular adverse events occurred in 1/14 patients in the low-dose BLENREP plus nirogacestat combination compared to 7/14 patients in the BLENREP monotherapy arm. The DE cohort utilized the CTCAE-5 ocular toxicity grading scale; the low-dose BLENREP plus nirogacestat combination demonstrated Grade 3 ocular adverse events in 2/10 patients. At the time of data cut-off, the objective response rate of low-dose BLENREP plus nirogacestat across the DE and CE cohorts was 38%, with 17% of patients achieving a VGPR or better. The ORR of the BLENREP monotherapy control arm was 50%, with no patients achieving a VGPR or better."

18:32 EDT Xencor reports initial dose-escalation Phase 1 data of XmAb 104 - Xencor reported initial dose-escalation data from the Phase 1 study evaluating XmAb 104, a PD-1 x ICOS bispecific antibody, in patients with advanced solid tumors. These results will be presented at the ASCO Annual Meeting on Sunday, June 5. DUET-3 is an ongoing Phase 1 study of XmAb104 to assess the candidate's safety and tolerability profile in patients with advanced solid tumors and to determine the maximum tolerated dose . The expansion portion of the study is currently enrolling patients with colorectal cancer, head and neck squamous cell carcinoma (HNSCC), non-squamous non-small cell lung cancer, sarcoma, melanoma and clear-cell renal cell carcinoma and is randomizing patients 1:1 to receive 10 mg/kg intravenous XmAb104 every two weeks as monotherapy or in combination with ipilimumab. "...we have observed biomarker activity consistent with engagement of both receptors. XmAb104 has been well tolerated and is exhibiting a distinct safety profile compared to other clinical ICOS programs, which, along with early anti-tumor activity in patients, supports its evaluation in expansion cohorts," said Chief Medical Officer Allen Yang. "The ongoing expansion portion of the study is testing XmAb104, with or without the anti-CTLA-4 antibody ipilimumab, as CTLA-4 blockade has been found to increase the frequency of ICOS-expressing T cells in multiple solid tumor types."

18:26 EDT Amgen to present new data from oncology pipeline at ASCO - Results From the PARADIGM Phase 3 Head-to-Head Trial of Vectibix(R) (panitumumab) Versus Bevacizumab in Untreated RAS Wild-Type Metastatic Colorectal Cancer* Largest Evaluation of Acquired Resistance to LUMAKRAS(R)/LUMYKRAS(R) (sotorasib) in KRAS G12C-mutated Cancers Inform Combination Treatment Approaches Amgen (AMGEN) will present new data from across its oncology medicines and biosimilars portfolio and pipeline at the ASCO Annual Meeting. Oral presentations will showcase Amgen's medicines for both lung and colorectal cancers with a plenary session highlighting the results from the PARADIGM Phase 3 head-to-head trial conducted by Takeda Pharmaceutical (TAK) in Japan comparing the efficacy of Vectibix - panitumumab - versus Avastin - bevacizumab -, both used in combination with chemotherapy, in patients with previously untreated RAS wild-type metastatic colorectal cancer. Data offer new insights to help inform combination treatment approaches with Lumakras. Investigators evaluated patterns of resistance to Lumakras in patients with NSCLC and CRC at disease progression. At least one newly acquired genomic alteration at progression was detected in 19 -28%- NSCLC patients and in 33 - 73% - CRC patients. The alterations were heterogeneous in both tumor types, with variants detected across multiple genes and pathways. Other research highlights include study updates on bemarituzumab, a potential first-in-class therapy for a subset of gastric and gastroesophageal cancers, AMG 193, being investigated for the treatment of solid tumors, and tarlatamab, an investigational, first-in-class molecule uniquely designed to target delta-like ligand in neuroendocrine cancers.

18:19 EDT CTI BioPharma to present pivotal data on pacritinib program - CTI BioPharma announced a poster presentation from the company's pacritinib program at the 2022 ASCO Annual Meeting. "These data reinforce pacritinib's role as a safe, differentiated JAK inhibitor. Our risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg twice a day is comparable to best available therapy, including ruxolitinib, and that pacritinib 200 mg twice daily could be a full-dose therapeutic option for patients with myelofibrosis, including those who experience severe thrombocytopenia," said CEO Adam Craig. "Earlier this year, VONJOTM - pacritinib - at 200 mg orally twice daily received accelerated FDA approval, becoming the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis...With a successful beginning to our commercial launch, these data reinforce VONJO's value as a new standard of care for cytopenic myelofibrosis patients with platelet counts less than50 109/L who have been waiting for new treatment options." Pacritinib is a novel JAK2/IRAK1 inhibitor that has shown significant activity in patients with myelofibrosis. This risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg BID is comparable to BAT. These results indicate that pacritinb 200 mg BID may represent a full-dose therapeutic option for patients with myelofibrosis, including those with thrombocytopenia.

18:15 EDT Ipsen's Cabometyx shows 'encouraging' efficacy results in different tumor types - Ipsen announced encouraging data to be presented for the multi-targeted tyrosine kinase inhibitor, Cabometyx, across a range of cancer types at ASCO 2022 Annual Meeting. Data presentations will include findings in metastatic non-small cell lung cancer, as well as established indications of advanced renal cell carcinoma and radioactive iodine-refractory differentiated thyroid cancer. These data show that the therapeutic potential of Cabometyx as a key treatment option in a broad range of tumors is continuing to be realized. Updated outcomes from the multicenter Phase Ib COSMIC-021 trial evaluating the combination of Cabometyx plus atezolizumab in an expanded patient population in metastatic NSCLC demonstrate encouraging clinical activity with manageable toxicity in people previously treated with an immune checkpoint inhibitor. These data lay the foundations for the potential of Cabometyx in metastatic NSCLC which is being further examined in an ongoing Phase III trial. Topline results of the study are expected to be announced in the second half of 2022. An exploratory analysis will also be presented investigating the relationship between depth of response and clinical outcomes evaluating Cabometyx in combination with nivolumab vs sunitinib in previously untreated advanced renal cell carcinoma. Overall, greater proportions of patients receiving Cabometyx plus nivolumab demonstrated deeper responses vs sunitinib. Additionally, two new data analyses from the pivotal Phase III trial COSMIC-311 evaluating Cabometyx in RAI-R DTC will be presented. Results show Cabometyx maintained superior efficacy vs placebo irrespective of histology subtype. Another analysis will be presented related to outcomes for prespecified subgroups who received prior lenvatinib and/or sorafenib treatment. Cabometyx maintained its PFS vs placebo irrespective of prior lenvatinib and/or sorafenib treatment. The safety profile identified in the three trials was consistent with that previously observed for Cabometyx in monotherapy and in combination.

18:10 EDT Adicet Bio's ADI-001 shows 67% response rate for NHL in Phase 1 trial - Adicet Bio announced that an abstract detailing updated safety and efficacy data from the company's Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin's Lymphoma -NHL- was made available as part of the ASCO Annual Meeting, to be held June 3-7. Data highlights as of the February 14 data-cut date were: six evaluable patients were enrolled. Overall, the patients were heavily pretreated. At Day 28, the overall response rate and the complete response rate were 67%. Of the four patients who achieved CR after treatment with ADI-001: two remained in CR with greater than or equal to three months post-treatment follow-up. One patient who had responded to ADI-001 developed COVID-19 related pneumonia and later died of complications from it, unrelated to ADI-001. Safety data were consistent with the previously reported well tolerated profile. No dose-limiting toxicities were documented.

17:59 EDT Aura Biosciences announces publication of preclinical data on AU-011 at ASCO - Aura Biosciences "announced the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors. AU-011 is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer. The abstract has been published online as part of the 2022 American Society of Clinical Oncology Annual Meeting, being held June 3-7, 2022, in Chicago, IL. "These data show that AU-011, a first in class VDC, in combination with immune checkpoint inhibition is effective against both primary tumors and distant metastases in a preclinical model, demonstrating its clinical potential for the treatment of choroidal melanoma and certain other cancers. This includes the potential to treat both the primary tumor in early-stage disease and to treat metastatic lesions, whether clinically present or not at initial treatment." said Dr. Cadmus Rich, Chief Medical officer of Aura Biosciences.

17:47 EDT Kinnate Biopharma to present trial design candidate KIN-3248 data at ASCO - Kinnate Biopharma "announced the presentation of the design and rationale of a Phase 1 trial-in-progress evaluating the Company's pan-FGFR inhibitor product candidate, KIN-3248. The details will be presented during a poster session on June 6, 2022, at the Annual Meeting of the American Society of Clinical Oncology, ASCO, taking place in Chicago, IL, June 3-7. In addition, in an abstract published in the ASCO meeting proceedings, the Company also shared updates from its preclinical in vitro and in vivo preclinical studies evaluating KIN-2787 in combination with binimetinib. In these studies, KIN-2787 demonstrated significant combination benefit in NRAS-mutant melanoma models. Taken together with its unique selectively, these data support the use of KIN-2787 in combination therapy in this patient segment. Melanoma tumor cell lines bearing NRAS Q61 alterations demonstrated synergistic benefit with KIN-2787 combined with binimetinib. Daily KIN-2787 plus binimetinib treatment in NRAS-altered melanoma xenograft models resulted in significant tumor growth inhibition benefit relative to either agent alone and was associated with added MAPK pathway biomarker suppression."

17:44 EDT Director of Inspired Entertainment Chambrello purchased $199K in company shares - Director of Inspired Entertainment Michael Chambrello purchased 20,070 shares of company stock at $9.92 per share on May 24, for a total transaction amount of $199,094.

17:42 EDT Zymeworks to present zanidatamab antibody data at ASCO - Zymeworks "announced new clinical data for the HER2-targeted bispecific antibody zanidatamab in both HER2-positive breast cancer and gastric/gastroesophageal junction adenocarcinoma. The data are being presented in two separate poster sessions at the American Society of Clinical Oncology Annual Meeting June 3-7, 2022 in Chicago, IL." Neil Josephson, M.D., Chief Medical Officer, states: "These encouraging new data sets presented at ASCO provide further validation of zanidatamab's potential in the treatment of advanced HER2-positive cancers and follow the release of other promising data in gastroesophageal and breast cancer in 2021. These new data continue to demonstrate the potential for zanidatamab to be an important advancement in the treatment of a wide range of HER2-expressing cancers, including in first-line treatment regimens."

17:38 EDT Sierra Oncology announces two abstracts accepted to ASCO - Sierra Oncology "announced two abstracts have been accepted into the program for the Annual Meeting of the American Society of Clinical Oncology, ASCO, being held June 3-7, 2022, in Chicago and online. An abstract presenting the full data from the pivotal phase 3 MOMENTUM study in myelofibrosis patients who are symptomatic and anemic has been selected for an oral presentation on June 7. An additional subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation."

17:34 EDT PMV Pharmaceuticals: Lead program, PC14586 accepted as oral presentation at ASCO - PMV Pharmaceuticals announced the online publication of the abstract for its lead program, PC14586, accepted as an oral presentation at the 2022 American Society of Clinical Oncology annual meeting being held June 3-7, 2022 in Chicago, Illinois. The published abstract describes preliminary outcomes from 29 patients, including 21 efficacy evaluable, from the ongoing Phase 1/2 PYNNACLE trial of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. These initial data from our Phase 1/2 tumor agnostic study enrolled patients across multiple tumor types over a broad range of doses. The preliminary clinical pharmacokinetics data showed dose proportional increases in Cmax and AUC. In addition, the safety profile was encouraging as PC14586 was well-tolerated. "Patients whose tumors carry a p53 mutation are known to have a poor prognosis. The patients who were enrolled in our study had very limited or no other standard treatment options available to them. Early efficacy and safety data from this Phase 1/2 trial provide the potential of a p53 therapy," said David Mack, Ph.D., President and CEO, PMV Pharma. "We look forward to Dr. Dumbrava's presentation of these data at ASCO and continuing to progress the PC14586 development program."

17:33 EDT Surface Oncology to present new SRF388 data at ASCO - Surface Oncology "announced the presentation of new clinical data on SRF388, a potential first-in-class IL-27 antibody. Data from the Phase 1/1b clinical trial of SRF388 as a monotherapy and in combination with pembrolizumab, Merck's anti-PD-1 therapy, will be presented in an oral abstract session at the 2022 American Society of Clinical Oncology, ASCO, Annual Meeting. " Chief Medical Officer Alison O'Neill states: "In the ongoing SRF388 Phase 1 trial, we observed three confirmed partial responses across three different indications with multiple other patients experiencing durable clinical benefit in the form of disease stabilization. While still early, these findings are compelling and support our view that SRF388 holds exciting potential in the treatment of a variety of tumor types, particularly in combination with other immuno-oncology therapies."

17:29 EDT Aravive reports Phase 1b/2 results of batiraxcept in renal cell carcinoma - Aravive is presenting updated Phase 1b/2 ccRCC data at the 2022 ASCO annual meeting June 3-7. Interim Phase 1b results include: batiraxcept 15 mg/kg in combination with cabozantinib 60 mg has a manageable safety profile in previously treated ccRCC; no dose-limiting toxicities have been observed; a similar safety profile was observed across the 15 mg/kg and 20 mg/kg dose cohorts. Batiraxcept given every 2 weeks suppressed serum GAS6 to below the level of quantitation in 25/26 patients showing a clear pharmacokinetic/pharmacodynamic relationship; 23/26 patients had batiraxcept trough levels above the minimally efficacious concentration of 13.8 mg/L by Cycle 2. The confirmed + unconfirmed response rate in the total population was 46% with a 50% confirmed response rate in the 15mg/kg batiraxcept group. The proportion of patients in the total population who were progression free at 7 months was 71%. The proportion of patients in the total population who had a duration of response of at least 7 months was 75%. 58% of total population achieved a better response on the batiraxcept trial than they did with their therapy prior to study entry, which was only 23%. The safety and clinical activity of this combination together with PK/PD data support a RP2D of 15 mg/kg. Enrollment in the registration directed Phase 3 program in PROC remains on pace to complete this year.

17:26 EDT Crocs Chairman Smach purchases 5000 shares of company stock - Crocs Chairman Thomas Smach purchased 5,000 shares of company stock at $49.99 per share on May 25, for a total transaction amount of 249,950.

17:23 EDT General Dynamics awarded $324.52M Space Development Agency contract - General Dynamics was awarded a contract in the amount of $324.52M, including a base amount of $162,954,122 and $161,56M in options, to establish the ground Operations and Integration segment for Tranche 1 of the National Defense Space Architecture. This effort designs, develops, integrates, verifies and delivers integrated mission operations and support activities, including operation center sustainment. Funds obligated at the time of award are defense-wide fiscal 2022 research, development, test and evaluation funds. Space Development Agency is the contracting activity.

17:21 EDT Raytheon Technologies awarded $408.4M Navy contract modification - Raytheon Technologies was awarded a $408.4M modification to a previously awarded, cost-plus-incentive-fee, fixed-price incentive, cost-plus-fixed-fee, cost reimbursable contract. This modification provides for F135 propulsion system annual sustainment including maintenance of support equipment and unique maintenance services for conventional take-off and landing/carrier variant and short take-off and landing. Additionally, this modification provides support for common program activities, unique and common base recurring sustainment, repair of repairables, field service representatives, as well as common replenishment of spares. These efforts are in support of the F-35 Lightning II aircraft for the Air Force, Air National Guard, Marine Corps, Navy, non-U.S. Department of Defense (DOD) participants, and Foreign Military Sales (FMS) customers. Work is expected to be completed in November 2022. FY22 operations and maintenance funds in the amount of $232.55M; FY22 operations and maintenance funds in the amount of $65.62M; FY22 operations and maintenance funds in the amount of $15.28M; FY22 operations and maintenance funds in the amount of $10.14M; non-U.S. DOD participant funds in the amount of $55.39M and FMS funds in the amount of $29,42M will be obligated at time of award, $323.6M of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

17:18 EDT Protagonist to present updated Phase 2 Rusfertide clinical results - Protagonist Therapeutics announced new data from its ongoing Phase 2 REVIVE study evaluating rusfertide in patients with polycythemia vera, PV. These results will be shared as an oral presentation at the 2022 American Society of Clinical Oncology, ASCO, Annual Meeting, being held in Chicago from June 3-7.

17:15 EDT Leap Therapeutics presents initial Phase 1b/2 data of DKN-01 in prostate cancer - Leap Therapeutics announced that initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing Leap's anti-Dickkopf-1 antibody, DKN-01, as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer will be presented at the upcoming 2022 American Society of Clinical Oncology Annual Meeting on June 3-7. DKN-01, as a monotherapy and in combination with docetaxel, was well tolerated by patients, with partial responses in all of the patients treated with DKN-01 in combination with docetaxel who had measurable disease. Accrual into the Phase 2 portion of this study is ongoing, alongside preclinical and correlative studies aiming to further investigate the mechanism of action of DKN-01 in prostate cancer and to identify the best clinical path forward. Data that will be presented at ASCO is from the completed Phase 1 portion of the study. Thirteen patients were enrolled. The primary endpoint of the Phase 1 dose escalation cohorts was safety, characterized by dose-limiting toxicity. No partial responses were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients. In the combination cohort, all 5 evaluable patients had a PR and by PSA50. Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer.

17:14 EDT OncoCyte presents DetermaIO data at ASCO supporting immunotherapy expansion - Oncocyte "announced new data from ongoing clinical research evaluating the utility of DetermaIO, the Company's proprietary test designed to determine the likelihood of benefit of immune checkpoint inhibitors, at the upcoming American Society of Clinical Oncology Annual Meeting, ASCO, taking place June 3-7, 2022 virtually and in-person in Chicago. DetermaIO was launched via an Early Access Program in Q4 of 2021 and is the first and only commercial test to assess multiple components of the tumor immune microenvironment, giving insight into the biology of the tumor that allows for physicians and their patients to make informed decisions about their treatment journey. The three posters to be presented by Oncocyte add to the growing body of evidence showing that the test identifies patients who respond to ICIs - including Keytruda, Opdivo, Tecentriq and Imfinzi - in lung, bladder, kidney, triple-negative breast, and now colon and gastric cancers, suggesting a pan-cancer utility for the test in both primary and metastatic settings."

17:13 EDT Zovio 'advances turnaround plan,' bolsters finances - "Zovio announced progress on its plans to reset and turnaround the company. Since taking the helm of Zovio in December, Hendricks has executed a series of decisive actions to set the company on a path to improve operational performance and strengthen its financial position. Specific actions taken by the company include: Enhanced the management team and organizational structure to drive better performance and agility to meet client's needs. Making progress with its strategic initiatives to stabilize and grow enrollment at the University of Arizona Global Campus. Continuing to reduce costs to be more in-line with its revenues. Positioning Fullstack Academy for strong and sustainable growth and expansion. Completed the divestiture of TutorMe. Obtaining and subsequently repaying bridge financing, leaving the company debt free. Continuing to review strategic alternatives that will create the greatest value for shareholders, including additional divestitures of the businesses it operates. "The actions we've taken over the last few months including the recent TutorMe divestiture represent meaningful steps in enhancing our financial flexibility to execute on our turnaround plan," Zovio CEO Randy Hendricks said. "While I'm pleased with our progress our work is not complete and we will continue to focus on how best to serve our clients, and their students, and to create value for our shareholders," Hendricks continued.

17:11 EDT BeiGene to present data from solid tumor and hematology portfolios at ASCO - BeiGene "will present data from its broad solid tumor and hematology portfolios in eight presentations at the upcoming American Society of Cancer Oncology, ASCO, Annual Meeting being held in Chicago from June 3-7, 2022. Highlights include new clinical data for its BTK-inhibitor zanubrutinib, or BRUKINSA: 1) Long-term safety and efficacy results from the Phase 3 ASPEN trial of BRUKINSA versus ibrutinib in patients with Waldenstrom macroglobulinemia, with median follow up of 43 months. 2) Primary analysis from the Phase 2 ROSEWOOD trial of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma.

17:08 EDT Mirati Therapeutics says disease control rate was 80% in study - Mirati Therapeutics announced positive results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib 600 mg BID in patients with non-small cell lung cancer harboring the KRASG12C mutation who have received at least one prior systemic therapy. Findings will be presented on June 3 at the 2022 American Society of Clinical Oncology Annual Meeting, as an oral presentation during the "Lung Cancer - Non-Small Cell Metastatic" session. As of October 15 , 116 patients were enrolled and treated in the study. Of the patients enrolled, 98% had prior treatment with a PD-1/L1 inhibitor following or in combination with chemotherapy. Median follow up was 12.9 months. Of the patients evaluable for response initial results showed that the objective response rate by Blinded Independent Central Review was 43%, the disease control rate was 80%, the median duration of response was 8.5 months and the median progression-free survival was 6.5 months "This important dataset demonstrates positive clinical activity with adagrasib across molecular and clinical subgroups, including patients with treated and stable CNS metastases." The Company also presented results from an exploratory, retrospective subgroup analysis from the Phase 2 NSCLC cohort of the KRYSTAL-1 study evaluating adagrasib in patients with KRASG12C-mutated NSCLC and stable, previously treated central nervous system metastases . These results showed CNS-specific activity, including a 33% intracranial ORR by response assessment in neuro-oncology-brain metastases . The IC DCR was 85% . "The exploratory, retrospective subgroup analysis of adagrasib in patients with stable and previously treated CNS metastases showed intracranial tumor regression," added Dr. Spira. "These data are encouraging and contribute to the rapidly advancing science seeking to better understand how KRASG12C inhibitors like adagrasib can help improve patient outcomes."

17:08 EDT Roche to present data demonstrating clinical benefit of Genentech's Glofitamab - Genentech, a member of the Roche Group (RHHBY), announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology, ASCO, Annual Meeting from June 3-7 and the European Hematology Association 2022 Congress from June 9-12. Data from the Phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab induces durable complete responses, CRs, in patients with relapsed or refractory diffuse large B-cell lymphoma who had received a median of three prior therapies.

17:04 EDT Harpoon Therapeutics to present study evaluating HPN328 at ASCO - Harpoon Therapeutics "announced interim safety and efficacy data from the ongoing dose escalation and expansion study evaluating HPN328, Harpoon's half-life extended TriTAC(R) targeting delta-like canonical Notch ligand 3 (DLL3), for the treatment of SCLC and other neuroendocrine cancers. The first scientific presentation of these interim data will be featured in a poster session at the American Society of Clinical Oncology, ASCO, Annual Meeting 2022, taking place in Chicago from June 3-7. The encouraging interim results, as of the data cut-off date of April 21, 2022, showed that HPN328 demonstrated anti-tumor activity and a favorable safety profile in patients with SCLC, neuroendocrine prostate cancer and other neuroendocrine cancers. Seven of 18 patients had a decrease in sum of target lesion diameters, with 3 of 11 patients with SCLC across all dose cohorts experiencing a greater than 30% decrease in sum of target lesion diameters. Additionally, 4 of 6 patients (67%) with SCLC treated at greater than or equal to 1.215mg/week experienced a decrease in sum of target lesion diameters. To date, there have been no dose-limiting toxicities observed and no discontinuations due to adverse events. Grade 1-2 CRS occurred in 22% of patients. No grade 3 or higher CRS or any immune effector cell associated neurotoxicity syndrome events have been observed."

17:01 EDT Galera Therapeutics' avasopasem data to be presented at ASCO - Galera Therapeutics "announced data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be highlighted in an oral presentation at the 2022 American Society of Clinical Oncology, ASCO, Annual Meeting on Friday, June 3, 2022 from 2:45 p.m. - 5:45 p.m. CDT during the Head and Neck Cancer session. Topline data was announced in December 2021. Results from the 455-patient Phase 3 trial demonstrated a meaningful reduction in patients' SOM burden across multiple endpoints, with statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient suffered SOM. Exploratory analyses, such as time to SOM onset and SOM incidence at various landmarks of radiotherapy delivered, also demonstrated clinical benefit of avasopasem in reducing the burden of SOM. Avasopasem also appeared to be generally well tolerated compared to placebo. These results are consistent with those from the positive 223-patient Phase 2b trial that was the basis for Breakthrough Therapy Designation."

16:35 EDT Red Robin jumps 13% to $9.76 after Q1 earnings beat

16:33 EDT Ulta Beauty jumps 7.6% to $406.50 after Q1 earnings beat and guidance raise

16:33 EDT Lifeway Foods receives noncompliance notice from Nasdaq - Lifeway Foods announced that it has received a notice from Nasdaq indicating that the company is not in compliance with Nasdaq Listing Rule 5250 since it has not yet filed its quarterly report on Form 10-Q for the quarter ended March 31 with the Securities and Exchange Commission. The company received an initial notice from Nasdaq, dated April 25, relating to the company's failure to timely file its annual report on Form 10-K for the year ended December 31.

16:30 EDT Moxian updates status under HFCAA - Moxian updated its status under the Holding Foreign Companies Accountable Act, or HFCAA. The company was provisionally named by the United States Securities and Exchange Commission as a Commission-Identified Issuer on May 20, following the company's filing of the annual report on Form 20-F for the fiscal year ended December 31, 2021 with the SEC on May 13. The company understands that this identification under the HFCAA and its implementation rules issued thereunder indicates that the SEC determines that the company used a registered public accounting firm whose working papers cannot be inspected or investigated completely by the Public Company Accounting Oversight Board of the United States, or PCAOB, to issue the audit opinion for its financial statements for the fiscal year ended December 31, 2021. As the company disclosed in the Form 20-F for the year ended December 31, 2021, pursuant to the HFCAA, the PCAOB issued a determination report on December 16, 2021 which found that the PCAOB is unable to inspect or investigate completely registered public accounting firms headquartered in Mainland China and the Special Administrative Region of Hong Kong. As the company's auditor that audited the company's financial statements for the 2021 fiscal year is one of the registered public accounting firms headquartered in Hong Kong, the PCAOB is unable to inspect or investigate completely the audit work because of the position taken by the Hong Kong authority.

16:28 EDT Dell Technologies ended Q1 with performance obligations of $42B - Dell Technologies ended the quarter with remaining performance obligations of $42B, up 14% year-over-year, deferred revenue of $27.4B, and cash and investments of $8.5B. Recurring revenue for the first quarter was approximately $5.3B, up 15%.

16:27 EDT Middlefield Banc and Liberty Bancshares announce merger, sees accretion - Middlefield Banc and Liberty Bancshares jointly announced that they have entered into an agreement and plan of reorganization. Pursuant to the agreement, each shareholder of Liberty will receive 2.752 shares of Middlefield's common stock. Based on Middlefield's closing share price of $24.95 on May 25, the transaction is valued at approximately $64.4M. The merger is expected to qualify as a tax-free reorganization for Liberty's shareholders, and Liberty's shareholders will own approximately 31% of the combined company upon completion of the transaction. The transaction has been approved by the boards of directors of both Middlefield and Liberty. Completion of the transaction is subject to customary closing conditions, including the receipt of required regulatory approvals and the approval of both Middlefield's shareholders and Liberty's shareholders. The transaction is expected to be completed during the fourth quarter of 2022. Pursuant to the agreement, Middlefield will add three new members to its board of directors including Zimmerly, Mark Watkins, Liberty's chairman of the board, and Spencer Cohn, a representative of Castle Creek Capital, Liberty's largest shareholder. Simultaneously upon entering into the agreement, Middlefield also entered into voting agreements with Liberty's directors and Castle Creek Capital, in which they agree to vote the Liberty common stock they own in favor of the agreement. Collectively these parties represent approximately 15.9% of Liberty's voting common shares. At closing, Castle Creek Capital will own approximately 7% of the pro forma company. Liberty also entered into voting agreements with Middlefield's directors in which they agree to vote the Middlefield common stock they own in favor of the agreement. Middlefield expects the transaction to be accretive to earnings in year one and to earn back the tangible book value dilution created from the transaction in approximately three years. After completion of the transaction, Middlefield anticipates it will remain well-capitalized. Liberty anticipates that its shareholders will benefit from double-digit earnings and dividend accretion as a result of the transaction.

16:23 EDT Dime Community announces new stock repurchase program - Dime Community announced that its board of directors approved a new stock repurchase program, which authorizes the purchase of up to 1,948,314 shares, or 5% of its outstanding common stock as of May 25, upon completion of its existing previously authorized stock repurchase program.

16:22 EDT iRadimed to appoint John Glenn CFO - iRadimed announced that John Glenn has been appointed Chief Financial Officer effective on or before June 20. Glenn will assume responsibility for all areas of accounting and finance, including business planning and modeling, organizational resource planning, investor and analyst relations, and required reporting and related filings with the SEC.

16:20 EDT Cavco announces new $100M stock repurchase program - On May 25, the Company's Board of Directors approved a new $100M stock repurchase program that may be used to purchase its outstanding common stock. The previous program that was approved on October 27, 2020 has now been fully utilized, with the remaining $39M being repurchased in the first quarter of fiscal year 2023.

16:17 EDT Gap reports Q1 SSS down 14% y/y - Q1 Online sales declined 17% compared to last year and represented 39% of total net sales. Q1 Store sales declined 10% compared to last year. The company ended the quarter with 3,414 store locations in over 40 countries, of which 2,825 were company operated. Q1 Gross margin was 31.5%, 930 basis points lower than last year.

16:15 EDT Johnson Controls appoints Rodney Clark as VP and Chief Commercial Officer - Johnson Controls has named Rodney Clark as VP and Chief Commercial Officer, effective June 1. Clark will be replacing Chief Commercial Officer Brian Young, who retired at the end of last year. Clark also will take on a portion of the role being transitioned from Michael Ellis, executive VP, Chief Customer and Digital Officer, who will retire at the end of the year. Clark most recently held the role of Corporate VP of Global Partner Sales and Channel Chief at Microsoft. Prior to this, he served as the corporate vice president of the Internet of Things and mixed reality sales.

16:13 EDT DocuSign announces leadership appointments - DocuSign appointed Inhi Cho Suh as President of Product and Technology, Jennifer Christie as Chief People Officer and Jim Shaughnessy as Chief Legal Officer, and promoted Jerome Levadoux to Chief Product Officer. Inhi Cho Suh will transition from her role on DocuSign's board of directors to lead the company's newly created Product and Technology group in July. Inhi has spent over 20 years at IBM. She will be stepping down from her DocuSign board seat and will remain on the board of AnitaB.org and Grace Hopper Conference. Jennifer Christie will be joining DocuSign as Chief People Officer in June, with Joan Burke stepping into a strategic advisor role. Previously, Christie was the Chief HR Officer at both Twitter and Bolt, and SVP of HR at American Express. Jim Shaughnessy will be joining the company as Chief Legal Officer this month. Most recently, he spent 10 years at Workday across roles including General Counsel and Senior Advisor for Corporate Affairs. Prior to joining DocuSign as Head of eSignature Products in 2016, Jerome was an SVP of Product Management and CMO at Recommind in addition to serving in senior product and IT roles at HP, SAP and Oracle.

16:13 EDT Zymergen, Octant enter agreement for sale of modular automation system - Zymergen announced it has entered into an agreement with Octant for the sale of a modular automation system to scale Octant's platform to develop breakthrough medicines. Zymergen's solution includes modular hardware, modern web-based software, custom and turnkey workflows, and active monitoring and support. This technology will be incorporated into Octant's existing platform that uses synthetic biology, high throughput multiplexed assays, synthetic chemistry, and computation to engineer and interrogate drugs, proteins, and signaling pathways. Over the course of this multiphase partnership, the two companies will work together to expand Octant's platform, enable new automated workflows, and increase throughput as instruments are added to the scalable system. Additional terms of the agreement were not disclosed.

16:10 EDT Y-mAbs trial for high-risk neuroblastoma meets primary endpoint - Y-mAbs Therapeutics announced that Dr. Shakeel Modak, MD from Memorial Sloan Kettering will present results from the naxitamab-based chemoimmunotherapy trial in patients with chemoresistant high-risk neuroblastoma , at the American Society of Clinical Oncology Annual Meeting to be held June 3-7, 2022. This clinical trial studied the combination of Humanized anti-GD2 antibody naxitamab, Irinotecan, Temozolomide and Sargramostim protocol, and included cohort of patients that were treated at MSK in a phase 2 protocol, and at Hospital Sant Joan de Deu per protocol on compassionate use basis. Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities. The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate according to the International Neuroblastoma Response Criteria of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease . In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue and skeletal MIBG uptake. CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42%. The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate according to the International Neuroblastoma Response Criteria of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease . In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue (48%) and skeletal MIBG uptake . CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42%. "We are very pleased to present data for the HITS protocol," stated Thomas Gad, Founder, President and Interim CEO. "Responses in patients with relapsed or progressive high-risk neuroblastoma are challenging, as chemo-resistant disease is considered an obstacle, so we are excited to see this study met its primary endpoint. This further demonstrates the potential role for DANYELZA in HR-NB. No other GD2 antibody has been studied in such a heavily pre-treated patient population."

13:31 EDT Aerojet Rocketdyne executive chairman issues statement on CEO Drake trial - Aerojet Rocketdyne Holdings Executive Chairman Warren Lichtenstein, who collectively with his affiliates and the participants in his solicitation owns approximately 5.5% of the company's outstanding shares, today issued the following statement regarding the trial pertaining to Aerojet Rocketdyne CEO Eileen Drake's alleged misuse of corporate resources, which concluded yesterday in the Delaware Court of Chancery: "As I have repeatedly stated, the contest for the future of Aerojet Rocketdyne comes down to two factors: credibility and vision. The Company's shareholders deserve leadership that has credibility and a well-articulated vision for stabilizing the business and unlocking long-term value. This week's trial and recent events demonstrate that Ms. Drake no longer possesses these vital qualifications and, in turn, should not lead Aerojet Rocketdyne. Regrettably, I view Ms. Drake's continued leadership of Aerojet Rocketdyne as the single biggest threat to shareholder value. Fortunately, there is a clear alternative proposed by my slate of director candidates: installing Mark Tucker, the Company's former Chief Operating Officer and a four-decade veteran of the aerospace industry, as the next Chief Executive Officer. Mr. Tucker has immense integrity and a viable strategy for enhancing cash flows, margins and revenues through precise execution. He is a known entity that led Aerojet Rocketdyne's growing operations and oversaw rigorous execution during a period of significant value creation from 2015 through 2020. He is ready to engage with all investors, and simply wants to be judged based on his ability to execute and vision for a new day at Aerojet Rocketdyne. Now that the trial over Ms. Drake's actions has concluded, I encourage shareholders to begin comparing Ms. Drake and Mr. Tucker, so that we can collectively determine which leader is best equipped to start executing and producing tangible results for customers, employees and investors."

13:03 EDT BridgeBio presents interim Phase 1 data on BBP-671 - BridgeBio Pharma announced interim Phase 1 data from healthy volunteers, supporting the development of BBP-671 for potential treatment of pantothenate kinase-associated neurodegeneration and organic acidemias. The data are being shared in a scientific poster session at the Pan American Parkinson and Movement Disorders Congress on May 26, 2022, in Miami, FL. BBP-671 is an investigational oral therapy designed to increase coenzyme-A levels by allosterically modulating pantothenate kinases, key enzymes in the CoA biosynthesis pathway. BBP-671 is being developed as a potential therapy for diseases in which CoA metabolism is deficient, including PKAN, propionic acidemia, and methylmalonic acidemia. PKAN is a rare neurological disorder characterized by progressively debilitating symptoms that begin in early childhood, including dystonia, rigidity, bradykinesia, dysphagia, visual impairment and dementia. PA and MMA are rare metabolic disorders caused by mutations in enzymes that participate in amino acid metabolism leading to life-threatening metabolic decompensations, as well as long-term complications involving multiple organ systems, including the heart, pancreas, kidney, liver and brain. PKAN, PA and MMA are rare diseases affecting an estimated 7,000 patients in the United States and European Union collectively. BridgeBio believes these initial findings from the Phase 1 study demonstrate target engagement and proof of mechanism of BBP-671 provided by evidence that BBP-671 can cross the blood brain barrier. The first-in-human Phase 1 study of BBP-671 in a total of 77 healthy volunteers was designed to provide single- and multiple dose safety, tolerability, pharmacokinetic, and pharmacodynamic data to support future development of BBP-671. Single and multiple ascending oral doses of BBP-671 were administered in a double-blind manner to six single and four multiple dose cohorts consisting of up to eight healthy volunteers per cohort. The data from the first part of the Phase 1 study included: BBP-671 was detected in healthy volunteer plasma and cerebrospinal fluid, which suggests BBP-671 is entering into the brain; BBP-671 increased whole blood acetyl-CoA levels, which BridgeBio believes is the first time a therapeutic intervention has demonstrated this and demonstrates target engagement and proof of mechanism of the drug; BBP 671 was generally well-tolerated following oral dosing in healthy volunteers with no serious adverse events observed; Mild treatment-related emergent adverse events included headache, abdominal pain and nausea; Asymptomatic neutropenia was observed in three individuals with repeat dosing of BBP-671; all returned to within normal limits within a few days without any sequelae upon cessation of therapy. Based on these positive data, BridgeBio intends to move forward with the second part of its Phase 1 clinical study in patients with PA and MMA in the second half of 2022, as well as initiate a pivotal Phase 2/3 clinical study in PKAN in 2023.

12:50 EDT JetBlue sees mid to high single digit cpacity growth by 2023

12:45 EDT JetBlue: Operational challenges in April had impact on revenue into May

12:26 EDT Avadel notified by FDA of need to add certification to REMS patent to NDA - In a regulatory filing earlier, Avadel Pharmaceuticals disclosed that on May 24, the company received a proposed, final label and medication guide for FT218 from the U.S. Food & Drug Administration. In addition, the company was notified by FDA that the FT218 New Drug Application, or "NDA," patent statement pertaining to US Patent No. 8,731,963, or the "REMS patent," was deemed inappropriate by FDA. As such, FDA has requested the company add a certification to the REMS patent to its NDA. FDA further confirmed, based on the final proposed label, that no additional patent certifications will be required. "Based upon the above, the company anticipates tentative approval of the FT218 NDA with potential full approval on or before the expiration of the REMS patent on June 17, 2023. Full approval could occur sooner if the REMS patent is delisted from FDA's Orange Book, a court determines the patent is invalid, not infringed or otherwise unenforceable, or a court determines that FDA erred in requesting a certification. The company believes in the potential of FT218 and its importance to the narcolepsy community. The company is committed to pursuing all options for FT218 to realize its full value," Avadel stated.

12:02 EDT Janssen granted orphan status for stem cell transplant conditioning - The FDA granted Johnson & Johnson's Janssen Research & Development orphan status for its treatment of patients undergoing myeloablative hematopoietic stem cell transplant conditioning to improve platelet recovery and reduce myeloablative bone marrow conditioning-related toxicities. Reference Link

12:00 EDT TDCX falls -8.1% - TDCX is down -8.1%, or -99c to $11.16.

12:00 EDT Direxion Daily Semiconductor Bear 3X Shares falls -9.7% - Direxion Daily Semiconductor Bear 3X Shares is down -9.7%, or -$5.02 to $46.58.

12:00 EDT Charah Solutions rises 20.8% - Charah Solutions is up 20.8%, or 54c to $3.14.

11:57 EDT Karyopharm's selinexor granted orphan designation as treatment of myelofibrosis - Karyopharm's selinexor was granted orphan designation as a treatment of myelofibrosis, according to a post to the agency's website. Reference Link

11:17 EDT FDA reports Abbott recalls Dragonfly OpStar Imaging Catheter - Abbott is recalling certain lots of the Dragonfly OpStar imaging catheter because the marker band farthest from the catheter tip may become loose and, in two instances, has been observed to separate from the catheter while being used on a person, the FDA announced. There have been 5 incidents and 1 injury related to this device issue. No deaths have been associated with the use of this device due to this issue, according to the FDA, which has identified this as a Class I recall, "the most serious type of recall." The recall was initiated by the firm on April 11, 2022, and 4,800 devices were recalled in the U.S., the FDA noted. Reference Link

10:55 EDT JetBlue up nearly 5% to $10.76 after providing updated guidance

10:52 EDT National Storage increases quarterly dividend 10% to 55c per share - National Storage Affiliates Trust announced that its Board of Trustees yesterday declared regular cash dividends for the second quarter 2022 payable on June 30, 2022 to shareholders of record on June 15, 2022 on the following securities: a dividend of 55c per common share, representing an annualized dividend rate of $2.20. This new rate represents a 45% increase from the second quarter 2021 dividend and a 10% increase from the previous quarter. a dividend of 37.5c per share on the Company's 6.000% Series A Cumulative Redeemable Preferred Shares.

10:19 EDT Revive Therapeutics provides update on Phase 3 trial for bucillamine in COVID-19 - Revive Therapeutics is pleased to provide an update on the Company's U.S. Food & Drug Administration Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company has received positive comments from the FDA in regards to the Company's request to determine and agree on the Study's potential new primary efficacy endpoints, including the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization. The FDA has agreed that the Company may unblind the pre-dose-selection data for the first 210 patients of the Study to further support the new primary endpoint. Before unblinding the pre-dose selection data for the first 210 patients, the Company will submit a Data Access Plan to the FDA in early June 2022 with the aim to unblind the pre-dose selection data and submit the amended Study protocol with the new primary efficacy endpoints to the FDA. In addition, the Data Safety and Monitoring Board are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19. The DSMB supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns reported.

10:03 EDT Hill awarded contract from Albanian Ministry of Infrastructure and Energy - Hill International announced it was awarded a contract from the Albanian Ministry of Infrastructure and Energy to provide Project Management services for the construction of the Llogara Tunnel. Located in the southwestern part of the Albanian coast in the Vlora region, the 155-million-euro project will provide a roadway under the Llogara pass, reducing the driving time from Vlora to Saranda by approximately 40 minutes as well as improving driver safety. Scheduled for completion in early 2025, the project will also support increased tourism in the region.

10:00 EDT Snowflake falls -12.8% - Snowflake is down -12.8%, or -$16.96 to $115.81.

10:00 EDT Goldenbridge Acquisition Ltd trading resumes

10:00 EDT Dollar General rises 15.7% - Dollar General is up 15.7%, or $30.62 to $225.96.

09:58 EDT MainStreet Bancshares appoints Tom Floyd as CLO - MainStreet Bancshares announced it has promoted Tom Floyd to Chief Lending Officer, entrusting him with strategic leadership over a growing loan portfolio that currently exceeds $1.4B. Floyd, who joined the $1.8B-asset bank in 2017, was previously Senior Vice President and Regional Lending Manager. As Chief Lending Officer, he is filling a vacancy created by the departure of an executive who left to pursue another opportunity.

09:47 EDT Eventbrite falls -8.3% - Eventbrite is down -8.3%, or -$1.03 to $11.39.

09:47 EDT Snowflake falls -13.5% - Snowflake is down -13.5%, or -$17.87 to $114.90.

09:47 EDT Modine Manufacturing rises 15.7% - Modine Manufacturing is up 15.7%, or $1.37 to $10.07.

09:44 EDT Willis Towers Watson raises share repurchase program by $1B - WTW announced that its Board of Directors approved an increase to the existing share repurchase authority in the amount of $1B. The $1B increase is in addition to the approximately $1.3B remaining on the current open-ended repurchase authority. T

09:41 EDT Manna Capital, Ball Corp. enter alliance for production, recycling center - Manna Capital Partners and Ball Corporation announced an alliance in which Manna will construct and operate a state-of-the-art aluminum can sheet rolling mill and recycling center in Los Lunas, New Mexico. Ball will enter into a long-term supply agreement and also intends to take a minority equity position in the mill.

09:39 EDT Nevada reports April statewide gaming win up 8.57% to $1.13B - Nevada reports April Las Vegas Strip gaming win up 22.78% verses last year to $593.46M. Publicly traded companies in the gambling space include Boyd Gaming (BYD), Caesars (CZR), Churchill Downs (CHDN), DraftKings (DKNG), Flutter Entertainment (PDYPY), Gan Limited (GAN), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN), William Hill (WIMHY) and Wynn Resorts (WYNN).

09:36 EDT Nutanix trading resumes

09:35 EDT Clearmind aims to inititate clinical trials with CMND-100 by end of 2022 - Clearmind Medicine has completed a highly constructive Pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration to discuss the development of the Company's MEAI- based proprietary compound CMND-100. "The FDA's interest in CMND-100 as a potential therapy for alcohol use disorder was extremely encouraging," said Dr. Adi Zuloff-Shani, Clearmind's CEO. "Their feedback to the proposed development program was positive, and we are working diligently towards initiating the clinical trials with CMND-100 by the end of 2022." CMND-100, Clearmind's lead product that is based on MEAI, a novel psychoactive compound, exerts a significant reduced desire to consume alcoholic beverages, and the company is developing it as a candidate therapy for the treatment of Alcohol Use Disorder. Clearmind submitted a pre-IND meeting package to the FDA in April; it included an overview of the development program, and questions about the regulatory requirements for opening an investigational new drug application.

09:31 EDT Co-Diagnostics completes principal design of test for monkeypox virus - Co-Diagnostics announced that it has completed the principal design work of a PCR test for the monkeypox virus currently exhibiting a multi-country outbreak. When complete, the new test will feature the company's patented CoPrimer technology and was designed using its proprietary software system. "One of the most important lessons the world learned following the COVID-19 pandemic is the importance of quick, decisive action in the face of any potential outbreak of transmissible viruses. This means being prepared for every scenario. Co-Dx was founded with the mission to increase the accessibility of affordable, high-quality molecular testing products around the world, and we look forward to eventually making this test available in affected regions as needed to help slow the spread of the virus through early and accurate detection," remarked CEO Dwight Egan.

09:24 EDT Liquidity Services selected to auction assets of major oil pipeline project - Liquidity Services has been selected by a North American energy company to sell equipment through its Capital Assets Group. Over 5,000 items from the canceled project will be available to energy buyers through Liquidity Services' online marketplace, AllSurplus. Auction highlights include large-bore valves, power generation and distribution equipment, induction motors, pipeline instrumentation, operational support equipment, pipeline fittings, and flanges. Cataloging and valuation of all 5,000 project assets are underway. Liquidity Services' Capital Assets Group will continuously add equipment as it becomes available.

09:20 EDT Perrigo's omeprazole mini capsules for heartburn approved by FDA - Perrigo has received final approval from the FDA for Omeprazole Magnesium Delayed-Release Mini Capsules, 20 mg over-the-counter. Perrigo expects to launch Omeprazole Minis later this year. This launch represents a first-to-market mini capsule form of omeprazole, which is indicated for treatment of frequent heartburn. This capsule is 70% smaller than the tablet version of omeprazole that is currently available, providing a differentiated and preferred product offering for consumers.

09:18 EDT Victoria's Secret launches VS&Co-Lab digital platform - Victoria's Secret & Co. is launching VS&Co-Lab, an inclusive shopping experience for all customers. The company said, "This curated digital platform connects the modern consumer with unique brands, bringing their stories and their intimates, lifestyle and swimwear products to the forefront. VS&Co-Lab launched as a new section on VictoriasSecret.com, where it will showcase brands that align with its values of innovation and inclusivity."

09:17 EDT Terreno Realty acquires two industrial properties in California for $27.2M - Terreno Realty acquired two industrial properties in Los Angeles and Inglewood, California on May 25 for a purchase price of approximately $27.2M. One industrial distribution building at 332 Hindry Avenue in Inglewood containing approximately 19,000 square feet on 0.9 acres with 12 dock-high and one grade-level loading positions and parking for 26 cars. The property is 70% leased to one tenant and the estimated stabilized cap rate is 2.4%; and one industrial distribution building at 8320-8400 Isis Avenue in Los Angeles containing approximately 40,000 square feet on 2.1 acres with ten dock-high and six grade-level loading positions and parking for 59 cars. The property is 100% leased to four tenants and the estimated stabilized cap rate is 3.2%.

09:11 EDT Sidus picks L3Harris software for LizzieSat Constellation - Sidus Space (SIDU), a Space-as-a-Service satellite company focused on commercial satellite design, manufacture, launch, and data collection, is pleased to announce its selection of L3Harris Technologies (LHX) InControl and OnTime software for command and control and mission planning for LizzieSat Constellation. InControl will provide satellite command and control software for on-orbit, factory test and ground system monitor and control. InControl supports the full range of command and control system requirements, including telemetry processing, data display and analysis, constellation monitoring and control, onboard system management and ground equipment monitoring and control. It is designed to support a fleet of satellites, treating each satellite and ground station as its own mission. OnTime is modular space mission planning software framework designed to plan, simulate and track mission success from inception to execution with user-specified levels of detail and plug and play capability with external tools. It is designed to aid mission planners by coordinating daily activities through a single user interface.

09:10 EDT Telus invests $8M to roll out PureFibre, 5G networks in Minganie - TELUS announces an $8 million private investment in the North Shore region this year, rolling out its PureFibre and 5G networks in the Innu community of Ekuanitshit and the municipalities of Longue-Pointe-de-Mingan and Port-Menier. This investment is paired with nearly $3 million from the Canadian and Quebec governments as part of the Operation High Speed program, and will bridge the digital divide by fostering digital innovation in local businesses, stopping rural depopulation of young people, promoting Innu culture and the tourism industry, and accelerating the development of virtual services in health and education.

09:09 EDT Sprinklr announces expanded partnership with TikTok - Sprinklr announced an expanded partnership with TikTok as an official partner in its all-new TikTok Content Marketing Specialty that is a part of the TikTok Marketing Partner Program. Sprinklr was TikTok's first advertising partner in 2020, and the addition of the Content Marketing Specialty makes Sprinklr the only platform capable of helping marketers manage, execute, and optimize both organic and paid content campaigns on TikTok.

09:08 EDT 3G Capital holds 7.9% of Kraft Heinz shares after share distribution - The Kraft Heinz Company received notice that funds affiliated with 3G Capital the Company's second largest stockholder, have distributed approximately 88M shares of Kraft Heinz common stock to external investors in its funds. The notice also indicated that following the distribution, 3G's co-founders and partners would continue to hold approximately 7.9% of the Company through 3G funds and that the remaining shares held by the 3G funds are subject to a voluntary 60-day lock-up. 3G has been a valued partner through a series of milestones that have transformed and strengthened the Company's business and market position over the last several years," said Miguel Patricio, Chief Executive Officer and Chair of the Board of Kraft Heinz. "We look forward to continuing to work with 3G as well as Berkshire Hathaway, our largest investor."

09:07 EDT Chevron announces new organizational structure - Chevron announced a simplified organizational structure intended to strengthen execution and pace to deliver on the company's objectives of higher returns and lower carbon. Effective October 1, the company will consolidate its upstream, midstream and downstream business segments under a new executive vice president, oil, products and gas, who will oversee the full value chain. As part of this change, the company is consolidating into two upstream regions - americas exploration and production and international exploration and production. The company is also organizing its strategy and sustainability, corporate affairs and business development functions under a new executive vice president, strategy, policy & development. The new leadership structure is expected to enable a more integrated approach to capital allocation, asset class excellence and value chain optimization, and facilitate more effective external engagement and business development impact.

09:05 EDT Vinco Ventures delays Cryptyde spin-off distribution date - Vinco Ventures last night announced that, due to contractual and regulatory conditions, the company's board of directors has decided to delay the distribution date for the previously announced spin-off of Cryptyde. On May 5, the company announced that each Vinco stockholder of record as of the close of business on May 18 would receive one share of Cryptyde common stock for every ten shares of Vinco common stock held and that such share dividend was expected to be distributed on or about May 27. The company currently expects the distribution date for the Cryptyde spin-off to occur on or about the end of the second quarter of 2022, subject to certain contractual and regulatory conditions being met or waived. After the separation, Cryptyde common stock is expected to trade on the Nasdaq Capital Market under the stock ticker symbol "TYDE" and Vinco will continue to trade on the Nasdaq Capital Market under the stock ticker symbol "BBIG." Vinco Ventures shares are down 39c, or 14%, to $2.43 in pre-market trading.

09:05 EDT VerifyMe announces first customer in U.K. - VerifyMe is pleased to announce its first customer in the UK. VerifyMe has its first UK based customer to use its smartphone-based authentication and consumer engagement solution. The customer, a new UK based cannabis company is purchasing VerifyMe tamper evident labels with dynamic QR codes for consumers to authenticate the product, download certificates of analysis, and engage with the brand for product promotions and more.

09:04 EDT Caterpillar to sponsor Major League Soccer - Caterpillar announced a multi-year sponsorship with Major League Soccer - MLS -. As a part of the sponsorship, MLS will collaborate with Caterpillar to integrate Cat products into the soccer ecosystem. Cat dealers will also have access to exclusive soccer experiences for their operators and customers as well as their families.

09:04 EDT Hagerty announces new digital classifieds platform - Hagerty announced a new digital classifieds platform where Hagerty Drivers Club members can buy and sell collectible and exotic cars, trucks and motorcycles. The platform is Hagerty's first foray into the private party transaction segment of the collectible car market, estimated to total about 43M insurable vehicles nationwide. In 2021, Hagerty observed its insurance members buying or selling approximately 280,000 collector cars, representing $9.5B in value.

09:02 EDT Zimmer Biomet names Keri Mattox Chief Communications and Administration Officer - Zimmer Biomet announced the appointment of Keri Mattox as Chief Communications and Administration Officer, reporting to President, CEO and Chairman Bryan Hanson. Mattox previously served as Senior Vice President, Investor Relations and Chief Communications Officer, and now adds responsibility for building and executing a comprehensive strategy around Environmental, Social and Governance initiatives and increasing CEO visibility, engagement and accessibility to her portfolio. Prior to joining Zimmer Biomet, she served as Global Lead, Integrated Corporate Communications at W2O Group, an international healthcare-focused marketing and communications firm.

09:01 EDT Guardion Health announces Viactiv Omega Boost Gel Bites available on Amazon - Guardion Health Sciences announced the availability of Viactiv Omega Boost Gel Bites on Amazon.com. The 1,200 mg Omega-3 Gel Bites are designed to provide total body support, including cardiovascular, brain, joint, and eye health.

08:59 EDT Maxeon Solar expands residential channel program in the U.S. - Maxeon Solar announced an agreement with CED Greentech to significantly expand Maxeon's differentiated channel program to residential installers in the U.S. The U.S. residential solar market is projected to grow 50% over the next 5 years, and as electric vehicle adoption grows in parallel, homeowners will require more power from the same roof sizes. Maxeon will offer its flagship IBC panels and its 40-year warranty. Products will be available for purchase later this year with deliveries starting in January 2023.

08:57 EDT Appen says Telus International revoking indicative proposal - Appen Limited (APPEF) stated in a notice to the ASX: "As announced this morning, Appen Limited received an unsolicited, conditional and non-binding indicative proposal from TELUS International to acquire 100% of Appen at an indicative cash offer price of A$9.50. The Indicative Proposal was subject to several conditions. Following receipt of the Indicative Proposal, Appen engaged with Telus in good faith through its advisers to better understand the conditions of the Indicative Proposal and to agree an appropriate confidentiality and standstill agreement, after which Appen was prepared to make available limited business and financial information. Appen and Telus negotiated the NDA to an agreed form and Appen had an expectation that the NDA would be executed by Telus imminently. Following media reports overnight, Appen was required to disclose the Indicative Proposal to the market. This afternoon, Telus informed us that they were revoking their Indicative Proposal. No reasons were given. No confidential information was provided to Telus. Appen will continue to update shareholders in accordance with its continuous disclosure obligations." Reference Link

08:52 EDT DigiMax launches three new solutions to complement CryptoHawk - DIGIMAX GLOBAL is pleased to announce that it has launched three new information or predictive services, all being served from the AI data engine first developed around CryptoHawk. The three services include: CryptoHawk API - electronic sharing of CryptoHawk data and predictions; Coindrop.Pro - Altcoin information service for investors and traders who are rewarded with airdrops; CommodityHawk - AI prediction of 10 separate commodities developed for institutional traders. While Coindrop is primarily a retail targeted product, the others are increasingly targeting institutional markets that see CryptoHawk as one of the most credible AI-driven prediction providers available in the marketplace today.

08:51 EDT Rubicon Technologies enters strategic partnership with Palantir - Rubicon Technologies announced that it has entered a strategic partnership with Palantir Technologies, enhancing and expanding its data, analytics, and reporting capabilities. As part of the agreement, the two organizations will also develop a joint go-to-market strategy for the commercialization of new Rubicon subscription data products and supporting workflows. The new partnership with Rubicon is supported by Palantir's Foundry operating system, a fully managed, modular SaaS offering that includes data integration, flexible analytics, visualization, model-building, operational decision-making, and decision capture. The scope of the new partnership with Palantir encompasses both internal and external deliverables, including: The development of new data collection and analysis tools; Provision of greater insight into waste, recycling, and sustainability performance for Rubicon's corporate customers, smart city partners, and hauler network; Further optimization of customer and hauler service levels; A joint go-to-market effort to commercialize advanced analytics capabilities. Palantir will also provide ongoing support to Rubicon, its customers, and partners through workflow development, onboarding, and training to maximize the value provided by these new tools.

08:46 EDT Glimpse Group to merge Brightline Interactive into new subsidiary company - The Glimpse Group announced that it has entered into a definitive agreement to merge Brightline Interactive into a new dedicated Glimpse subsidiary. BLI is a global provider of VR, AR, 5G integration, spatial computing, and deep tech software and service solutions. It designs, builds, integrates, and supports immersive and interactive experiences, training scenarios, and simulations for both government and commercial customers. Key commercial customers include companies such as AT&T and Coca-Cola. BLI has a significant presence in the government sector as a direct contractor, including projects with Federal Emergency Management Agency, the Federal Aviation Administration, the United States Air Force, and the National Institutes for Health, to name a few. BLI has 28 employees, was founded in 2004 and is based in Ashburn, VA. In addition, BLI has been issued one US patent: "System and Method for Generating an Augmented Reality Experience" and has been issued an allowance of a second VR patent application, expected to be to be finalized in Q3, 2022. Erik Muendel will be spearheading integration between the various groups and playing an advisory role on technical solutions, process and creative direction for BLI during its transition into the Glimpse organization. BLI generated revenue of approximately $5.0 million in calendar year 2021, an increase of approximately 25% compared to approximately $4.0 million in calendar year 2020. BLI's gross margins for calendar year 2020 were in the 50-55% range, with breakeven to slightly positive cash flow from operations. BLI's recognized revenue and financials have not been audited yet and may change upon review and audit. Expected synergies from the deal include: Increase Glimpse's annual revenue by approximately 33%; Place Glimpse on a potential $15 million annual revenue run rate, which we believe cements Glimpse's position as one of the largest independent VR and AR software and services companies; Significantly improve business, operating and financial scale, further solidifying Glimpse's operating base; Generate compelling go-to-market synergies across Glimpse's diverse ecosystem of subsidiary companies; Improve positioning and capabilities towards the Government and Department of Defense as a direct contractor; Adds 1 issued and 1 allowed patent, bringing Glimpse's total issued VR and AR patents to 9 expected in the short term; Increase employee base to over 175 immersive technologies software developers, engineers, and 3D artists with cutting-edge capabilities Deepen Glimpse's robust ecosystem of VR/AR companies and expertise; Expand diversification across industries, subsidiary companies, customers, technologies, and geographies. In addition, Tyler Gates, BLI's CEO and Managing Partner, will continue as its General Manager post transaction and join Glimpse's executive team as Chief Futurist. Mr. Gates will add significant immersive technology industry experience and relationships, specifically around strategy, vision and industry partnerships. In addition, Tyler will serve as a Glimpse Board observer. Transaction Summary: Total potential purchase price of $32.5 million, with an initial payment of $8 million; $24.5 million of the potential purchase price is dependent on the achievement of revenue growth milestones over the next three years; Of the total potential purchase price, up to $15 million is in cash and $17.5 million is in Glimpse common shares, priced at around the time of issuance over the next three years when the revenue milestones are met and with a minimum issuance price of $7.00/share; There are no contingencies to this transaction, which is expected to officially close during Q3 CY '22; The transaction is expected to be immediately accretive to Glimpse; Post deal, Glimpse is expected to have approximately $16 million cash on its balance sheet, with no material liabilities, preferred equity or debt.

08:42 EDT Gaucho Group completes improvements, expansion to winery facilities - Gaucho Group announced the completion of its winery's multi-year expansion and infrastructure improvement initiative, that has resulted in a larger and better equipped facility to produce premium quality, small batch wines/ Algodon Wine Estates has over the past 36 months placed significant investment into the acquisition of additional stainless steel tanks, new French oak barrels, and the expansion of its winery and wine cave, including: improvements to its microvinification area and wine cellars that includes stone wall finishings that have been quarried from the local Sierra Pintada Mountains, and produce natural temperature control ideal for barrel aging and storage; the addition of new stainless-steel tanks specially created to produce quality small batch wines, a new tasting room lined with wine racks for bottle aging, and featuring a central keystone, iconic and grand in scale, that was hand selected and quarried from the local Sierra Pintada Mountains, and serves as a tasting table in the center of the tasting room; a new bottling center with improved technology and machinery, as well as a grand rooftop terrace above the winery offering sweeping vineyard views, intended for wine tastings, special occasions and other social events. Algodon's current winery capacity includes 485,000 liters. which can be broken down to include tank storage of 280,000 liters, barrel storage of 135,000 storage, and 70,000 liters of bottle storage.

08:39 EDT Moleculin Biotech begins dosing in Phase 1a clinical trial of COVID-19 candidate - Moleculin Biotech commenced dosing in its first-in-human Phase 1a study to evaluate the safety and pharmacokinetics of WP1122 in healthy volunteers for the treatment of COVID-19. The Phase 1a, first-in-human, overlapping Single and Multiple ascending dose will investigate the effects of WP1122 administered as an oral solution in healthy human volunteers in the U.K. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development will be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. Moleculin is also in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies could occur.

08:38 EDT Sellas Life Sciences reports preliminary data from Phase 1/2 trial of GPS - SELLAS Life Sciences announced top-line clinical data from its Phase 1/2 trial of galinpepimut-S, the Company's Wilms Tumor-1-targeting peptide immunotherapeutic, in combination with Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in patients diagnosed with WT1 relapsed or refractory platinum resistant advanced metastatic ovarian cancer. Data from 15 patients enrolled in the study, conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., has been preliminarily analyzed with final data for all 17 patients enrolled in the clinical trial expected by the end of 2022. All enrolled patients were resistant to standard of care platinum-based therapy and 78.5 percent of evaluable patients were refractory to or had failed their first- or second-line therapies with 21.5 percent having failed three or more lines of therapy, including one patient who failed five previous lines of therapy. Of the 15 patients, 13 received at least three doses of GPS, the last of which was in combination with pembrolizumab, and were evaluable for response outcomes. Summary of Top-Line Clinical Data: The overall response rate of the trial is, similar to the response to checkpoint inhibitors. An ad hoc analysis of clinical outcomes in this cohort shows a disease control rate, the sum of overall response rate and rate of stable disease, of 53.9 percent at a median follow-up of 43.1 weeks. In a checkpoint inhibitor single agent study in a similar platinum-resistant ovarian cancer patient population treated with a checkpoint inhibitor alone, the observed DCR was 37.2 percent, consistent with a DCR rate increase of 45 percent in the GPS combination with pembrolizumab over that seen for checkpoint inhibitors alone. Median progression-free survival was 12 weeks compared to 8.4 weeks for checkpoint inhibitors alone seen in studies with similar patient populations, a 43 percent increase in the GPS combination with pembrolizumab. Patients with fewer previous lines of chemotherapy experienced a more favorable median PFS than those with more than two previous lines: for patients with two or fewer previous lines of therapy treated with GPS in combination with pembrolizumab, median PFS was 24 weeks. With 43.1 weeks of follow-up the median overall survival has not been reached. The safety profile of GPS in combination with pembrolizumab was similar to pembrolizumab alone, with the only addition of low-grade rapidly resolving local reactions at the GPS injection site, consistent with observations from other GPS clinical studies.

08:36 EDT Galecto to present data on GB1211 at ASCO annual meeting - Galecto announced two poster presentations at the upcoming 2022 American Society of Clinical Oncology Annual Meeting, being held June 3-7, 2022 in Chicago, IL. The first poster, entitled: "Resistance to anti-PD-1/anti-PD-L1: GB1211 reverses galectin-3 induced blockade of pembrolizumab and atezolizumab binding to PD-1/PD-L1," demonstrates that, in pre-clinical models, GB1211 reversed a galectin-3 induced blockage of PD-1/PD-L1 checkpoint inhibitors and restored the binding of these checkpoint inhibitors. Multiple clinical studies have shown that patients with high galectin-3 expressing tumors generally have a poor response to PD-1/PD-L1 checkpoint inhibitors, potentially as a result of resistance to these widely-used therapeutics. GB1211, Galecto's orally active, potent and selective galectin-3 inhibitor candidate, is designed to block the galectin-3 carbohydrate recognition domain and reduce tumor resistance to PD-1/PD-L1 checkpoint inhibitors. The abstract will be presented during the poster presentation session on Sunday, June 5, 2022, from 8:00 - 11:00 am CT. The second poster entitled: "GALLANT-1: Galectin-3 inhibitor GB1211 plus atezolizumab in patients with non-small cell lung cancer - a randomized double-blind study," highlights the Phase 2 trial design for GB1211 in NSCLC. This trial is designed to investigate the ability of GB1211 to increase the efficacy of checkpoint inhibitors.

08:34 EDT SciSparc announces Ethics Committee approval to conduct Phase IIb trial - SciSparc announced it received Ethics Committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel, to conduct the Company's Phase IIb clinical study for SCI-110 in patients suffering from Tourette Syndrome. The Company is evaluating additional clinical sites to join the Phase 2b trial to expedite patient enrollment in a timely manner. TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With onset before age 18, about half to two-thirds of TS cases improve during adolescence, while adults are generally more severe patients. Tics may be associated with a premonitory sensation to perform a specific action, which may lead to "relief" once performed. The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients. The patients will be randomized in a 1:1 ratio to receive either SCI-110 or SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using Yale Global Tic Severity Scale, the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for the entire population and separately for the SCI-110 and placebo groups. The launch of the trial is pending approvals by the Ministry of Health in both countries.

08:32 EDT Oriental Culture Holding partners with Hangzhou Metaverse Internet Technology - Oriental Culture Holding's wholly-owned subsidiary, HKDAEx, has entered into a strategic cooperation memorandum of understanding with Hangzhou Metaverse Internet Technology, or HMIT. The parties will cooperate and integrate their respective industry resources to provide services to global users in connection with NFTs for cultural and artwork collections, including the mint, sales, auctions, trading of NFTs. HKDAEx's platform is open for collectors, artists, art dealers and owners worldwide.

08:29 EDT Zentek opens industrial scale ZenGUARD facility in Ontario - Zentek is pleased to announce the grand opening of its industrial scale ZenGUARD antimicrobial production facility in Guelph, Ontario on Friday June 17th, 2022, at 2:00 pm. This facility is one of the largest nanomaterials-based manufacturing facilities in the world.

08:22 EDT Medtronic: Procedure volumes in most markets reached pre-Covid levels by Q4E

08:18 EDT Rookout joins GitLab's Alliance Partner Program - Rookout announced it has joined GitLab Inc.'s Alliance Partner Program as a Technology Partner. GitLab is The One DevOps Platform for software innovation. This strategic relationship delivers seamless debugging of source code hosted on GitLab repositorie

08:16 EDT Hemp, Inc. announces CBD-CBG-CBN Natural Sleep Aid Capsules available for sale - Hemp announced that its CBD-CBG-CBN Natural Sleep Aid Capsules are available for sale completing its Super Cannabinoids Sample Pack on the King of Hemp website. The Super Cannabinoid Sample Pack includes one bag of CBD-CBG-CBN Sleep Aid Capsules for sleeplessness; one bag of CBD-CBG Pain and Anxiety Relief Capsules; and, three 1 ml bottles of the CBD-CBG Super Tinctures. The company said, "Driven by the passion to keep innovating and offering exceptional wellness products, Hemp, Inc.'s blended CBD-CBG-CBN natural, effective Sleep Aid Capsules help you rest easy, fall asleep faster, and stay asleep longer. The added benefits of CBD and CBG improve the effectiveness of the CBN by reducing pain and helping to alleviate anxiety. The Pain and Anxiety Relief Capsules are formulated with 250mg of CBD and 83 mg of CBG. The Sleep Aid Capsules are formulated with 170 mg of CBD, 50 mg of CBG, and 24 mg of CBN. For those who want to amplify their health and wellness routines, these natural, effective, non-habit-forming capsules provide a convenient, more traditional form to effectively absorb the rich benefits of CBD, CBG, and CBN. The Super Tinctures are also very popular with our customers. Formulated with 10,000 mg of cannabinoid, the tinctures boast rapid absorption and bio-availability with 4 times the potency of most other hemp-derived tinctures on the market. Its high-quality ingredient combination has shown impressive results with excellent customer satisfaction."

08:13 EDT Sandstorm Gold files early warning report Entree Resources - Sandstorm Gold (SAND) is divesting its approximately 25% stake in common shares of Entree Resources (ERLFF) to 1363013 B.C. Ltd., a wholly-owned subsidiary of Royalty North Partners. Sandstorm and RNP signed a letter of intent, as amended and restated on May 1, whereby Horizon Copper will acquire certain assets from Sandstorm, including 49,672,515 Entree Shares representing approximately 25.2% of the outstanding Entree Shares. Sandstorm and Horizon Copper have entered into a definitive agreement for the sale of its Entree Shares, for a deemed value of C$0.87 per Entree Share, in consideration for a promissory note in the principal amount of C$43.2M. The 49,672,515 Entree Shares represent approximately 25.2% of the outstanding Entree Shares or 25.7% of the outstanding Entree Shares. Upon completion of the Disposition, no Entree Shares and 1,200,000 Entree Warrants will be owned by Sandstorm. Subject to RNP obtaining the acceptance of the TSX Venture Exchange, the Disposition is expected to be completed on or about May 31. Sandstorm is proceeding with the Disposition for investment portfolio management purposes.

08:11 EDT Satellogic launches four additional satellites on SpaceX Transporter-5 mission - Satellogic announced the launch of four additional satellites from Cape Canaveral Space Force Station. They were delivered to a sun-synchronous low-Earth orbit on SpaceX's Transporter-5 mission on May 25 onboard the Falcon 9 reusable, two-stage rocket, under SpaceX's Rideshare program. All four satellites have made contact with Satellogic's ground station network with good health reports. The successful launch increases the Company's fleet to 26 operational satellites, an important milestone keeping Satellogic on track to have 34 satellites in orbit by Q1 2023 and achieve up to seven daily revisits over points of interest. The four new spacecraft are the updated NewSats Mark IV model, which is more cost effective than its predecessor and has increased onboard storage as well as improvements to its propulsion and navigation systems. "Since 2020, we have doubled the size of our constellation and expect the significant expansion of our fleet to continue," stated Emiliano Kargieman, CEO and Co-Founder of Satellogic. "We are focused on growing the number of our satellites in orbit in order to make Earth Observation data more accessible and affordable to governments and organizations around the world."

08:10 EDT Wireless Telecom's Boonton introduces NGX1000 Programmable Noise Generator - Wireless Telecom Group announced that its Boonton brand has entered the noise generation market with the introduction of the NGX1000 Programmable Noise Generator, a new series of instruments that deliver a fast, simple way to add RF and microwave noise in communications system to test reliability, robustness, and performance - all packaged in a compact form factor for easy benchtop or rackmount use. The NGX1000 combines high-performance noise generation technology from Noisecom with the latest Boonton instrument platform that offers an easy-to-use modern interface, enabling flexible, programmable noise generation for broad use in the semiconductor, military, aerospace, satellite, medical, and communications industries.

08:08 EDT Capstone Green Energy gets order for projects in Italy - Capstone Green Energy announced that IBT Connecting Energies GmbH exclusive distributor for Italy, has secured orders for two waste-to-energy projects in the Sardinia region of Italy. Three C65 microturbines will be deployed at two wastewater treatment facilities operated by Acciona Agua SA in Alghero and Cagliari, Italy. The microturbine systems are expected to be commissioned in December 2022. "We are pleased to see continued order flow out of the European region given the unprecedented macroeconomic conditions in their energy markets," said Darren Jamison, Chief Executive Officer of Capstone Green Energy. "This is a perfect example of how customers are reducing their dependence on fossil fuel sources for power generation through sustainable biogas to energy projects."

08:08 EDT CytomX Therapeutics doses first patient in Phase 1 study of CX-904 - CytomX Therapeutics announced that the first patient has been dosed in a Phase 1 dose-escalation study of CX-904. CX-904 is a conditionally activated T-cell-engaging bispecific designed to target the epidermal growth factor receptor on cancer cells and the CD3 receptor on T cells within the tumor microenvironment.

08:06 EDT Bionano Genomics announces publicationof study using OGM - Bionano Genomics announced the publication of the first peer-reviewed research study using optical genome mapping to analyze genetic aberrations found in pediatric patients with acute myeloid leukemia. This research demonstrates the use of OGM to identify minimal residual disease markers and other novel variants that can impact therapeutic treatment and case management for pediatric AML patients. MRD markers can be followed over the course of treatment and used to determine whether treatment is working or whether the patient has relapsed. AML is the second most frequently diagnosed blood cancer in children. It is a remarkably complex disease, characterized by a wide spectrum of genome variations including structural variants. In the peer-reviewed study, published in Cancers, researchers at University Hospital Essen analyzed samples from 24 pediatric patients with AML using OGM and traditional methods including FISH and karyotyping to determine if OGM could provide an all-in-one methodological approach to identify relevant genetic aberrations that impact AML diagnosis and stratification into groups for treatment. In 70 percent of cases, significantly more SVs were detected using OGM than cytogenetic methods, and these SVs are believed to be highly relevant to the understanding of pathogenesis of AML. Additional findings of the study: 32 previously unknown aberrations discovered; 1 was a high-risk marker detected only by OGM. In 2 cases, OGM detected novel fusion partners of a gene known to play a role in hematopoiesis, thereby providing information on new MRD markers. The researchers also noted that OGM's high sensitivity has particular significance in cases where none of the previously known markers for PCR-based MRD monitoring could be identified, which is approximately 30% of pediatric AML in Germany, where the study was conducted.

08:05 EDT Westwood Holdings Group to acquire Salient Partners' asset managment business - Westwood Holdings Group has entered into a definitive agreement with Salient Partners, pursuant to which Westwood will acquire Salient's asset management business. Salient is a real asset and alternative investment firm that offers a suite of strategies focused on energy and infrastructure, real estate and tactical alternative investments. The firm has $4.5 billion in assets under management. This strategic acquisition will increase Westwood's total AUM by 32% to $18.4 billion, providing pro forma specialization and scale across the combined company's Multi-Asset, Real Assets and Alternative Strategies. An investor presentation on this transaction will be available on Westwood's website, westwoodgroup.com. Westwood is acquiring Salient's four distinct investment capabilities, all of which bolster Westwood's growing Multi-Asset, Real Assets and Alternatives platform: Energy Infrastructure - A recognized leader and innovator in the MLP and Energy Infrastructure space, Salient's Energy Infrastructure team has worked together for over a decade and is highly regarded for its intellectual capital and thought leadership. Salient's Energy Infrastructure strategies total $2.5 billion in AUM and are available in the form of separately managed accounts, open-end mutual funds, a closed-end fund and private funds. Tactical Equity - With $1.4 billion in AUM, Salient's Liquid Alternatives strategies are highly scalable. Sub-advised by Broadmark Asset Management, the Tactical Equity strategies are offered in the form of mutual funds and separately managed accounts. Broadmark has compiled an exceptional 23-year track record successfully mitigating volatility, while seeking to produce above-average, risk-adjusted returns in all market environments with less downside volatility than the S&P 500 Index. Through this transaction, Westwood will also acquire a substantial minority ownership stake in Broadmark. Real Estate - Salient's Real Estate team has a respected legacy that stretches over two decades of offering differentiated approaches to investing in liquid real estate securities that are designed to deliver attractive current yield and appropriate risk-adjusted total returns. Salient's Real Estate strategies total $306 million in AUM and are available in the form of mutual funds and separately managed accounts. Private Investments - Salient also has substantial experience sourcing and raising assets for private investment vehicles across energy and real asset strategies. Current AUM in private investments totals $286 million. The investment and distribution capabilities of Westwood and Salient are highly complementary and are expected to enhance the combined organization's ability to provide attractive investment outcomes for a wide range of institutional, intermediary and wealth management clients. Salient brings strong product advocacy within top-tier intermediary platforms and access to several thousand individual financial advisor relationships. The opportunities provided by increased scale and product availability are expected to be quickly leveraged by an expanded distribution team to benefit our clients and investment teams. Westwood is acquiring Salient's asset management business for an upfront payment of $35 million on closing, with deferred payments of up to $25 million over several years, upon satisfaction of certain revenue retention and growth targets. The transaction is subject to customary closing conditions, including fund shareholder and other client approvals. The transaction is expected to close before the end of 2022 with significant immediate accretion to earnings. Westwood, Salient and Broadmark's strategies will continue under their existing fund names until close of the transaction and will be managed by the investment teams as they exist today, with the same stated investment objectives. Salient and Broadmark's strategies are expected to directly benefit from the additional risk and performance analysis that Westwood provides to its current investment processes. Under the terms of the transaction, Westwood will maintain its debt-free balance sheet and will fund the upfront consideration using cash on hand.

08:04 EDT Byrna Technologies acquires the assets of Fox Labs for $2.17M - Byrna Technologies has acquired the assets of Fox Labs, which has been in business for more than 30 years and produces pepper spray, catering primarily to law enforcement and other security professionals. Byrna is acquiring substantially all the assets of Fox Labs for $2.17M from longtime owner and CEO, Ed Ferguson. Byrna intends to retain the Fox Labs brand. Along with the acquisition, Byrna is acquiring the rights to Sudecon, a pepper and tear gas neutralizing agent. Byrna plans to create its own line of Byrna branded sprays. As part of the acquisition strategy, Byrna hired David Happe to serve as President of the newly created Self-Defense Aerosol Spray division. Happe was the former Executive Vice President of Mace pepper spray and most recently was a consultant to Fox Labs. Happe, who joined the Byrna team on May 23, 2022, is responsible for global sales of both the Byrna and Fox Labs branded self-defense sprays.

08:03 EDT Northeast utility selects NV5 Global for $35M LNG infrastructure upgrade - NV5 Global announced that it has been awarded a $25 million contract by a prominent Northeast utility to provide engineering, procurement, and installation of a new LNG vaporization system at the utility's plant. The new vaporization system will replace the existing system at the facility to increase storage capacity and reliability, while providing additional operational flexibility for the storage and delivery of natural gas to the utility's service area. The design phase of the 20-month project is underway, and final delivery of the new vaporization system is expected to be completed in the fourth quarter of 2023.

07:55 EDT LanzaTech discovers method to produce sustainable PET bottles - A consortium, including LanzaTech and Danone, led to the discovery of a new route to monoethylene glycol, which is a key building block for polyethylene terephthalate, resin, fibers and bottles. The technology converts carbon emissions from steel mills or gasified waste biomass directly into MEG. The carbon capture technology uses a proprietary engineered bacterium to convert carbon emissions directly into MEG through fermentation, bypassing the need for an ethanol intermediate, and simplifying the MEG supply chain. The direct production of MEG was proven at laboratory scale and the presence of MEG was confirmed by two external laboratories. While there is no organism in nature known to produce MEG, through this proof-of-concept stage, LanzaTech has used Synthetic Biology and AI tools to discover multiple novel pathways to make MEG directly from carbon emissions. By combining and prototyping various sets of enzymes identified from different sources in novel ways, LanzaTech has successfully reprogrammed its ethanol producing bacteria to fix and channel carbon into MEG. This early-stage proof of concept work shows for the first time that it is possible for a bacterium to directly produce MEG from gas. By producing MEG directly, the new technology avoids the multiple processing steps required to convert ethanol into ethylene, then ethylene oxide and then to MEG. LanzaTech anticipates that when scaled successfully after a multiyear development phase, the direct production process will lead to PET bottles and PET fibers with a reduced environmental impact. LanzaTech is partnering with leading companies to improve the environmental impact of packaging. Given the success of this proof-of-concept phase, LanzaTech, with the support of Danone, plans to continue the scale-up phase of its direct-to-MEG technology.

07:53 EDT Vivid Seats announces exchange offer, consent solicitation - Vivid Seats announced that it has commenced an exchange offer and consent solicitation relating to its outstanding public warrants to purchase shares of its Class A common stock, par value $0.0001 per share. The purpose of the Offer and Consent Solicitation is to simplify the Company's capital structure and reduce the potential dilutive impact of the warrants, thereby providing the Company with more flexibility for financing its operations in the future. Vivid Seats also announced that its Board of Directors has authorized the repurchase of up to $40 million of the Company's outstanding shares of its Class A Common Stock following the completion of the Offer and Consent Solicitation and until the end of March 2023. The Company intends to fund the share repurchase program with cash from operations and cash on hand. No share repurchases will be made under the share repurchase program until the Offer is complete. The Company is offering to all holders of its public warrants the opportunity to receive 0.240 shares of Class A Common Stock in exchange for each outstanding public warrant tendered by the holder and exchanged pursuant to the Offer. Pursuant to the Offer, the Company is offering up to an aggregate of 4,351,864 shares of its Class A Common Stock in exchange for the public warrants. Concurrently with the Offer, the Company is also soliciting consents from holders of the public warrants to amend the warrant agreement that governs all of the public warrants to permit the Company to require that each public warrant that is outstanding upon the closing of the Offer be converted into 0.213 shares of Class A Common Stock, which is a ratio 12.7% less than the exchange ratio applicable to the Offer. Pursuant to the terms of the Warrant Agreement, all except certain specified modifications or amendments require the vote or written consent of holders of at least 65% of the outstanding public warrants. Accordingly, the adoption of the Warrant Amendment will require the consent of holders of at least 65% of the outstanding public warrants. Eldridge Industries, LLC, which holds approximately 28.5% of the outstanding public warrants, has agreed to tender its public warrants in the Offer and to consent to the Warrant Amendment in the Consent Solicitation pursuant to a tender and support agreement. Accordingly, if holders of an additional approximately 36.5% of the outstanding public warrants consent to the Warrant Amendment in the Consent Solicitation, and the other conditions of the Offer are satisfied or waived, then the Warrant Amendment will be adopted. The offering period will continue until 11:59 p.m., Eastern Daylight Time, on June 29, 2022, or such later time and date to which the Company may extend, as described in the Company's Schedule TO and Prospectus/Offer to Exchange. Tendered warrants may be withdrawn by holders at any time prior to the Expiration Date. The Offer and Consent Solicitation are being made pursuant to a Prospectus/Offer to Exchange dated May 26, 2022, and Schedule TO, dated May 26, 2022, each of which have been filed with the U.S. Securities and Exchange Commission and more fully set forth the terms and conditions of the Offer and Consent Solicitation. The Company's Class A Common Stock and public warrants are listed on The Nasdaq Global Select Market under the symbols "SEAT" and "SEATW," respectively. As of May 23, 2022, a total of 18,132,766 public warrants were outstanding.

07:47 EDT Goodbody Health announces launch of core health diagnostic check - Goodbody Health has launched its core UK Health check which offers a comprehensive summary of a person's health. Keenly priced at GBP99, this new test includes innovative in-clinic diabetes and cholesterol tests, with results finalised in minutes. These tests determine a person's risk for developing cardiac health problems or diabetes over the next 10 years. Consistent with our value of 'Know More - Live Better", knowing more about one's current wellness empowers the individual to take better control of their health.

07:43 EDT Costamare announces closing of $500M syndicated loan facility - Costamare announces the closing of a 5-year syndicated loan facility for an amount of up to $500 million. Proceeds from the loan will be used to refinance the existing indebtedness of 17 containerships with an average age of 14 years and for general corporate purposes. The original maturity of the existing indebtedness for 16 out of 17 vessels would have occurred prior to the maturity of the new syndicated facility. The facility was significantly oversubscribed. Full drawdown of the facility is expected to be concluded by the end of Q2 2022.

07:41 EDT Marathon Gold announces filing of draft EA Report for Valentine Gold Project - Marathon Gold is pleased to announce that a draft Environmental Assessment Report has been filed by the Impact Assessment Agency of Canada for the Valentine Gold Project. The draft EA Report, and accompanying draft conditions for EA release, will be available for 30 days for public review and comment. At the conclusion of this period, the Minister of Environment and Climate Change Canada will be in a position to make a Decision Statement on the acceptability of the Project for development. A positive Decision Statement will mark the completion of the federal EA. A parallel provincial EA concluded successfully on March 17, 2022, with approval of the Project by the Cabinet of the Government of Newfoundland and Labrador. Of note, the draft EA Report concludes that the Project is not likely to cause significant adverse environmental effects, taking into account the implementation of appropriate mitigation measures. The Minister's agreement with this finding will mean that the Minister is able to make a Decision Statement without reference to the federal Cabinet.

07:36 EDT CloudMD launches Kii Personalized & Connected Care - CloudMD Software & Services is excited to announce the launch of Kii Personalized & Connected Care by CloudMD, the new brand identity for its integrated, health services offering. Kii, is the company's flagship offering which integrates several of its best-in-class technologies and services into one exceptional, connected, and personalized experience for employees that will continue to disrupt the traditional employer healthcare industry. Kii is focused on personalizing care by taking a whole-person approach with an emphasis on continuity of care across mental, physical and workplace safety. Over the last 6 months, the CloudMD team has been working to develop the new Kii brand identity and positioning for its integrated platform, which has already seen successful adoption in the marketplace. The new Kii brand reflects a brand purpose of empowering individuals to take control of their health and plays off the word "key" ie. "Holding the key to your health". The essence of the brand is meant to embody caring, the whole body, trust, and connectivity. The Kii brand promise is to provide connected care, which is the key enabler to an individual's health and wellbeing and ability to thrive.

07:33 EDT Ryan to receive investments from Onex, Ares Management - Rya and Onex Corporation (ONEXF) announced a private equity fund managed by Ares Management Corporation (ARES) has committed to acquiring a significant minority equity interest in Ryan, valuing the Company at $2.5 billion. The investment was made in partnership with Ryan's management team and the Company's existing investor Onex Partners, Onex' flagship private equity platform, who will retain a significant minority equity interest in Ryan. This combined partnership will drive the next stage of growth for the Company. Headquartered in Dallas, Texas, Ryan is a leading global tax services and software provider with an integrated suite of federal, state, local, and international tax services, and is the largest firm in the world dedicated exclusively to business taxes. Its multidisciplinary team of more than 3,500 professionals and associates serves over 18,000 clients in more than 60 countries, including many of the world's most prominent companies. The transaction is expected to close in the third quarter of 2022, subject to customary closing conditions.

07:31 EDT Ekso Bionics appoints Jerome Wong as interim CFO - Ekso Bionics Holdings announced the appointment of Jerome Wong as Interim CFO following the departure of current CFO Jack Glenn. Mr. Glenn resigned effective June 17, 2022 to pursue a new position at another public company. Mr. Glenn's resignation is not the result of any dispute or disagreement with the Company including any matters relating to the Company's accounting practices or financial reporting. Wong, 48, has served as the Company's Controller since May 2017 and brings more than 20 years of experience in finance, accounting and strategy to this role, focusing on high and medical technology and life sciences in public companies.

07:29 EDT WisdomTree enters cooperation agreement with ETFS Capital, Lion Point - WisdomTree Investments announced that it has entered into a cooperation agreement with stockholders ETFS Capital Limited and Lion Point Capital to further enhance the composition of the Company's Board of Directors and corporate governance. Pursuant to the cooperation agreement and consistent with the Company's ongoing process of Board refreshment, the size of the Board will be increased to nine members, and two new independent directors, Lynn Blake and Deborah Fuhr, will be appointed to the Board, effective immediately. After conducting further interviews with Ms. Fuhr and gaining a better understanding of her other commitments, the Board is now satisfied that they do not prevent her from serving as a WisdomTree director. Ms. Blake will join the Compensation Committee, and Ms. Fuhr will join the Nominating and Governance Committee of the Board. The two new directors also will join a newly formed four-member Operations and Strategy Committee. This committee will help to evaluate operational improvement opportunities and Company strategy. Smita Conjeevaram, an independent director, will serve as Chair of the Operations and Strategy Committee, and independent director Anthony Bossone will also serve on the committee. Additionally, the Company has determined to seek stockholder approval at its upcoming 2022 Annual Meeting of Stockholders to declassify the Board. If stockholder approval is obtained, the Board will begin the declassification process at the 2022 Annual Meeting and will be de-classified fully in 2024. Pursuant to the cooperation agreement, the Company also announced that it will terminate the stockholder rights plan adopted in March 2022, effective June 2, 2022. The Company also announced that, separate from this cooperation agreement, independent director Harold Singleton III will join the WisdomTree Audit Committee, effective immediately. ETFSC is the largest stockholder in WisdomTree, owning approximately 18.6% of the Company's voting and non-voting common stock and preferred shares combined, and Lion Point is one of WisdomTree's top stockholders owning approximately 3.1% of the voting shares. Under the terms of the cooperation agreement, ETFSC and Lion Point have agreed to withdraw their slate of nominees and vote their shares in favor of all the Board's nominees and support all Board recommended proposals at the 2022 Annual Meeting, subject to certain limited exceptions. ETFSC and Lion Point also have agreed to abide by customary standstill provisions and voting commitments.

07:25 EDT Tilray launches CBD brand Pollen on Amazon UK - Tilray Brands announced the launch of POLLEN, a CBD lifestyle brand with a new approach to wellness, on Amazon UK. The company said, "Designed to help uncomplicate wellness routines and elevate the CBD experience for consumers, POLLEN offers a unique product mix of tasty CBD gummies and drink drops in three signature lines; 'Powerbank' to promote a natural energy boost, 'No Pressure' to soften the pressure of everyday stresses and restore your body's natural bounce, and 'Soothe You' for mind and body balance. Each POLLEN product is formulated with CBD and a range of flavorful and vegan-friendly ingredients that simply taste and feel good." POLLEN CBD Gummies offer 300mg of CBD per pack and are independently tested for an accurate dosage every time. All POLLEN products are plant-based, pesticide-free, vegan-friendly.

07:23 EDT Nurix Therapeutics initiates first of Phase 1b expansion cohorts for NX-2127 - Nurix announced that it has initiated the first of several potential Phase 1b expansion cohorts in its ongoing Phase 1 trial of NX-2127, an orally administered degrader of Bruton's tyrosine kinase with immunomodulatory activity. The first expansion cohorts will focus on patients with chronic lymphocytic leukemia. The expansion into CLL is based on recent positive data from Nurix's ongoing Phase 1a dose escalation study of NX-2127, including: Meaningful clinical benefit including multiple confirmed responses by IWCLL criteria observed in highly pre-treated relapsed/refractory CLL patients with a median of 6 prior therapies; Clinical responses in patients with BTK mutations that confer resistance to current BTK targeted therapies including both covalent and noncovalent BTK inhibitors; All patients show robust and durable BTK degradation; All patients show Immunomodulatory activity mediated through the E3 ligase cereblon; Overall biologic activity in all patients at the 100 mg dose with a favorable safety profile.The Phase 1b expansion cohorts will include up to 40 CLL patients enrolled across multiple clinical sites in the United States. Patients will have received two or more prior regimens including a BTK inhibitor. All patients will be dosed at 100 mg orally once daily. The Phase 1a dose escalation portion of the trial will continue to enroll non-CLL patients at doses ranging from 50mg to 300mg orally once daily. Nurix will host a research & development day for analysts and investors that will be held today May 26, 2022 from 8:00 a.m. to 11:00 a.m. ET in New York City. The R&D Day will feature a presentation by guest speaker, Anthony Mato, M.D., MSCE, director of the chronic lymphocytic leukemia Program at Memorial Sloan Kettering Cancer Center, who will provide a perspective on the clinical experience and unmet need in hematologic malignancies. The event will include presentations from Nurix's management team, who will provide a comprehensive update on Nurix's four clinical programs, DELigase discovery platform and future development plans.

07:21 EDT Marimaca Copper announces results from annual general, special meeting - Marimaca Copper is pleased to report that all of its incumbent directors were re-elected at its annual general meeting of shareholders, held virtually via webcast on Wednesday 25, 2022. At the Meeting, shareholders also authorized the Company to appoint PricewaterhouseCoopers LLP, Chartered Professional Accountants, as auditors of the Company for the ensuing year and authorize the board of directors of the Company to determine the remuneration to be paid to the auditors and authorized the Company to implement a warrant early exercise incentive program, as more particularly described in the Company's management information circular dated April 28, 2022 and filed under the Company's SEDAR profile at www.sedar.com. In accordance with the requirements of the Toronto Stock Exchange, the Warrant Early Exercise Incentive Program was approved by a majority of "disinterested shareholders", being shareholders of the Company who do not also hold Warrants. The Company sought approval for the Warrant Early Exercise Program in order to provide the Company with a mechanism to provide an incentive for the early exercise of its common share purchase warrants The Company currently has 11,069,054 Warrants issued and outstanding, each of which entitles the holder to acquire one common share of the Company for an exercise price of $4.10 per share at any time up to and including December 3, 2022.

07:17 EDT TopBuild to host 2022 Investor Day - TopBuild Corp. will host an in-person, invitation-only Investor Day in New York City today, Thursday, May 26, 2022 starting at 8:00 a.m. Eastern Time. The event is expected to conclude at approximately 12:00 p.m. Robert Buck, President and Chief Executive Officer, Rob Kuhns, Chief Financial Officer, and other members of the senior management team will provide an in-depth review of the Company's business drivers and long-term growth strategies, including innovative products and technology, sustainability focus and capital allocation. In addition, the Company is introducing 2025 financial objectives. During the event, there will be an opportunity for both live and webcast attendees to ask questions during two Q&A sessions.

07:16 EDT Alibaba comments on COVID-19 resurgence in China - The company said, "Since mid-March 2022, our domestic businesses have been significantly affected by the COVID-19 resurgence in China, particularly in Shanghai. Considering the risks and uncertainties arising from COVID-19, which we are not able to control and are difficult for us to predict, we believe it is prudent at this time not to give financial guidance as we typically do at the start of the fiscal year. However, we believe our Company will continue to generate strong operating cash flow to maintain strategic flexibility as we calibrate our operations against changing economic and competitive circumstances. In fiscal year 2023, our operating principles include focusing on sustainable, high-quality revenue growth and optimizing our cost structure to enhance overall return."

07:12 EDT Axcella done enrolling of trial for long COVID and prioritize portfolio - Axcella Therapeutics announced that it has prioritized its clinical development portfolio after rapid enrollment for its Phase 2a clinical trial in Long COVID. The company affirmed topline data readout for its Phase 2a Long COVID trial in early Q3 2022 and interim data readout for NASH in late Q3 2022. The company is suspending its Phase 2 clinical trial in OHE, Overt Hepatic Encephalopathy, while exploring potential partnership for the program. Patient enrollment is complete in the prospective, placebo controlled, randomized trial conducted at the John Radcliffe Hospital at Oxford University in England. Lead researcher Dr. Betty Raman, British Heart Foundation Oxford Centre of Research Excellence Clinical Transition Intermediate Fellow, said, "We have completed enrollment of the forty patients for this integral study on schedule. We look forward to sharing the results of the trial given the ever growing patient need for a product to address Long COVID fatigue." "Achieving completion of enrollment is a significant milestone in the development path of AXA1125 as a potential treatment for Long COVID, a large and growing consequence of the global pandemic," said Margaret Koziel, M.D., Chief Medical Officer at Axcella. "We believe mitochondrial dysfunction is a key driver of Long Covid induced fatigue. Preclinical and clinical data indicate that AXA1125 may have an important impact."

07:10 EDT Burlington Stores drops 8% to $144.00 after Q1 results, guidance miss estimates

07:09 EDT Enbridge advances construction of natural gas pipeline for Venture Global - Enbridge announced the advancement of its Venice Extension Project and Gator Express Meter Project to deliver 1.5 billion cubic feet per day of natural gas to Venture Global's Plaquemines LNG facility located in Plaquemines Parish, LA. The Projects generally will involve 36-inch diameter pipe, metering, and compressor station additions and improvements. The Gator Express Meter Project is expected to be in service in 2023 and Venice Extension Project is expected to be in service in 2024, with an estimated cost for both projects of $400M, which is underpinned by long-term take or pay contracts.

07:05 EDT Broadcom board authorizes new $10B share repurchase program - The company's Board of Directors has authorized a new share repurchase program to repurchase up to $10B of its common stock through December 31, 2023. This new share repurchase authorization is in addition to the share repurchase program authorized in December 2021, under which it may repurchase the current remaining $3B of common stock through December 31, 2022, Broadcom said.

07:01 EDT Broadcom to acquire VMware for about $61B in cash and stock

07:00 EDT Medtronic increases quarterly cash dividend to 68c per share - The company announced that effective May 25, the Medtronic board of directors approved an increase in Medtronic's cash dividend for the first quarter of fiscal year 2023, raising the quarterly amount to 68c per ordinary share. This would translate into an annual amount of $2.72 per ordinary share, an 8% increase from the prior $2.52. Medtronic has a long history of dividend growth, and the company is a constituent of the S&P 500 Dividend Aristocrats index. The announcement marks the 45th consecutive year of an increase in the dividend payment. Including the increase, Medtronic's dividend per share has grown by 48% over the past 5 years and has grown at a 16% compounded annual growth rate over the past 45 years. The company remains committed to returning a minimum of 50% of its free cash flow to shareholders, primarily through dividends, and to a lesser extent, share repurchases. The dividend is payable on July 15 to shareholders of record at the close of business on June 24.

06:58 EDT Macy's reports Q1 digital sales up 2% y/y and 34% q/q - Q1 Inventory was up 17% year-over-year and down 10% versus 2019. Inventory turnover, on a trailing twelve-month basis, increased 9% over 2021 and 18% over 2019.

06:51 EDT Pfizer granted FDA Fast Track designation for ervogastat/clesacostat combination - Pfizer announced the U.S. FDA has granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis with liver fibrosis: ervogastat and clesacostat. Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need. The FDA's decision is informed by the results of Pfizer's nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. These data were recently published in Nature Medicine.

06:50 EDT Burlington Stores names Kristin Wolfe as CFO - Burlington Stores (BURL) announced that Kristin Wolfe has been appointed CFO, effective on or about August 1. As previously announced, the employment of John Crimmins, the company's current CFO, will end on August 31. The month overlap will allow for both executives to transition, and Crimmins will provide consulting services to the company through the end of February 2023. Wolfe joins Burlington from Ross Stores (ROST), where she served in a wide range of financial, strategic and operational roles.

06:34 EDT Babcock & Wilcox reports April North American orders of over $23M - Babcock & Wilcox has booked more than $23M in orders for parts and services for utility and industrial customers in North America in the month of April, as overall demand for these services has returned to pre-pandemic levels. Significant orders include environmental aftermarket parts and services for electrostatic precipitators and other equipment, pulp and paper upgrades and services, pulverizer mill parts, B&W's Diamond Power ash-handling and boiler cleaning product lines and more.

06:12 EDT Boeing, NASA complete Starliner uncrewed flight test to space station - NASA and Boeing safely landed the company's CST-100 Starliner spacecraft Wednesday in the desert of the western United States, completing the uncrewed Orbital Flight Test-2 to the International Space Station to help prove the system is ready to fly astronauts. About four hours after departing the space station, Starliner touched down onto its airbags at 4:49 p.m. MDT, wrapping up the six-day flight, which tested the end-to-end capabilities of the crew-capable spacecraft. The landing followed a deorbit burn at 4:05 p.m., separation of the spacecraft's service module, and successful deployment of its three main parachutes and six airbags. "NASA's Commercial Crew Program and our industry partner, Boeing, today took a major and successful step on the journey toenabling morehuman spaceflight missions to the International Space Station on American spacecraft from American soil," said NASA Administrator Bill Nelson. "The OFT-2 mission represents the power of collaboration, which allows us to innovate for the benefit of humanity and inspire the world through discovery. This golden era of spaceflight wouldn't be possible without the thousands of individuals who persevered and poured their passion into this great achievement."

06:11 EDT Lucid Group recalling 1,100 Air cars over display issue - Lucid Motors is recalling 1,100 2022 Air vehicles because display screens may fail to work due to a wiring harness possibly not being secured properly. Lucid said it was not aware of any failures due to the condition. The National Highway Traffic Safety Administration said a disabled screen would not show critical information, such as the speedometer, gear selection indicators, and warning lights. Dealers will inspect and secure the wiring harness.

06:03 EDT Joby Aviation receives Part 135 Air Carrier Certificate from FAA - Joby Aviation has received a Part 135 Air Carrier Certificate from the Federal Aviation Administration - FAA -, allowing Joby to begin on-demand commercial air taxi operations. Joby received the certification ahead of schedule, with completion of the process originally expected in the second half of 2022. The Part 135 Air Carrier Certificate is one of three FAA approvals required for Joby to operate its electric vertical take-off and landing - eVTOL - aircraft as an air taxi service in cities and communities across the U.S., alongside a Type Certificate and a Production Certificate. Once Joby receives a type certificate for its eVTOL aircraft, the company will complete the FAA review process to add the new aircraft type to its existing air carrier certificate. The company's future aerial ridesharing service is expected to launch in 2024. Joby's all-electric aircraft is designed to transport a pilot and four passengers up to 150 miles on a single charge at speeds of up to 200 mph. Joby recently announced the results of acoustic testing with NASA, which confirmed the aircraft hit the company's target for low noise emissions during take-off and landing as well as overhead flight.

05:36 EDT LumiraDx HbA1c test receives CE Marking - LumiraDx announced its HbA1c test has achieved CE Marking. Used with the LumiraDx Platform, the test provides results in under seven minutes from sample application for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes, all at the point of care.

05:15 EDT Nokia, TWM announce 5G coverage expansion deal - Nokia announced that it has been selected by Taiwan Mobile, or TWM, in an expansion deal to enhance the operator's 5G coverage across the country. Under the deal, Nokia will provide its latest AirScale portfolio supporting TWM's commitments to RE100 and reaching 100% renewable energy by 2040. It will also provide a smooth network evolution path following the completion of the proposed merger with Taiwan Star.