Stockwinners Market Radar for May 19, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:51 EDT Intercept announces outcome of FDA meeting to review NDA for obeticholic acid - Intercept Pharmaceuticals announced the outcome of the U.S. FDA Gastrointestinal Drugs Advisory Committee Meeting to review the company's New Drug Application for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis. Twelve of 16 voting-eligible GIDAC members voted "no" (with two abstentions) on the voting question, "given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?" Fifteen of 16 voting-eligible GIDAC members (with no abstentions) voted to "defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered." "We are disappointed in the outcome of today's meeting," said Jerry Durso, President and CEO of Intercept. "We continue to disagree with the FDA on certain characterizations of OCA's efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests, as discussed in today's meeting. The robust body of evidence provided by Intercept was underscored by public testimony from the liver community, who supported OCA as an option to address the urgent treatment need in NASH and the use of NITs to manage this devastating disease in clinical practice."

17:38 EDT GoHealth confirms receipt of acquisition proposal from Centerbridge, NVX - GoHealth, as noted in a recent 13D filing, has received a proposal from its two largest shareholders to acquire all of the outstanding Class A Common Stock and LLC Interests that these shareholders do not already own. Independent members of GoHealth's Board will review the proposal in due course. The company remains committed to serving Medicare Advantage beneficiaries, working with health plans, and generating value for all stakeholders.

17:22 EDT ViaSat's proposed acquisition of Inmarsat approved by U.S. FCC - Viasat and Inmarsat are pleased that Viasat's proposed acquisition of Inmarsat has received approval from the U.S. Federal Communications Commission. The FCC's decision leaves the European Commission's competition review as the key ongoing regulatory process in relation to the transaction. The transaction is expected to close later this month, subject to required regulatory approvals, clearances and other customary closing conditions.

17:11 EDT Envirotech Vehicles receives expected Nasdaq notice on delayed filing - Envirotech Vehicles announced that it received a notification letter from the Nasdaq Stock Market, LLC stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) because it has not yet filed its Form 10-Q for the period ended March 31, 2023 and because it remains delinquent in filing its Form 10-K for the period ended December 31, 2022, as previously disclosed. In accordance with the prior notification letter regarding the delayed filing of the Form 10-K, EVTV has until June 20, 2023 to submit a plan to regain compliance with the Nasdaq Listing Rules. If Nasdaq accepts the Company's plan, then Nasdaq may grant the Company up to 180 days from the prescribed due date for filing the Form 10-K to regain compliance. The Company continues to work diligently to file its Form 10-K and Form 10-Q and expects to regain compliance with the Nasdaq Listing Rule.

16:46 EDT FDA panel votes 12-2 against Intercept's pre-cirrhotic fibrosis treatment - A panel for the Food and Drug Administration voted 12-2 against clearing Intercept's use of obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis. The Gastrointestinal Drugs Advisory Committee voted 12 against, 2 in favor of the tratement, with two abstentions, and voted 15-1 to defer approval on the treatment. The FDA isn't required to follow the recommendations of its advisers.

16:24 EDT Celularity says MLASC treatment resulted in alterations in Phase 1 study - Celularity announced results from an exploratory analysis of Phase 1 data evaluating alterations in gene and protein signatures associated with reduced inflammation and fistula formation resulting from therapy with mesenchymal-like adherent stromal cells in adult patients with Crohn's disease. These data were presented at the 26th Annual Meeting of the American Society of Gene & Cell Therapy, which is being held May 16-20th in Los Angeles. In this study, two patient groups were evaluated: patients who responded to MLASC therapy and patients who received placebo. For each of the 24 patients, mRNA gene expression data and proteomics data were provided at early pre-treatment, at pre-treatment baseline, at early post-treatment and at later post-treatment. The results of this analysis showed that in CD, MLASC treatment resulted in alterations in gene and protein signatures associated with inflammation and fistula formation. This analysis provides some insight into pathways associated with severity of CD and suggests that gene and protein profiling of blood plasma might be useful for assessing disease severity and treatment response. It also suggests that MLASCs may be a potential therapeutic option in both managing the disease but also, importantly, in limiting fistula formation. "Crohn's disease is a devastating condition for patients, and we believe these data help us begin to see the potential role that cell therapy may play in its treatment," said Robert J. Hariri, M.D., Ph.D., Celularity's CEO, Chairman and Founder. "Furthermore, these results validate our decision to progress our novel genetically modified allogeneic placental-derived MLASC, APPL-01, in Crohn's disease, where this cell therapy candidate has the potential to make a significant difference. Celularity's unique technology platform is grounded in our use of the post-partum placenta as the source of cells and biomaterials, enabling independent but complementary product opportunities in cellular and regenerative medicine. We're moving forward with confidence to assess the potential immunomodulatory and pro-regenerative therapeutic benefits of MLASCs as we advance the development of therapeutic options for patients."

16:13 EDT Toro Corp. to sell M/T Wonder Polaris, M/T Wonder Bellatrix for aggregate $71.5M - Toro Corp. announced that on May 18, 2023 and on May 12, 2023, the Company entered into two separate agreements with an unaffiliated third-party for the sale of the M/T Wonder Polaris, a 2005-built Aframax/LR2 tanker, at a price of $34.5M, and the M/T Wonder Bellatrix, a 2006-built Aframax/LR2 tanker, at a price of $37M. The conclusion of the sale agreements is subject to the execution of definitive documentation customary for these types of transactions. Both vessels are expected to be delivered to their new owner during the second quarter of 2023. The company expects to record during the second quarter of 2023 a net gain on the sale of the M/T Wonder Polaris of approximately $22.4M, excluding any transaction-related costs, and a net gain on the sale of the M/T Wonder Bellatrix of approximately $20.5M, excluding any transaction-related costs.

16:10 EDT General Mills director Cordani sells 8,675 common shares - In a regulatory filing, General Mills director David Cordani disclosed the sale of 8,675 common shares of the company on May 17 at a price of $89.5501 per share.

16:06 EDT EUDA Health receives Nasdaq listing delinquency letter - EUDA Health Holdings Limited announced that it received a delinquency notification letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC on May 18, 2023 due to the company's non-compliance with Nasdaq Listing Rule 5250(c)(1) as a result of the company's failure to timely file its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023. Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission. As reported on April 10, 2023, the Company has received a similar notice from Nasdaq on April 5, 2023 as a result of the Company's failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31, 2022. The Notice states that the Company has up to June 5, 2023 to submit to Nasdaq a plan to regain compliance with the Nasdaq Listing Rules. If Nasdaq accepts the Company's plan, then Nasdaq may grant the Company up to September 27, 2023 for filing the Form 10-K and the Form 10-Q to regain compliance. If Nasdaq does not accept the Company's plan, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. If our appeal fails, the Company's securities may be delisted.

16:03 EDT Calyxt announces 1-for-5 reverse stock split - Calyxt announced that it will effect a 1-for-5 reverse stock split of its common stock that is expected to be effective concurrent with the anticipated closing date of the merger on Wednesday, May 31. The new CUSIP number for the combined company's common stock following the merger and the reverse stock split is 17166A 101. On May 18, Calyxt stockholders approved the reverse stock split and gave Calyxt's board of directors discretionary authority to select a ratio for the split ranging from 1-for-2 to 1-for-10. Calyxt's board of directors approved the reverse stock split at a ratio of 1-for-5 on May 19.

16:02 EDT Calyxt shareholders approve merger with Cibus - Calyxt announced the results of the special meeting of its stockholders held on May 18. At the special meeting, Calyxt's stockholders voted in favor of all proposals, including the proposal to approve the issuance of shares of Class A common stock and Class B common stock to the equity holders of Cibus Global as part of the previously announced proposed merger with Cibus. The closing of the merger is anticipated to take place on or around Wednesday, May 31, subject to the satisfaction of the remaining closing conditions. Following the closing of the merger, the combined company is expected to change its name from Calyxt to Cibus, trade on The Nasdaq Capital Market under the ticker symbol "CBUS," and be led by Cibus' existing management team.

14:31 EDT Krystal Biotech up 5% after receiving FDA approval for Vyjuvek - Krystal Biotech up $3.94, or 5%, to $91.39 after the FDA approved Vyjuvek for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa, or DEB.

14:05 EDT Adidas to release existing Yeezy product in May 2023 - Adidas announced it will begin selling some of the remaining inventory of adidas YEEZY products, with an initial release end of May 2023. A range of existing designs will be available exclusively through adidas.com/yeezy and the adidas CONFIRMED app. A significant amount will be donated to selected organizations working to combat discrimination and hate, including racism and antisemitism. These include but are not limited to the Anti-Defamation League and the Philonise & Keeta Floyd Institute for Social Change. The release will mark the first time that products have been available to consumers since adidas terminated the YEEZY partnership in October 2022. The products will be existing designs and designs initiated in 2022 for sale in 2023. Additional releases of existing inventory are currently under consideration, but timing is yet to be determined. Today's announcement has no immediate impact on the company's current financial guidance for 2023. Since terminating the YEEZY partnership in October, adidas has been exploring multiple scenarios for the potential use of the existing YEEZY inventory. The process involved seeking feedback and listening to a diverse group of employees, organizations, communities, and consumers for how to responsibly manage the existing product. The company went ahead with already committed production orders after the partnership was terminated. This was done to help protect its supply chain partners from being negatively affected by cancellations, the company said.

13:52 EDT FDA approves Krystal Biotech's Vyjuvek for treatment of wounds in DEB patients - The U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa, or DEB, with mutation(s) in the collagen type VII alpha 1 chain gene. The approval of Vyjuvek was granted to Krystal Biotech. "Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder. Today's action demonstrates the FDA's ongoing commitment to supporting the development and evaluation of new treatments that address unmet needs for rare diseases or conditions," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. Reference Link

13:02 EDT Baker Hughes reports U.S. rig count down 11 to 720 rigs - Baker Hughes reports that the U.S. rig count is down 11 from last week to 720 with oil rigs down 11 to 575, gas rigs unchanged at 141 and miscellaneous rigs unchanged at 4. The U.S. Rig Count is down 8 rigs from last year's count of 728 with oil rigs down 1, gas rigs down 9 and miscellaneous up 2. The U.S. Offshore Rig Count is down 1 to 21, up 3 year-over-year. The Canada Rig Count is down 9 from last week to 85, with oil rigs up 2 to 39, gas rigs down 11 to 46. The Canada Rig Count is down 3 rigs from last year's count of 88 with oil down 1, gas rigs down 2.

12:59 EDT Fresh2 Group to change ticker symbol to 'FRES' - Fresh2 Group Ltd., formerly AnPac Bio-Medical Science Co., announced that its ticker symbol on the Nasdaq Stock Market will change to "FRES" effective at the open of market trading on May 22, 2023 following the company's name change from AnPac Bio-Medical Science Co., Ltd to Fresh2 Group Ltd. The company has traded under the ticker "ANPC" since the company's initial public offering in 2020. Haohan Xu, Co-CEO of the company commented: "Transitioning to the ticker 'FRES' is the most recent step we have taken toward our strategic initiative to focus on the recently engaged new business line of business-to-business food trade and delivery platform for U.S. local restaurants and supermarkets."

12:36 EDT AbbVie says FDA approves EPKINLY - AbbVie announced that the U.S. Food and Drug Administration has approved EPKINLY as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapies. EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. "DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances."

12:31 EDT Ledyard appoints Josephine Moran as CEO, succeeding Kathy Underwood - Kathy Underwood, CEO of Ledyard Financial Group and Ledyard National Bank, announced at the company's Annual Meeting of Shareholders on May 18th that she will be retiring on July 3, 2023. Josephine Moran, President of Ledyard, assumed the role of President & CEO, effective May 18, 2023. Underwood will continue to serve on Ledyard's Board of Directors. Moran joined Ledyard on January 31, 2022, as President and Chief Banking Officer.

12:09 EDT Bridger Aerospace Group Holdings Inc trading resumes

12:02 EDT Adamis Pharmaceuticals announces 1-for-70 reverse stock split - Adamis Pharmaceuticals announced that it will effect a 1-for-70 reverse stock split of its common stock that will become effective on May 22. Adamis' common stock will continue to trade on the Nasdaq under the symbol "ADMP" and will begin trading on a split-adjusted basis when the market opens on May 22. The reverse stock split is primarily intended to increase the market price per share of the company's common stock to regain compliance with the minimum bid price requirement for maintaining its listing on Nasdaq.

12:00 EDT Crescera Capital Acquisition Corp trading resumes

12:00 EDT Flowers Foods falls -10.3% - Flowers Foods is down -10.3%, or -$2.96 to $25.88.

12:00 EDT Mytheresa rises 10.5% - Mytheresa is up 10.5%, or 40c to $4.20.

12:00 EDT Farfetch rises 18.0% - Farfetch is up 18.0%, or 78c to $5.12.

11:26 EDT Centerbridge, GoHealth co-founders propose to buy rest of shares for $20/share - In a regulatory filing earlier, Centerbridge and related entities alongside the co-founders of GoHealth disclosed that on the evening of May 18, the reporting persons and the "founder stockholders" delivered a non-binding proposal to the Board of Directors of GoHealth, offering to acquire all of the outstanding shares of Class A Common Stock and LLC Interests that the reporting persons and the founder stockholders do not already own for a price per share or LLC Interest equal to $20.00. "The proposal is non-binding, and the reporting persons and the founder stockholders have not proposed any specific structure for the proposed transaction nor have they received any feedback from the ," the filing stated. In morning trading, GoHealth shares are up 60c, or 3.5% to $18.04. Reference Link

11:02 EDT Creative Realities rejects unsolicited proposal by Pegasus Capital - As previously reported, on May 1, Creative Realities received a revised proposal from Pegasus Capital Advisors, L.P., on behalf of itself and certain of its affiliates, to acquire all of the outstanding shares of common stock of the company that are not owned by Pegasus for a purchase price of $2.85 per share in cash. The Revised Proposal followed an earlier proposal from Pegasus to acquire all of the outstanding shares of common stock of the company that are not owned by Pegasus for a purchase price of $2.49 per share in cash effected March 27, 2023. The Original Proposal was rejected by a special committee of the Company's non-executive, independent directors. Creative Realities said: "The Special Committee, in consultation with its advisors, carefully reviewed and considered the Revised Proposal to determine what course of action it believed to be in the best interests of the Company's shareholders. The Special Committee has concluded that the Revised Proposal undervalues the Company based on the Company's existing business and current and future prospects, and is not in the best interests of the Company's existing shareholders. The Special Committee advised Pegasus that it has rejected the Revised Proposal. The Special Committee remains available to evaluate and respond to any revised proposal. There can be no assurance that any revised proposal or definitive offer will be made or accepted, that any agreement will be executed, or that any transaction will be consummated."

10:46 EDT FDIC completes New York Community Bancorp secondary offering - In a regulatory filing, New York Community Bancorp (NYCB) disclosed that on May 19, the Federal Deposit Insurance Corporation, as receiver of Signature Bridge Bank, National Association, completed the previously announced underwritten secondary offering of 39,032,006 shares of common stock of New York Community Bancorp. The offering was made through a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the company's shelf registration statement on Form S-3ASR. "The company did not sell any shares in, nor did it receive any proceeds from, the Offering. The FDIC Receiver received all of the net proceeds from the Offering. In connection with the Offering, the company entered into an Underwriting Agreement, dated May 16, by and among the company, the FDIC Receiver and Barclays Capital Inc.. The Underwriting Agreement contains representations and warranties and covenants that are customary for transactions of this type. In addition, the company has agreed to indemnify the Underwriter and the FDIC Receiver against certain liabilities on customary terms," the filing stated.

10:14 EDT Biocept trading halted, volatility trading pause

10:00 EDT Flowers Foods falls -8.6% - Flowers Foods is down -8.6%, or -$2.48 to $26.36.

10:00 EDT Foot Locker falls -25.6% - Foot Locker is down -25.6%, or -$10.62 to $30.91.

10:00 EDT CI&T rises 12.1% - CI&T is up 12.1%, or 42c to $3.92.

09:50 EDT Suntuity to become public through Beard Energy Transition Acquisition deal - Suntuity Renewables and Beard Energy Transition Acquisition have entered into a definitive agreement that would result in the combined company becoming publicly traded. Upon closing of the transaction, the combined company will be named "Suntuity Inc." and its Class A common stock and warrants are expected to be listed on the New York Stock Exchange under the new ticker symbol (STY). Pursuant to the business combination agreement, Beard will acquire Suntuity for a pre-money equity value of $190M. In connection with the transaction, the combined company, New Suntuity, will issue 19M new shares to current members of Suntuity. Existing Suntuity members will exchange 100% of their equity interests in Suntuity for equity in New Suntuity. Cash proceeds will consist of cash from Beard's trust account after redemptions by Beard's public stockholders. In connection with the transaction, Suntuity has also already raised $15M in funded debt financing. The business combination has been unanimously approved by the boards of directors of both Beard and Suntuity and is expected to close in the fourth quarter, subject to regulatory and stockholder approvals and other customary closing conditions. Upon closing of the transaction, Suntuity's senior management are expected to continue to serve in their existing roles. Current Suntuity members are expected to own approximately 40% of the combined company at close of the transaction, assuming no redemptions by Beard's public stockholders.

09:47 EDT Dick's Sporting falls -6.2% - Dick's Sporting is down -6.2%, or -$8.42 to $127.49.

09:47 EDT Ouster rises 8.1% - Ouster is up 8.1%, or 44c to $5.84.

09:47 EDT Farfetch rises 21.0% - Farfetch is up 21.0%, or 91c to $5.25.

09:38 EDT Pulse Biosciences trading resumes

09:31 EDT Chart Industries, KES agree to collaborate on CCUS projects - Koch Engineered Solutions has signed a Memorandum of Understanding with Chart Industries, positioning both companies to provide full carbon capture solutions to key customers and industries. The agreement will enable both companies to collaborate in the development and implementation of Chart's Cryogenic Carbon Capture technologies, identifying sites where Chart's Sustainable Energy Solutions CCC technology can be deployed and developed. KES' capabilities include those of Koch-Glitsch, Koch Specialty Plant Services and Optimized Process Designs.

09:17 EDT RocketFuel Blockchain, Zebra Digital partner for B2B crypto solutions - RocketFuel Blockchain announced its collaboration with Zebra Digital. Zebra Digital is a client of PaymentCloud, a Payment Solution Provider working with RocketFuel. The company is an infrastructure, technology, advisory, & consulting firm that through its wide network of financial clientele is offering their customers various cross-border business to business money movement solutions utilizing stablecoins and other forms of cryptocurrency. RocketFuel is acting a facilitating agent for these transactions, ensuring full compliance and security between buyers and sellers.

09:06 EDT Orchard Therapeutics announces updates on portfolio of HSC gene therapies - Orchard Therapeutics announced multiple clinical and preclinical updates from its portfolio of investigational hematopoietic stem cell gene therapies in neurometabolic and neurodegenerative disorders. The data are being featured in several oral presentations at the ongoing 26th Annual Meeting of the American Society of Gene and Cell Therapy in Los Angeles. OTL-203 Skeletal Data Summary Yesterday's oral presentation showcased new skeletal data for all eight proof-of-concept trial patients with a median follow-up of 3.78 years, ranging from 3.14 to 4.58 years, compared to a median of two years reported in the November 2021 New England Journal of Medicine publication. As previously reported, all eight participants achieved the primary endpoint of supraphysiologic blood alpha-L-iduronidase activity. Growth velocity, cognition and motor function post-treatment were collected as secondary and exploratory endpoints. At baseline, most patients presented with severe joint range of motion impairment, severe acetabular dysplasia and varying degrees of dorso-lumbar kyphosis. Treatment with OTL-203 was generally well tolerated and demonstrated extensive metabolic correction over four years after treatment. All patients showed sustained engraftment of gene-corrected cells with blood IDUA activity reaching supraphysiologic levels after treatment and normal or near-normal substrate levels maintained at last follow-up. Persistent IDUA activity and substrate reduction in the cerebrospinal fluid were also seen as of last follow-up, and all patients were able to remain off treatment with enzyme replacement therapy. In addition: All patients exhibited longitudinal growth within expected reference ranges of healthy children according to age and gender, with a median height gain greater than that observed in an external cohort of HSCT patients at three years of follow-up. A clinically measurable reduction in both sitting and standing kyphosis was observed in the majority of patients. MRI spine score showed a general stabilization in all patients with no relevant signs of progression in dorso-lumbar kyphosis, vertebrae deformity and dens alterations. All patients progressively acquired fine and gross motor skills. Improvements in joint range of motion were seen compared to pre-treatment in shoulder flexion, shoulder abduction and hip and knee extension angles as compared with an external cohort of HSCT patients. The current standard of care for MPS-IH is allogeneic hematopoietic stem cell transplant, which does not adequately address the growth and skeletal manifestations of the disease, among other clinical outcomes. Orchard plans to initiate a global 40 patient, registrational, randomized controlled trial compared to standard of care in the second half of 2023. OTL-201 Neurocognitive Data Summary: The oral presentation tomorrow will showcase updated neurocognitive data for all five patients from the ongoing proof-of-concept study, with the median follow-up now extended to 2.5 years from a previous median of 1.5 years with a range of 9 to 24 months. At the time of last follow up, the median age of treated patients was 41.6 months. Biochemical data continue to be consistent with previously reported results and demonstrated sustained engraftment, supraphysiological levels of N-sulphoglucosamine sulphohydrolase enzyme and significant reduction of abnormal heparan sulfate levels in all compartments including the central nervous system. Treatments with OTL-201 was generally well-tolerated in the study population. No serious adverse events have been reported as of the recent data cut-off and there has been no evidence of insertional oncogenesis or clonal dominance in samples analyzed to date. Updated neurocognitive results show: With extended follow-up, four out of five patients continued to gain cognitive skills in line with development in healthy children. Two patients were able to progress to a more advanced cognitive test, which has not been observed in natural history patients due to progression of disease and cognitive impairment. Evidence of developmental gains including acquisition of speech, continence and complex play requiring concentration which are not seen in untreated MPS-IIIA natural history patients was also observed in treated patients. MPS-IIIA represents a significant medical need given there are no approved therapies and treatment with allogeneic HSCT has not been shown to be effective for this patient population. Patients enrolled in the ongoing proof-of-concept trial will be followed for a minimum of three years during which time the study investigators will continue to report additional biochemical and clinical outcomes. OTL-204 Preclinical Data Summary: Today's oral session is the first presentation supporting preclinical efficacy of OTL-204 in the progranulin form of frontotemporal dementia. Orchard, in collaboration with Dr. Alessandra Biffi at the University of Padua, developed therapeutic lentiviral vectors expressing the human GRN gene that were tested and validated using in vitro studies. Data from in vivo studies indicate effective GRN protein delivery to the CNS of knockout mice transplanted with gene-modified HSCs. A therapeutic effect in transplanted knockout mice is evidenced by normalization of glucosylsphingosine, a specific lipid biomarker in the plasma, a strong reduction of lipofuscinosis and microgliosis, as well as markers of neuroinflammation in the thalamus, hippocampus and prefrontal cortex. Cohorts of knockout mice are being further evaluated both at behavioral and pathological level to accumulate additional evidence supporting the therapeutic approach.

09:02 EDT Candel Therapeutics announces new data from ongoing Phase 1 trial of CAN-3110 - Candel Therapeutics announced new data from an ongoing phase 1 investigator-sponsored clinical trial of its herpes simplex virus-1 replication-competent viral immunotherapy candidate, CAN-3110, in patients with high-grade glioma that has recurred after standard of care treatment. The data were presented today in an Oral Presentation Session at the 26th Annual Meeting of the American Society of Gene & Cell Therapy. "After one dose of CAN-3110, we observed encouraging responses in individual patients with recurrent high-grade glioma, including responses in both injected and uninjected lesions," said Francesca Barone, MD, PhD, Chief Scientific Officer of Candel. "We are encouraged by the increased survival of treated patients in two independent cohorts observed to date. We believe the responses are notable, given that recurrent high-grade gliomas are fast-growing, spread quickly and are treatment-resistant." New clinical data from arm B and updated data from arm A demonstrated the following results as of the data cutoff date: CAN-3110 was well tolerated without dose-limiting toxicities. mOS in arm B is ongoing at 12.0 months and supports the encouraging clinical activity of CAN-3110 observed in in arm A. Responses were observed in both injected and uninjected lesions in patients with multifocal disease. In addition to the two patient case studies disclosed from arm A, one patient from arm B exhibited continued reduction in tumor volume approximately one year after CAN-3110 treatment. Clinical response for this patient, currently in follow-up, continues without additional treatment. Analysis of post treatment samples demonstrated evidence of HSV antigen expression and replication in uninjected tumor tissue associated with CD8+ T cell infiltration, which may explain the clinical responses observed in uninjected tumors. Additional extensive biomarker studies including histology, transcriptomics, and single cell sequencing are ongoing.

09:02 EDT Verizon upgrades network at Indianapolis Motor Speedway - With more than 300,000 fans expected to attend the 107th Indianapolis 500 on Sunday, May 28, 2023, Verizon has upgraded the network at Indianapolis Motor Speedway so attendees can stream and share their experiences quickly and reliably. Verizon is also bringing fans closer to the action with 5G Multi-View, which allows fans at the event to customize their viewing experience in real-time. Fans can toggle between seven different camera angles of live action from the track on their phones, including the live TV broadcast.

09:01 EDT Cytek Biosciences announces $50M stock repurchase program - Cytek Biosciences announced that its Board of Directors has approved the repurchase of up to an aggregate of $50 million of its common stock, subject to compliance with applicable law. The Company's common stock is listed on The Nasdaq Global Select Market under the symbol "CTKB". The repurchase program will continue until the end of the fiscal year unless extended or shortened by the Board of Directors.

08:46 EDT Morgan Stanley's James Gorman sees CEO succession within 12 months - Morgan Stanley CEO James Gorman, at the company's annual meeting of shareholders, said he plans to step down as CEO within the next 12 months and will become the executive chairman when a new CEO is appointed. Gorman says the board has identified three potential candidates to succeed him.

08:40 EDT Stereotaxis, Abbott partner for EnSite X EP System integration - Stereotaxis (STXS) announced a global collaboration with Abbott (ABT) to integrate Abbott's EnSite X EP System with Stereotaxis' Robotic Magnetic Navigation systems. The companies said, "The combination of Abbott's leading cardiac mapping system with Stereotaxis' advanced robotic technology brings together highly detailed real-time diagnostic information with the unprecedented precision and stability of robotics during therapy delivery. Technology integration enhances the physician experience, streamlines procedural workflow, and supports the improved treatment of patients with abnormal heart rhythms. Stereotaxis and Abbott have successfully completed integration of their technologies and performed testing demonstrating joint compatibility." The integrated technologies are cleared for use in Europe with additional regulatory clearances expected in the coming months.

08:31 EDT SAB Biotherapeutics presents virtual R&D day portfolio update - SAB Biotherapeutics announced that it will be hosting its Virtual 2023 Annual R&D Day on Wednesday, June 14, 2023, at 1:30 P.M. CT. During the event, SAB will provide a company overview of our novel immunotherapy platform DiversitAb along with a portfolio progress update including recent Breakthrough Therapy and Fast Track designations for SAB-176 anti-Influenza therapeutic and prophylactic biologics candidate. In addition, SAB Executives and special guest KOL speaker, Dr. Michael Haller, will present important data validating SAB-142, a Type 1 diabetes therapeutic candidate. Persons attending will learn about these important advancements in a powerful new class of biologics developed by SAB's DiversitAb platform that produces targeted, high-potency, fully-human immunoglobulin antibodies without the need for human donors.

08:14 EDT Hologic receives FDA clearance for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay - Hologic announced that the FDA has granted 510(k) clearance for the company's Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2, influenza A, influenza B and respiratory syncytial virus, or RSV.

08:04 EDT Taysha Gene Therapies presents preclinical data on TSHA-102 - Taysha Gene Therapies presents preclinical data from neonatal mouse models on TSHA-102 for Rett syndrome, including new data in wild-type mice, at the American Society of Gene and Cell Therapy 26th Annual Meeting. TSHA-102 utilizes a miniMECP2 gene and a novel miRNA-Responsive Auto-Regulatory Element technology designed to regulate cellular MECP2 expression. In a Taysha-sponsored study, the safety and efficacy of TSHA-102 were explored in both neonatal wild-type and Mecp2-/Y knockout mice, respectively. Preclinical data in neonatal wild-type mice suggest miRARE suppressed toxic overexpression after early intervention with TSHA-102: In wild-type mice treated with TSHA-102, new data showed no deleterious impact on survival, neurobehavioral functions and overall health, suggesting miRARE regulated expression of MeCP2 with the below results from the study: No toxicity relative to vehicle treatment No reduction in survival over 36-weeks; No treatment effect on Bird Score (a measure of Rett syndrome-like behaviors and pathologies) analysis relative to vehicle treatment; No impact on overall growth over the course of the study. This builds on prior preclinical data in neonatal Mecp2-/Y knockout mice showing miRARE regulated MECP2 expression levels in deficient CNS cells with early intervention of TSHA-102: In Mecp2-/Y knockout mice treated with TSHA-102 with the below results from the study: 47% survived the 36-week study vs a median survival of 8.1 weeks with vehicle-treated knockout mice, representing a significant greater than4-fold extension of their lifespan; Restoration of normal and faster-than-normal growth; Aggregate Bird Score was significantly improved at several time points, with a significant delay in the onset of severe Rett syndrome-like phenotypes, including the delayed average age of onset for severe clasping from approximately 7 to 21 weeks and severely abnormal gait from approximately 8 to 20 weeks

08:03 EDT Innovid receives NYSE continued listing standards notice - Innovid announced that, on May 18, 2023, it received written notice from the New York Stock Exchange that it is not in compliance with Section 802.01C of the NYSE Listed Company Manual because the average closing price of the company's common stock was less than $1.00 per share over a consecutive 30 trading-day period. The NYSE notice does not result in the immediate delisting of the company's common stock from the NYSE.

08:02 EDT Strata Skin Sciences announces TheraClearX product demonstration - STRATA Skin Sciences announced Joel Cohen, MD, Director of AboutSkin Dermatology in Greenwood Village, Colorado will be demonstrating the TheraClearX device at the Music City Scale Symposium for Cosmetic Advances and Laser Education at the Grand Hyatt in Nashville, Tennessee from May 17-21, 2023. "Product demonstrations, such as this one, help physicians better understand TheraClearX and its capabilities to work synergistically with topical pharmaceutical treatments and help increase compliance in patients," stated Dr. Joel L. Cohen. "At my practice, AboutSkin Dermatology, we view TheraClearX as an important step in early efficacy for patients with newer onset acne as well as mild to moderate acne, delivering results quickly in the first few weeks of treatment. In our practice, TheraClearX helps patients see visible improvements, and can be used to manage acne flares or be used for maintenance sessions."

08:02 EDT Applied Digital announces $50M loan to accelerate growth - Applied Digital announced that the Company has reached an agreement for a loan with a maximum principal amount of $50M. The Company intends to use the loan, which has a 2-year term and 9.0% interest rate, to provide additional liquidity to fund the buildout of its AI Cloud platform and datacenters.

08:01 EDT Secoo Holding receives NASDAQ notice related to late filing of form 20-F - Secoo announced that it has received a letter from the NASDAQ Stock Market, dated May 18, 2023, notifying the Company that it is not in compliance with the requirements for continued listing set forth in NASDAQ Listing Rule 5250(c) because it did not timely file its annual report on Form 20-F for the year ended December 31, 2022. In accordance with NASDAQ Listing Rules, the Company has 60 calendar days from the date of the Delinquency Letter to submit a plan to regain compliance with NASDAQ Listing Rules. If NASDAQ accepts the Compliance Plan, NASDAQ may grant the Company an extension until November 13, 2023 to regain compliance. Secoo intends either to file its 2022 Annual Report or submit the Compliance Plan within the prescribed 60-day period. The Deficiency Letter has no immediate impact on the listing of the Company's ordinary shares represented by American depositary shares on the Nasdaq Capital Market.

07:33 EDT BioSig announces new data signals may be used for more precise approach - Researchers from Cleveland Clinic will be presenting data from three abstracts at Heart Rhythm 2023 that evaluated an optimized radiofrequency ablation technique for pulmonary vein isolation-a type of ablation procedure used to treat atrial fibrillation-compared to the existing standard, the Ablation Index. Researchers used BioSig Technologies proprietary PURE EP Platform for real-time tissue-specific feedback to achieve equal lesion quality and dimension in a third of the time as conventional methods that rely on surrogate metrics. Reducing procedure time: The first abstract, entitled "Unipolar Signal Modification-Guided Radiofrequency Ablation," conducted in swine and human models, found radiofrequency ablation guided by unipolar signal modification achieved identical transmural lesion dimensions for atrial tissue thickness less than three millimeters, with ablation time being significantly shorter than ablation index-guided procedures. Maintaining accuracy: The second abstract, entitled "Feasibility of Unipolar Signal Guided Ablation in Creating Contiguous Lines of Conduction Block: A Proof-of-Concept Study," demonstrated that unipolar electrograms accurately placed and spaced transmural lesions to prevent gaps, creating a successful bidirectional block in four of the five swine models. Enhancing precision: The third abstract, entitled "Comparison of Unipolar Electrogram Monitoring during Radiofrequency Ablation in Viable and Ablated Myocardium: Loss of the S-component" showed that unipolar electrogram monitoring can differentiate between healthy and scarred tissue in both singular isolated lesions and contiguous lesions that constitute an ablation line.

07:18 EDT CureVac granted motion to transfer U.S. litigation with Pfizer, BioNTech - CureVac (CVAC) announced that its motion to transfer the ongoing patent litigation filed by Pfizer (PFE)/BioNTech (BNTX) in the federal district court of Massachusetts has been granted, moving the case to the Eastern District of Virginia. The transfer is expected to significantly accelerate progress of the litigation, allowing for a likely 2024 trial date. The motion to transfer the case is now part of a broadened counterclaim CureVac is filing that alleges infringement of nine U.S. patents by the manufacture and sale of the SARS-CoV-2 vaccine Comirnaty. This significantly expands the scope of the case beyond the three patents originally named by Pfizer/BioNTech. These nine patents cover foundational and highly relevant separate innovations in mRNA vaccine design, formulation and manufacturing specific to SARS-CoV-2 vaccines. Corresponding patent litigation in Germany has been ongoing since June 2022. A preliminary opinion issued in April 2023 by the German Federal Patent Court supports the validity of one of the CureVac patents at issue, EP 1 857 122 B1, which was challenged by BioNTech in September 2022. The German litigation, which originated with a filing by CureVac regarding four of its intellectual property rights, now covers a fifth intellectual property right. CureVac filed a patent infringement lawsuit in Germany against BioNTech in early June 2022. A nullity action covering one of the patents at issue was filed by Pfizer/BioNTech in September 2022. In the U.S., Pfizer/BioNTech filed its case in the federal district court of Massachusetts in late July 2022, asking for confirmation that Comirnaty does not infringe three CureVac patents. These patents are included in the nine relevant U.S. patents of CureVac's counter claim: 11,135,312; 11,149,278; 11,286,492; 11,345,920; 10,760,070; 11,241,493; 11,471,525; 11,576,966; and 11,596,686.

07:16 EDT Foot Locker names Mike Baughn as new CFO - Foot Locker (FL) "announces the appointment of Mike Baughn as Executive Vice President and CFO, effective June 12, 2023. Mike joins us from Kohl's Corporation (KSS) where he most recently served asExecutive Vice President of Finance and Treasurer. He brings to Foot Locker more than 15years of experience in various financial leadership roles across Kohl's."

07:10 EDT Intercept announces Nasdaq halt of trading, FDA advisory committee meeting - Intercept Pharmaceuticals announced that NASDAQ has halted trading of the company's common stock. The U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee is meeting today to review obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis. As previously reported, the FDA has assigned a Prescription Drug User Fee Act target action date of June 22, 2023. The timeline for review of the NDA by the FDA remains subject to change. Trading of the company's common stock will resume at the discretion of NASDAQ.

07:06 EDT TELA Bio invests in surgeon training, education with upcoming cadaver lab - TELA Bio announced it will be hosting its next cadaver lab on May 19 in Tampa, Florida. The upcoming program, "Advanced Hernia Repair with OviTex Reinforced Tissue Matrix," will provide surgeons the opportunity to learn innovative open and robotic-assisted hernia repair techniques. TELA Bio has partnered with key opinion leaders in general and plastic and reconstructive surgery to develop a series of interactive medical education programs focused on the safe and effective use of OviTex in a variety of hernia repair techniques. Since the beginning of 2023, the company has conducted 98 medical education programs, including national and regional cadaveric labs, surgical observations, and various virtual education programs.

07:03 EDT ETFS Capital publishes presentation on changes wanted at WisdomTree - ETFS Capital, the largest combined owner of common stock of WisdomTree, published a presentation detailing the clear case for change at WisdomTree to help protect and enhance long-term stockholder value. The investor presentation highlights: "$1.4 billion of stockholder value which was destroyed under the oversight of WisdomTree's entrenched and unaccountable board of directors... The Board has offered no credible plan to create stockholder value and to date has been unable to translate record growth in AUM and net inflows into comparable gains in revenue growth and operating margin... In our view, the Company's corporate governance is abysmal and has led to the Company's substantial pay-for-performance disconnect... The Board consists of a majority of directors with no relevant industry experience, which explains the Company's repeated failure to launch new successful products. Against a backdrop of a history of poor capital allocation and failed investments, management's desire to transform the Company from an ETF issuer to a consumer-focused DeFi business - through WT Prime - seems a wildly ambitious and unrealistic quest," ETFS Capital said.

07:02 EDT Bluejay Diagnostics updates clinical, regulatory strategy for IL-6 - Bluejay Diagnostics announced an updated clinical and regulatory strategy for the Symphony IL-6 biomarker test to measure acuity in sepsis patients. The Company plans to modify the clinical trials design to evaluate Symphony IL-6 as a tool to risk stratify hospitalized sepsis patients. Bluejay is adapting its clinical trial design to obtain more patient data, which aligns the regulatory strategy with recent FDA feedback. The trial previously included only severe COVID-19 patients, which have substantively declined since the trial initiated. The Company plans to amend the study to include hospitalized sepsis patients, expanding the inclusion to facilitate a rate of enrollment necessary to maintain the previously disclosed Symphony IL-6 regulatory submission timeline of the first half of 2024. The trial modification may also support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients. Bluejay plans to submit a pre-submission application to the FDA presenting the new study design during the second quarter of 2023.

06:06 EDT Rocket Pharmaceuticals presents 'positive' data from PKD, LAD-I programs - Rocket Pharmaceuticals announced positive data from the Pyruvate Kinase Deficiency, Fanconi Anemia, Severe Leukocyte Adhesion Deficiency-I and Danon Disease clinical programs and PKP2-arrhythmogenic cardiomyopathy preclinical program presented at the 26th Annual Meeting of the American Society of Gene and Cell Therapy in Los Angeles, California. Robust and sustained efficacy in both adult PKD patients up to 30 months post-RP-L301; first pediatric patient results suggest efficacy similar to adult cohort with initial greater than five-point increase in hemoglobin. Sustained genetic correction observed in eight of 12 evaluable Fanconi Anemia patients, and phenotypic correction and concomitant hematologic stabilization observed in seven of 12 patients 12-42 months after RP-L102 in Phase 2 pivotal trial. 100% overall survival at 12 months post-RP-L201 and favorable safety profile for all LAD-I patients with 12-24 months of follow-up. Robust preclinical proof of concept studies showed RP-A601 for PKP2-ACM decreased arrhythmias and increased survival.

05:19 EDT Agilent intends to appeal PTAB decision regarding CRISPR guide RNA - Agilent announced the company intends to appeal the U.S. Patent and Trademarks Office, or USPTO, Patent Trial and Appeal Board's, or PTAB, Final Written Decision in connection with the Inter Partes review, or IPR, of U.S. Patent Nos. 10,337,001 & 10,900,034. The PTAB recently reversed the USPTO's original decision granting claims directed towards chemically modified synthetic CRISPR guide RNA. Agilent respectfully disagrees with the PTAB's opinion of unpatentability in view of prior art previously considered by the USPTO during its primary examination. The work presented in the two Agilent Patents is also discussed in a publication as part of a broader collaboration with Stanford University in the widely cited paper: Hendel, Ayal et al. "Chemically modified guide RNAs enhance CRISPR-Cas genome editing in human primary cells." Nature biotechnology vol. 33,9 (2015): 985-989. doi:10.1038/nbt.3290. The company said, "The Agilent Patents describe synthesis and testing of hundreds of chemically modified CRISPR guide RNA molecules that were shown to improve the efficiency of CRISPR-based gene editing. Prior to the work done by Agilent's inventors, it was not known whether the many chemical modifications Agilent made to the various and long guide RNAs would disrupt functionality of the gRNA:Cas enzyme complex. That answer was discovered and disclosed by the Agilent inventors as a multidisciplinary team and using Agilent's own patented chemical synthesis methods. Building upon its years of expertise in nucleic acid synthesis, Agilent offers the scientific community both research-grade and cGMP-grade guide RNA products incorporating chemical modifications. Agilent's SureGuide research-grade gRNA products are made and sold in Agilent's production facility in Santa Clara, California. Agilent's Nucleic Acid Solutions Division makes and sells its large-scale, cGMP-grade ClinGuide products in its state-of-the art production facilities headquartered in Boulder, Colorado. Agilent is confident in the innovative contributions made by its scientists and intends to appeal to the United States Court of Appeals for the Federal Circuit. This patent family also remains open with ongoing prosecution of new claims. Agilent's Patents will persist until all appeals have been exhausted, and the PTAB decision does not affect Agilent's continued leadership in CRISPR technologies as a provider of superior-quality guide RNAs. The PTAB's decision in no way affects Agilent's ability to make or sell chemically modified gRNA guides."

05:13 EDT Autoliv China, Nio sign cooperation framework agreement for safety technology - Autoliv China, a subsidiary of Autoliv (ALV), and Nio (NIO) have signed a strategic cooperation framework agreement. The collaboration includes several new safety technologies for electric vehicles with an overarching focus on sustainable solutions. The strategic cooperation between Nio and Autoliv marks a significant milestone in our shared objective to redefine the way people experience transportation. Under the agreement, Nio and Autoliv will develop safety products for electric vehicles and sustainable technologies. The new technologies will include a passenger airbag that deploys from the headliner using an environmentally friendly inflator. Furthermore, the companies are co-developing a new airbag concept that provides full protection for different seating positions. This allows for better protection, and more freedom to design the interior of the vehicle. It also includes biology-based materials for both airbag cushions and seatbelt webbing.