Stockwinners Market Radar for June 24, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:26 EDT Antelope Enterprise Holdings receives Nasdaq deficiency letter - Antelope Enterprise Holdings announced its receipt of a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market. The company received the deficiency letter on June 23, which notified the company that for the last 30 consecutive business days the bid price for the company's common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The deficiency letter does not result in the immediate delisting of the company's common stock from the Nasdaq Capital Market.

17:34 EDT Spirit Airlines board says JetBlue's revised offer 'not a Superior Proposal' - Spirit Airlines (SAVE) announced the signing of a second amendment to its previously announced merger agreement with Frontier Group Holdings (ULCC), parent company of Frontier Airlines, dated February 5. Based on the improved terms offered by Frontier, the Spirit Airlines Board of Directors reiterates its unanimous recommendation that Spirit stockholders vote FOR the merger agreement with Frontier. As part of its determination to recommend the Frontier merger agreement, Spirit's Board of Directors carefully reviewed the terms of JetBlue's (JBLU) revised proposal received on June 20 and instructed Spirit's management and advisers to engage in extensive discussions with JetBlue, including negotiating further the terms of JetBlue's draft merger agreement and providing extensive additional due diligence to JetBlue and its advisors. After considering this review and discussions, Spirit's Board of Directors determined JetBlue's revised offer is not a Superior Proposal. Under the terms of the Amended Agreement, which has been approved by the Boards of Directors of both companies: Frontier will increase the per-share cash consideration payable to Spirit stockholders to $4.13 in cash, in addition to the per-share stock consideration of 1.9126 shares of Frontier that Frontier previously agreed to pay Spirit stockholders. Frontier has also agreed that $2.22 per share will be prepaid to Spirit stockholders on a record date to be determined as a cash dividend following approval of the transaction by Spirit stockholders and consistent with all applicable laws, including restrictions under the CARES Act. The $2.22 per share dividend will be funded by Frontier. Frontier will increase its reverse termination fee to $350M to Spirit in the unlikely event the combination is not consummated for antitrust reasons. The number of directors of the combined company to be named by Frontier will increase by one and the number of directors of the combined company to be named by Spirit will decrease by one.

17:28 EDT Portland General Electric to replace Digital Turbine in S&P 400 at open on 6/29

17:17 EDT Molecular Data receives Nasdaq notification - Molecular Data announced that it had received a letter from The Nasdaq Stock Market LLC, notifying the company that to date, it has not regained compliance with the Rule 5250(c)(1). Since the company is already before a Hearings Panel for its failure to comply with the $1.00 minimum bid price requirement set forth in Listing Rule 5550(a)(2),pursuant to Listing Rule 5810(d)(2), rather than submit a compliance plan for Staff's review, the company is to address the matter before the Hearings Panel.

17:09 EDT BAE Systems awarded $12B government contract - BAE Systems Technology Solutions & Services, Rockville, Maryland, has been awarded a $12,000,000,000 cost-plus-award-fee contract for Integration Support Contract (ISC) 2.0. The main function of ISC 2.0 is to support the government as the lead systems integrator and augment government resources for Intercontinental Ballistic Missile weapon system systems engineering and integration and professional services. Work will be primarily performed at Hill Air Force Base, Utah, and is expected to be completed by Dec. 24, 2040. This award is the result of a competitive request for proposals through publication on the Federal Business Opportunities website and five offers were received. The Air Force Nuclear Weapon Center, Hill AFB, Utah is the contract activity.

16:31 EDT IT Tech Packaging receives deficiency notification from NYSE American - IT Tech Packaging announced that, it had received a deficiency letter from NYSE American LLC stating that the company is not in compliance with the continued listing standards as set forth in Section 1003(f)(v) of the NYSE American Company Guide. The Letter stated that because the company's common stock had been trading for a low price per share for a substantial period of time, the company was not in compliance with Section 1003(f)(v) of the Company Guide. The NYSE American staff determined that the company's continued listing is predicated on it effecting a reverse stock split of its common stock or otherwise demonstrating sustained price improvement within a reasonable period of time, which the staff determined to be until December 23, 2022. The Company intends to complete a reverse stock split in order to regain compliance with the listing standards set forth in the Company Guide.

16:22 EDT Blonder Tongue Laboratories to delist from NYSE American, will trade on OTCQB - Blonder Tongue Laboratories announced its delisting from the NYSE American and commencement of trading on the OTCQB. As previously disclosed, Blonder Tongue Laboratories, Inc. received written notification from NYSE American LLC stating that the staff of NYSE Regulation had determined to commence proceedings to delist the common stock of the company from the Exchange. NYSE Regulation staff has determined that the company is no longer suitable for listing pursuant to Section 1009(a) of the NYSE American Company Guide as the company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii) and (iii) of the Company Guide by the end of the maximum 18-month compliance plan period, which expired on December 10, 2021. The company appealed such determination, and a hearing was scheduled to take place on June 28, 2022. On June 24, 2022, after the company's Board of Directors determined the company will not be able to regain compliance with the above referenced listing standards in the short term, the company canceled the appeal hearing and requested its Common Stock be withdrawn from being listed on the Exchange. As a result, the company expects the trading of the Common Stock on the Exchange to be terminated on June 24, 2022. The company expects the Common Stock to commence trading under the symbol "BDRL" on the OTCQB marketplace operated by OTC Markets Group Inc. The company expects the Common Stock to commence trading on the OTCQB on June 27, 2022.

16:16 EDT Jupai Holdings trading halted, news pending

16:09 EDT Bird Global receives non-compliance notice from NYSE over trading share price - Bird Global announced that it received 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 Class A Common Stock was less than $1.00 over a consecutive 30 trading-day period. The notice does not result in the immediate delisting of Bird's Class A Common Stock from the NYSE. The company plans to notify the NYSE by July 5, 2022 that it intends to cure the stock price deficiency and to return to compliance with the NYSE continued listing standard. The company can regain compliance at any time within the six-month period following receipt of the NYSE notice if on the last trading day of any calendar month during the cure period the Company has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month. The company intends to consider available alternatives, including, but not limited to, a reverse stock split, subject to stockholder approval no later than at the company's next annual meeting of stockholders, if necessary to cure the stock price non-compliance. Under the NYSE's rules, if the company determines that it will cure the stock price deficiency by taking an action that will require stockholder approval at its next annual meeting of stockholders, the price condition will be deemed cured if the price promptly exceeds $1.00 per share, and the price remains above that level for at least the following 30 trading days.

16:07 EDT Cyxtera Technologies set to join Russell 2000 Index - Cyxtera is set to join the broad-market Russell 2000 Index at the conclusion of the 2022 Russell indexes annual reconstitution, effective after the US market opens on June 27, according to a preliminary list of additions posted June 3.

16:06 EDT Clover Health is set to join the Russell 3000 Index - Clover Health Investments is set to be added as a member of the broad-market Russell 3000 Index, effective after the US market opens on June 27, 2022 as part of the 2022 Russell indexes reconstitution, according to a preliminary list of additions posted on June 3, 2022. Annual reconstitution of the Russell indexes captures the 4,000 largest US stocks as of May 6, 2022, ranking them by total market capitalization. Membership in the Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.

16:01 EDT Intergroup trading resumes

15:52 EDT Entrada Therapeutics Inc trading halted, volatility trading pause

15:23 EDT Plains All American director McCarthy acquires 200,000 common units - In a regulatory filing, Plains All American director Kevin McCarthy disclosed the acquisition of 200,000 common units of the company on June 23 at a price of $9.8061 per share.

15:09 EDT Zhong Yang Financial Group Ltd trading resumes

15:04 EDT Zhong Yang Financial Group Ltd trading halted, volatility trading pause

13:37 EDT Toyota, Suzuki to start production of new SUV model in India - Toyota (TM) and Suzuki (SZKMY) signed a memorandum of understanding for a business alliance in 2017. Since then, the two companies have been bringing together Toyota's strength in electrification technologies and Suzuki's strength in technologies for compact vehicles for joint collaboration in production and in the widespread popularization of electrified vehicles. Toyota and Suzuki are promoting mutual supply of vehicles globally, which is one of the collaborations in the business partnership, and the two companies will now start production of a new SUV model developed by Suzuki at Toyota Kirloskar Motor Pvt. Ltd. from August. Maruti Suzuki India Limited and TKM will market the new model in India as Suzuki and Toyota models, respectively. Furthermore, the two companies are planning to export the new model to markets outside India including Africa.

13:32 EDT Bungie to reimburse workers traveling to seek an abortion - Video game maker Bungie, the company behind the "Destiny" series of games, released the following statement following the U.S. Supreme Court's decision to overturn Roe v. Wade: "Last month, we stated without reservation that all of us deserve to choose our own path and access the healthcare we need. The decision by the U.S. Supreme Court to overturn Roe v. Wade cuts off millions of Americans from that access and leaves open the possibility of even further restrictions on life-saving healthcare for all of us. Bungie is committed to ensuring that every one of our employees and their families have safe and affordable access to essential healthcare needs. As we continue to expand our digital-first workplace to more states, we will now be implementing a travel reimbursement program for any employee to use when they or a dependent cannot get access to the healthcare they need where they live. We remain undeterred in our commitment to stand up for reproductive choice and liberty." The Fly notes that Bungie earlier this year agreed to be acquired by Sony. Reference Link

13:02 EDT Baker Hughes reports U.S. rig count up 13 to 753 rigs - Baker Hughes reports that the U.S. rig count is up 13 from last week to 753 with oil rigs up 10 to 594, gas rigs up 3 to 157 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 283 rigs from last year's count of 470 with oil rigs up 222, gas rigs up 59 and miscellaneous rigs up 2. The U.S. Offshore Rig Count is flat at 16, up 2 year-over-year. The Canada Rig Count is down 2 from last week to 154, with oil rigs flat at 104, gas rigs down 2 to 50. The Canada Rig Count is up 28 rigs from last year's count of 126, with oil rigs up 22, gas rigs up 6.

12:59 EDT Teva says interim results from PEARL study of Ajovy 'promising' - Teva Pharmaceuticals Europe B.V. announces "promising" interim results from its Pan-European Real World study, or PEARL, presented for the first time at the European Academy of Neurology, or EAN, Congress in Vienna, Austria. The two-year Pan-European Real World (PEARL) prospective, observational study of AJOVY, looks at its effectiveness in patients with chronic migraine or episodic migraine, and is an ongoing study sponsored by Teva Pharmaceuticals Europe BV. These findings further offer insight into the treatment of migraine in real-world clinical practice. The interim findings were presented by Faisal Mohammad Amin, Associate Professor of Neurology at the University of Copenhagen, Denmark. Out of the total planned 1100 patients in PEARL, 389 patients are included in the interim analysis presented. These findings show that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more, over the six-month period from the start of treatment. Additionally improvements could be seen in migraine-related disability in the six-month period after the first dose. "The study is particularly relevant to clinicians due its patient cohort, who come from 11 countries and approximately 100 study centres. This patient group illustrates both diverse populations and also a range of reimbursement settings which are important for treatment access in Europe," the company said. The study will continue to capture data on effectiveness, and safety of fremanezumab, as well as the reason for and the outcomes of stopping and re-starting treatments. Dr. Danilo Lembo, Vice President and Head of EU Medical Affairs at Teva, said: "The PEARL study is encouraging as these findings confirm that preventive treatment of chronic and episodic migraine is appropriate with fremanezumab in a real world setting. Our commitment to real-world evidence studies helps clinicians to better understand the lived experience of people with migraine, support the evolution of best clinical practice and demonstrate the impact of migraine and what preventive treatments can achieve. The real life experience of European patients being able to access preventive treatment is bleak. Beyond our own data and research, a recent study from the European Migraine and Headache Alliance showed that 40% of patients needed more than five years to access migraine treatments. We need real structural change to come from healthcare systems if we are to ultimately reduce the burden of migraine."

12:56 EDT Bristol-Myers: Zeposia Phase 3 data shows improved cognitive function - Bristol Myers Squibb announced new post-hoc analyses from the Zeposia Phase 3 DAYBREAK open-label extension and Phase 3 SUNBEAM trials, showing early Zeposia use demonstrated cognitive benefits in people with relapsing multiple sclerosis, with the greatest effect seen in people with high thalamic volume, supporting an association between preserved brain volume and improved long-term cognitive outcomes. These data are being presented at the European Academy of Neurology Congress taking place in Vienna, Austria, from June 25-28. In these new exploratory analyses, Zeposia treatment showed improved or preserved cognitive function in a majority of patients, with the greatest improvement seen when used early in the disease when TV remains high, supporting a positive association between preserved BV and long-term cognitive performance. Zeposia was well tolerated with more than 80% of people who started the Phase 3 SUNBEAM trial remaining on continuous therapy through 48 months of the Phase 3 DAYBREAK OLE study. Findings from the new research showed that people with high versus low BV, particularly TV, had higher cognitive performance, as assessed by the symbol digit modalities test score, at baseline. This trend remained stable or improved over 4-5 years of Zeposia treatment, leading to improved or preserved cognitive function in almost 80% of people with high TV and approximately 66% of people with low BV at Month 48 of the Phase 3 DAYBREAK OLE study.

12:02 EDT Valneva receives marketing authorization in Europe for VLA2001 - Valneva announced that the European Commission has granted marketing authorization in Europe for Valneva's inactivated whole-virus COVID-19 vaccine, VLA2001, for use as primary vaccination in people from 18 to 50 years of age. The marketing authorization will cover all 28 European Union Member States as well as Iceland, Liechtenstein, and Norway. This new marketing authorization in Europe follows conditional marketing authorization in the United Kingdom, which was granted in April 20222, and emergency use authorization granted in the United Arab Emirates and Bahrain in May 2022 and March 2022, respectively.

12:00 EDT Terran Orbital falls -14.2% - Terran Orbital is down -14.2%, or -92c to $5.56.

12:00 EDT Zevia rises 14.7% - Zevia is up 14.7%, or 39c to $3.05.

12:00 EDT Zendesk rises 27.9% - Zendesk is up 27.9%, or $16.16 to $74.11.

10:51 EDT Northern Lights Acquisition Corporation (Class A Stock) trading resumes

10:45 EDT Carnival Cruise Line brand to reach nearly 110% occupancy in Q3, says CEO - Comments taken from Q2 earnings conference call.

10:32 EDT JE Cleantech Holdings Ltd trading halted, volatility trading pause

10:00 EDT Direxion Daily Semiconductor Bear 3X Shares falls -5.8% - Direxion Daily Semiconductor Bear 3X Shares is down -5.8%, or -$3.72 to $59.87.

10:00 EDT Kenon falls -19.5% - Kenon is down -19.5%, or -$10.46 to $43.10.

10:00 EDT Blue Apron rises 14.9% - Blue Apron is up 14.9%, or 43c to $3.35.

09:50 EDT USA Truck trading resumes

09:47 EDT Direxion Daily Semiconductor Bear 3X Shares falls -6.0% - Direxion Daily Semiconductor Bear 3X Shares is down -6.0%, or -$3.80 to $59.79.

09:47 EDT Kenon falls -18.8% - Kenon is down -18.8%, or -$10.06 to $43.50.

09:47 EDT Blue Apron rises 9.2% - Blue Apron is up 9.2%, or 27c to $3.19.

09:40 EDT Kyowa Kirin receives positive CHMP opinion for use of CRYSVITA - Kyowa Kirin announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended that CRYSVITA be approved for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults. CRYSVITA is also already licensed for use in the rare disease X-Linked Hypophosphataemia, for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults. The EC will review the CHMP recommendation and a final decision on the expansion of the recommended use for CRYSVITA for the treatment of FGF23-related hypophosphataemia in TIO associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults is expected in the coming months. This means that use of CRYSVITA in this TIO indication is not currently approved in the EU or GB.

09:36 EDT Freeline to present new clinical data for FLT180a at ISTH - Freeline Therapeutics announced the upcoming presentation of "new and important" clinical data for its AAVS3-based gene therapy candidate FLT180a at the International Society on Thrombosis and Haemostasis, or ISTH, Congress to be held in London, July 9-13. "The presentation will provide safety and initial efficacy data from the first cohort of the Phase 1/2 B-LIEVE trial, which aims to confirm the FLT180a dose and immune management regimen for the pivotal Phase 3 trial planned for 2023. The goal of treatment with FLT180a is to provide a functional cure for people with hemophilia B by delivering predictable and sustained normalization of coagulation Factor IX levels with a good safety profile. The poster, PB0213, will be presented between 6:30pm-7:30pm BST on Sunday, July 10, 2022. The abstract has been published on the ISTH website," the company stated. Reference Link

09:27 EDT Zendesk up 30% to $75.55 after agreeing to be acquired for $77.50 per share

09:25 EDT Leafly set to join Russell 3000, Russell 200 Indexes - Leafly Holdings is set to join the broad-market Russell 3000 Index at the conclusion of the 2022 Russell indexes annual reconstitution, effective after the US market opens on June 27, 2022, according to a preliminary list of additions posted earlier this month. "Inclusion in the Russell 3000 is a reflection of the progress we have made since becoming a public company earlier this year," said Yoko Miyashita, CEO of Leafly. "As the cannabis industry expands and Leafly continues to be a trusted resource and marketplace, I am pleased with the visibility this will create within the investment community and excited to build upon our success."

09:18 EDT Boxlight announces launch of new website - Boxlight Corporation announces the launch of their redesigned website to better serve partners, customers, and investors. "The redesigned website will offer visitors improved navigation and functionality, a user-friendly experience, and differentiate the Boxlight solutions, including those from Clevertouch Technologies, Mimio, and FrontRow," the company said.

09:17 EDT Carnival provides update on bookings - CEO Donald noted, "It is reinforcing to see continued strength in demand with our guests overcoming far more restrictive protocols than broader society and travel at large, leading to a near doubling of booking volumes since last quarter with near-term bookings even outpacing 2019. We were encouraged by close-in demand and remain focused on optimizing occupancy while preserving long term pricing." Donald added, "As friction from protocols is removed and society becomes increasingly more comfortable managing the virus, we expect to see demand continue to build, as we have already seen with the strength in Carnival Cruise Line's closer-to-home cruises." Booking volumes for all future sailings during the second quarter of 2022 were nearly double the booking volumes during the first quarter of 2022; the company notes these were its best quarterly booking volumes since the beginning of the pandemic, albeit still below 2019 levels. Booking volumes for the second half of 2022 sailings, since the beginning of April, have been higher than 2019 levels. The company believes this is a reflection of the previously expected extended wave season. (Due to the ongoing resumption of guest cruise operations, the company's current booking trends will be compared to booking trends for 2019 sailings.) While cumulative advance bookings for the second half of 2022 are below the historical range, the company's booked position is consistent with its expected improving occupancy levels for the second half of 2022. Cumulative advance bookings for the second half of 2022 are at lower prices, with or without future cruise credits, normalized for bundled packages, as compared to 2019 sailings. Cumulative advanced bookings for the full year 2023 continue to be both at the higher end of the historical range and at higher prices, with or without FCCs, normalized for bundled packages, as compared to 2019 sailings.

09:12 EDT Dr. Reddy's acquires injectable product portfolio from Eton Pharmaceuticals - Dr. Reddy's Laboratories (RDY) announced that it has acquired a portfolio of branded and generic injectable products from Eton Pharmaceuticals (ETON). The portfolio includes the Biorphen Injection and Rezipres Injection NDAs with nine separate combinations of strengths and presentations and one first-to-file approved ANDA for Cysteine Hydrochloride for the U.S. One strength each of Biorphen and Rezipres are currently commercially available in the U.S. The acquisition will complement Dr. Reddy's U.S. institutional business with limited competition injectable products. Under the terms of the agreement, Dr. Reddy's acquired the Eton portfolio for an upfront payment of approximately $5M in cash, plus contingent payments of up to $45M. "Long before the COVID-19 pandemic, there have been concerns about access to some critical care products for hospitals and health systems. This acquisition provides our North America organization with a foundational footprint to help address products that are not always readily available for patients," says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy's. "For these and many other reasons, I believe we are well-positioned to integrate the portfolio and grow the business."

09:08 EDT Polestar lists successfully on Nasdaq - Polestar, the Swedish electric performance car brand, begins trading on the Nasdaq in New York as of 24 June. Polestar will trade under the ticker PSNY. "This is a hugely proud moment for the entire team at Polestar," says Thomas Ingenlath, CEO of Polestar. "We will now open a new chapter in our story that can be summarised in one word - growth. By 2025 we aim to be selling 290,000 cars per year, 10 times as many as we sold in 2021. We already have a real and successful business; this listing gives us the funds and platform to help deliver our ambitious future plans and drive industry-leading sustainability goals forward."

09:06 EDT BriaCell announces publication on Bria-IMT data - BriaCell Therapeutics announced the publication of novel scientific data and clinical data on BriaCell's lead candidate, Bria-IMT. The abstract of the paper was published on-line in Recent Patents on Anti-Cancer Drug Discovery, a publication focused on research in leading therapeutic areas, targets, and agents related to anti-cancer drug discovery. The publication highlights BriaCell's approach to developing novel cellular immunotherapies for cancer and the safety and efficacy of Bria-IMT against advanced breast cancer in a prior clinical study through a potentially unique mechanism of action. As previously reported, clinical data in 4 advanced breast cancer patients who had failed multiple prior treatments showed that the Bria-IMT immunotherapy regimen was safe and well tolerated and produced immune responses in all 4 patients. Importantly, the overall survival was over 33 months for three of the four patients suggesting an overall survival benefit. Rapidly disappearing tumors in the lung, the breast and the soft tissues of one patient re-appeared after treatment was ceased; then the tumors rapidly shrunk again upon re-treatment with the Bria-IMT regimen. Complete regression of brain metastases was observed in the patient who matched Bria-IMT at two HLA types suggesting a unique mechanism of action for Bria-IMT.

09:02 EDT PowerSchool launches new products to aid students, educators - PowerSchool announced that it will provide schools and districts this coming school year with two new products: Unified Insights MTSS and Unified Classroom Curriculum and Instruction. Unified Insights MTSS helps educators support the needs of the whole child by providing a single solution to analyze, collaborate, and act on critical student data. Unified Classroom Curriculum and Instruction will better connect curriculum mapping and instructional delivery, which gives more time to focus on teaching and learning. "We've created these products to transform how educators can support their students," said Marcy Daniel, Chief Product Officer, PowerSchool. "Starting with Unified Insights MTSS, this comprehensive solution adapts to a district's existing tiered support framework, so educators can better meet the needs of the whole child with connected data, educator workflow support tools, and time-saving integration

09:02 EDT Ralph Lauren announces nomination of Cupp to board of directors - Ralph Lauren Corporation (RL) announced that Deb Cupp, President of Microsoft North America (MSFT), has been nominated as a director for election at the Company's 2022 Annual Meeting of Stockholders, to be held on August 4, 2022. The Company also announced that Judith McHale, who has served on the Ralph Lauren Board of Directors since 2001, will not stand for reelection after her term, which is set to expire in August.

08:58 EDT Rockwell Medical CEO Russell Ellison to step down, Mark Strobeck to succeed - Rockwell Medical announced that the Board of Directors has appointed Mark Strobeck, Ph.D., as President and CEO, effective July 1. Dr. Strobeck will also join the company's Board of Directors. Russell Ellison, M.D., M.Sc., will be stepping down as President and CEO and as a member of the company's Board of Directors effective June 30. Mark Strobeck, Ph.D. brings 20+ years of operating, business development, capital raising and investing experience in life sciences for both private and public biotechnology companies. Prior to joining Rockwell Medical, Mark was a Managing Partner at Aquilo Partners, a life science investment banking firm specializing in mergers and acquisitions and strategic partnering transactions.

08:55 EDT USA Truck trading halted, news pending

08:43 EDT Zendesk to be acquired by investor group for $10.2B - Zendesk announced it has entered into a definitive agreement to be acquired by an investor group led by leading global investment firms Permira and Hellman & Friedman in an all-cash transaction that values Zendesk at approximately $10.2B. Under the terms of this agreement, Zendesk shareholders will receive $77.50 per share. The offer represents a premium of approximately 34% over Zendesk's closing stock price on June 23, 2022, the last full trading day prior to this announcement. "This is the start of a new chapter for Zendesk with partners that are aligned with the strength of our agile products and talented team, and are committed to providing the resources and expertise to continue our growth trajectory," said Mikkel Svane, founder, chairman and CEO, Zendesk. "With Hellman & Friedman and Permira's support, we'll continue to execute on our long-term strategy with our customers as our top priority, taking full advantage of the opportunity we see to help businesses navigate the ever changing expectations and demands of their customers." The transaction, which has been unanimously approved by Zendesk's Board of Directors, is expected to close in the fourth quarter of this year and is subject to customary closing conditions, including Zendesk stockholder approval. Hellman & Friedman and Permira have arranged for debt and equity financing commitments for the purpose of financing the transaction. Upon closing of the transaction, Zendesk will operate as a privately-held company.

08:37 EDT Velan Capital, Repertoire Partners comments on proposed sale of Radius Health - Velan Capital Investment Management and Repertoire Partners, collectively one of the largest stockholders of Radius Health, with beneficial ownership of approximately 7.7% of the outstanding shares and economic exposure to approximately 10.1% of the outstanding shares, issued the following comment in response to the proposed acquisition of Radius by Gurnet Point Capital and Patient Square Capital in a transaction valued at up to approximately $890M: "While we are pleased that other parties also recognize there is untapped value in Radius and its assets, we are continuing to evaluate whether this deal represents a fair price for stockholders. We look forward to discussing the terms of this transaction with other stockholders and reviewing further disclosures about the rationale and process leading up to this decision. We also continue to believe that our director nominees - Eric Ende, Cynthia Flowers and Ann MacDougall - would be valuable additions to the Board, whether by providing objective perspectives on the fairness and advisability of this proposed transaction or if Radius ultimately remains a standalone entity. We plan on continuing to engage with our fellow investors regarding the proposed deal and our nomination of director candidates."

08:34 EDT Memorial Hermann, Contessa partner for new at-home care options - Memorial Hermann Health System announced a new partnership with Contessa to deliver home-based medical, rehabilitation and palliative care to its patients. Through the partnership, Memorial Hermann will be able to offer acute hospital care, post-hospitalization skilled nursing care, and palliative care to patients from the convenience of their own homes, rather than only the traditional brick-and-mortar inpatient or rehabilitation facilities. Contessa's hospital care at home model is proven to reduce readmission rates by 44 percent, decrease hospital length of stay by 35 percent, and achieve a patient satisfaction rate of more than 90 percent.

08:33 EDT Albireo Pharma present new Bylvay data at ESPGHAN conference - Albireo Pharma announced the presentation of new data at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition being held in Copenhagen, Denmark. The data provided new analyses of the Phase 3 PEDFIC 1 and PEDFIC 2 trials of Bylvay demonstrating that dose escalation can provide greater benefits in relieving patients' pruritus, with similar tolerability, as well as showing that reductions in pruritus are associated with important improvements in sleep and other quality of life measures in children with all types of progressive familial intrahepatic cholestasis. Bylvay PEDFIC 1 and PEDFIC 2 Data: Bylvay is a potent, non-systemic once daily ileal bile acid transport inhibitor that is the only treatment approved in Europe for the treatment of all types of PFIC in patients aged 6 months or older and the only treatment approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC. The PEDFIC 1 trial was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. Evidence of Improved Pruritus Response with Bylvay Dose Escalation: Oral Presentation: Efficacy and Safety Outcomes in Patients with Progressive Familial Intrahepatic Cholestasis Who Had an Odevixibat Dose Escalation: Pooled Results from the PEDFIC 1 and PEDFIC 2 Studies. In the pooled analysis population, 21 patients with PFIC treated with Bylvay who had a treatment response on 40 undefined/kg/day maintained their response and/or had further improvements with dose escalation to 120 undefined/kg/day. Among those with dose escalation, additional patients became pruritus responders at the higher dose and some non-responders became pruritus responders at the higher dose in the PEDFIC studies. Bylvay was generally well tolerated throughout dose escalation. In patients who received 40 undefined/kg/day of Bylvay during PEDFIC 1 and escalated to 120 undefined/kg/day in PEDFIC 2, the majority of TEAEs were mild or moderate in severity. Long-Term Data Demonstrate Efficacy of Bylvay Across PFIC Subtypes: Oral Presentation: Analysis of Quality of Life, Hepatic Biochemical Markers, and Sleep in Patients With Progressive Familial Intrahepatic Cholestasis Who Had a Pruritus Response With Odevixibat Treatment. Results of pooled analysis population of 82 patients treated with Bylvay including 44 pruritus responders of PEDFIC 1 and PEDFIC 2 show that patients across various types of PFIC who had a pruritus response with Bylvay experienced improvements in quality of life, sleep and hepatic biomarkers that were sustained for up to 72 weeks. From baseline to week 72, pruritus responders had significant quality of life improvements, as assessed by mean PedsQL total scores and PedsQL FI total scores. Data also indicated that pruritus responders had significant improvements in several caregiver-reported sleep parameters, including reductions in days with blood due to scratching, days needing help falling asleep, days needing soothing, and days sleeping with caregiver. Among all pruritus responders, 86% had any TEAE, none of which were drug related serious TEAEs.Two patients experienced TEAEs that led to study discontinuation, which included splenomegaly, diarrhoea, jaundice, decreased weight, and/or hypophagia. Oral Presentation: Changes in Hepatic Parameters, Growth, Sleep, and Biochemical Markers With Odevixibat Treatment Across Patients With Various Types of Progressive Familial Intrahepatic Cholestasis. Patients with all types of PFIC treated with Bylvay for up to 72 weeks, with some tracked up to 128 weeks, experienced reductions in autotaxin levels and increases in C4 levels, as well as variable changes in hepatic parameters, sleep characteristics and growth. 84 patients received Bylvay during the pooled analysis period. Patients of almost all PFIC types experienced mean improvements in caregiver-reported sleep parameters. Patients of most PFIC types generally had mean increases in height and/or weight Z scores with Bylvay treatment; patients with PFIC1 and PFIC3 experienced more variable changes in weight Z scores. Among all patients, 85% had any TEAE, which was similar across all PFIC types and mild or moderate in severity. All serious TEAEs were assessed as unrelated to study drug. Evidence of Bylvay Efficacy, With and Without Concomitant UDCA: e-Poster Abstract #363: Total, Primary, and Secondary Serum Bile Acid Concentrations in Patients With Progressive Familial Intrahepatic Cholestasis With Serum Bile Acid Response or Not With Odevixibat Treatment: Assessing the Contribution of Ursodeoxycholic Acid Concentration. A large proportion of patients in the PEDFIC 1 trial were on UDCA at baseline, but still had elevated sBAs and pruritus. This analysis assessed whether excluding UDCA concentrations from total sBA measurements altered the proportion of patients who had a sBA response to Bylvay and showed no appreciable changes. Moreover, patients who had a sBA response experienced large reductions in sBAs, whether or not they were on concomitant UDCA. Albireo will also be hosting a company-sponsored symposium that will feature case-based expert discussion on real-life experience of treating PFIC with an IBAT inhibitor.

08:31 EDT First High-School Education receives NYSE notice of non-compliance - First High-School Education Group announced that it has received a letter from the New York Stock Exchange dated June 21, notifying the company that it is below compliance standards due to the trading price of the company's American depositary shares and that the applicable cure period for the company to regain compliance expires on December 21.

08:17 EDT Mirum presents data from programs on maralixibat at ESPGHAN meeting - Mirum Pharmaceuticals presented data from clinical programs evaluating maralixibat in patients with Alagille syndrome at the 54th Annual ESPGHAN Meeting. These data further characterize LIVMARLI's clinical potential in pediatric patients including evaluation of its impact on long-term event-free survival. H-O-018: Maralixibat-treated patients with ALGS demonstrate improved event-free survival in a natural history comparison with patients from the GALA database: Application of real-world evidence analytics: The presentation reported on an analysis independently conducted and presented by Dr. Bettina Hansen and the Global Alagille Alliance Study Group. The analysis evaluated time to first clinical event using six years of follow-up data from pooled ALGS maralixibat studies and compared it against an external natural history control cohort from the GALA clinical database. The analysis demonstrated a highly significant improvement in six-year event-free survival translating to a 70% overall reduction for clinical outcomes with maralixibat. H-O-012: Predictors of 6-year event-free survival in patients with ALGS treated with maralixibat, an IBAT inhibitor: Data from the pooled maralixibat clinical studies with up to six years of follow up were analyzed to determine predictors of event-free and transplant-free survival in patients with ALGS. The laboratory markers that were predictive of event-free and transplant-free survival included specific thresholds of week 48 total bilirubin and week 48 serum bile acids. In addition, improvement in pruritus from baseline to week 48 was also predictive of event-free and transplant-free survival.

08:12 EDT Lifetime Brands announces results of annual general meeting - Lifetime Brands announced the results of the votes taken at the Company's 2022 Annual Meeting of Stockholders held Thursday, June 23, 2022. Stockholders elected the following directors to serve until the next Annual Meeting of Stockholders: Jeffrey Siegl, Executive Chairman, Lifetime Brands.; Robert Kay, CEO, Lifetime Brands; Rachael Jarosh, Former President and CEO, Enactus; John Koegel, Principal, Jo-Tan; Cherrie Nanninga, Partner, Real Estate Solutions Group; Craig Phillips, Retired Senior Vice President - Distribution, Lifetime Brands; Veronique Gabai-Pinsky, Former Global President, Vera Wang Group; Bruce Pollack, Managing Partner, Centre Partners Management, Michael Regan, Retired Certified Public Accountant; Michael Schnabel, Senior Partner, Centre Partners Management. In addition, stockholders ratified the appointment of Ernst & Young LLP as the Company's independent registered public accounting firm for the year ending December 31, 2022. On a non-binding advisory basis, stockholders approved the 2021 compensation of the Company's named executive officers. Stockholders approved the amendment and restatement of the Company's Amended and Restated 2000 Long-Term Incentive Plan.

08:09 EDT SiteOne Landscape completes acquisition of Yard Works - SiteOne Landscape Supply announced the company completed its acquisition of Yard Works, a wholesale distributor of bulk landscape supplies with 13 locations in Central Virginia. "For over 20 years, Yard Works has built a strong reputation in Central Virginia as an industry leader in bulk mulch and soil," said Doug Black, Chairman and CEO of SiteOne Landscape Supply. "We are excited to welcome this talented team to the SiteOne family and expand our product offering and capabilities in providing superior value to our combined customers in the Virginia market." This is the fifth acquisition in 2022 for SiteOne.

08:08 EDT Moving iMage board of directors authorizes $1M share repurchase program - Moving iMage Technologies announced that its Board of Directors authorized a share repurchase program permitting the Company to purchase up to an aggregate of $1M of common stock over the next 12 months. "Since coming public last July, our financial performance and fundamentals have steadily improved, while our stock price has not reflected this performance," said Phil Rafnson, chief executive officer. "With a strong, debt-free balance sheet that had nearly $1 per share in cash as of our most recent earnings report and revenue guidance of 155-169% growth for fiscal 2022, we believe the stock is significantly undervalued. Given this gap in perception, our board of directors has approved a $1 million buyback over the next 12 months."

08:07 EDT Harrow Health announces launch of IOPIDINE 1%, MAXITROL in US - Harrow Health announced the completion of the transfer to Harrow of the New Drug Applications, NDAs, of recently acquired, FDA-approved ophthalmic medicines, IOPIDINE 1%, MAXITROL 3.5mg/10,000 units/0.1%, and MOXEZA 0.5%. Harrow also announced that IOPIDINE 1% and MAXITROL are now commercially available; Harrow intends to commercialize MOXEZA 0.5% at a later date. Harrow purchased these medicines in December 2021 and has been receiving net profits from unit sales during the NDA transfer process. "We are pleased to have completed the transfer of the NDAs for these workhorse products, allowing us to market and sell these well-known products under the Harrow umbrella," said Mark L. Baum, CEO of Harrow Health. "We believe there is strong interest from physicians and their patients, hospitals, and ambulatory surgery centers (ASCs) in these products. The transfer of these NDAs gives Harrow a foundation to begin market access initiatives and lead conversations with commercial payer decision makers as we continue to execute our branded ophthalmic pharmaceuticals strategy."

08:06 EDT Virgin Orbit on target for next launch window to open June 29 - Virgin Orbit's launch system is in place at the Mojave Air and Space Port. The dress rehearsals are complete, and the company remains on track for its upcoming Straight Up launch, with a launch window opening on June 29 at 10 pm PDT. The launch will support the United States Space Force's STP-S28A mission and carry payloads for the Department of Defense, DOD, Space Test Program, STP. The target orbit for Straight Up is approximately 500 km above the Earth's surface at a 45-degree inclination.

08:05 EDT Gilead announces CHMP of the EMA adopted a positive opinion for lenacapavir - Gilead Sciences announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral, in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The CHMP positive opinion is a scientific recommendation to the European Commission, EC, to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The final European Commission decision is expected later this year. The positive opinion is supported by data from the Phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral, in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.

08:03 EDT Pliant Therapeutics to present data in support of INTEGRIS-PSC Phase 2a trial - Pliant Therapeutics announced the presentation of two scientific posters at the International Liver Congress 2022 of the European Association for the Study of the Liver, taking place June 22-26, 2022, in London, United Kingdom. The poster "Rationale for Evaluation of PLN-74809 Treatment in Participants with Primary Sclerosing Cholangitis in Phase a Study INTEGRIS-PSC" summarized preclinical data on the antifibrotic activity of PLN-74809 in two preclinical models of biliary fibrosis as well as in precision-cut liver slices from patients with primary sclerosing cholangitis or primary biliary cirrhosis. Results showed dose-dependent reductions of key drivers of fibrosis in a mouse model of biliary fibrosis including hepatic collagen, collagen proportionate area, TGF-beta signaling and cholestasis. In precision-cut liver slices, PLN-74809 reduced TGF-beta-driven COL1A1 and COL1A2 gene expression in a dose-dependent manner. In addition, PLN-74809 demonstrated a favorable tolerability profile based on available blinded safety data and pharmacokinetic findings from participants with PSC enrolled in Part 1 of the ongoing Phase 2a INTEGRIS-PSC study that evaluated a once-daily dose of 40 mg. The evaluation of PLN-74809 at doses of 80 mg and 160 mg is currently underway. The poster "Dual Inhibition of Integrins alphavss6 and alphavss1 Decreases Portal Pressure and Liver Fibrosis in Rats with Biliary Cirrhosis" reviewed preclinical data showing that PLN-75068, a dual alphavss6 / alphavss1 inhibitor tool compound, reduced TGF-beta signaling in the livers of rats with biliary cirrhosis as measured by the reduction of SMAD2 phosphorylation. In addition, a dose-dependent decrease in liver fibrosis, as assessed by collagen proportionate area, was observed along with dose-dependent inhibitory effects on the TGF-beta target genes Ctgf, Serpine1 and SMAD7. Lastly, PLN-75068 improved portal hypertension in this biliary cirrhosis model.

08:01 EDT Adverum Biotechnologies granted PRIME designation for ADVM-022 in Wet AMD - Adverum Biotechnologies announced that the European Medicines Agency has granted ADVM-022 Priority Medicines designation for the treatment of wet age-related macular degeneration. Adverum's lead gene therapy candidate, ADVM-022 is a one-time, intravitreal injection for the treatment of patients with wet AMD. A Phase 2 study in wet AMD is planned to investigate the 2x10^11 vg/eye dose and a new, lower 6x10^10 vg/eye dose of ADVM-022, as well as new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids. Adverum anticipates dosing the first patient in the third quarter of 2022.

07:41 EDT Huazhu Group announces voting results of 2022 Annual General Meeting - Huazhu Group announced that the 2022 annual general meeting of the Company was held on June 24, 2022. During the AGM, the following proposed resolutions were duly passed: the resolution as set out in the notice of the AGM dated May 10, 2022 regarding the ratification of appointment of Deloitte Touche Tohmatsu Certified Public Accountants LLP as auditor of the Company for 2022 and the authorization for the directors of the Company to determine the remuneration of the auditor; the resolution as set out in the Notice of AGM, subject to and conditional upon the approval of the Registrar of Companies in the Cayman Islands, regarding the change of the English name of the Company from "Huazhu Group Limited" to "H World Group Limited" with effect from the date of entry of the new English name in place of the existing English name and the dual foreign name in Chinese of the Company on the register of companies maintained by the Registrar of Companies in the Cayman Islands; the resolution as set out in the Notice of AGM regarding the amendment of the memorandum and articles of association of the Company to reflect the Change of Name, subject to the Change of Name taking effect; and the resolution as set out in the Notice of AGM regarding the authorization of each director or officer of the Company or Conyers Trust Company Limited to take any and every action that might be necessary, appropriate or desirable to effect the foregoing resolutions as such director, officer or Conyers Trust Company Limited, in his, her or its absolute discretion, thinks fit and to attend to any necessary registration and/or filing for and on behalf of the Company.

07:38 EDT Eton to focus commercial portfolio on products that treat rare diseases - Following the transaction, Eton's commercial activities will be solely focused on rare disease products with a portfolio of four product candidates, two of which are currently FDA-approved commercial products. ALKINDI SPRINKLE; Carglumic Acid tablets; Dehydrated alcohol injection: Product candidate for methanol poisoning that has been submitted to the FDA and has received orphan drug designation.; ZENEO hydrocortisone autoinjector: Product candidate under development for the potential treatment of adrenal crisis, which is expected to be submitted to the FDA in 2023.

07:34 EDT Regeneron, Intellia Therapeutics present data from Phase 1 study of NTLA-2001 - Intellia Therapeutics (NTLA) and Regeneron Pharmaceuticals (REGN) announced additional positive interim data from an ongoing Phase 1 study of their lead investigational in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin amyloidosis. The data were presented in an oral presentation at the European Association for the Study of the Liver International Liver Congress 2022, taking place June 22-26 in London. The presentation included extended follow-up data from 15 patients with hereditary ATTR amyloidosis with polyneuropathy treated across four single-ascending dose cohorts in Part 1 of the study. Results demonstrated sustained durability of serum transthyretin reduction through the last measured timepoint in the ongoing observation. These data support NTLA-2001's continued development as a potential one-time treatment to permanently inactivate the TTR gene and reduce the disease-causing protein. At the highest dose evaluated, treatment with NTLA-2001 at 1.0 mg/kg resulted in a 93% mean and 98% maximum serum TTR reduction by day 28 across the six patients treated. With longer-term follow-up data now available, these deep reductions continue to be sustained through six months, with an observed mean reduction of 93%. Additionally, three patients in the 1.0 mg/kg cohort have reached nine months in the follow-up period with no evidence of a loss in TTR reduction after a single dose. In the 0.7 mg/kg dose cohort, the 86% mean serum TTR reduction observed at day 28 also remained durable through six months. Further, in the 0.1 and 0.3 mg/kg cohorts, patients have now reached 12 months of follow-up, and a durable response to treatment continues to be observed. Notably, patients in the 0.3 mg/kg cohort sustained an 89% mean serum TTR reduction at 12 months. At all four dose levels, NTLA-2001 was generally well tolerated through the follow-up period. The majority of adverse events were mild in severity with 73% of patients reporting a maximal adverse event severity of Grade 1. There was a single possibly related serious adverse event of vomiting reported in a patient with concomitant medical history of gastroparesis in the 1.0 mg/kg dose group. The most frequent adverse events included headache, infusion-related reactions, back pain, rash and nausea. All infusion-related reactions were considered mild, resolving without clinical sequelae. The safety and activity profile of NTLA-2001 observed in Part 1 indicates that NTLA-2001 has a favorable therapeutic window. These data combined with pharmacokinetic modeling and simulation data support the utilization of a fixed dose of 80 mg in Part 2, which is anticipated to yield similar exposures to the 1.0 mg/kg dose. Dosing is ongoing in Part 2, the single-dose expansion cohort of the polyneuropathy arm.

07:32 EDT Eton Pharmaceuticals trading halted, news pending

07:31 EDT Cytokinetics announces FDA committee date to review omecamtiv mecarbil NDA - Cytokinetics announced that the U.S. Food and Drug Administration has informed the company that the previously announced meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for omecamtiv mecarbil is currently scheduled for December 13, 2022. The FDA has assigned the NDA a Prescription Drug User Fee Act target action date of February 28, 2023. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction.

07:23 EDT SolGold announces amendment to EGM resolutions - In a shareholder letter, the company said, "You will have recently received a Notice of Meeting for an Extraordinary General Meeting of SolGold to be held on 30 June 2022. This communication is to give you notice of a proposed amendment to be put to the EGM, to one of the definitions contained within the proposed Long Term Incentive Performance Plan Rules and Performance Bonus Plan Rules that the Company is seeking approval for under Resolutions 2 and 3 of the Notice of Meeting. Resolutions 1 and 4 and the accompanying documentation remain unchanged. The issued proxy form also remains unchanged. Amendment to Definition under Incentive Plans: The UK Companies Act 2006 requires the Board of Directors of SolGold to promote the success of the Company for the benefit of its members as a whole and, in doing so, has taken into account the interests of wider stakeholders. Some of our members have communicated reservations about one aspect of the defined term of "Change of Control" within the Long Term Incentive Performance Plan Rules and Performance Bonus Plan Rules . The concern relates to the 30% threshold applied on a disposal of assets. Having taken those members' concerns into consideration, a variation to the definition that lifts the threshold for measurement of a Change of Control on the disposal of assets to 50% will now be incorporated into the Incentive Plans. The other limbs of the Change of Control definition were already at the 50% threshold and remain unchanged. The Board acknowledges the concerns raised by members and accordingly the definition of 'Change of Control' within the Incentive Plans is varied as summarised below, Change of Control means the occurrence of any one or more of the following events: the sale, lease, exchange or other disposition, in a single transaction or a series of related transactions, of assets, rights or properties of the Company which have an aggregate book value greater than 50% of the book value of the assets, rights and properties of the Company on a consolidated basis to any other person or entity, other than a disposition to a wholly-owned Affiliate in the course of a re-organisation of the assets of the Company and its Affiliates;...The Board believes these amendments to be favourable to the interests of shareholders and thanks those members that took the time to engage with the Group on this matter."

07:20 EDT Alto Ingredients elects Maria Gray to board of directors - Alto Ingredients (ALTO) announced the shareholders approved all of the proposals in the proxy at the Annual General Meeting of Shareholders, including electing Maria Gray, as an independent director of the board, effectively immediately. The board membership remains at seven, and Gray replaces John Prince, who retired as part of a Board refreshment and focus on increasing board diversity. Gray has been an advisor to the Alto Ingredients board since June 2021. From 2012 to 2021, Ms. Gray served in several capacities, including as a Senior Health, Safety, and Environmental Professional and as a Project Process Engineering Lead, at Marathon Petroleum Company (MPC).

07:17 EDT BioMarin receives positive CHMP opinion in Europe for valoctocogene roxaparvovec - BioMarin announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. A final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in Q3. The one-time infusion is planned to be marketed under the brand name ROCTAVIAN for the treatment of severe hemophilia A in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5. Roctavian is the first gene therapy to be recommended for approval in Europe for hemophilia A.

07:14 EDT Amryt Pharma to pursue Formal Dispute Resolution for Oleogel-S10 NDA - Amryt announces that the company plans to submit a Formal Dispute Resolution Request for the company's New Drug Application for Oleogel-S10 for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa, a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US. Amryt recently had a Type A meeting with the US Food and Drug Administration to discuss the issues raised in the Complete Response Letter received in February 2022 relating to Amryt's NDA for Oleogel-S10. Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway in the FDA's Center for Drug Evaluation and Research by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. Joe Wiley, CEO of Amryt Pharma, commented: "The Formal Dispute Resolution process provides an opportunity to raise our scientific disagreement within CDER. We believe this represents the right approach toward approval in the US for Oleogel-S10, as we work toward bringing this therapy to EB sufferers in desperate need. Filsuvez was, this week, approved in Europe by the European Commission, and we continue to believe that the strong body of data from the EASE trial, which was the largest ever Phase 3 trial conducted in EB, supports FDA approval of this vital therapy for EB patients with a high unmet medical need."

07:06 EDT Quotient says financial statements prepared on basis assuming going concern - The accompanying consolidated financial statements have been prepared on a basis which assumes that Quotient will continue as a going concern. However, the Company has incurred net losses from operations in each year since it commenced operations in 2007 and had an accumulated deficit of $725.0 million as of March 31, 2022. The Company expects to include a disclosure within its Annual Report on Form 10-K in respect of certain conditions concerning the Company's overall liquidity position that raise substantial doubt about its ability to continue as a going concern.

07:05 EDT Can-Fite BioPharma announces study on CF602 - Can-Fite BioPharma announced its study titled "A3 adenosine receptor allosteric modulator CF602 reverses erectile dysfunction in a diabetic rat model" was published in the peer-reviewed journal Andrologia. A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite's CF602, an allosteric modulator of the A3 adenosine receptor, applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure, smooth muscle:collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase. "There is a clear and unmet need in the market today for an effective alternative to PDE5 inhibitors for non-responders to the leading sexual dysfunction drugs and diabetics, many of whom cannot safely be prescribed PDE5 inhibitors. With a growing body of data and IP estate around CF602, we are evaluating potential strategic partnerships to advance CF602 toward market," stated Can-Fite CEO Dr. Pnina Fishman.

07:03 EDT Pebblebrook Hotel acquires Gurney's Newport Resort & Marina for $174M - Pebblebrook Hotel Trust announced that on June 23, 2022, it acquired the AAA Four Diamond 257-room Gurney's Newport Resort & Marina in Newport, Rhode Island for $174M. Gurney's Newport is a ten-acre waterside resort located on Goat Island in Newport, Rhode Island. Gurney's Newport features 257 guestrooms, including 18 suites, and 80,000 square feet of indoor and outdoor event space. "We are very excited to acquire this extremely unique premier resort within the vibrant, high barrier to entry Newport market," said Jon Bortz, Chairman, President, and Chief Executive Officer of Pebblebrook Hotel Trust. "Gurney's Newport is the only resort-style property in Newport, and it is one of the very few true waterside resorts on the Northeastern Seaboard, drawing strong demand from New York, Boston and Providence... With group and individual travelers increasingly seeking a unique resort experience with open-air amenities, Gurney's Newport is well-positioned to continue to grow in the highly attractive Newport market." The acquisition of Gurney's Newport brings the total number of properties in the Company's portfolio to 55.

06:54 EDT CarMax plans to open ten new locations in FY23 - The company said, "During the first quarter of fiscal 2023, we opened one new retail location in Edison, New Jersey, our first retail store in the New York metro market. In fiscal 2023, we plan to open a total of ten new locations."

06:50 EDT European Commission approves KEYTRUDA as adjuvant treatment for melanoma - Merck announced that the European Commission has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. Additionally, the EC approved expanding the indications for KEYTRUDA in advanced melanoma and stage III melanoma to include adolescent patients aged 12 years and older. The approval of KEYTRUDA for the adjuvant treatment of patients with resected stage IIB or IIC melanoma was based on results from the Phase 3 KEYNOTE-716 trial, in which KEYTRUDA significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 39% compared to placebo in this patient population at a median follow-up of 20.5 months. KEYTRUDA in this adjuvant setting also significantly prolonged distant metastasis-free survival, reducing the risk of distant metastasis by 36% compared to placebo in this patient population at a median follow-up of 26.9 months. The safety of KEYTRUDA monotherapy has been evaluated in 7,631 patients across tumor types. The incidences of immune-related adverse reactions were 36.1% for all Grades and 8.9% for Grades 3-5 for KEYTRUDA monotherapy in the adjuvant setting. No new immune-related adverse reactions were identified for KEYTRUDA monotherapy in the adjuvant setting. This approval allows marketing of KEYTRUDA for this indication in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland. In the EU, KEYTRUDA was previously approved for the treatment of adult patients with advanced melanoma and for the adjuvant treatment of adult patients with stage III melanoma and lymph node involvement who have undergone complete resection.

06:46 EDT Yelp CEO discusses the company's remote workforce - "Over time we came to realize that the future of work at Yelp is remote. It's best for our employees, and for our business. Today, I shared with our team why Yelp is leading the way in creating the workplace of the future," the company's co-founder and CEO Jeremy Stoppelman said in a blog post. "Employees are more satisfied working remotely as they can spend precious time they would have otherwise spent commuting doing the things they love with the people who mean the most to them. In surveying our own employees, 86% of respondents said they'd prefer to work remotely most or all of the time, 87% report that working remotely has made them more effective at work, and 93% of employees and their managers report they can meet their goals remotely.... The most telling signal for us that people strongly prefer remote work has been the under-utilization of our offices... Globally, about 1% of our workforce is choosing to come into the office every day. After observing how employees have been using our offices, we've decided to close our most consistently underutilized offices on July 29, in New York, Chicago and Washington D.C., as well as reduce our footprint in Phoenix...I've shared my thoughts on why forcing people back to the office, even in a hybrid model, is the wrong approach. It requires employees to live near an office, potentially driving up their housing costs, and to endure unpaid time spent commuting. It also means hiring is artificially constrained by geography... Yelp continues to experience the benefits of a remote workplace and it's the clear path forward for us. We're excited to continue to design the future of remote work at Yelp together with our employees."

06:38 EDT Giga-tronics awarded $660K order from Aerospace customer - The company states: "Giga-tronics Incorporated announced that its high-performance RADAR filter division Microsource has received an initial $660,000 production order from a Fortune 500 Aerospace customer. Microsource produces custom Yttrium-Iron-Garnet based microwave components designed specifically for the intended operational application of each customer. Additionally, Microsource produces a line of tunable, synthesized Band Reject Filters that solve interference problems in RADAR/Electronic Warfare applications, as well as low noise oscillators used on shipboard and land-based self-protection systems. Giga-tronics will provide the customer with RADAR filters for fighter jets. This initial order for 12 jets is the first installment of an expected follow-on order during the next 90 days. The Company expects to recognize some of the revenue from the initial contract within the current quarter."

06:33 EDT K92 Mining: ISS, Glass Lewis recommend shareholders vote for all items at AGM - K92 Mining announced that independent proxy advisory firms, Institutional Shareholder Services and Glass Lewis & Co. have each recommended K92 shareholders vote "FOR" all the proposed resolutions at the upcoming Annual General Meeting of Shareholders.

06:31 EDT Emergent BioSolutions: FDA approves BLA for AV7909 - Emergent BioSolutions announced that the U.S. FDA accepted for review the Biologics License Application for AV7909. AV7909 is the company's new anthrax vaccine candidate evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.

06:03 EDT IGEN Networks to provide Medallion GPS to New York State counties - IGEN Networks Corporation announced its successful bid to provide IGEN's commercial fleet solution Medallion GPS to New York State Counties. All political subdivisions and districts located in the State of New York will be entitled to make purchases of fleet services from the awarded contract. IGEN's Medallion GPS fleet services will include its patented "Digital Telematics Signature", which offers accuracy in measuring and scoring driver behavior across all Light-Commercial Fleet vehicles and their drivers.

06:01 EDT Arthur J. Gallagher acquires INNOVU Group Holding Company, no terms disclosed - Arthur J. Gallagher & Co. announced the acquisition of Wexford, Ireland-based INNOVU Group Holding Company. Terms of the transaction were not disclosed. Founded by Ronan Foley in 2018, INNOVU Insurance is a retail insurance broker offering a broad variety of commercial and personal insurance products and services, as well as financial services, to clients across a diverse range of industry sectors from seven offices throughout Ireland.

05:55 EDT Stellantis expands relationship with Vulcan Energy - Stellantis N.V. and Vulcan Energy Resources announced Stellantis' EUR50M equity investment in Vulcan and an extension of the original binding offtake agreement to 10 years. The equity investment will go towards Vulcan's planned production expansion drilling in its producing Upper Rhine Valley Brine Field. Vulcan is already producing geothermal energy from its URVBF and plans to produce lithium hydroxide with zero fossil fuels and net zero carbon footprint as part of the Zero Carbon Lithium Project. As part of the Dare Forward 2030 strategic plan, Stellantis announced plans of reaching 100% of passenger car battery electric vehicle sales mix in Europe and 50% passenger car and light-duty truck BEV sales mix in the United States by 2030. Stellantis will be the industry champion in climate change mitigation, becoming carbon net zero by 2038, with a 50% reduction by 2030.

05:43 EDT Sanofi, GSK: Covid-19 vaccine 'successful' against omicron - Sanofi (SNY) and GSK (GSK) announced data from their vaccine trial which evaluated an adjuvanted bivalent D614 and Beta vaccine candidate. Sanofi-GSK's vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high omicron variant circulation, the companies said in a statement. The vaccine candidate showed a favorable safety and tolerability profile. Earlier this month Sanofi reported data from two trials conducted with its new next-generation COVID-19 booster vaccine candidate modeled on the Beta variant antigen and including GSK's pandemic adjuvant. The data supporting this next-generation booster vaccine will be submitted to regulatory authorities and indicate the potential of Sanofi-GSK's next-generation Beta-based booster to be a relevant response to public health needs, the companies said. In Stage 2 of the Phase 3 COVID-19 vaccine trial VAT08 of more than 13,000 participants 18 and above years of age, the Sanofi-GSK Beta-containing vaccine candidate demonstrated an efficacy of 64.7% against symptomatic COVID-19 and 72% efficacy in omicron-confirmed symptomatic cases. In previously seropositive populations, the Sanofi-GSK vaccine candidate demonstrates an overall efficacy of 75.1% against symptomatic infection, and 93.2% in omicron-confirmed symptomatic cases, according to the sequencing analysis performed to date. Throughout Stage 1 and Stage 2 of the VAT08 trial, the Sanofi-GSK vaccine demonstrated a favorable safety and tolerability profile.