Stockwinners Market Radar for November 10, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

MRNA

Hot Stocks

20:05 EST Harbour BioMed, Moderna enter into collaboration agreement - Harbour BioMed "announced that Nona Biosciences, a subsidiary wholly owned by the Company, had entered into a license and collaboration agreement with ModernaTX a global biotechnology company pioneering messenger RNA therapeutics and vaccines. The strategic collaboration will focus on discovering and developing nucleic acid-based immunotherapies for select oncology targets using the Company's proprietary heavy chain only antibody discovery platform. Upon the execution of the agreement and subject to terms and conditions thereof, Moderna will be granted an exclusive sub-licensable license to exploit a panel of sequences against multiple targets, derived from the Company's HCAb platform, to develop products using nucleic acids. Moderna will assume full responsibility for all upcoming development, manufacturing, regulatory, and commercialization activities. Moderna would also be granted an option to obtain an exclusive sub-licensable license to exploit sequences against additional targets. Pursuant to the agreement, Nona Biosciences shall receive an upfront payment, and potential milestone payments based on pending achievement of certain regulatory, development, and sales milestones, and tiered royalties."
BLK

Hot Stocks

19:09 EST BlackRock CEO sells $10M in common stock - In a regulatory filing, BlackRock disclosed that its CEO Laurence Fink sold 14.6K shares of common stock on November 8th in a total transaction size of $10M.
MRO

Hot Stocks

18:58 EST Marathon Oil exec Henderson sells 80,000 common shares - In a regulatory filing, Marathon Oil executive VP of operations Michael Henderson disclosed the sale of 80,000 common shares of the company on November 8 at a price of $32.5556 per share.
BA

Hot Stocks

18:44 EST U.S. watchdog initiates audit into FAA's oversight of Boeing MAX features - The U.S. Department of Transportation's Office of the Inspector General said an audit has been initiated into the Federal Aviation Administration's oversight of the maneuvering characteristics augmentation system and the angle-of-attack disagree indicator on Boeing MAX aircraft. "The Federal Aviation Administration (FAA) is responsible for overseeing the safety and certification of all civilian aircraft manufactured and operated in the United States," the office said in a statement. "During the original certification process for the Boeing 737 MAX aircraft, Boeing included limited information on the Maneuvering Characteristics Augmentation System (MCAS) in its initial briefings to FAA; MCAS was later cited as a contributing factor to two fatal Boeing 737 MAX crashes in 2018 and 2019. In addition, in August 2017, Boeing engineers identified that not all 737 MAX 8 aircraft were equipped with an Angle-of-Attack (AOA) disagree alert despite intending for it to be standard for the fleet. The Chairmen of the House Committee on Transportation and Infrastructure and its Aviation Subcommittee requested this audit. This will be our fourth review related to FAA's certification of the 737 MAX. Our objectives will be to evaluate FAA's compliance with applicable statutes, regulations, and policies in overseeing Boeing actions for (1) the inoperability of the AOA disagree alert on the majority of the MAX fleet in 2019 and (2) the inclusion of MCAS as part of the speed trim in the 737 MAX design." Reference Link
META...

Hot Stocks

17:44 EST FTC restores rigorous enforcement of law banning unfair methods of competition - The Federal Trade Commission issued a statement that restores the agency's policy of rigorously enforcing the federal ban on unfair methods of competition. Congress gave the FTC the unique authority to identify and police against these practices, beyond what the other antitrust statutes cover. But in recent years the agency has not always carried out that responsibility consistently. The FTC's previous policy restricted its oversight to a narrower set of circumstances, making it harder for the agency to challenge the full array of anticompetitive behavior in the market. Today's statement removes this restriction and declares the agency's intent to exercise its full statutory authority against companies that use unfair tactics to gain an advantage instead of competing on the merits. "When Congress created the FTC, it clearly commanded us to crack down on unfair methods of competition," said FTC Chair Lina M. Khan. "Enforcers have to use discretion, but that doesn't give us the right to ignore a central part of our mandate. Today's policy statement reactivates Section 5 and puts us on track to faithfully enforce the law as Congress designed." Companies that may be impacted include Meta Platforms (META), Alphabet (GOOG) and Apple (AAPL). Reference Link
PEGA APPN

Hot Stocks

17:42 EST Pegasystems enters into settlement agreement with Appian - According to a regulatory filing, on November 9, 2022, Pegasystems (PEGA) entered into a confidential settlement agreement with Appian Corporation (APPN) and Business Process Management, resolving the litigation previously pending in the United States District Court for the District of Massachusetts and styled Pegasystems Inc. v. Appian Corporation and Business Process Management, Inc., Case No. 19-cv-11461-PBS-MPK. The parties have also filed a Stipulation of Dismissal with Prejudice dismissing all claims and counterclaims in the Massachusetts Litigation. The litigation between the Company and Appian in Fairfax County, Virginia, which is pending appeal, is not impacted by resolution of the Massachusetts Litigation.
AIG

Hot Stocks

17:37 EST AIG announces five-year employment agreement with CEO Peter Zaffino - American International Group announced that AIG and Peter Zaffino, President & CEO and Chairman of the Board, have entered into an agreement securing Zaffino's employment through November 10, 2027.
VMI

Hot Stocks

17:37 EST Valmont gains nationwide drone waiver from FAA - Valmont "announces that the Federal Aviation Administration granted the company a nationwide Beyond Visual Line of Sight waiver. The BVLOS waiver gives Valmont the ability to fly their multi-hour capable unmanned drones for commercial inspections of utility lines across the nation at a moment's notice, eliminating the need to wait for geographic approval from the FAA. In addition to the removal of the geographic restriction, the entire diverse fleet of Valmont's unmanned aerial systems were included. Using drone technology allows Valmont to collect high-resolution images and infrastructure performance data safely and quickly. It also opens the door to future waivers as the company moves toward a completely autonomous solution."
CVV

Hot Stocks

17:31 EST CVD Equipment gets $3.7M aerospace order for coating system - The company states: "CVD Equipment announced that it has received an order for a Production Chemical Vapor Infiltration (CVI) System valued at approximately $3.7M. The system will be used to manufacture Ceramic Composite Materials (CMCs) for Aerospace Gas Turbine Engines. CVD is a leading manufacturer of Chemical Vapor Infiltration and Tow-Coating Systems for use in the aerospace industry. Although gas turbine engine production was greatly impacted due to the COVID-19 pandemic and the resulting decline in long haul travel, the aerospace industry is showing signs of recovery, although we do not expect a recovery to pre-pandemic levels until later in 2023. The increased demand for fuel-efficient/fuel-economy aircraft is driving development of next generation engine platforms that are energy efficient with reduced weight and reduced operating emissions. Advanced materials such as CMCs, enable increased fuel efficiency, along with higher strength and 1/3rd the weight compared to conventional nickel-based superalloys."
FNF

Hot Stocks

17:30 EST Fidelity National acquires St. Louis Title, Security Title and Benchmark Title - Fidelity National Financial announced the acquisition of St. Louis Title, Security Title Insurance Agency and Accurate Disbursing of St. Louis, Missouri, and Benchmark Title of Southern Illinois. St. Louis Title, Security Title, Accurate Disbursing and Benchmark Title were founded in 2005 and have grown to become one of the market leaders in the St. Louis metropolitan area. John Schaefer, the current manager, will continue to lead all operations.
GOOG...

Hot Stocks

17:28 EST Google expands its user choice billing pilot - Paul Feng, VP, Product Management said in part on Google's Android Developers Blog: "Building on Android's long history of continuously evolving to provide users and developers more flexibility and choice, we announced earlier this year that we would begin exploring expanded billing options on Google Play (GOOG, GOOGL)) through our user choice billing pilot..Pilot participants can offer an additional billing system alongside Google Play's billing system for their users in select countries...When we announced the pilot, we noted that we were starting with Spotify (SPOT) as our very first partner. We've been working closely with the Spotify team and are excited to announce that this week they begin rolling out an initial test implementation of user choice billing to their users in select countries. We expect the experience will likely evolve over time as they continue to iterate and learn. Spotify has announced more detail on this rollout here. We're also excited that Bumble (BMBL) has joined to partner with us in our user choice billing pilot. We're working with their teams and we anticipate their users will begin seeing this choice in-app in select countries in the coming months. Additionally, with strong interest from developers around the world, in September we opened participation in the pilot to to all developers of non-gaming apps... we are excited to announce that based on the positive response and initial feedback from developers and users, we are expanding the pilot to users in the United States, Brazil, and South Africa." Reference Link
TNDM

Hot Stocks

17:23 EST Tandem Diabetes t:slim X2 care study demonstrates improvement in all endpoints - The company states: "Tandem Diabetes announced results from a prospective, multicenter, single-arm study of adults living with type 2 diabetes who achieved improvement in all clinical endpoints with the use of the t:slim X2 insulin pump with Control-IQ technology. Presented today at the 22nd Annual Diabetes Technology Meeting, the data demonstrated the system to be safe during 6 weeks of use, with a substantial improvement in time in range and mean glucose related to a reduction in hyperglycemia and no increase in continuous glucose monitor CGM-measured hypoglycemia. Both prior multiple daily injection users and prior basal insulin only users showed similar levels of improvement. Study participants indicated a high level of satisfaction with the system."
SP

Hot Stocks

17:14 EST SP Plus acquires assets of India-based DIVRT - SP Plus has acquired certain assets of DIVRT, a developer of software and technology solutions that enable frictionless parking capabilities. SP+ has acquired all the intellectual property of DIVRT and a team of over 20 technology engineers based in India.
IGMS

Hot Stocks

17:12 EST IGM Biosciences director Behrens acquires 60,000 common shares - In a regulatory filing, IGM Biosciences director M. Kathleen Behrens disclosed the purchase of 60,000 common shares of the company on November 8 at a price of $17.1425 per share.
MIDD

Hot Stocks

17:05 EST Middleby acquires Escher Mixers, terms not disclosed - Middleby announced the acquisition of Escher Mixers, a designer and manufacturer of highly-engineered spiral and planetary mixers for the industrial baking industry. Escher customers include large grocery and retail chains, and they provide established solutions for the artisanal bread and pastry industries. Located in Vicenza, Italy, the company has annual revenues of $15M.
TCS

Hot Stocks

17:02 EST Container Store appoints new Chief Merchandising Officer and new COO - Container Store appointed Stacey Shively as new Chief Merchandising Officer and promoted Chief Information Officer Dhriti Saha to COO effective Monday, November 14. Shively most recently served as a Senior VP at Bed Bath and Beyond. Shively joined Bed Bath & Beyond in 2021 as the senior vice president and head of merchandising and product development. Prior to Bed Bath & Beyond, she served as the senior vice president, general merchandise manager for JCPenney's home division where she was responsible for overseeing their merchandising strategies for home product categories. As the new COO, Dhriti Saha will maintain his oversight of technology, information security, product management, retail operations and will add logistics to his purview.
MAR

Hot Stocks

17:01 EST Marriott raises quarterly dividend 33% to 40c per share - Marriott International announced that its board of directors declared a quarterly cash dividend of 40c per share of common stock, which represents a 33% increase over the previous quarterly dividend amount of 30c per share and reflects the company's earnings growth and strong cash generation. The dividend is payable on December 30, 2022, to shareholders of record as of the close of business on November 23, 2022. The company also announced that its board has increased the authorization to repurchase the company's Class A common stock by an additional 25M shares, for a total of approximately 30.8M shares currently authorized for repurchase. Year-to-date through November 9, 2022, the company has repurchased 11.6M shares for $1.8B.
DVAX

Hot Stocks

16:56 EST Dynavax COO Novack sells over 52,000 common shares - In a regulatory filing, Dynavax president and COO David Novack disclosed the sale of 52,204 common shares of the company on November 8 at a price of $12.47 per share.
BWMN

Hot Stocks

16:42 EST Bowman Consulting sees initial FY23 net service billings $270M-$290M - Sees initial FY23 adjusted EBITDA at $42M-$48M.
FLO

Hot Stocks

16:42 EST Flowers Foods sees FY22 CapEx $150M-$160M - With $60M-$70M related to the ERP upgrade. Sees FY22 effective tax rate in the range of 24.0%-24.5%.
RARE

Hot Stocks

16:41 EST Ultragenyx announces departure of CFO Dier - Ultragenyx Pharmaceutical announced that Mardi Dier, Chief Financial Officer, CFO, and Executive Vice President, is leaving the company, effective November 15, 2022, to assume the dual role of CFO and Chief Business Development Officer at privately held ACELYRIN. Ted Huizenga, Chief Accounting Officer, and Aaron Olsen, Senior Vice President of Corporate Strategy and Finance, will lead ongoing finance activities during the search for a successor.
RIGL

Hot Stocks

16:39 EST Rigel Pharmaceuticals' olutasidenib in AML and MDS featured in publication - Rigel Pharmaceuticals announced the publication of data in The Lancet Haematology, which summarizes the Phase 1 results of the Phase 1/2 study of olutasidenib, an investigational, oral, small molecule inhibitor of mutant isocitrate dehydrogenase-1. Olutasidenib was assessed as a monotherapy or in combination with azacitidine, in patients with mIDH1 acute myeloid leukemia - AML - or myelodysplastic syndrome - MDS -. The published data suggest that olutasidenib, with or without azacitidine, was well-tolerated and was associated with improvements in clinical efficacy endpoints in patients with mIDH1 AML. "These data from the first phase of the Phase 1/2 study suggest that olutasidenib may be both efficacious and well-tolerated, findings that are reinforced by the subsequently reported data from the Phase 2 registrational trial, which generated compelling efficacy and safety data that highlight olutasidenib as a potential treatment option for mIDH1 relapsed/refractory AML," said Wolfgang Dummer, Rigel's chief medical officer. "The NDA for olutasidenib, submitted by Forma Therapeutics, is under FDA review and we look forward to a potential approval in early 2023." Treatment-naive AML patients saw a 77% overall response rate and a 54% complete response plus CR with partial hematological recovery. These results provide strong rationale for future evaluation of either sequential or triplet therapy in this setting. This study showed that olutasidenib has the potential to provide an additional treatment option for mIDH1 AML.
WTER

Hot Stocks

16:37 EST Alkaline Water now projects $20M in total cost savings, margin enhancements - The Alkaline Water Company Inc. provided an update on its Pathway to Profitability, announcing another $5M in potential costs savings and margin enhancements. Total estimated savings, once fully implemented throughout fiscal years 2023 and 2024, are now approximately $20M compared to fiscal year 2022. This morning, the company also announced that it expects to report record revenue of approximately $19.6M when it files its 10-Q for its second quarter fiscal 2023 next Monday, November 14th, 2022, after market close. "The Alkaline Water Company continues to find ways to be more efficient while maintaining strong sales momentum in pursuit of our ultimate goal of becoming a profitable company," stated Frank Lazaran, President and CEO of The Alkaline Water Company. "We have now identified approximately $20 million in total savings and margin improvement compared to last fiscal year. Though it will take time to see the full benefits of the measures we're taking to improve our bottom line, we look forward to sharing with our shareholders next week the early progress we've made in our first full quarter on our Pathway to Profitability."
TMO

Hot Stocks

16:35 EST Thermo Fisher authorizes $4B in share repurchases - Thermo Fisher Scientific announced that its board of directors has authorized the repurchase of $4B of shares of its common stock in the open market or in negotiated transactions. The authorization has no expiration date.
NOG

Hot Stocks

16:35 EST Northern Oil and Gas increases borrowing base to $1.6B from $1.3B - Northern Oil and Gas "announced the completion of its semi-annual borrowing base redetermination under its reserves-based revolving credit facility. The borrowing base under the facility was increased from $1.3 billion to $1.6 billion, and NOG has chosen to increase the elected commitment amount from $850.0 million to $1.0 billion."
AZN

Hot Stocks

16:35 EST FDA approves tremelimumab combo for metastatic non-small cell lung cancer - On November 10, the Food and Drug Administration approved tremelimumab, or Imjudo, from AstraZeneca Pharmaceuticals in combination with durvalumab, or Imfinzi, from AstraZeneca Pharmaceuticals and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer, or NSCLC, with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations. Reference Link
OCX

Hot Stocks

16:34 EST OncoCyte has engaged advisor to assist in evaluating alternatives - The company said: "Looking ahead, we remain on track to submit our dossier for DetermaIO reimbursement in coming weeks. Additionally, our corporate development activities are yielding several interesting opportunities, and we have engaged Perella Weinburg Partners as our advisor to assist us in identifying and evaluating a range of potential strategic alternatives.On a parallel path, we continue to explore avenues to bolster our cash runway and to reduce our spend. We believe that Oncocyte has a bright future in front of us as the product development efforts from the past few years transition to market launches of several new high-value, reimbursed tests over coming quarters."
OCX

Hot Stocks

16:33 EST OncoCyte on track to submit dossier for DetermaIO reimbursement in coming weeks
STLD

Hot Stocks

16:32 EST Steel Dynamics announces additional $1.5B share repurchase program - Steel Dynamics announced that the company's board of directors authorized an additional share repurchase program of up to $1.5B of the company's common stock. The authorization is effective immediately and is additive to the previous $1.25B program, which had $245M remaining authorized and available for repurchase on September 30.
TOST

Hot Stocks

16:30 EST Toast jumps 8% to $21.60 after Q3 results and FY22 guidance raise
SNAL

Hot Stocks

16:29 EST Snail announces $5M share repurchase program - Snail, which came public earlier today, announced that its board of directors has authorized a share repurchase program under which Snail may repurchase up to $5M in outstanding shares of its Class A common stock, subject to ongoing compliance with Nasdaq listing rules.
AFL TRUP

Hot Stocks

16:20 EST Aflac, Trupanion announce joint venture in Japan - Aflac (AFL) and Trupanion (TRUP) are announcing a joint venture between Aflac Life Insurance Japan and Trupanion to provide high-value pet insurance in Japan. The joint venture, Aflac Pet Insurance, will leverage Aflac's strong brand, insurance expertise, and broad distribution network in Japan with Trupanion's expertise and leadership in pet insurance. Beginning in the second half of 2023, pending necessary regulatory approvals, Aflac Pet Insurance will offer high-value pet medical insurance designed to help pet owners budget for unexpected care for their pets.
AIZ

Hot Stocks

16:18 EST Assurant raises quarterly dividend 3% to 70c per share - Assurant announced that its Board of Directors approved a quarterly dividend increase of 2c to 70c per share of common stock. The dividend will be payable on December 19, 2022 to stockholders of record as of the close of business on November 28, 2022. "We have a compelling strategy with strong business fundamentals, and we continue to be good stewards of our capital," said Keith Demmings, President and CEO, Assurant. "Our ability to increase our dividend for the 18th consecutive time since our initial public offering is a testament to the strength of our ongoing and future cash generation."
BOLT

Hot Stocks

16:17 EST Bolt Biotherapeutics: Cash on hand expected to fund operations through 2025
MNTS

Hot Stocks

16:17 EST Momentus chief revenue officer Harms to retire - Momentus announced that Dawn Harms, Chief Revenue Officer, will retire effective Dec. 31, 2022. "We express our heartfelt thanks to Dawn for her leadership, resilience, and dedication to our company and our customers," said Momentus Chief Executive Officer John Rood. "Dawn's contributions were integral to the transformation of our Company, particularly as we started trading on the NASDAQ last August, and as we flew our first demonstration mission in May 2022. On behalf of the entire team, we wish Dawn the best in her well-earned retirement." Harms joined Momentus in 2019 as Chief Revenue Officer, leading the Company's commercial sales strategy. Momentus plans to announce a successor to Harms later this year.
DOCS

Hot Stocks

16:09 EST Doximity board authorizes $70M share buyback program - The board of directors of Doximity authorized another program to repurchase up to $70 million of the Company's Class A common stock. The repurchases are expected to be executed from time to time over the next 12 months, subject to general business and market conditions and other investment opportunities, through open market purchases or privately negotiated transactions, including through Rule 10b5-1 plans.
NSA

Hot Stocks

16:09 EST National Storage appoints Fischer to Executive Chair, Cramer to CEO - National Storage Affiliates Trust announced its Board of Trustees has elevated Tamara Fischer, Chief Executive Officer, CEO, to Executive Chair, effective April 1, 2023. Tammy has served as an officer of NSA since its IPO in 2015 and as its CEO and member of the Board of Trustees of NSA since 2020. As part of this planned transition of responsibilities, effective April 1, 2023, David Cramer will be appointed Chief Executive Officer, in addition to his current role as President. Arlen Nordhagen will remain on the Board and will transition to Vice Chair, from his current role as Executive Chairman. The Board further announced the appointment of Derek Bergeon to Executive Vice President and Chief Operating Officer effective April 1, 2023. Derek joined NSA in 2019 and currently serves as Senior Vice President, Operations.
POSH

Hot Stocks

16:08 EST Poshmark no longer issuing guidance - The company said, "Given Poshmark's pending acquisition by Naver Corp., it is no longer issuing forward-looking guidance."
IAS

Hot Stocks

16:02 EST Integral Ad Science names CFO, effective December 5 - Integral Ad Science announced the appointment of Tania Secor as CFO, effective December 5, 2022. Secor will lead the global finance team and report directly to Lisa Utzschneider, CEO of IAS. Most recently, she served as Global CFO of R/GA and Reprise, Interpublic Group's digital innovation and digital media agencies, respectively.
NICE

Hot Stocks

15:28 EST Nice announces $250M share repurchase program
GM SRE

Hot Stocks

15:26 EST GM, Sempra's SDG&E to explore vehicle-to-grid and vehicle-to-home technology - San Diego Gas & Electric (SRE) and General Motors (GM) announced an agreement to investigate the feasibility of integrating bidirectional Electric Vehicles into the electric grid as a local energy resource. Following GM's announcement of its newest business unit, GM Energy, the study will examine the hardware, software, processes and construction considerations necessary to accelerate wider adoption of Vehicle-to-Grid Integration capabilities, the companies said. Reference Link
CMRX

Hot Stocks

15:26 EST Rubric Capital reports 8.51% stake in Chimerix, suggests liquidation - According to a regulatory filing, Rubric Capital disclosed an 8.51% stake in Chimerix, representing 7.5M common shares. In the filing, which allows for activism, Rubric Capital included a letter to the board of Chimerix saying it believes the company should begin a winddown process and commence a strategic alternatives process. "Chimerix is on the wrong path and is being frivolous with shareholder value," the letter reads. "Continuing to invest in ONC201 despite the likely need for an expensive phase 3 trial is not an appropriate course of action for a company of this size and with such an onerous cost of capital. Considering this, we believe the Board must simultaneously begin a winddown process to maximize liquidation value available to shareholders and commence a strategic alternatives process for ONC201. The market appears to agree with us, as simply liquidating the Company would result in a return of up to 125% from the close on Tuesday, November 8th. Beyond the share price, shareholders have clearly demonstrated their dissatisfaction via the most recent annual meeting. Despite there being no alternative slate, no board nominee received a majority vote of the shares outstanding. One candidate only received 29% of the votes cast. Clearly shareholders are dissatisfied."
GTBP

Hot Stocks

15:18 EST GT Biopharma CEO says 'pleased with progress' with TriKE platform - GT Biopharma announced it will present two poster presentations at the Society for Immunotherapy of Cancer's 37th Annual Meeting, or SITC 2022, to be held in Boston, Massachusetts and virtually on November 8-12. The two posters highlight tri-specific killer engagers for the treatment of mesothelioma and prostate cancer. "We are pleased with the progress that has been made in assessing the broad applicability of our novel TriKE platform across solid tumors" said Michael Breen, Executive Chairman and Interim CEO of GT Biopharma. "Our TriKE structure consisting of an anti-CD16 nanobody which binds to NK cells and triggers antibody directed cell-mediated cytotoxicity, IL-15 cross-linker that binds to NK cells inducing self-sustaining expansion and extended survival and an anti-tumor associated antigen which binds to well-known tumor antigens. The TriKE modular platform allows for targeting multiple tumor-associated antigens. As such, we remain excited in our progress to date while looking forward to submitting an Investigational New Drug application in 2023 for lead assets GTB-3650 targeting CD33 positive tumors and GTB-5550 targeting B7H3 positive tumors, respectively."
RDFN...

Hot Stocks

15:13 EST Redfin says annual home price growth slows to 3% - "Home-sale prices rose 3.2% year over year during the four-week period ending November 6, the smallest increase since July 2020, according to a new report from Redfin (RDFN) the technology-powered real estate brokerage. The median home sale price has fallen 8.4% from its all-time high in June, when the average 30-year fixed mortgage rate was over a point lower than it is now. Home prices rose half a percent during the same period last year. Early stage demand may be leveling off as serious homebuyers who must be in the market now grow accustomed to mortgage rates near 7% and their ability to negotiate with sellers on price and terms improves. Mortgage purchase applications ticked up last week after six weeks of declines. Redfin's Homebuyer Demand Index-a measure of requests for home tours and other home-buying services from Redfin agents-increased 2.8% in the week ending November 6. "This morning's report that the overall inflation rate is finally starting to back off makes it even more likely that the Fed will slow their rate increase to 50 basis points next month," said Redfin Deputy Chief Economist Taylor Marr," said Redfin in a statement earlier, in part. Other publicly traded companies with exposure to real estate brokerage include RE/MAX Holdings (RMAX), Compass (COMP), Zillow Group (Z) and The Real Brokerage Inc. (REAX). Reference Link
LTRY

Hot Stocks

14:50 EST Lottery.com names Matthew Howard McGahan chairman - Lottery.com announced the appointment of an existing director, Matthew Howard McGahan as Chairman of the Board. This announcement comes at a transformational time for the company. The company has also appointment two new Board members; Barney Battles and Naila Chowdhury. These appointments fill two recent vacancies on the company's Board. The company looks forward to benefiting from Barney's significant professional accountancy related expertise and Naila's experience in building global business partnerships.
SCLX SRNE

Hot Stocks

14:50 EST Scilex to begin trade on Nasdaq on November 11 under symbol 'SCLX' - Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics (SRNE), announced that shares of its common stock will trade on the Nasdaq Capital Market on Friday, November 11, under the ticker symbol "SCLX". Scilex's trading debut comes after the completion of its business combination with Vickers Vantage Corp. I, a special purpose acquisition company. The combined company now operates as Scilex Holding Company. Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and CEO of Sorrento, said: "This is an extremely exciting moment for the Scilex team. Ringing the opening bell at Nasdaq is indicative of our team's hard work and celebration of our continued growth. I am confident and excited for Scilex's future growth and journey ahead."
MMM DD

Hot Stocks

14:50 EST California AG sues DuPont, 3M over 'toxic forever chemicals' - California Attorney General Rob Bonta has filed a lawsuit against the manufacturers of per- and polyfluoroalkyl substances, commonly referred to as PFAS, for "endangering public health, causing irreparable harm to the state's natural resources, and engaging in a widespread campaign to deceive the public." In the lawsuit, Attorney General Bonta alleges that these manufacturers, including 3M and DuPont, knew or should have known that PFAS are toxic and harmful to human health and the environment, yet continued to produce them for mass use and concealed their harms from the public. As a result, these toxic "forever chemicals" are pervasive across California's bays, lakes, streams, and rivers; in its fish, wildlife, and soil; and in the bloodstream of 98% of Californians. "PFAS are as ubiquitous in California as they are harmful," said Attorney General Bonta. "As a result of a decades-long campaign of deception, PFAS are in our waters, our clothing, our houses, and even our bodies. The damage caused by 3M [MMM], DuPont [DD], and other manufacturers of PFAS is nothing short of staggering, and without drastic action, California will be dealing with the harms of these toxic chemicals for generations. Today's lawsuit is the result of a years-long investigation that found that the manufacturers of PFAS knowingly violated state consumer protection and environmental laws. We won't let them off the hook for the pernicious damage done to our state." In the lawsuit, Attorney General Bonta alleges that the manufacturers knew or should have known about the dangers of PFAS when they made and/or sold products containing them and that the manufacturers' failed to warn about the dangers of PFAS and in many cases concealed them. The lawsuit seeks injunctive relief, damages, penalties, restitution, and abatement. Requested relief includes statewide treatment and destruction of PFAS, including, but not limited to, the treatment of drinking water by regulated water systems; water drawn from private wells and unregulated systems used for drinking water and irrigation; and water from other wastewater treatment plants and systems. The lawsuit also seeks payment of funds necessary to mitigate the impacts to human health and the environment through environmental testing, medical monitoring, public noticing, replacement water (for period between testing and installation of treatment), and safe disposal and destruction.
SCLX SRNE

Hot Stocks

14:49 EST Scilex to begin trade trade on Nasdaq on November 11 under symbol 'SCLX' - Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics (SRNE), announced that shares of its common stock will trade on the Nasdaq Capital Market on Friday, November 11, under the ticker symbol "SCLX". Scilex's trading debut comes after the completion of its business combination with Vickers Vantage Corp. I, a special purpose acquisition company. The combined company now operates as Scilex Holding Company. Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and CEO of Sorrento, said: "This is an extremely exciting moment for the Scilex team. Ringing the opening bell at Nasdaq is indicative of our team's hard work and celebration of our continued growth. I am confident and excited for Scilex's future growth and journey ahead."
AMD

Hot Stocks

14:36 EST AMD calls new EPYC processors 'world's fastest and most energy efficient' - AMD has announced the general availability of the 4th Gen AMD EPYC processors with "unmatched performance for critical workloads across cloud, enterprise and high performance computing." The company stated: The 4th Gen AMD EPYC processors bring next-generation architecture, technology, and features to the modern data center. Built on the 'Zen 4' core, the highest performance core ever from AMDiv, the processors deliver leadership performance, energy efficiency and help customers accelerate data center modernization for greater application throughput and more actionable insights." Reference Link
DELL AMD

Hot Stocks

14:34 EST Dell announces next generation PowerEdge servers with 4th Gen AMD EPYC processor - Dell Technologies (DELL) announces the next generation of Dell PowerEdge servers with 4th Generation AMD (AMD) EPYC processors. "With their highest application performance to date, these new systems are designed to help customers more effectively power today's demanding, compute-centric workloads such as data analytics," the company stated. "Customers demand uncompromised compute performance delivered in the most sustainable manner possible. Our latest PowerEdge servers are purpose built-to meet the needs of today's demanding workloads with efficiency and resiliency. With up to double the performance of the previous generation, combined with the latest in power and cooling innovations, these servers are designed to meet the growing demands of our customers," added Rajesh Pohani, vice president of portfolio and product management for PowerEdge, HPC and Core Compute at Dell Technologies.
MU AMD

Hot Stocks

14:32 EST Micron says DDR5 memory now available for 4th Gen AMD EPYC processors - Micron Technology (MU) announced availability of DDR5 memory for the data center that is validated for the new AMD EPYC 9004 Series processors. "The combination of 4th Gen AMD EPYC processors and Micron DDR5 delivers up to two times memory bandwidth on the STREAM benchmark and up to two times performance improvement on select HPC workloads such as computational fluid dynamics, Weather Research and Forecasting modeling and CP2K molecular dynamics," the company stated.
AMZN

Hot Stocks

14:19 EST Amazon reveals new design for Prime Air's delivery drone due 2024 - "We're now introducing our next generation delivery drone: the MK30. Due to come into service in 2024, this drone will be lighter and smaller than the MK27-2, the drone that will be making deliveries in Lockeford and College Station. The MK30's increased range, expanded temperature tolerance, safety-critical features, and new capability to fly in light rain will enable customers to choose drone delivery more often...We know our customers will only feel comfortable receiving drone deliveries if they know the system is safe and reliable. Our drones can encounter new, unexpected situations and still make safe decisions-autonomously and safely. We've created a sophisticated and industry-leading sense-and-avoid system that will allow our drones to operate at greater distances while safely and reliably avoiding other aircraft, people, pets, and obstacles...We're now introducing our next generation delivery drone: the MK30. Due to come into service in 2024, this drone will be lighter and smaller than the MK27-2, the drone that will be making deliveries in Lockeford and College Station. The MK30's increased range, expanded temperature tolerance, safety-critical features, and new capability to fly in light rain will enable customers to choose drone delivery more often." said the Amazon staff, in part, in an earlier statement. Reference Link
META...

Hot Stocks

14:17 EST Senator Rubio, Representative Gallagher call for national TikTok ban - U.S. Senator Marco Rubio and U.S. Representative Mike Gallagher announced that they are introducing legislation which would ban TikTok and "other social media companies that are effectively controlled by the CCP" from operating in the United States. Companies that compete with TikTok for advertising dollars include Meta Platforms' (META) Facebook and Instagram, Alphabet's (GOOGL) Google and YouTube and Snap's (SNAP) Snapchat. Reference Link
SONY...

Hot Stocks

14:17 EST Sony says 'Modern Warfare II' tops PS5 digital downloads in October - Sony (SONY) said that Activision's (ATVI) "Call of Duty: Modern Warfare II" reached the top of the PlayStation 5 digital charts in both the U.S. and Europe in October 2022, with Warner Bros. Discovery's (WBD) "Gotham Knights" coming in second place in the U.S. and Canada and third place in Europe. Electronic Arts' (EA) "FIFA 23" was second in Europe and third in the U.S. and Canada, while Take-Two's (TTWO) "Grand Theft Auto V" and "NBA 2K23" made the top ten in both regions. Also in both regions' top ten was CD Projekt's (OTGLY) "Cyperpunk 2077." Reference Link
BTC...

Hot Stocks

13:37 EST FTX US says trading may be halted 'in a few days' - FTX US posted the following announcement at the top of its site: "trading may be halted on FTX US in a few days. Please close down any positions you want to close down. Withdrawals are and will remain open. We will give updates as we have them." Reference Link
VCKA

Hot Stocks

13:34 EST Vickers Vantage Corp I trading resumes
VCKA

Hot Stocks

13:29 EST Vickers Vantage Corp I trading halted, volatility trading pause
SGEN TAK

Hot Stocks

13:14 EST Seagen announces FDA approval for Adcetris in new indication - Seagen (SGEN) announced that the Food and Drug Administration has approved Adcetris for the treatment of pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. Seagen and Takeda (TAK) jointly develop Adcetris. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize Adcetris in the rest of the world.
CRHC

Hot Stocks

13:06 EST NYSE to suspend trading immediately in Cohn Robbins, start delisting proceedings - The New York Stock Exchange announced that the staff of NYSE Regulation has determined to commence proceedings to delist three securities of Cohn Robbins Holdings Corp. from the NYSE, including the Class A ordinary shares. Trading in the company's securities will be suspended immediately. The NYSE will apply to the Securities and Exchange Commission to delist the company's securities upon completion of all applicable procedures, including any appeal by the company of the NYSE Regulation staff's decision.
SILO

Hot Stocks

13:00 EST Silo executive sees traditional, psychedelic drug combo as 'much more powerful'
SILO

Hot Stocks

13:00 EST Silo Pharma CEO says 'everything fully staffed' as COVID reopening continues
SILO

Hot Stocks

13:00 EST Additional data from ongoing studies expected in early 2023, Silo CEO says
ROP

Hot Stocks

12:48 EST Roper Technologies raises dividend 10% to 68.25c per share - Roper Technologies announced that its board of directors has declared a quarterly cash dividend of 68.25c per share, payable on January 23, 2023 to stockholders of record as of January 9, 2023. This represents an increase of 10% over the dividend paid in each quarter of 2022, or an expected 25c increase on an annual basis, or 6.25c on a quarterly basis, Roper noted.
IOVA

Hot Stocks

12:37 EST Iovance Biotherapeutics announces updated clinical data for lifileucel - Iovance Biotherapeutics announced updated clinical data for lifileucel in advanced melanoma during a rapid oral presentation at the Society for Immunotherapy of Cancer Annual Meeting. The oral presentation for the C-144-01 trial included efficacy data from 153 patients with advanced melanoma enrolled in Cohort 2 and Cohort 4 with a median study follow up of 36.5 months. All patients had progressed on or after immune checkpoint inhibitor therapy and targeted BRAF/MEK inhibitor therapy where appropriate. There are no treatments approved by the U.S. Food and Drug Administration for the C-144-01 study population. The current available care is chemotherapy. SITC C-144-01 Data Highlights for Pooled Analysis: Heavily Pretreated Patient Population with Substantial Disease Burden: Patients had received a median of 3 lines of prior therapy, including anti-PD-1 therapy in 100% of patients and anti-CTLA-4 therapy in 81.7% of patients, with prior combination anti-PD-1 and anti-CTLA-4 therapy received in 53.6% of patients. Baseline disease characteristics were generally similar between Cohorts 2 and 4. However, Cohort 4 patients showed both a higher disease burden and a higher proportion of patients with elevated lactate dehydrogenase, a well-known negative prognostic factor in melanoma. Clinically Meaningful ORR and Deepening of Responses Over Time: The ORR assessed by an independent review committee using RECIST v1.1 was 31.4%, with 9 complete responses and 39 partial responses. The median time from lifileucel infusion to best response was 1.5 months, and responses deepened over time. Initial PRs converted to CRs in 7 patients, as late as 2+ years post-lifileucel, including 1 conversion to CR in approximately 10 months since the initial data analysis in the abstract. mDOR and Durability at 2+ Years: The mDOR was not reached. Responses lasted for 24 months or greater in 41.7% of responders. Long-Term Benefit from One-Time Lifileucel Therapy: The DOR and overall survival KM plots show plateaus characteristic of immunotherapy, supporting the potential for long-term benefit from lifileucel therapy. Median had not been reached in patients who achieved a response at first assessment. mOS in all patients was 13.9 months. Responses Across All Subgroups: Responders to lifileucel included patients with ICI primary-resistant disease, those who received prior anti-CTLA-4 therapy and/or targeted therapies, and responses were observed regardless of PD-L1 status. LDH and target lesion sum of diameters were correlated with ORR. Higher odds of response with lower tumor burden suggest that early intervention with lifileucel after ICI may maximize benefit. Safety: Treatment-emergent adverse events were consistent with the underlying disease and known AE profiles of nonmyeloablative lymphodepletion and interleukin-2. Incidence of TEAEs decreased rapidly within the first 2 weeks after lifileucel infusion. 94.7% Manufacturing Success Rate: All patients in both cohorts received the same lifileucel treatment using Iovance's proprietary 22-day manufacturing process. Lifileucel was manufactured within specification in 94.7% of patients across Cohorts 2 and 4.
ENVX

Hot Stocks

12:30 EST Enovix names Ajay Marathe COO - Enovix announced the appointment of Ajay Marathe as COO reporting to CEO Harold Rust. Marathe's 38-year career includes stints as COO, CIO and foreign-subsidiary CEO of major technology companies including Western Digital Corporation, Lumileds LLC and Advanced Micro Devices, where he served for 23 years first as Thailand Plant Manager responsible for assembly and test of six million units per week, and then VP of Operations of the 2,500-employee Computation Products group, and then VP of Operations for all Asian assembly and test, and finally CEO of the AMD India LLC startup created to serve the entire country. Enovix CEO, Harold Rust said, "We wanted to find a senior semiconductor executive who thinks 'millions not thousands' and scored with Ajay, a known Silicon Valley industry figure."
AMZN GPS

Hot Stocks

12:06 EST Gap launches collection of 'family essentials' with Amazon Fashion - Gap (GPS) announced its launch with Amazon Fashion (AMZN) in the U.S. and Canada, offering a selection of "basic, modern essentials for the family," including hoodies, t-shirts, denim, socks, underwear and sleepwear for adults, teens, kids and baby. The launch will also include babyGap-branded nursery furniture and baby gear like strollers, bassinets, explorer wagons, play yards and more. "Collaborating with Amazon Fashion provides us a new channel to deliver Gap's modern American essentials to even more customers in the U.S. and Canada. We are excited to take this step with Amazon Fashion, to expand our product offering and to deepen our connection with consumers through the Gap brand store," said Mark Breitbard, President and CEO, Gap brand. Reference Link
TWTR

Hot Stocks

12:02 EST Twitter CISO Lea Kissner departs - In a Thursday tweet, Twitter's chief information security officer Lea Kissner said, "I've made the hard decision to leave Twitter. I've had the opportunity to work with amazing people and I'm so proud of the privacy, security, and IT teams and the work we've done. I'm looking forward to figuring out what's next, starting with my reviews for @USENIXSecurity". Reference Link
ORCL

Hot Stocks

12:02 EST Oracle names Stuart Levey chief legal officer - Oracle announced that Stuart Levey has been named executive vice president and chief legal officer. "Stuart has one of the sharpest legal minds in the country," said Oracle CEO, Safra Catz. "His depth of experience in technology, finance, and national security make him a perfect fit to lead our legal team as it navigates changing policies, complex regulations, and our rapidly growing cloud business." Levey has more than three decades of leadership in both the private and public sectors. From 2012 until 2020, he worked for global banking giant HSBC Holdings. There, as Chief Legal Officer he managed a department of more than 900 lawyers worldwide.
TZA

Hot Stocks

12:00 EST Small Cap Bear 3x falls -17.7% - Small Cap Bear 3x is down -17.7%, or -$6.52 to $30.42.
DRV

Hot Stocks

12:00 EST Debt Resolve falls -21.0% - Debt Resolve is down -21.0%, or -$13.47 to $50.68.
SOXS

Hot Stocks

12:00 EST Direxion Daily Semiconductor Bear 3X Shares falls -24.1% - Direxion Daily Semiconductor Bear 3X Shares is down -24.1%, or -$13.17 to $41.44.
YETI

Hot Stocks

12:00 EST Yeti rises 29.9% - Yeti is up 29.9%, or $9.08 to $39.42.
W

Hot Stocks

12:00 EST Wayfair rises 32.9% - Wayfair is up 32.9%, or $9.47 to $38.22.
RNG

Hot Stocks

12:00 EST RingCentral rises 35.1% - RingCentral is up 35.1%, or $9.95 to $38.31.
IBEX

Hot Stocks

11:50 EST Ibex Ltd trading resumes
RUN...

Hot Stocks

11:47 EST California issues revised proposal on rooftop solar subsidies - Administrative Law Judge Kelly Hymes has proposed a decision on revising net energy metering tariffs and subtariffs in California, according to a post to the state's Public Utilities Commission. The CPUC notes that the proposed decision "has no legal effect" until and unless the Commission hears the item and votes to approve it, adding that this item "may be heard, at the earliest, at the Commission's December 15, 2022 Business Meeting." Companies that may be impacted include Sunrun (RUN), Sunnova Energy (NOVA), iSun (ISUN) and SunPower (SPWR). Reference Link
IBEX

Hot Stocks

11:45 EST Ibex Ltd trading halted, volatility trading pause
SBET

Hot Stocks

11:44 EST Entrypoint to acquire SharpLink's legacy telecommunications business - SharpLink announced that Israel-based Entrypoint South has signed a Share and Asset Purchase Agreement with the Company to acquire SharpLink's legacy Mer Telecommunications Systems business in a one-year earn-out transaction, subject to customary closing conditions and required regulatory approval from the Israel Innovation Authority. In consideration of Entrypoint acquiring all rights, title, interests and benefits to Legacy MTS, including 100% of the shares of MTS Integratrak Inc., one of the Company's US subsidiaries, it will pay SharpLink an earn-out payment equal to three times Legacy MTS' Earnings Before Interest, Taxes and Depreciation for the year ending December 31, 2023, up to a maximum earn-out payment of $1M. Legacy MTS's business concentrates on worldwide provision of telecom expense management solutions which assist enterprises and organizations to make smarter choices with their telecommunications spending at each stage of the service lifecycle, including allocation of cost, proactive budget control, fraud detection, processing payments and spending forecasting. In July 2021, SharpLink merged with Mer Telemanagement Solutions Ltd., which at the time owned the Legacy MTS business, in a go-public transaction. Following the merger, SharpLink has operated Legacy MTS and its related subsidiaries as a business unit which has been reported in financial filings as its Enterprise TEM segment. In June 2022, SharpLink's Board of Directors provided management with approval to enter into negotiations with prospective buyers of Legacy MTS due to the fact that Legacy MTS's business is not complementary nor of any strategic benefit to SharpLink's focus on the emerging U.S. sports betting and iGaming industries.
LVO

Hot Stocks

11:34 EST LiveOne board authorizes $2M increase to stock repurchase program - LiveOne announced that its board of directors has authorized it to expand its previously announced stock repurchase program by up to an additional $2,000,000 worth of shares of its common stock to be repurchased from time to time. Since April 1, 2022, LiveOne has repurchased 2,000,000 shares under the program. The authorization to repurchase will expire on December 31, 2023.
LVO

Hot Stocks

11:34 EST LiveOne implementing additional cost, expense reductions - As part of LiveOne's focus on generating cash from operations on a consolidated basis, LiveOne is implementing additional cost and expense reductions from both operations and corporate overhead, which is anticipated to increase the previously implemented annual cost savings to a total of over $25 million in its fiscal year ending March 31, 2023
AGBA

Hot Stocks

11:21 EST AGBA Acquisition Ltd trading resumes
IMMP MRK

Hot Stocks

11:17 EST Immutep announces clinical results from Phase II trial of eftilagimod alpha - Immutep (IMMP) announces new clinical data from the TACTI-002 all-comer PD-L1 Phase II trial evaluating Immutep's lead product candidate, eftilagimod alpha in combination with MSD's (MRK) anti-PD-1 therapy KEYTRUDA in 114 patients with 1L NSCLC. The new data was presented today in a late-breaking abstract oral presentation at the 37th Annual Society of Immunotherapy of Cancer Meeting by Wade T. Iams, MD, Assistant Professor of Medicine, Vanderbilt-Ingram Cancer Center Division of Hematology/Oncology. Key Findings from TACTI-002 Phase II Trial in 1L NSCLC Patients - Data cut-off date 1 July 2022: Primary Endpoint - The primary endpoint of overall response rate by iRECIST increased to 40.4% in the TACTI-002 all-comer PD-L1 Phase II trial in 1L NSCLC. ORR improved across all PD-L1 status groups by central assessment compared with data reported at the American Society of Clinical Oncology's Annual Meeting in June 2022. Encouraging ORR of 48.3%, 44.7%, 55.0%, and 31.3% was established in patients expressing a PD-L1 Tumor Proportion Score of greater than1%, 1-49%, greater than50%, and less than1%, respectively. Secondary Endpoints - Despite ~75% of patients in the trial having PD-L1 TPS less than50%, promising results were achieved in secondary endpoints of interim median Progression Free Survival and Disease Control Rate: Median PFS was 6.6 months overall and 9.3 months for patients with a PD-L1 TPS of greater than or equal to1%, an increase from 8.4 months as reported at ASCO 2022. DCR of 79.3% for patients with TPS of greater than1% and improved for all PD-L1 groups except TPS less than1%. Of note, efti in combination with pembrolizumab has been granted Fast Track designation in combination with pembrolizumab in 1L NSCLC patients expressing PD-L1 TPS greater than or equal to1%. Duration of Response - Deep and durable responses, with interim median DoR of 21.6 months, compares favourably to historical controls, including anti-PD-1 therapy combined with chemotherapy: Response onset is early, and responses are long-lasting; Less than 10% of responding patients progress within 6 months. Tumour Response by Tumor Type - Comparable ORR & DCR for squamous and non-squamous histologies. Pharmacodynamic Analysis - First pharmacodynamic data from efti plus pembrolizumab combination shows statistically significant increase in IFN- and CXCL10 serum biomarkers for systemic TH1 response, further substantiating efti's unique systemic stimulation of the immune system. This is similar to the biomarker analysis from Immutep's randomized AIPAC Phase IIb trial in metastatic breast cancer, which showed efti in combination with chemotherapy significantly increased the number of circulating immune cells and CXCL10 serum levels, compared to baseline. The increase in these pharmacodynamic markers was significantly linked to improved OS in the efti group, but not in the placebo group in the AIPAC trial. Safety - Treatment with efti plus pembrolizumab is safe and well-tolerated with no new safety signals, continuing the combination's favourable safety profile to date that is consistent with previously reported studies for pembrolizumab monotherapy. Only 9.6% of patients have discontinued due to adverse events related to study treatment, which is in line with the data reported at ASCO 2022, consistent with the discontinuation rate for pembrolizumab monotherapy, and below historical discontinuation rates from other immunotherapy-immunotherapy & immunotherapy-chemotherapy combination trials. The combination of efti plus pembrolizumab is showing encouraging efficacy in 1L NSCLC patients across all PD-L1 status groups, including in PD-L1 low and PD-L1 negative patients. The combination is very well tolerated, and the low discontinuation rate is consistent with pembrolizumab monotherapy. The data support continued late-stage development in this indication.
AGBA

Hot Stocks

11:16 EST AGBA Acquisition Ltd trading halted, volatility trading pause
AGBA

Hot Stocks

11:12 EST AGBA Acquisition announces shareholder approval of business combination - AGBA Acquisition announced that all proposals presented to shareholders at the special meeting of shareholders held on November 9, 2022 at 9:00 p.m. Eastern Time relating to AGBA's business combination with TAG Holdings Limited were approved by shareholders. Holders of AGBA's ordinary shares that elected to redeem shares in connection with AGBA's special meeting of stockholders may withdraw such redemption requests by no later than 12:00 p.m. Eastern Time on November 11, 2022. A total of 3,339,229 shares were tendered for redemption in connection the special meeting of shareholders. The final redemption price is $11.617 per share redeemed.
IQV

Hot Stocks

11:06 EST Iqvia, Clalit Health Services partner to advance research in Israel - IQVIA announced a long-term collaboration with Clalit, the largest health services organization in Israel, to launch the first Prime Site in the country. The collaboration combines IQVIA and Clalit's capabilities in clinical trial delivery, real-world research, data and genomics. Clalit operates a network of 14 hospitals and over 1600 primary care clinics. The health services organization provides full therapeutic coverage with significant expertise in, but not limited to, oncology, pediatric rare disease, and genomics. With this combined expertise, the collaboration will allow for focus on the future of innovation, including precision medicine and the delivery of data driven trials.
AON

Hot Stocks

10:47 EST Aon acquires risk assessment modeling firm ERN, terms not disclosed - Aon announced the expansion of the its catastrophe modeling and consultancy capabilities in Latin America with the acquisition of ERN, a Mexico-based leader in risk assessment modeling. The acquisition aims to bring additional value to Aon's insurer clients, which face three key issues in navigating natural catastrophe and climate volatility: the increasing cost of secondary perils, the ability to understand an evolving climate, and the need to create a custom view of risk to make better business decisions. Aon is working with clients to develop their own view of risk - an important component in achieving the differentiation necessary for successful renewals outcomes in the tightening reinsurance market. The transaction sees ERN joining Aon's Reinsurance Solutions business, where it will collaborate with the Impact Forecasting team, whose modeling suite enables firms to analyze the financial impacts of catastrophic events with a view to developing effective reinsurance, underwriting and exposure management strategies. Founded in 1996, ERN has developed modeling capabilities that are specific to Latin America and backed by strong expertise and research. Lawler will serve as CEO of this business and ERN founders Eduardo Reinoso and Dr. Mario Ordaz will join Aon as senior scientific advisors. Terms of the transaction, which has closed, were not disclosed.
VIGL

Hot Stocks

10:45 EST Vigil Neuroscience Inc trading resumes
SNY GSK

Hot Stocks

10:46 EST Sanofi-GSK next-generation COVID-19 booster vaccine approved by EC - After the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older, Sanofi (SNY) and GSK (GSK) announced. "Designed to provide broad protection against multiple variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK's pandemic adjuvant. VidPrevtyn Beta is indicated as a booster for active immunization against SARS_CoV_2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements," the companies stated.
SNY GSK

Hot Stocks

10:41 EST Sanofi, GSK's VidPrevtyn Beta approved by European Commission - After the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older. Designed to provide broad protection against multiple variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK's pandemic adjuvant. VidPrevtyn Beta is indicated as a booster for active immunization against SARS_CoV_2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements.
ASML

Hot Stocks

10:40 EST ASML up 10% to $539.48 after buyback, outlook at investor day
ASML

Hot Stocks

10:36 EST ASML announces share buyback program of up to EUR 12B - ASML said it expects to continue to return significant amounts of cash to shareholders through a combination of growing dividends and share buybacks. ASML announced a new share buyback program, effective today and to be executed by December 31, 2025. It intends to repurchase shares up to an amount of EUR 12.0B, of which it expects a total of up to 2M shares will be used to cover employee share plans.
VIGL

Hot Stocks

10:35 EST Vigil Neuroscience Inc trading halted, volatility trading pause
HUDI

Hot Stocks

10:12 EST Huadi International Group Co trading resumes
VACC

Hot Stocks

10:11 EST Vaccitech cancer vaccine 'shows promise' in animal studies, NIH researchers say - An experimental therapeutic cancer vaccine, SNAPvax, designed by Robert Seder, M.D., and colleagues at the NIAID Vaccine Research Center together with collaborators from Vaccitech North America, induced "two distinct and desirable immune system responses that led to significant tumor regression in mice," report investigators from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Vaccitech has announced plans to advance the SNAPvax platform for use in treating human papilloma virus-associated cancer in 2023, the NIH report noted. Reference Link
HUDI

Hot Stocks

10:05 EST Huadi International Group Co trading halted, volatility trading pause
ALK BA

Hot Stocks

10:01 EST Alaska Air Cargo selects Boeing to convert 2 passenger aircraft to freighters - Alaska Air Cargo (ALK) announced Boeing (BA) will provide the conversion work for two 737-800 Boeing Converted Freighters to add to its dedicated freighter fleet serving the state of Alaska. The conversion work will be done at Cooperativa Autogestionaria de Servicios Aeroindustriales in Costa Rica. The two 737-800BCF aircraft will increase the Alaska Air Cargo freighter fleet from three to five aircraft that are dedicated to serving the state of Alaska. The two 737-800 airplanes will come from Alaska Airlines' existing passenger fleet and will be leased from BBAM. The planes will be converted from their passenger configuration to an all-freight aircraft beginning in 2023 with completion of the final aircraft by early 2024.
AZUL

Hot Stocks

10:00 EST Azul falls -15.2% - Azul is down -15.2%, or -$1.33 to $7.47.
SOXS

Hot Stocks

10:00 EST Direxion Daily Semiconductor Bear 3X Shares falls -16.4% - Direxion Daily Semiconductor Bear 3X Shares is down -16.4%, or -$8.97 to $45.64.
WEBS

Hot Stocks

10:00 EST Web Street, Inc. falls -18.2% - Web Street, Inc. is down -18.2%, or -$9.33 to $41.80.
WRBY

Hot Stocks

10:00 EST Warby Parker rises 21.2% - Warby Parker is up 21.2%, or $2.81 to $16.04.
RNG

Hot Stocks

10:00 EST RingCentral rises 23.0% - RingCentral is up 23.0%, or $6.51 to $34.87.
YETI

Hot Stocks

10:00 EST Yeti rises 24.1% - Yeti is up 24.1%, or $7.30 to $37.64.
ASGOF

Hot Stocks

09:54 EST Asante Gold says Bibiani ramp up remains on track - Asante Gold announced that the Bibiani Gold Mine ramp up remains on track and commercial production has been established with three months of consistent production since the first gold pour was completed in early July 2022. Operational highlights include: The first gold pour at Bibiani was completed July 7, 2022, two months ahead of schedule. Metallurgical performance and gold production is on track with the ramp up schedule. All process plant and mine facilities have been operating on a 24 hour per day basis from late June, with ~220,000 tonnes in September and~206,000 tonnes in October. Asante plans to increase throughput to 250,000 tonnes ore per month by Q1 2023. Gold production in September was above 9,300 ounces, 17% above the Company's start up plan. October production was 9,910 ounces, 15% above plan. Gold production will continue to ramp up to ~20,000 oz per month by early 2023. The Walsh Pit continues to outperform relative to our initial planned gold production. As this pit has been developed, the grade control drilling program has been a key component to development of this trend. The Company's plan to extend the Bibiani open pit Life of Mine from 8.3 years to +10 years is on track with successful development exploration at Russel South and drilling programs continue at the Grasshopper and Elizabeth deposits as planned. The Company will continue its near mine development exploration program with planned drilling of approximately 30,000 metres per year for 2022, 2023 and 2024. The Bibiani orebodies typically dip near-vertical and are open at depth. Bibiani has initiated an underground mine planning study to define development of an underground mine operation that will access mineralized deposits below the Main Pit and the satellite pits. Asante anticipates the underground mine program initiative will increase annual gold production significantly and proceed from 2025 and extend mine life beyond the period of open pit mining.
AMV

Hot Stocks

09:52 EST AMV Stock trading resumes
MSGM

Hot Stocks

09:51 EST Motorsport Games completes 1-for-10 reverse stock split - Motorsport Games confirmed that the 1-for-10 reverse stock split of the Company's Class A and Class B common stock became effective as of 12:01 a.m. EST on November 10, 2022. Motorsport Games effected the reverse stock split by filing a charter amendment with the Delaware Secretary of State. The reverse stock split was previously approved by the Company's Board of Directors and stockholders pursuant to Sections 228 and 242 of the Delaware General Corporation Law. The Company's Class A common stock began trading on the NASDAQ on a split-adjusted basis when the market opened today, November 10, 2022, under a new CUSIP number, 62011B 201. As a result of the reverse stock split, each 10 shares of the Company's Class A and Class B common stock issued and outstanding immediately prior to the Effective Time were automatically combined into 1 share of Class A common stock and Class B common stock, respectively, subject to the elimination of fractional shares, as described below. The same 1-for-10 reverse stock split ratio was used to effect the reverse stock split of both Motorsport Games Class A and Class B common stock, and accordingly, all stockholders were affected proportionately. The reverse stock split reduced the Company's issued and outstanding shares of common stock from approximately 11,673,587 shares of Class A common stock and 7,000,000 shares of Class B common stock to approximately 1,167,358 and 700,000 shares, respectively. The number of shares of Class A common stock subject to the Company's outstanding employee and director stock options, as well as the relevant exercise price per share, will be proportionately adjusted to reflect the reverse stock split. Accordingly, the approximately 821,962 outstanding stock options will be reduced to approximately 82,196 outstanding stock options. The number of shares authorized for issuance under the Company's stock plan will also be reduced from 1,000,000 shares of Class A common stock to 100,000 shares of Class A common stock using the same 1-for-10 split ratio. The Company has notified NASDAQ that the Company is not in compliance with the Nasdaq Listing Rules requiring minimum of 500,000 publicly held shares.
DRV

Hot Stocks

09:47 EST Debt Resolve falls -13.9% - Debt Resolve is down -13.9%, or -$8.89 to $55.26.
SOXS

Hot Stocks

09:47 EST Direxion Daily Semiconductor Bear 3X Shares falls -16.6% - Direxion Daily Semiconductor Bear 3X Shares is down -16.6%, or -$9.04 to $45.57.
WEBS

Hot Stocks

09:47 EST Web Street, Inc. falls -19.8% - Web Street, Inc. is down -19.8%, or -$10.10 to $41.03.
LOCL

Hot Stocks

09:47 EST Local Bounti rises 21.0% - Local Bounti is up 21.0%, or 53c to $3.05.
RNG

Hot Stocks

09:47 EST RingCentral rises 21.2% - RingCentral is up 21.2%, or $6.00 to $34.37.
YETI

Hot Stocks

09:47 EST Yeti rises 21.6% - Yeti is up 21.6%, or $6.56 to $36.90.
PFE BNTX

Hot Stocks

09:46 EST Pfizer, BioNTech receive positive CHMP opinion for Covid-19 vaccine booster - Pfizer (PFE) and BioNTech SE (BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine has been recommended for marketing authorization by the European Medicines Agency Committee for Medicinal Products for Human Use for children 5 through 11 years of age. The European Commission will review the CHMP recommendation and is expected to make a final decision soon. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized in the European Union as a booster dose for individuals aged 12 years and older. Today's CHMP recommendation to include children 5 through 11 years of age was based on safety and immunogenicity data from the companies' Omicron BA.1-adapted bivalent vaccine in individuals 12 years and older, data from the initially approved 10-microgram pediatric formulation of the companies' original COVID-19 vaccine, manufacturing data from the companies' pediatric formulation of the Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies' Omicron BA.4/BA.5-adapted bivalent vaccine. Recent clinical data from an ongoing Phase 2/3 trial of the companies' BA.4/BA.5-adapted bivalent booster in adults 18 years of age and older demonstrated a strong immune response against the BA.4 and BA.5 sublineages, measured 30 days after immunization, with a safety and tolerability profile similar to the companies' original COVID-19 vaccine. In addition to this trial and the already submitted data, a Phase 1/2/3 pediatric study is ongoing that evaluates different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups. Data from both these trials will be shared with regulatory authorities around the world as soon as they become available.
WYY

Hot Stocks

09:42 EST WidePoint says PKI technology delivers on CISA guidance - WidePoint Corporation announced that the company's Public Key Infrastructure Identity & Access Management solution delivers on new guidance issued by CISA, the Cybersecurity & Infrastructure Security Agency of the U.S. Department of Homeland Security. CISA released two fact sheets to highlight threats against accounts and systems using certain forms of Multi-Factor Authentication. CISA urges all organizations to implement phishing-resistant MFA to protect against phishing and other known cyber threats. Public Key Infrastructure is at the top of the phishing-resistant MFA technologies.
LEXX

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09:41 EST Lexaria Bioscience expects to begin DEM-A22-1 program on November 15 - Lexaria Bioscience announces that study program DEM-A22-1 is expected to begin on November 15, 2022. This is Lexaria's first-ever study to investigate whether its patented DehydraTECH-processed cannabidiol may potentially have therapeutic utility against dementia.
SEE

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09:40 EST Sealed Air invests $9M in solar farm powering California manufacturing facility - Sealed Air has invested $9 million in a solar farm that is now powering its Madera, California manufacturing facility. The solar panels, which sit on 11 acres of company-owned land adjacent to the facility, are expected to help reduce energy spend at this site by $1 million annually. The 265,000 square foot plant, which manufactures BUBBLE WRAP brand original cushioning, SEALED AIR brand Korrvu retention and suspension packaging, mailers, and other solutions, will have 98% of its electricity powered by the solar field.
UAVS

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09:37 EST Ageagle Aerial Systems hosted eBee TAC demonstration for NATO Armed Forces - AgEagle Aerial Systems announced that the Company recently hosted an eBee TAC Tech Day outside of Brussels, Belgium, presenting to and providing live flight demonstrations for more than two dozen advanced drone experts from two countries within the NATO Armed Forces. Held in collaboration with AgEagle's value added reseller in the Netherlands, Geometius, the event focused on educating attendees on eBee TAC's strong competitive differentiation, robust capabilities and diverse range of tactical applications, including geo-mapping; barrack organization and installation; emergency response; airfield damage assessment; natural resource management, battlefield situational awareness; air space management; terrain visualization and facilities management and inspection, among others.
VRAR T

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09:36 EST Brightline Interactive to power technology demonstration with AT&T - Brightline Interactive is powering and connecting its immersive technologies in collaboration with AT&T for an integrated technological demonstration at the I/ITSEC, the largest training and simulation tradeshow in the United States. This will be the first instance where two fully rollable NOVA simulator domes and an additional mixed reality user are connected via AT&T's 5G network, driving super-fast data throughput, leading to minimal delay in visual presentation, thereby enabling complex and realistic multi-user training in a fully immersive environment. AT&T has integrated a temporary 5G network inside of Brightline's immersive laboratory for application testing, staging, and metrics capture in preparation for the I/ITSEC tradeshow.
CELU

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09:35 EST Celularity presents preclinical data on CYNK-101 at SITC - Celularity announced that it will present preclinical data on the development of its novel placental-derived allogeneic genetically modified natural killer cell therapy program CYNK-101 in combination with avelumab. Celularity will report its findings in a poster presentation at the 37th Annual Meeting of The Society for Immunotherapy of Cancer, SITC. "Developing placental CD34+-derived natural killer cells with high affinity and cleavage resistant CD16 in combination with Avelumab for enhanced therapy against PD-L1+ solid tumors" Highlights: CYNK-101 is a cryopreserved, off-the-shelf, allogeneic, placental CD34+ derived NK cell therapy, overexpressing a high IgG binding affinity, proteinase cleavage resistant, CD16 variant. The results demonstrate the synergistic effect of combining CYNK-101 with avelumab to drive antibody-dependent cellular cytotoxicity activity against PD-L1+ solid tumor cells in vitro, including non-small cell lung cancer, triple-negative breast cancer, and bladder cancer tumor cells. CYNK-101 cells provide a combination immunotherapy option by harnessing the anti-tumor activities of both targeted biologics and innate cytotoxicity of NK cells. Further development of CYNK-101 in combination with therapeutic antibodies for these solid tumor indications is warranted.
LIVC

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09:34 EST Live Current Media completes acquisition of assets of PowerSpike - Live Current Media completed the acquisition of the assets of PowerSpike, including all code to PowerSpike's powerful influencer management software and all social media sites supporting the product. The all-stock transaction was concluded on November 9th, 2022. The PowerSpike product is a comprehensive and extendable influencer management software platform that includes scalable data tracking and analysis tools, client facing reporting and monitoring applications with real-time chat processing and inference tools. More significantly, the tech stack has the ability to screen and source millions of social media handles, filtering for subject matters, number of followers, and other key characteristics. More than seventy thousand creators have already signed up to use PowerStrike and the assets include a list of another ten million influencers in numerous niches. Capitalizing on a growing demand for acquiring and analyzing data, the Company plans to expand and to monetize the new platform features by integrating and rolling out this unique platform across all other products within the Company's product portfolio and ecosystem.
INKT

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09:33 EST MiNK Therapeutics presents clinical data at SITC 2022 - MiNK Therapeutics announced the presentation of new data from five presentations at the 2022 Society for Immunotherapy of Cancer, SITC, Annual Meeting. "Allogeneic unmodified iNKTs show reductions in target and non-target lesions or disease stabilization in patients with solid tumor cancers when administered alone and in combination with pembrolizumab or nivolumab." Phase 1 data show early signals of activity with disease stabilization in patients refractory to standard of care and those who have progressed on KEYTRUDA or OPDIVO. agenT-797 preferentially kills tumor-promoting M2 macrophages while preserving pro-inflammatory M1 macrophages associated with anti-tumor responses. agenT-797 can be dosed up to 1000x106 cells without lymphodepletion showing no signs of neurotoxicity and cytokine release syndrome. agenT-797 shows 70% survival in severe viral ARDS compared to site reference controls; potential for a variant agnostic approach to infections. In Phase 1/2 study, agenT-797 shows survival of 70% in mechanically ventilated patients compared to ~10% in a comparative case control population: Increased 90-day survival in a subgroup of patients on respiratory bypass of 75% compared to 30% in a comparative cohort with median survival of 119.5 vs 47 days. agenT-797 demonstrates a favorable safety profile. MiNK's FAP-CAR-iNKT therapeutic candidate, MiNK-215, demonstrates robust efficacy in non small cell lung cancer preclinical models, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor specific CD8+ T cell infiltration through tumor stroma. FAP-CAR-iNKT demonstrates a drastic increase of CD8+ T cells infiltrating the tumor and significantly increased tumor killing compared to T cells in murine models. MiNK-413 is a differentiated allogeneic IL-15-armored-BCMA-CAR-iNKT therapeutic candidate, a next generation approach designed to overcome the limitations of current autologous cell therapies. MiNK-413 demonstrates superior tumor clearance in a systemic multiple myeloma models, compared to control BCMA-CAR. MiNK-413 has the potential to target a broader population of patients with multiple myeloma.MiNK's proprietary CARDIS platform enables high-throughput rapid selection and optimization of functional CARs, like MiNK-413 and MiNK-215 .Allo-iNKTs reinvigorate partially exhausted T cells and improve effector functions within the tumor microenvironment; critical mechanisms in rescuing PD-1 refractory tumors. In addition to their direct anti-tumor activity, allogeneic iNKT cellsimprove immune effector function of immune cells in the tumor microenvironment.agenT-797 restores the cytotoxic capacity, activation, and cytokine production of partially exhausted T cells.
RL

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09:32 EST Ralph Lauren sees gross margin expansion in 2H
LPTH

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09:32 EST LightPath announces qualification of BD6 material for space applications - LightPath Technologies announced that the Company's BD6 infrared glass has passed radiation testing and is qualified for use as a replacement for Germanium in space applications. The testing of LightPath's BD6 as part of a European Space Agency project comes in parallel to efforts by the US Department of Defense, European defense agencies, and others to reduce their dependence on Germanium by qualifying an alternative. The tests performed as part of the ESA project were designed to simulate the radiation the material would be exposed to during ESA missions, including both Gamma and Proton tests. The tests show that LightPath's Black Diamond material and Anti Reflective Coating can withstand radiation exposure to in-orbit tasks.
RL

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09:32 EST Ralph Lauren sees FY23 gross margin up 30-50bps
JUPW

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09:32 EST Jupiter Wellness reopens enrollment in trial comparison of JW-100, EUCRISA - Jupiter Wellness announced that it has re-opened enrollment in a clinical trial aimed at evaluating the superiority of JW-100, a novel cannabidiol topical cream, in a head-to-head study against EUCRISA, an FDA Approved topical treatment for eczema developed by Pfizer. The study was put on hold to solve stability issues in the original JW-100 formulation. These issues were addressed and resolved to the satisfaction of the study's clinical investigators.
AMV

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09:31 EST AMV Stock trading halted, volatility trading pause
RL

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09:31 EST Ralph Lauren sees FY23 operating margins at low end of 14%-14.5% range
AREC

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09:30 EST American Resources' ReElement secures manufacturing readiness grant - American Resources Corporation announced that it has been awarded a $200,000, state-level, advanced manufacturing grant from the Indiana Economic Development Corporation for its patented critical battery element purification and separation technology being commercialized in Noblesville, Indiana.
TRMR

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09:29 EST Tremor International produces forecast of 2022 FIFA World Cup trends - Tremor International announced the release of its 2022 World Cup Global Consumer Trends Report, comprising consumer surveys in the United States, Canada, the United Kingdom, Germany, Australia, Malaysia and Singapore. FIFA anticipates that five billion people across the globe will tune into the 2022 FIFA World Cup which will take place in Qatar starting November 20. At a time when media viewing habits are dramatically evolving, the increasing rate of global CTV engagement provides the opportunity to maximize digital video advertising investment in the tournament across all screens. Tremor International's report not only forecasts viewership trends, but also the factors that we believe drive fans to watch throughout and the benefits to brands which align with one of the world's biggest sporting events.
ADAG

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09:28 EST Adagene announces clinical data at SITC 2022 on ADG116 - Adagene announced clinical data from phase 1b/2 studies of its anti-CTLA-4 antibody candidate, ADG116, in two poster presentations at the Society for Immunotherapy of Cancer's, SITC, Annual Meeting taking place in Boston. Key findings as of the data cutoff date on September 19, 2022 include: Compelling, differentiated safety profile demonstrated with ADG116 monotherapy up to 15 mg/kg: ADG116 is well tolerated across dose levels with repeat dosing. Grade 1/2 and Grade 3/4 treatment-related adverse events were reported in 28 and 3 patients, respectively. With repeat dosing and tracking for late-onset toxicities in the same 10mg/kg cohort, the overall rate of Grade 3 or higher TRAEs is 13%. For reference, the reported rate of TRAEs Grade 3 and higher for the currently approved anti-CTLA-4 therapy, ipilimumab, is approximately 36% at 10 mg/kg in first-line monotherapy in melanoma patients. There were no Grade 3 or higher TRAEs reported at the 15 mg/kg dose level for ADG116 monotherapy. Combination dosing optimization advances: Although ADG116 with toripalimab at 6 mg/kg did not meet the target toxicity level, 3 mg/kg of ADG116 every three weeks with toripalimab was both manageable within the TTL and demonstrated impressive efficacy in difficult-to-treat tumors. Further dose optimization is planned, including ongoing evaluation of an extended dosing interval of ADG116 every six weeks plus toripalimab to meet the desired TTL. Potential combination efficacy demonstrated in cold tumors, and an intriguing case study of a confirmed, durable complete response in head and neck cancer. Findings from a second poster, "A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of an Anti-CTLA-4 NEObody(TM) ADG116 in Combination with Pembrolizumab in Patients with Advanced/Metastatic Solid Tumors: A Preliminary Update", established a safe and potentially active dose level for ADG116 in combination with pembrolizumab. Data evaluating ADG116 in combination with pembrolizumab in six heavily pre-treated patients primarily with cold tumors further support the differentiated safety profile of ADG116 dosed at 3 mg/kg every three weeks, and its efficacy potential when combined with pembrolizumab at a flat dose of 200 mg. No TRAEs higher than Grade 3 were reported and no DLT was observed.
CLLS

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09:26 EST Cellectis presents preclinical data on TALEN-edited Smart CAR T-cells - Cellectis announced that preclinical data will be presented on TALEN-edited smart CAR T-cells overcoming key challenges of targeting solid tumors at the Society for Immunotherapy of Cancer's 37th Annual Meeting. The poster presentations highlight the following preclinical data: Title "Multi-armored allogeneic MUC-1 CAR T-cells efficiently control triple negative breast cancer tumor growth." This poster highlights TALEN-edited smart CAR T-cells targeting MUC1- expressing solid tumors. MUC1 is a tumor-associated antigen that is overexpressed in triple-negative breast cancer and other solid tumor malignancies. MUC-1 CAR T-cells infiltrate tumors more efficiently and extend survival when enhanced with attributes catered towards the tumor microenvironment of TNBC tumors. TGFBR2 knock-out circumvents the inhibitory effects of TGFbeta1, and IL-12 release follows CAR T-cell activation pattern restricting it to the tumor site for increased safety. Enhanced MUC-1 CAR T-cells could address some of the current challenges in development of CAR Ts for TNBC patients with unmet medical needs. Overall, the company can efficiently generate allogeneic CAR T-cells and engineer them to overcome several key challenges of immune suppressive solid tumors. Title: "TALEN(R)-edited smart CAR T-cells leverage solid tumor microenvironment for specific and effective immunotherapy." This poster highlights innovative T-cell engineering strategies designed to increase the activity of CAR T-cells for solid tumors while mitigating toxicity risk. Therapeutic efficacy of CAR T-cell therapy has so far been restricted to only a few malignancies, with solid tumors proving to be especially recalcitrant to efficient therapy. Our TALEN(R)-based gene editing platform allows innovative T cell engineering strategies that can combat some of the challenges posed by CAR T cell development for solid tumors.Inducible expression of a tumor-antigen directed CAR by a constitutive CAR specific to TME cues greatly enhanced anti-tumor activity, while limiting 'on target, off-tumor' cytotoxicity. Additionally, CAR-induced gene expression could boost anti-tumor CART only within the TME. Cellectis' gene editing strategies could increase CAR T cell persistence and anti-tumor activity while staying restricted to the tumor milieu. This proof-of-concept study demonstrates the feasibility of developing CART cell engineering strategies that can improve solid tumor targeting while mitigating potential safety risks, paving the way for clinical development.
DSX

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09:25 EST Diana Shipping announces delivery of m/v DSI Polaris - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has taken delivery of the m/v DSI Polaris, a 2018 built Ultramax dry bulk vessel of 60,404 dwt. The vessel is one of nine modern Ultramax dry bulk vessels that the Company entered into an agreement to purchase in August 2022.
CEAD

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09:25 EST CEA Industries unit announces non-equity strategic alliance with Hydrobuiler - Surna Cultivation Technologies, a subsidiary of CEA Industries, has entered into a non-equity strategic alliance, combining its controlled environment agriculture systems engineering and technologies with Hydrobuilder Holdings' commercial-first omnichannel platform. "Solidifying this relationship with Hydrobuilder Holdings is a breakthrough achievement for Surna," stated Tony McDonald, Chairman and CEO of CEA Industries Inc. "Our combined offering can fully serve our customers with every conceivable service and product they would need to build out or refurbish an indoor cultivation facility. I am confident this will not only be of great value to our customers but will be a great source of growth for both our companies."
TIVC

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09:25 EST Tivic Health announces manufacturing partnership with Microart Services - Tivic Health announced it has entered into an agreement with Microart Services, headquartered in Buffalo, New York, to manufacture, on a non-exclusive basis, certain components and sub-assemblies of the company's current and future products.
PSHG

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09:25 EST Performance Shipping announces delivery of M/T P. Aliki - Performance Shipping announced that, through a separate wholly-owned subsidiary, it has taken delivery of the M/T P. Aliki, a 2010-built LR2 Aframax oil product tanker of 105,304 dwt that the Company entered into an agreement to purchase in August 2022. As previously announced, the M/T P. Aliki was acquired for a total purchase price of US$36.5 million and financed with US$18.25 million cash on hand and US$18.25 million from the recently announced term loan facility with Alpha Bank S.A. The vessel is the Company's first LR2. Following the delivery, as previously disclosed, the vessel will enter into a time charter contract with Trafigura Maritime Logistics Pte Ltd. commencing in mid-November at a daily rate of US$45,000 per day for a period of minimum seven months to a maximum of ten months at the option of the charterer.
ALLK

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09:24 EST Allakos presents preclinical data on AK007 - Allakos announced a poster presentation at the Society for Immunotherapy of Cancer's, SITC, 37th Annual Meeting. The poster presentation highlights pre-clinical data supporting Siglec-10 as a promising myeloid target for enhancing anti-tumor immunity in solid tumors. SITC Poster Details: The poster titled "Antibody blockade of the immunoinhibitory receptor Siglec-10 polarizes tumor-associated myeloid cells and promotes anti-tumor immunity" will be presented on Friday, November 11th, key findings include: Siglec-10 is a myeloid inhibitory checkpoint receptor selectively expressed on tumor associated macrophages and dendritic cells. Siglec-10 expression is upregulated in multiple solid cancers and inversely correlates with patient survival in colon adenocarcinoma. Siglec-10 antagonist mAb monotherapy treatment inhibited tumor growth in a syngeneic colon adenocarcinoma model in Siglec-10 transgenic mice. Reduced tumor growth was associated with an expansion and activation of TAMs, dendritic cells, and T lymphocytes in the tumor, consistent with the mechanism of action.
STZ

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09:24 EST Constellation Brands completes elimination of Class B Common Stock - Constellation Brands completed the previously announced reclassification transaction and eliminated its Class B Common Stock. Trading in the Class B Common Stock will cease after the markets close today, at which time Constellation's publicly listed stock will consist solely of Class A Common Stock. In connection with completing the transaction, the company has deposited for distribution the $64.64 per share cash consideration, or approximately $1.5 billion in aggregate, to holders of Class B Common Stock. Financing for the cash payment was provided through funding of the previously announced delayed draw term loan credit agreement and Constellation's existing commercial paper program. The interest expense associated with this financing is expected to be $80 - $90 million on an annual basis based on current market rates. Giving effect to the interest expense associated with the financing, the company now expects interest expense for fiscal 2023 to be approximately $390 - $400 million. As part of the delayed draw term loan agreement, Constellation has the right to prepay the borrowing in whole or in part, without premium or penalty, ahead of its three-year maturity date. In addition, upon completion of the transaction, Robert and Richard Sands, who previously served as Executive Chairman of the Board and Executive Vice Chairman of the Board, respectively, retired from their executive positions with Constellation. As a result of the retirement of Robert and Richard Sands from their executive positions, Constellation expects to realize an estimated $15 - $20 million in pretax annual compensation savings. The company anticipates to initially attain $15 million of these annual savings in fiscal 2024 and to reach the estimated $15 - $20 million in run-rate savings within three years of the reclassification transaction as certain benefits accessible by Robert and Richard Sands are terminated.
MDNA

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09:23 EST Medicenna reports data from Phase 1/2 ABILITY study of MDNA11 - Medicenna Therapeutics announced new safety, pharmacokinetic, and pharmacodynamic data from the first four dose escalation cohorts of the Phase 1/2 ABILITY study of MDNA11, the Company's "beta-only" long-acting IL-2 super-agonist. The data are featured in two posters being presented at the Society for Immunotherapy of Cancer, or SITC, 37th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8-12. The ABILITY study is currently enrolling patients in its fifth dose-escalation cohort, two 30 microgram/kg "priming" doses of MDNA11 followed by fixed doses of 90 microgram/kg. Initial anti-tumor activity from the fifth dose escalation cohort, alongside a broader update from all of the trial's dose escalation cohorts, is expected in the first quarter of 2023. "The clinical data being presented at SITC are encouraging and reassert MDNA11's potential as a best-in-class IL-2 super-agonist by virtue of its desirable PK, PD, and safety features, along with the promising signs of anti-tumor activity it has displayed in heavily pre-treated, end-stage patients," said Fahar Merchant, PhD, President and CEO of Medicenna. "We were particularly pleased to see MDNA11's PK profile remaining consistent with repeat dosing, which suggests the absence of an anti-drug antibody response. Moreover, we have continued to see MDNA11 selectively and dose-dependently stimulating anti-cancer immune cells through ABILITY's low and mid-dose cohorts, suggesting potential for further increases in anti-tumor activity as we enroll patients in higher dose cohorts that employ the optimized dosing schedule that will be implemented in the trial's dose expansion phase."
VCNX

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09:23 EST Vaccinex, collaborators present two abstracts related to pepinemab trials - Vaccinex announced that two abstracts, including an oral presentation and a poster related to investigator-sponsored trials for pepinemab combinations, are being presented at The Society for Immunotherapy of Cancer's, SITC, 37th Annual Meeting. These studies describe novel biomarkers of response and resistance to immunotherapy that inform new potential treatment options in combination with Vaccinex's pepinemab antibody. Oral Presentation of pepinemab combinations with immune checkpoint blockade for neoadjuvant treatment of Stage III melanoma: Dr. Brian Olson presented results of a collaborative study with Vaccinex investigating biomarkers and benefit of neoadjuvant combination immunotherapy including Vaccinex's pepinemab antibody in patients with resectable Stage III melanoma who went on to receive adjuvant therapy with nivolumab after surgery. 100% of patients who received the triple combination of pepinemab, nivolumab and ipilimumab were recurrence free at 24 months. This contrasted with recurrence free survival of less than 40% in patients who received the dual combination of pepinemab and nivolumab or pepinemab and ipilimumab. Poster Presentation of pepinemab combination with adoptive cell therapy for patients with HER2+ metastatic breast cancer: The important role of CD4+ T cells in directing a productive immune response was also the rationale for an independent adoptive cell therapy trial in breast cancer presented by collaborators. In preclinical studies, it was shown that SEMA4D antibody blockade in combination with a dendritic cell vaccine improved trafficking of dendritic cells to tumors and stimulated expansion of tumor-specific B and T cells, resulting in improved regression of both primary and distant tumors.
TMNA

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09:22 EST Tingo Mobile launches operations in Ghana - Tingo opened a head office in Accra, Ghana and has launched nationwide operations. Tingo Mobile's business in Ghana is held through a wholly owned subsidiary, Tingo Mobile Ghana. Ghana is regarded as a hugely important market for Tingo Mobile and its Pan-African expansion strategy, not least because of its strong and well-developed agricultural sector, as well as its considerable and thriving export market in non-staple products. Tingo Mobile has committed to work closely with the Ghanaian Government and its Ministry of Food and Agriculture to achieve its goal of growing Ghana's agriculture sector's contribution towards Gross Domestic Product, to be in excess of 25% by 2025, compared to 19.1% in 2020, including through the improvement of crop production efficiency and crop yield, as well as the reduction of post-harvest losses. To coincide with its launch, Tingo Ghana has agreed on a landmark trade deal with the Kingdom of Ashanti, through the Ashanti Kingdom Investment Trust. The Kingdom of Ashanti presides over Ghana's Ashanti Region, which has a population of approximately 5.4 million, and through its dominant position in Ghana and Ghana's agricultural sector, also has a degree of influence over much of the country's population of 32 million. Under the terms of the trade deal, the Ashanti Kingdom Investment Trust has committed to enroll a minimum of 2 million new members with Tingo within 120 days of signing and has agreed on a target to increase such enrollments to at least 4 million members. Tingo Mobile is replicating in Ghana the same proven business model that has generated more than $526 million of revenues and $298 million of net income before tax in Nigeria in the first half of 2022. In addition to rolling out its Nwassa Agri-Fintech marketplace platform in Ghana, Tingo Mobile is also plans to launch the TingoPay SuperApp in the coming weeks, to include payment services, in partnership with Visa.
XAIR

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09:22 EST Beyond Cancer presents new invivo data at SITC meeting - Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc, announced promising new in vivo combination data that support the potential of the company's novel gaseous nitric oxide therapy to treat various types of solid tumors in combination with immune checkpoint inhibitor therapies, including anti-PD-1. These data were published in an abstract by the Society for Immunotherapy of Cancer and will be presented in a poster presentation today at the 37th Annual SITC Meeting in Boston, MA. "The results presented this week offer an encouraging first look at the potential synergistic effect of ultra-high concentration nitric oxide and anti-PD-1 therapy," stated Dr. Selena Chaisson, CEO and Director. "Immunotherapies are a cornerstone in current treatment options for tumors, and we are excited to see these in vivo data show the ability of a single treatment of UNO when used in combination with anti-PD-1 have a positive impact on tumor regression rates and overall survival. We believe these promising data provide a strong rationale for the continued advancement of this program in combination with immune checkpoint therapies.""Our previous work has shown the ability of UNO therapy to impart an immune response that is capable of preventing metastases in mice with CT26," stated Hila Confino, Chief Scientific Officer of Beyond Cancer. "Our combination data presented today at the SITC 2022 Annual Meeting show an effect on the primary tumor and, importantly, can treat metastatic disease and not just prevent it. We look forward to presenting further details on the ability of UNO to stimulate an anti-cancer immune response."
BCTX

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09:21 EST BriaCell reports breast cancer efficacy data with Bria-IMT treatment - BriaCell Therapeutics announces positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients. Disease control, tumor shrinkage, and potential survival benefit were observed amongst 12 patients in the Phase I/IIa clinical study of Bria-IMT in combination with Incyte's retifanlimab. Title: An off-the-shelf personalized cellular approach to immunotherapy for the treatment of advanced solid tumors: In summary, the findings show evidence of clinical and survival benefits in heavily pre-treated advanced breast cancer patients, suggesting an additive or synergistic effect of Bria-IMT in combination with PD-1 inhibitors, and supporting the strategy of using the Bria-IMT combination regimen with retifanlimab for the treatment of advanced breast cancer patients. Overall, the company is very impressed by the clinical data of the combination study to date and look forward to sharing additional data at the upcoming SABCS conference in December. Title: Evidence of immune system activation by Bria-OTS+ and Bria-PROS. Both Bria-OTS+ for advanced breast cancer, and Bria-PROS(TM) for advanced prostate cancer, were able to activate naive T cells, suggesting their potential capabilities to produce very strong immune responses in patients. Results show that the very strong immune responses observed may be due to: direct activation of the components of the immune system such as naive T cells, and indirect activation of the immune system components via production of immune activating molecules.
IMMP

Hot Stocks

09:21 EST Immutep reports 'encouraging' initial data from INSIGHT-003 at SITC 2022 - Immutep Limited announced "encouraging" initial clinical data from the investigator-initiated INSIGHT-003 trial has been published in a poster presentation at the Society for Immunotherapy of Cancer, or SITC, Annual Meeting 2022. INSIGHT-003 is the first trial evaluating Immutep's lead product candidate, eftilagimod alpha, or "IMP321," as part of a triple combination therapy with standard-of-care anti-PD-1 therapy and chemotherapy. Initial results from INSIGHT 003" provided initial efficacy details on 11 of 14 patients currently treated with subcutaneous efti in combination with pembrolizumab and doublet chemotherapy delivered intravenously in 1st line NSCLC patients. Safety-related information was provided for the 14 patients currently enrolled in the trial. The initial clinical data show that the approach is well-tolerated and provides "promising early signals" of therapeutic activity with an Objective Response Rate, or ORR, of 72.7% and a Disease Control Rate, or DCR, of 90.9%. 81.8% of patients had a PD-L1 Tumour Proportion Score of less than50%. This is generally consistent with the overall patient population in this indication where roughly 70% of patients have a PD-L1 expression level below 50%. These patients are usually less responsive to anti-PD-1 based therapy compared with patients having a TPS of greater than=50%, necessitating new approaches to fight their cancers. For the 9 patients in the INSIGHT-003 trial having PD-L1 TPS of less than 50%, the ORR was also a "promising" 66.7% and DCR was 88.9%.
NRIX

Hot Stocks

09:20 EST Nurix Therapeutics reports completion of DeTIL-0255 Phase 1 safety run-in - Nurix Therapeutics presented preclinical data supporting the utility of its CBL-B inhibitors to enhance cell therapy at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, which is being held November 8 - 12th in Boston. Nurix also announced the successful completion of the safety run-in portion of the ongoing Phase 1 trial of DeTIL-0255 in patients with advanced gynecologic malignancies and revealed that it has received feedback from the FDA regarding the potential combination of DeTIL-0255 with the oral CBL-B inhibitor NX-1607. The FDA feedback, the preliminary safety profile of DeTIL-0255, and the potential benefits of combining DeTIL-0255 with in vivo pharmacologic inhibition of CBL-B with NX-1607 provide a path for a potential future combination trial to explore whether inhibiting CBL-B both ex vivo and in vivo may enhance the anti-tumor potential of adoptive cell therapy. "We believe that our portfolio of first-in-class CBL-B inhibitors has the potential to improve outcomes for patients with solid tumors and enhance the field of cell therapy," said Robert J. Brown, M.D., executive vice president of clinical development at Nurix. "Pending successful completion of Nurix's NX-1607 Phase 1a dose escalation trial, we envision expanding the use of NX-1607 as a single agent in selected indications in 2023. We also can see a path to exploring the potential for a combination strategy with DeTIL-0255 in accordance with recent feedback from the FDA." The Phase 1 safety run-in includes three patients with advanced epithelial ovarian cancer who have been dosed with DeTIL-0255 and have cleared the initial safety evaluation. Expansion of the Phase 1 trial will be postponed, pending potential inclusion of NX-1607 in future cohorts.
AGFS

Hot Stocks

09:20 EST AgroFresh, Ceradis sign exclusive distribution agreement for CeraFruta - AgroFresh Solutions and Ceradis Crop Protection announced they have entered into an exclusive license and distribution agreement to bring CeraFruta, a new organic bio-solution that fights fungal decay, to the post-harvest space. The agreement between the two companies will launch in the U.S., leveraging AgroFresh's experience working with customers on innovative solutions that reduce food loss and promote sustainable agriculture. "AgroFresh is committed to bringing to market a full range of novel, natural and biologic solutions that maximize produce freshness and help reduce food loss and waste," said Clint Lewis, Chief Executive Officer for AgroFresh. "We're excited to collaborate with the team at Ceradis on this innovative new organic solution, helping our customers continue to find the most sustainable ways to deliver fresh produce to global consumers."
NRIX

Hot Stocks

09:19 EST Nurix Therapeutics announces initial Phase 1 NX-1607 data presented at SITC - Nurix Therapeutics presented initial biomarker data demonstrating successful target engagement of CBL-B in its ongoing Phase 1 clinical trial with oral dosing of NX-1607. These data are being presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, which is being held November 8 - 12th in Boston. Nurix has identified and characterized novel proximal biomarkers including phosphorylated hematopoietic lineage cell-specific protein 1 whose levels increase when CBL-B is inhibited and can be measured in ex vivo stimulated whole blood in animals and humans indicating the ability of these cells to become activated in the presence of an antigen signal such as those found in the tumor microenvironment. pHS1 is an important downstream signal of T cell activation. Preliminary pharmacokinetics and pharmacodynamic measurement of pHS1 were used to characterize the activity of NX-1607 in a first-in-human clinical trial. These data demonstrate dose-responsive target engagement as measured by increases in biomarker levels in stimulated human whole blood with NX-1607 treatment reaching levels associated with anti-tumor activity in animal models at dose level 1 and increasing at higher doses. Preliminary PK data suggest NX-1607 has dose-proportional exposures and a mean half-life of 6 to 8 hours at doses ranging from 5 mg to 50 mg.
CDAK

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09:18 EST Codiak presents preclinical data on exoASO-STAT6, exoASO-C/EBPB - Codiak BioSciences announced new preclinical data from its exoASO-STAT6 and exoASO-C/EBPbeta programs. exoASO-STAT6, an engineered exosome precision medicine candidate designed to selectively deliver antisense oligonucleotides to disrupt STAT6 signaling in tumor-associated macrophages and induce an anti-tumor immune response, demonstrated a strong preclinical pharmacokinetic and pharmacodynamic profile in preclinical models. Codiak has also identified PD biomarkers with clinical translational potential and described a rationale for selecting cancer subtypes that could benefit from treatment with exoASO-STAT6."Taken together, these data presented at SITC paint a compelling picture of the potential of our programs and our platform. Our work on exoASO-STAT6 highlights broad activity across multiple challenging, checkpoint therapy-resistant preclinical models, robust and consistent translation from these models to clinical readiness, and our PD-driven approach to patient selection. Targeted delivery to hepatic TAMs in HCC represents a novel strategy for the precise delivery of drug payloads to the right population of patients," said Sriram Sathyanarayanan, Ph.D., Chief Scientific Officer, Codiak. "Our data with exoASO-C/EBPbeta demonstrate the potential for broad anti-tumor activity in extra-hepatic tumors mediated by a differentiated mechanism of myeloid cell delivery of ASOs to distant tumor sites, leading to modulation of MDSCs and resulting in a T-cell mediated anti-tumor activity."
CUE MRK

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09:18 EST Cue Biopharma reports new data from ongoing Phase 1 trial of CUE-101 combo - Cue Biopharma (CEU) announced the presentation of new "positive data" from its ongoing Phase 1 trial evaluating its lead interleukin 2 (IL-2)-based biologic, CUE-101 in combination with pembrolizumab, or Keytruda (MRK), as a first line therapy for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma, or HNSCC. The data will be presented in a poster at the Society for Immunotherapy of Cancer's 37th Annual Meeting, or SITC 2022, to be held in Boston, Massachusetts and virtually on November 8-12. The poster will also provide an update from the company's ongoing fully enrolled Phase 1b trial evaluating CUE-101 monotherapy as third line and beyond therapy in the same patient population. Additionally, the company will present two posters discussing the design of its ongoing Phase 1 trial evaluating its second IL-2 based candidate, CUE-102, for the treatment of Wilms' Tumor 1 positive malignancies, and preclinical data regarding its mechanistic effect in vitro and in vivo. "We are very encouraged with the overall response rate observed in the trial so far with CUE-101, and its potential to improve standard of care for HPV+ head and neck cancer patients," said Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the clinical trial. "There is an urgent need for more effective and durable treatment options with less side effects as more than half of all patients with recurrent/metastatic HNSCC given the current standard of care will experience disease progression. I look forward to following this promising CUE-101 clinical data through."
HOWL

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09:17 EST Werewolf Therapeutics presents preclinical data on mWTX-330 - Werewolf Therapeutics announced that it will present preclinical data on mWTX-330, a mouse surrogate of its interleukin-12 INDUKINETM product candidate, WTX-330, at the 37th Annual Meeting of the Society for Immunotherapy of Cancer being held November 8-12, 2022, in Boston, and virtually. Study data demonstrate that systemic administration of mWTX-330, a mouse surrogate INDUKINE molecule, generates potent anti-tumor activity in a cleavage-dependent manner and protective memory against re-challenge in multiple murine syngeneic tumor models. Additionally, the data showed substantial infiltration and robust IL-12 signaling in intratumoral CD8+ T cells. Data from the SITC poster presentation demonstrate that mWTX-330: generates robust anti-tumor immunity following activation in the tumor microenvironment; activates multiple immune cell populations, including CD8+ T cells, CD4+ T cells, and NK cells; protects against later rechallenge with the same tumor cell line in mice that rejected primary tumors; is better tolerated than chimeric IL-12, significantly expanding the therapeutic window of this cytokine due to the INDUKINE molecule design.
TPST

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09:17 EST Tempest Therapeutics presents data on TPST-1120 - Tempest Therapeutics announced the presentation of data on TPST-1120, an oral selective peroxisome-proliferator activated receptor-alpha antagonist, and TPST-1495, a dual antagonist of both EP2 and EP4 prostaglandin receptors, at the Society for Immunotherapy of Cancer 37th Annual Meeting taking place November 10-12, 2022 in Boston, MA. The biomarker results presented from the TPST-1120 Phase 1 clinical study demonstrate pharmacodynamic changes in circulating blood in patients who received clinical benefit from therapy that are consistent with blocking the activity of PPAR-alpha. In addition, data presented from TPST-1495 showed that its dual antagonism of EP2 and EP4 generated significantly greater immune activation in human immune cells and anticancer activity in mouse tumor models than single inhibitors of either receptor, or the COX-2 inhibitor, celecoxib. TPST-1120: "Pharmacodynamic and Predictive Biomarkers Associated with Response in Cancer Patients Treated with TPST-1120: a First-in-class, Small Molecule Antagonist of Peroxisome-Proliferator Activated Receptor-Alpha"" In a late-breaking poster presentation, data from a Phase 1 trial with monotherapy and nivolumab combination arms were used to assess gene expression changes in post-treatment whole blood from 30 patients and to perform baseline mutational analysis on ctDNA to identify potential biomarkers. The data showed that seven genes were modulated by TPST-1120 exposure, including genes associated with enhanced immune responsiveness, stimulation of monocytes or macrophages and PPAR-alpha blockade. The results were consistent across monotherapy and combination arms. Patients in the combination arm who had a partial response to treatment had significant elevations in multiple genes, including those associated with Th17 development, lipid transport and down-regulation of CD155, a TIGIT ligand. Mutational analysis revealed that patients with a PR or stable disease were more likely to bear mutations in isocitrate dehydrogenase and phosphatase and tensin homolog compared to patients with progressive disease. TPST-1495: "Dual Blockade of the EP2 and EP4 PGE2 Receptors with TPST-1495 is an Optimal Approach for Drugging the Prostaglandin Pathway" In a second presentation, the data demonstrated that TPST-1495 was more effective than EP2 and EP4 single antagonists, and the COX-2 antagonist, celecoxib, in mouse and human whole blood assays. TPST-1495 conferred a near complete restoration of immune function in cellular assays, even in the presence of high PGE2 concentrations. In lung carcinoma tumors and in a spontaneous tumor mouse model of CRC, TPST-1495 decreased tumor size and number of tumors. Immunohistochemistry analysis of the resected small intestine tumors revealed increased immune infiltrate and an enhanced adaptive immune transcriptional profile.
IKNA

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09:16 EST iKena: IK-175, nivolumab showed 20% ORR, 40% DCR in trial - Ikena Oncology presented initial clinical data from its ongoing IK-175 clinical program in urothelial carcinoma at the Society for Immunotherapy of Cancer 37th Annual Meeting in Boston, MA. Initial results demonstrate durable antitumor activity in heavily pretreated patients in both monotherapy and combination arms in urothelial carcinoma patients who all progressed on prior checkpoint inhibitors. Data highlights: Durable antitumor activity across evaluable patients; Initial analysis included 43 patients treated across all arms; Dose expansion in urothelial carcinoma: 20 response evaluable patients. IK-175 monotherapy: 1 confirmed partial response with a duration of response of 14.9 months and ongoing; 1 stable disease patient; IK-175 combination with nivolumab: 2 confirmed partial responses with DoR 4.5-6 months and ongoing; 2 stable disease patients. Overall response rate 20%, disease control rate 40%. IK-175 was well tolerated, with a predictable and manageable safety profile.
PRTG

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09:15 EST Portage Biotech presents updated data on Phase 1/2 trial on PORT-2 - Portage Biotech announced the presentation of updates from its ongoing Phase 1/2 study of PORT-2, an invariant natural killer T cell agonist for patients with non-small cell lung cancer and advanced melanoma, at the Society for Immunotherapy of Cancer's 37th Annual Meeting. "We are encouraged by the growing patient data set that supports the preliminary Phase 1 results showing that PORT-2 has a favorable safety and tolerability profile as a monotherapy at all doses tested to date," said Dr. Ian Walters, Chief Executive Officer of Portage Biotech. "We continue to see single agent activity of PORT-2 at the 3 mg/m2 dose, which is the mid-dose level in our study. Based on the results so far, we are confident in the mechanistic potential of PORT-2 to activate both the adaptive and innate immune system and reduce the suppressive cells in the tumor microenvironment." Dr. Walters continued, "Furthermore, in these patient populations that have failed multiple previous lines of treatment, it is essential that we provide new therapeutic options that could be administered as a monotherapy or complement other approaches. Having recently announced our clinical collaboration with Merck, we are pleased to have begun treating patients with PORT-2 in combination with pembrolizumab. PORT-2 has been shown to increase PD-L1 expression and thus has the potential for synergistic combination with checkpoint inhibitors and for the expansion of the use of anti-PD-1 therapy to an entirely new group of patients who do not currently respond to treatment. Interestingly, we observed a dose dependent increase in CD86+ B cells (which function as antigen presenting cells) in the blood of patients following PORT-2, which has been associated with response to checkpoint inhibitors. We look forward to sharing further updates from the current study as well as progress in our randomized clinical trial evaluating PORT-2 as a monotherapy and in combination with pembrolizumab in the coming year."
ROIV

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09:14 EST Roivant's Affivant to present data on AFVT-2101 at SITC - Affivant, a Roivant Sciences company, will present a poster at the 37th Annual Meeting of The Society for Immunotherapy of Cancer, SITC, highlighting preclinical data for AFVT-2101. AFVT-2101 is a tetravalent, bispecific Innate Cell Engager that bridges folate receptor alpha on tumor cells with CD16A expressing innate immune cells, to induce potent and selective targeted tumor cell killing. The following poster will be presented live at SITC on November 11th: Title: AFVT-2101, an innate immune-cell engager that selectively targets FOLR1 expressing tumor cells to safely harness potent anti-cancer responses. The poster shows that AFVT-2101 binds selectively to CD16A. Physiological levels of competing IgG do not alter binding efficacy. AFVT-2101 induces potent and selective ADCC, even on FRalpha low expressing cell lines. AFVT-2101 is also shown to induce efficient ADCP in vitro. Co-culture of PBMCs, tumor cells and AFVT-2101 showed concentration-dependent release of pro-inflammatory cytokines and minimal off-target cytokine release, confirming a potent but safe in vitro profile of AFVT-2101.
BDSX

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09:13 EST Biodesix presents new data from INSIGHT study at SITC - Biodesix announced that Wallace Akerley, MD, medical oncologist at the University of Utah Huntsman Cancer Institute, will present new interim data from the large multi-center prospective observational registry study INSIGHT at the Society for Immunotherapy of Cancer, SITC, 37th Annual Meeting. The data highlights the ability of the VeriStrat test, a novel predictive and prognostic blood-based host immune classifier, to stratify immune checkpoint inhibition treatment response in patients with advanced non-small cell lung cancer, NSCLC. The poster, titled "Host Immune Profiling in First-line Immunotherapy Treated Advanced Stage Non-Small Cell Lung Cancer: Results from the INSIGHT Registry Study," will be presented on Friday, November 11. Results from a prior analysis of the VeriStrat test published in the Journal for ImmunoTherapy of Cancer in October 2021 demonstrated that approximately 2,000 patients with at least one year of follow up classified by VeriStrat as host immune classifier hot (HIC-Hot) had better outcomes, on average living 2-3 times longer when compared to patients classified by VeriStrat as host immune classifier cold. A classification of HIC-H, also known as VeriStrat Good, implies that the normal tumor directed immunity is active and patients are potentially responsive to therapies that boost immune response. HIC-C classification, also known as VeriStrat Poor, correlates to what experts refer to as an "immune desert," where tumor directed immunity is compromised.
CRBP

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09:12 EST Corbus Pharmaceuticals' CRB-601 shows tumor growth inhibition - Corbus Pharmaceuticals is presenting new preclinical data for CRB-601 in a poster presentation at the Society for Immunotherapy of Cancer Annual Meeting in Boston. The latest preclinical data demonstrate "significant tumor growth inhibition" by CRB-601 as a single agent and in combination with anti-PD-1 treatment. In addition, treatment with CRB-601 appears to restore sensitivity to checkpoint inhibitors in the Pan02 and 4T1 syngeneic tumor models, regarded as "desert" tumors that are non-responsive to current CPIs. Collectively these data suggest that treatment with CRB-601 could address tumors with an immune excluded phenotype, as represented by this model, and facilitate sensitization to anti-PD-1 therapy. "CRB-601 demonstrates robust pre-clinical anti-tumor activity alone and in combination with anti-PD-1 therapy in tumors exhibiting a range of sensitivities to anti-PD-1 therapy. The ability of CRB-601 to significantly reduce the growth of tumors that are non-responsive to CPIs and to sensitize these tumors to CPI therapy continues to support our hypothesis that effective blockade of latent TGFbeta activation should lead to enhanced immune cell invasion in the tumor microenvironment and augment the effects of anti-PD-1 therapy. The increased activity of CRB-601 in tumors expressing alphavbeta8 provides a promising biomarker for patient selection and stratification," commented Rachael Brake, Chief Scientific Officer. Corbus is currently developing CRB-601 as a potential treatment for solid tumor cancers, and the program is on schedule for an IND submission in mid-2023.
ZEAL

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09:12 EST Zealand Pharma expects revenue from license agreements in 2022 - The company will no longer provide guidance on net product revenue, reflecting the completion of the asset purchase agreement for V-Go with MannKind Corporation and the completion of the global license and development agreement for Zegalogue with Novo Nordisk. In 2022, Zealand expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, Zealand does not intend to provide guidance on such revenue. Net operating expenses in 2022 are expected to be DKK 1,000 million +/-10%*. This is unchanged from our updated guidance issued on March 30, 2022.
FUV

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09:11 EST Arcimoto announces new experience center at Royal Sonesta Kaua'i Resort Lihue - Arcimoto announced plans to open Arcimoto Kaua'i, a new experience center located at Royal Sonesta Kaua'i Resort Lihue. First rentals are anticipated to begin in December. "Kaua'i is a leader in eco-tourism, with a community focused on sustainability and preserving this very special island. We're thrilled to bring Arcimoto vehicles to the Royal Sonesta for an unforgettable, sustainable driving experience," said Lynn Yeager, Arcimoto Chief Experience Officer. "With limited rental car availability and over 100,000 monthly visitors to Kaua'i, we are able to offer hotel guests, tourists and the local community a one-of-a-kind, pure-electric way to explore one of the most beautiful places on the planet. The Royal Sonesta will be a flagship location in our rental business as we continue to partner with amazing hotels in destination cities worldwide."
SNSE

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09:10 EST Sensei Biotherapeutics presents preclinical data at SITC for SNS-101 - Sensei Biotherapeutics presented preclinical data for SNS-101, a conditionally active VISTA-blocking antibody, as well as characterization of VSIG4, an immune checkpoint targeted by Sensei's discovery-stage SNS-102 program, at the Society for Immunotherapy of Cancer, SITC, 37th Annual Meeting. Poster presentation titled, "SNS-101, a highly pH-selective VISTA:PSGL-1 inhibitory antibody, potentiates anti-PD-1 sensitivity, expands memory T-cells and enhances tumor infiltration of CD8 T-cells" Summary: SNS-101 did not bind to human or non-human primates VISTA+ monocytes, neutrophils and natural killer cells in blood or other normal tissue compartments. SNS-101 induced significant expansion of naive CD8 T-cells and memory CD4 and CD8 T-cells in vivo without activation or depletion of monocytes. SNS-101 exhibited linear elimination kinetics in non-human primates, overcoming TMDD-induced pharmacokinetic limitations observed with other anti-VISTA antibodies. IND filing for SNS-101 is anticipated in the first half of 2023. Poster presentation titled, "Functional characterization of the inhibitory activity and identification of novel T-cell receptors for the tumor-associated macrophage receptor VSIG4." Highlights: Development of multiple functional assays demonstrated VSIG4-mediated suppression of primary human CD4 T-cells. Through the LRC-TriCEPS proteomics screen, a set of potentially novel T cell receptor candidates that interact with VSIG4 were identified. A Cas9/CRISPR-based target gene knockdown methodology will be implemented for validation of VSIG4-interacting T-cell receptor candidates. An initial set of pH-selective anti-VSIG4 antibodies have been identified and further optimization is ongoing to identify a lead antibody.
NRIX

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09:10 EST Nurix Therapeutics announces initial NX-1607 Phase 1 data - Nurix Therapeutics presented initial biomarker data demonstrating successful target engagement of CBL-B in its ongoing Phase 1 clinical trial with oral dosing of NX-1607. These data are being presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, which is being held November 8 - 12th in Boston. NX-1607 Program: Title: Initial clinical characterization of novel proximal biomarkers for NX-1607, a first-in-class oral CBL-B inhibitor, in patients with advanced malignancies: Nurix has identified and characterized novel proximal biomarkers including phosphorylated hematopoietic lineage cell-specific protein 1 whose levels increase when CBL-B is inhibited and can be measured in ex vivo stimulated whole blood in animals and humans indicating the ability of these cells to become activated in the presence of an antigen signal such as those found in the tumor microenvironment. pHS1 is an important downstream signal of T cell activation. Preliminary pharmacokinetics and pharmacodynamic measurement of pHS1 were used to characterize the activity of NX-1607 in a first-in-human clinical trial. These data demonstrate dose-responsive target engagement as measured by increases in biomarker levels in stimulated human whole blood with NX-1607 treatment reaching levels associated with anti-tumor activity in animal models at dose level 1 and increasing at higher doses. Preliminary PK data suggest NX-1607 has dose-proportional exposures and a mean half-life of 6 to 8 hours at doses ranging from 5 mg to 50 mg. Title: NX-1607, a small molecule inhibitor of the CBL-B E3 ubiquitin ligase, promotes T and NK cell activation and enhances NK-mediated ADCC in a mouse lymphoma tumor model: These studies demonstrate that in addition to enhancing T-cell activation, NX-1607 renders T cells resistant to Treg and TGF-beta-mediated suppression. In addition, the data demonstrate that NX-1607 treatment augments NK cell activity both in vitro, in an antibody-dependent cellular cytotoxicity assay using human NK cells, and in vivo, in a xenograft mouse tumor model. In a murinexenograftmodel of non-Hodgkin's lymphoma, the combination of NX-1607 and rituximab significantly enhanced tumor growth inhibition and tumor rejections when compared to single agents' activity. Importantly, the survival benefit provided by the combination of NX-1607 plus rituximab was abrogated by depletion of NK cells.
NKTR MRK

Hot Stocks

09:09 EST Nektar's NKTR-288 shows enhanced anti-tumor activity in - Nektar (NJTR) announced the first presentation of preclinical data for NKTR-288 at the 2022 Society for Immunotherapy of Cancer Annual Meeting. NKTR-288 is a novel polyethylene glycol-conjugate of interferon gamma designed to modify binding of IFN-gamma to its substrates and optimize the duration of IFN-gamma signaling. IFN-gamma is a cytokine that induces cellular antigen presentation and enhances tumor antigen-specific cytotoxic T cell response, and may have applications in a number of therapeutic areas, including oncology and infectious diseases, among others. The presentation showed the sustained pharmacological properties of NKTR-288 relative to native cytokine, including durable exposure and induction of the well characterized interferon gamma response. These data support further evaluation of NKTR-288 as a monotherapy or in combination with checkpoint inhibitors in the clinical setting. Also presented at SITC by Nektar's partner, Merck (MRK), is a trials in progress poster of the Phase 2 JAVELIN Bladder Medley study. The ongoing clinical trial includes evaluation of Bavenio - avelumab -, Merck's anti-PD-L1 therapy, in combination with NKTR-255, Nektar's IL-15 receptor agonist designed to increase the proliferation and survival of natural killer cells and memory CD8+ T cells to enhance anti-tumor immunity. Merck KGaA is running this study and is on track to generate comparative progression-free survival data for this study by the end of 2024.
HSCS

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09:08 EST HeartSciences' MyoVista technology used to develop AI-ECG algorithm - Heart Test Laboratories announced that an independent study utilizing its MyoVista proprietary technology was featured in Advocate Aurora Health's Journal of Patient-Centered Research and Reviews. The publication concluded that the MyoVista technology ECG-derived machine learning model "provides a cost-effective strategy for predicting patient subgroups in whom an integrated milieu of systolic and diastolic dysfunction is associated with a high-risk of major adverse cardiovascular events." Key study highlights: Patients from West Virginia University served as the validation set and were followed up over a three-year period for clinical outcomes including MACE rehospitalization and cardiac death. Results demonstrate the potential of AI-ECG algorithms for rapid decision-making in an office-based setting to evaluate and monitor the progress of the patient and justify appropriate downstream referral for additional tests like echocardiography or other interventions. The Deep Neural Network AI-ECG model demonstrated significantly increased probability for identifying patients at high-risk compared to low risk of MACE. The AI-ECG model results were similar to an echo-based model, suggesting comparable utility. Data used to develop the AI-ECG algorithm was collected from a multi-center trial, which included 727 patients from the Icahn School of Medicine at Mount Sinai, The University of California Los Angeles and Windsor Cardiac Center, Windsor Ontario
GRTS

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09:07 EST Gritstone announces overall survival results from GRANITE Phase 1/2 study - Gritstone bio announced updated overall survival results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, for the treatment of advanced solid tumors. These results, along with results from a clinicopathologic analysis of metastatic MSS-CRC patients with and without a molecular response, will be presented via a poster at the Society for Immunotherapy of Cancer 37th Annual Meeting. The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, nivolumab and subcutaneous anti-CTLA-4 antibody ipilimumab in advanced solid tumors. This study enrolled and treated 29 patients with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. Of 13 patients with MSS-CRC, 6 experienced a molecular response defined as greater than or equal to30% reduction in circulating tumor DNA and continue to have an overall survival advantage compared to those patients without a molecular response.Updated OS data from GRANITE Phase 1/2: 6 of 13 treated patients with MSS-CRC had a molecular response and the observed median overall survival in this group will now exceed 22 months. This compares to a median overall survival not yet reached and exceeding 18 months as reported in May 2022. Clinicopathologic characteristics from GRANITE Phase 1/2: 4 of 6 patients with molecular response had liver metastasis. All patients had PD-L1 expression less than1% and low levels of IFNg-related gene expression. Median tumor mutational burden was 2.9 and 3.6 mutations/MB in those with and without molecular response, respectively.
ALLO

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09:07 EST Allogene Therapeutics presents pre-clinical data on immune 'cloaking' - Allogene Therapeutics presented pre-clinical data on a novel approach to immune "cloaking" designed to protect AlloCAR T cells from rapid host rejection. The technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer cell rejection and while preserving CAR T cell function. The findings were presented today during a poster session at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, SITC. The development of "off-the-shelf" CAR T products that utilize cells from healthy donors have the potential to make CAR T therapies scalable and accessible to more patients. This preclinical study evaluated an alternative approach to immune evasion by selectively targeting NLRC5 and RFX5, transcriptional regulators that control expression of HLA molecules. NLRC5 knockout avoids CD8 T cell mediated rejection and RFX5 knockout avoids rejection by both CD8 and CD4 T cells, allowing the possibility to avoid a broader spectrum of T cell-mediated rejection with just one edit, in contrast to alternative approaches that require two edits. "We believe that novel approaches to cloaking may further increase the efficacy of off-the-shelf CAR T products through avoidance of immune rejection," said Barbra Sasu, Ph.D. Chief Scientific Officer at Allogene. "As we look to deliver on the promise of AlloCAR T cell products, we are investigating several novel approaches to supplement or potentially even replace our current platform for immune rejection avoidance. The data presented today is promising, showing that knockout of NLRC5 and RFX5 reduced T cell rejection whilst minimizing NK cell rejection and without impacting CAR T cell performance."
CHH

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09:07 EST Choice Hotels signs agreement with Noble Investment Group - Choice Hotels signed an agreement with Noble Investment Group to develop nine WoodSpring Suites hotels in Georgia and South Carolina over the next two years, signaling increased institutional interest in the largest economy extended-stay brand in the market.
ONCY RHHBY

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09:06 EST Oncolytics' pelareorep shows 69% response rate in pancreatic cancer study - Oncolytics (ONCY) announced updated results from the phase 1/2 GOBLET study's first-line advanced/metastatic pancreatic ductal adenocarcinoma cohort. Patients in this cohort are treated with the combination of pelareorep, Roche's (RHHBY) anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The updated data are featured in a poster presentation at the ongoing Society for Immunotherapy of Cancer 37th Annual Meeting in Boston. Objective response rate and clinical benefit rate in GOBLET's PDAC cohort - n=13 - were 69% and 85%, respectively, as of the SITC poster's data cutoff date. One of thirteen evaluable patients achieved a confirmed CR, eight of thirteen evaluable patients achieved a PR, two of thirteen evaluable patients achieved stable disease. The observed ORR of 69% is substantially higher than the average ORR of ~25% reported in historical control trials of gemcitabine and nab-paclitaxel in pancreatic cancer. The studied treatment combination has been well tolerated, with no safety concerns identified to date.
MICT TMNA

Hot Stocks

09:06 EST Tingo Mobile launches operations in Ghana - MICT, Inc. (MICT) and Tingo, Inc. (TMNA), announced that Tingo Mobile, which is being wholly acquired by MICT with a scheduled completion date of November 30, 2022, has today opened a head office in Accra, Ghana and has launched nationwide operations. Tingo Mobile's business in Ghana is held through a wholly owned subsidiary, Tingo Mobile Ghana. Ghana is regarded as a hugely important market for Tingo Mobile and its Pan-African expansion strategy, not least because of its strong and well-developed agricultural sector, as well as its considerable and thriving export market in non-staple products. Tingo Mobile has committed to work closely with the Ghanaian Government and its Ministry of Food and Agriculture to achieve its goal of growing Ghana's agriculture sector's contribution towards Gross Domestic Product, to be in excess of 25% by 2025 compared to 19.1% in 2020, including through the improvement of crop production efficiency and crop yield, as well as the reduction of post-harvest losses. To coincide with its launch, Tingo Ghana has agreed on a landmark trade deal with the Kingdom of Ashanti, through the Ashanti Investment Trust. The Kingdom of Ashanti presides over Ghana's Ashanti Region, which has a population of approximately 5.4 million, and through its dominant position in Ghana and Ghana's agricultural sector, also has a degree of influence over much of the country's population of 32 million. Under the terms of the trade deal, the Ashanti Investment Trust has committed to enroll a minimum of 2 million new members with Tingo within 120 days of signing and has agreed on a target to increase such enrollments to at least 4 million members. Tingo Mobile is replicating in Ghana the same proven business model that has generated more than $526 million of revenues and $298 million of net income before tax in Nigeria in the first half of 2022. In addition to rolling out its Nwassa Agri-Fintech marketplace platform in Ghana, Tingo Mobile also plans to launch the TingoPay SuperApp in the coming weeks, to include payment services, in partnership with Visa. The Nwassa platform is expected to benefit from significant revenues on both the buy-side and sell-side in Ghana where, because of more developed agricultural practices, farmers have a greater demand for inputs, including equipment, fertilizers, and pesticides, for example. Such market conditions in Ghana are expected to lead to a higher level of Average Revenue Per User, which in turn is expected to lead to a further increase in profitability in 2023 and beyond.
IMRX

Hot Stocks

09:05 EST Immuneering presents preclinical data on its second program IMM-6-415 - Immuneering reported promising preclinical data in a poster presentation at the Society for Immunotherapy of Cancer, SITC, 37th Annual Meeting, highlighting the activity of IMM-6-415, the company's second program. Highlights from the presentation are as follows: Title: Cyclic disruption of the mitogen-activated protein kinase pathway by the Dual MEK inhibitor, IMM-6-415, enhances PD1 and CTLA4 checkpoint blockade in RAS mutant tumors. In this preclinical study, Immuneering researchers tested IMM-6-415 alone and in combination with anti-PD1 or CTLA4 checkpoint inhibitors in a series of preclinical models to characterize single-agent activity as well as combination therapy with checkpoint inhibitors in RAS-mutant colorectal cancer and non-small cell lung cancer models driven by diverse MAPK pathway mutations. Cell-based 2D biochemical and 3D pharmacologic assays were performed showing that IMM-6-415 reduced pERK and pMEK across all RAF and RAS mutant models tested. Humanized 3D tumor models revealed a promising sensitivity profile for IMM-6-415 in RAF- and RAS-mutant models. Multiple in vivo studies were performed in RAS mutant and wildtype models. The maximum effective dose for BID dosing of IMM-6-415 was 175 to 180 mg/kg BID PO based on Colon 26 and A549 animal studies, yet enhanced MEKio + CPI combinations were identified at only 120 mg/kg BID PO IMM-6-415. At 28 days treatment, 33% of CT-26 mice remained on study in the anti-PD-1 or anti-CTLA-4 alone treated groups, whereas 58% mice remained in the IMM-6-415 treatment arm at 120 mg/kg BID PO. However, 92% and 83% mice remained in the IMM-6-415 plus anti-PD-1 or anti-CTLA-4 combination at the same doses.
BGS

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09:05 EST B&G Foods cuts quarterly dividend to 19c from 47.5c per share - Along with its Q3 earnings announcement yesterday, B&G Foods also declared a reduced quarterly cash dividend of $0.19 per share of common stock. The dividend is payable on January 30, 2023 to stockholders of record as of December 30, 2022.
RL

Hot Stocks

09:04 EST Ralph Lauren expects choppiness to continue in NT, says consumer 'resilient' - Comments taken from Q2 earnings conference call.
JRSH

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09:02 EST Jerash Holdings enters MOU for JV with Busana Apparel Group - Jerash also announced that on November 9, 2022, it signed a memorandum of understanding to establish a joint venture company with Busana Apparel Group to produce garments for Busana's retail customers that are expressing interest to geographically diversify and add production in Jordan, which has long-standing duty-free export agreements with the U.S., the EU and other countries.
BA

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09:01 EST Boeing, Silk Way West Airlines announce order for 777-8 Freighters - Boeing and Silk Way West Airlines have finalized an order of two 777-8 Freighters, with options for two additional airplanes. The two companies announced the agreement at a signing ceremony today at Boeing Commercial Airplanes' Seattle Delivery Center.
BCLI

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09:00 EST BrainStorm trading resumes
MRNA

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08:58 EST Moderna shares ESG highlights at first ESG Day - Moderna highlighted progress on its environmental, social and governance strategy presented at the Company's first ESG Day. "As a company, we care deeply about our patients, our employees, the environment and our communities. We recognize that we have an opportunity to change medicine for all, and we will continue to make corporate responsibility a critical part of who we are and what we do," said Stephane Bancel, Moderna's Chief Executive Officer. "Maintaining our focus on ESG is a key part of our work at Moderna, and we will continue to engage, listen and understand what our stakeholders expect from us as a sustainable responsible business and leader in mRNA medicines." Moderna's efforts are driven by the belief that: With the potential of our science comes a responsibility to the multitude of patients our technology could help, regardless of whether they have a disease shared by millions, or one that is unique to them alone. We have a responsibility to help ensure the sustainability of our planet, and we will consider our impact on the environment in the decisions that we make. We can and should use our expertise and resources to give back to the communities in which we operate. We have a responsibility to our employees to provide fulfilling, purposeful careers. We hold ourselves to high ethical standards across all areas of our business and with our stakeholders while ensuring we have the governance and practices in place to meet these standards. Moderna launched its corporate social responsibility framework in 2018 and released its first ESG report in June 2022. Moderna's corporate responsibility strategy considers the needs and priorities of its key stakeholders and the areas where the Company believes it can have a direct impact today and in the future. The Company's work is centered on five focus areas: Medicines for Patients, Culture & Employees, Community, Environment, and Governance & Ethics.
ASPI

Hot Stocks

08:57 EST ASP Isotopes announces pricing of IPO, Nasdaq listing - ASP Isotopes announced the pricing of its initial public offering of 1,250,000 shares of its common stock at a public offering price of $4.00 per share, for aggregate gross proceeds of approximately $5.0 million before deducting underwriting discounts, commissions, and other offering expenses. In addition, ASPI has granted the underwriters a 45-day option to purchase up to an additional 187,500 shares of common stock at the public offering price per share, less the underwriting discounts and commissions, to cover over-allotments, if any. The shares are expected to begin trading on the Nasdaq Capital Market LLC on November 10, 2022, under the ticker symbol "ASPI" and the offering is expected to close on or about November 14, 2022, subject to satisfaction of customary closing conditions. Revere Securities LLC is acting as sole book-running manager for the offering.
VOXR FQVLF

Hot Stocks

08:53 EST Vox Royalty acquires Canadian royalty porfolio from First Quantum Minerals - Vox Royalty announced that it has executed a binding royalty sale and purchase agreement dated November 9, 2022 with First Quantum Minerals to acquire rights to a portfolio of up to four Canadian royalties, for total consideration of up to C$650,000. Pursuant to the terms of the purchase and sale agreement, on closing, Vox will issue C$525,000 of Vox common shares, being 164,319 common shares at an issue price of C$3.1950 per common share for the Estrades and Opawica royalties. Closing of the Transaction remains conditional upon final acceptance by the TSX Venture Exchange. Additional closings and cash payments of C$100,000 and C$25,000 will be due and payable following the exercise of separate third-party option agreements, the issuance of the Winston Lake and Norbec & Millenbach royalties to FQM, and the assignment of the Winston Lake and Norbec & Millenbach royalties to Vox. The Transaction is subject to the final acceptance of the TSX Venture Exchange, which the Company expects will be delivered during Q4 2022.
BWV

Hot Stocks

08:52 EST Blue Water expects cash to fund operations through end of Q3 of 2024 - Cash was $29.1 million as of September 30, 2022, as compared to $1.9 million as of December 31, 2021. The increase was primarily due to the closing of BWV's initial public offering in February 2022, a private placement that closed on April 19, 2022, and a private placement that closed on August 11, 2022. The Company believes its cash and cash equivalents are sufficient to fund operations through at least through the end of Q3 2024.
BWV

Hot Stocks

08:51 EST Blue Water announces 5M share repurchase program - On November 9, 2022, the Board approved a share repurchase program to allow for the Company to repurchase up to 5 million shares, with discretion to management to make purchases subject to market conditions.
CRHC

Hot Stocks

08:48 EST Cohn Robbins Holdings trading halted, news pending
IDR

Hot Stocks

08:48 EST Idaho Strategic provides highlights from latest Paymaster hole - Idaho Strategic Resources is pleased to provide highlights from its latest Paymaster hole, GC 22-224. The goal of the latest holes in this area between the Paymaster and Joe Dandy Shoots of the Golden Chest is to test the potential of 'connecting' the two shoots at the 800-Level underground and defining additional gold resources. The "800-Level" is of specific importance given it is also the level of current underground production in the Skookum Shoot, which lies directly north of the Paymaster. If indeed the Paymaster and Joe Dandy connect at or near the 800-level, it could provide the Company the opportunity to mine two veins within the same shoot, which should greatly improve efficiency and ultimately production costs. The Company is in the process of evaluating the costs to determine if/when development into the Paymaster-Joe Dandy area may make sense. The highlight of GC 22-224 is the 54.7 grams per tonne gold vein intercept over 0.32 meters true thickness, from 133.6 m to 134.1 m and 27.0 grams per tonne gold intercepted over 0.19 meters true thickness from 134.1 m to 134.4 m. As previously discussed, and as illustrated in the tables below, the Joe Dandy and Paymaster share similar characteristics - such as gold-bearing veins flanking either side of a quartz monzonite sill. Thus far, it appears the Paymaster could be accessed by connecting to the existing Skookum ramp as an escapeway and driving a new ramp for haulage purposes. Core hole GC 22-224 was drilled just prior to moving the company drill rig to the previously discussed summer drill locations in the Murray Gold Belt. IDR's Vice President of Exploration, Rob Morgan commented, "We have always been excited about the potential of the Paymaster and Joe Dandy shoots at the Golden Chest. It is only recently that production/development has reached a depth in the Skookum shoot where it may make sense to begin development toward the Paymaster and Joe Dandy. Based on our drill results and our knowledge of the Golden Chest Mine, the Paymaster and Joe Dandy look to be steady and predictable veins with extremely good ground support, which is exactly what we like to see when it comes to increased mining and associated economics."
AREC

Hot Stocks

08:47 EST American Resources announces $200K state-level grant from Indiana - American Resources announced that it has been awarded a $200,000, state-level, advanced manufacturing grant from the Indiana Economic Development Corporation for its patented critical battery element purification and separation technology being commercialized in Noblesville, Indiana.
YTEN

Hot Stocks

08:47 EST Yield10 Bioscience beings winter 2022/2023 field test, seed production program - Yield10 Bioscience announced that the Company has begun its winter 2022/2023 field test and seed production program for Camelina at sites in the United States, Canada, Argentina and Chile. Yield10's winter 2022/2023 field test program, which is being conducted at more than 20 sites, is intended to evaluate several varieties of elite Camelina by collecting data on agronomical performance, seed yield, oil content, and herbicide tolerance, where applicable. Herbicide Tolerance: Yield10 is conducting contra-season field tests of candidate herbicide tolerance traits in Camelina. Yield10 has selected potential commercial events of Camelina lines displaying herbicide tolerance and will evaluate field performance and conduct seed scale-up activities for producing seed for larger field tests planned for spring 2023. Agronomy Trials: Yield10 will conduct agronomy trials of winter Camelina varieties as part of a program to develop standardized protocols to achieve the best germination, stand establishment and yields. Commercial Seed Production: Yield10 has contracted with growers to plant Camelina varieties E3902, WDH3 and WDH2 to produce commercial seed. Demonstration Fields: As part of its market development efforts, Yield10 has planted winter Camelina in fields suitable for hosting grower events in 2023.
SLS MRK

Hot Stocks

08:46 EST Sellas Life Sciences announces data from its Phase 1/2 trial of galinpepimut-S - SELLAS Life Sciences Group (SLS) announced confirmatory top-line clinical data from the final analysis of results from its Phase 1/2 clinical trial of galinpepimut-S, the Company's Wilms Tumor-1-targeting peptide immunotherapeutic, in combination with Merck's anti-PD-1 therapy, pembrolizumab, in patients diagnosed with WT1 relapsed or refractory platinum-resistant advanced metastatic ovarian cancer. Data from 17 patients enrolled in the study, conducted under a Clinical Trial Collaboration and Supply Agreement with Merck (MRK), have undergone final analysis for safety and efficacy. All enrolled patients were resistant to standard of care platinum-based therapy and 76.5 percent of the patients were refractory to or had failed their first- or second-line therapies. Summary of Top-Line Overall Survival and Progression-Free Survival Data: Median Overall Survival was 18.4 months compared to 13.8 months in a checkpoint inhibitor single agent study in a similar patient population treated with checkpoint inhibitor alone; Median Progression-Free Survival was 12 weeks compared to eight weeks in a checkpoint inhibitor single agent study in a similar patient population treated with checkpoint inhibitor alone; The overall response rate of the trial is 6.3 percent with a disease control rate (DCR), which is the sum of overall response rate and rate of stable disease, of 50.1 percent at a median follow-up of 14.4 months. In a checkpoint inhibitor single agent study in a similar platinum-resistant ovarian cancer patient population treated with a checkpoint inhibitor alone, the observed DCR was 37.2 percent, consistent with a DCR rate increase of approximately 45 percent in the GPS combination with Keytruda over that seen for checkpoint inhibitors alone. Importantly, survival and disease control benefits were observed in patients harboring tumors with any level of detectable PD-L1 expression, i.e., those with Combined Positive Score, CPS, of one or higher. In the Phase 1/2 study, patients with a CPS score of less than one showed a median OS of 3.2 months vs. patients with a CPS greater than or equal to one who had a median OS of 18.4 months and, as it relates to time to progression, patients with a CPS score of less than one had a median PFS of 1.9 months and patients with a CPS score of greater than or equal than one showed a median PFS of 3.8 months. The safety profile of GPS in combination with pembrolizumab was similar to pembrolizumab alone, with the only addition of low-grade, rapidly resolving local reactions at the GPS injection site, consistent with observations from other GPS clinical studies.
LGVN

Hot Stocks

08:44 EST Longeveron announces completion of enrollment in Phase 2a trial of Lomecel-B - Longeveron announced the completion of enrollment in its Phase 2a trial of Lomecel-BTM in patients with mild Alzheimer's Disease, AD. "We are pleased to have completed enrollment in our Phase 2a study of Lomecel-BTM for Alzheimer's Disease. We look forward to building on our Phase 1b study, which met its primary endpoint of safety and was published in a leading journal, Alzheimer's and Dementia, the Journal of the Alzheimer's Association this year. We are excited to advance our program designed to assess the therapeutic potential of Lomecel-BTM in patients with AD," said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer of Longeveron.
TRYPF

Hot Stocks

08:44 EST Tryp Therapeutics announces poster presentations at SfN Conference - Tryp Therapeutics announced that the Company's collaborators from the University of Michigan will present two scientific posters in the upcoming Society for Neuroscience Conference, to be held from November 12-16, 2022 in San Diego. Details of the poster presentations are as follows: Title: Psilocybin Attenuates Mechanical Allodynia and Thermal Hyperalgesia in a Rodent Model of Formalin-Induced Chronic Pain: The study results demonstrated that a single intravenous dose of psilocybin can attenuate mechanical allodynia and thermal hyperalgesia for up to 4 weeks post dose. Title: Intravenous Psilocybin Alters Brain Network Dynamics in Rats: This study demonstrated a change in EEG recordings in rats receiving an IV infusion of psilocybin coincident with achieving the psychedelic state. Jim Gilligan, Chief Executive Officer, stated, "We are excited our collaborators at the University of Michigan are presenting the results of our two recent studies. The first study explored intravenous psilocybin and its effect in a recognized rat model of fibromyalgia. This model exhibits increased sensitivity to touch and hypersensitivity to elevated temperatures. Administration of a single intravenous infusion of psilocybin resulted in a decrease in both pain and heat sensitivity persisting until the end of the study. Tryp is the first company to pursue the use of psychedelics in nociplastic pain indications including fibromyalgia. These results support the potential clinical utility of psilocybin assisted therapy in the treatment of patients with fibromyalgia. The second study demonstrated a change in EEG recordings coincident with achieving the psychedelic state. Rats received a continuous intravenous infusion of psilocybin over a period of 60 minutes while EEG data were simultaneously monitored. The results demonstrate the ability to detect changes in EEG patterns coincident with attaining the psychedelic state. In addition, upon cessation of the infusion a return to baseline EEG patterns correlated with decreasing blood levels of psilocin. This study will help facilitate Tryp's program to utilize EEG recordings to optimize dose and infusion rates of TRP-8803 in planned upcoming clinical trials."
LEN

Hot Stocks

08:44 EST Lennar says construction on largest community of 3D-printed homes is underway - Lennar and ICON, a construction technologies company pioneering large-scale 3D printing, announced that construction on the largest community of 3D-printed homes is underway and reservations will begin in 2023. Situated north of Austin in the city of Georgetown's master-planned community of Wolf Ranch by Hillwood Communities, a Perot company, the 100-home community combines innovative robotics, software and advanced materials to create homes that are technologically advanced, environmentally sustainable and architecturally striking. Each Lennar home in Wolf Ranch is co-designed by the renowned architectural firm BIG-Bjarke Ingels Group. Prices are anticipated to start from the mid-$400,000s.
RCON

Hot Stocks

08:43 EST Recon Technology regains compliance with Nasdaq minimum bid price requirement - Recon Technology received notification from Nasdaq confirming the company has cured the bid price deficiency, and that the Company is in compliance with all applicable listing standards. The company's stock will continue to be listed and traded on The Nasdaq Stock Market.
LINC

Hot Stocks

08:42 EST Lincoln Educational introduces medical assistant training at East Windsor campus - Lincoln Educational Services announces the introduction of a Medical Assistant career training program at the East Windsor, CT campus. Healthcare employers nationwide are facing unprecedented challenges in demand for services and a severe lack of qualified candidates for these Allied Health support positions. Lincoln Tech's new program, expected to launch November 30th, aims to address that gap.
IMNN

Hot Stocks

08:42 EST Imunon enters into technology evaluation agreement with Acuitas Therapeutics - IMUNON and Acuitas Therapeutics announced the signing of an agreement to evaluate the combination of IMUNON's PLACCINE nucleic acid vaccine constructs formulated with Acuitas' proprietary lipid delivery technology. Under the agreement, IMUNON will evaluate administration of its vector constructs formulated in various Acuitas LNP formulations for gene expression and immunogenicity in murine models. "We are delighted to enter into this technology evaluation agreement with Acuitas Therapeutics, an organization renowned for its delivery technology capabilities, particularly with its LNP systems for mRNA vaccines," said Corinne Le Goff, Ph.D., President and Chief Executive Officer of IMUNON. "In light of the recent successes with our PLACCINE technology and promising proof-of-concept SARS CoV-2 data in non-human primates, we believe the time is right to explore the expansion of our technology to other types of delivery systems as we position our nucleic acid-based modality as the future of vaccinology."
NCR

Hot Stocks

08:42 EST NCR Corp. announces Jennifer Personette as new CMO - NCR Corporation announced that Jennifer Personette has been named its new Chief Marketing Officer. A passionate and visionary strategist, Personette builds on eight years leading NCR's global marketing, brand strategy and customer experience. "Jennifer has played an integral role in NCR's transformation, leading the evolution of our brand," said Michael D. Hayford, NCR CEO. "She has not only built understanding and enthusiasm among NCR's global team, but also created meaningful customer experiences that have enabled our growth and success."
DDD

Hot Stocks

08:41 EST 3D Systems, ALM announce partnership to expand access to 3D printing materials - 3D Systems and ALM announced they have entered into a partnership to expand access to industry-leading 3D printing materials. ALM will add 3D Systems' DuraForm PAx material to its portfolio, providing its customers access to a unique copolymer specifically designed for use with available Selective Laser Sintering, SLS, technologies. As a result, ALM's customers will have access to an expanded materials portfolio enabling them to choose the best material for their application. "We're excited to announce this collaboration with ALM, not only to expand access to this game-changing copolymer but to also show what's possible when two industry leaders work towards a shared goal," said Dr. David Leigh, EVP and chief technology officer for additive manufacturing, 3D Systems. "By joining together, 3D Systems and ALM are not only helping manufacturers innovate more rapidly, but we're also able to redirect our innovation pipelines to create more first-to-market materials. I believe this in turn will also foster future 3D printing technology innovations thus creating additional options for manufacturers to procure the optimal solution for their application."
KDP

Hot Stocks

08:41 EST Keurig Dr Pepper CEO Ozan Dokmecioglu resigns, Bob Gamgort to succeed - Keurig Dr Pepper announced the resignation of Ozan Dokmecioglu as CEO and a member of the KDP Board of Directors. Bob Gamgort, the company's current Executive Chairman and former CEO, was reappointed by the Board to the role of CEO, in addition to continuing as Chairman. Dokmecioglu agreed to resign due to violations of the company's Code of Conduct that were unrelated to strategy, operations or financial reporting.
BLDP HTOO

Hot Stocks

08:40 EST Ballard Power and Fusion Fuel commission H2Evora green hydrogen plant - Ballard Power (BLDP) and Fusion Fuel (HTOO) completed the interconnection of Fusion Fuel's H2Evora plant to the Portuguese electric grid and successfully commissioned the facility. The demonstration project, comprised of 15 HEVO-Solar units and associated balance of plant equipment, will produce 15 tons of green hydrogen per year and avoid the emission of 135 tons of CO2 annually. The facility includes a 200-kilowatt FCwaveTM fuel cell module supplied by Ballard Power, which is used to convert its green hydrogen into electricity. The integration of Fusion Fuel's solar-to-hydrogen HEVO solution and Ballard's fuel cell technology is a proof of concept for the use of hydrogen as a flexible energy storage vector and off-grid power supply.
DCT

Hot Stocks

08:40 EST Duck Creek Technologies announces Mutual Benefit will utilize its SaaS solution - Duck Creek Technologies announces that core solutions customer, Mutual Benefit Group, a longtime customer of the insurtech, has elected to utilize the cloud-based software-as-a-service, SaaS, solution Duck Creek Distribution Management to enhance agency management, data and compensation capabilities. Duck Creek's distribution management solution will provide the auto, home and business commercial lines insurer with an improved agent experience and an increased level of customer engagement. "Mutual Benefit Group prides itself on the strength of its relationships and their support of the independent agent network is a key part of delivering excellence for its policyholders," said Eugene Van Biert, Chief Operating Officer at Duck Creek Technologies. "Similar to the insurer, we are focused on creating an ease of doing business that delivers technical comfort and enables our users to feel supported throughout the customer lifecycle. The strong relationship that Duck Creek has cultivated with Mutual Benefit Group over time has positioned us to work collaboratively with one another and help the insurer achieve its distribution management goals."
IINN

Hot Stocks

08:39 EST Inspira Technologies granted patent by Israeli Patent Office - Inspira Technologies announced that the Israeli Patent Office granted a patent for a key safety component of the INSPIRA ART system. The component is to be located on the patient's neck and is designed to secure a neck cannula from moving or dislodging. Cannula movement can occur during a change of a patient's posture in bed, during physiotherapy treatment, while an awake patient is taken by the medical staff out of bed for a short walk and/or during transportation within and between hospitals.
ADD

Hot Stocks

08:38 EST Color Star Technology and Banger to cooperate in game development - Color Star Technology's subsidiary, Color Metaverse, reached a strategic cooperation agreement with Banger Games. In the future, the two parties will cooperate closely on metaverse game development, digital copyrights and related technologies. Banger is a gaming platform. Color Star's ColorWorld Metaverse platform also has a game development segment. The subsidiary company Color Metaverse is focused on developing its business of digital commerce and products in the metaverse and the gaming platform that unifies both Web2 and Web3 games. After the Agreement is reached, the two parties will not only conduct joint development of metaverse games and establish a technology partnership, but will also take full advantage of their respective platforms and networks, combining gamification, cryptocurrency, NFT blockchain technology, etc. to create a new business model.
VTRS AZN

Hot Stocks

08:37 EST Viatris wins court decision invalidating AstraZeneca's Symbicort patent - Viatris (VTRS), a global healthcare company announced that it and Kindeva Drug Delivery L.P. have won a significant court decision in which the U.S. District Court for the Northern District of West Virginia found that AstraZeneca's (AZN) Symbicort patent, U.S. Patent No. 10,166,247, is invalid. The district court determined that the patent is invalid on two separate grounds - lack of written description and lack of enablement. Viatris President Rajiv Malik said: "We are extremely pleased with the court's decision as it clears away yet another of AstraZeneca's invalid patents, which have only served to block generic versions and delay access to this important product for American patients. This affirms Viatris' continuing efforts to break down barriers to patient access for important medicines. We already have FDA approval for our generic Symbicort product, and we look forward to the opportunity to bring our more affordable product to market."
MCHP

Hot Stocks

08:37 EST Microchip announces LAN8840, LAN8841 Gigabit Ethernet transceiver devices - Microchip Technology announces the LAN8840 and LAN8841 Gigabit Ethernet transceiver devices that meet IEEE 1588v2 standards for Precision Timing Protocol. The LAN8840/41 Ethernet devices are enabled with Linux drivers and deliver flexible Ethernet speed options including 10BASE-T, 10BASE-Te, 100BASE-TX and 1000BASE-T. The LAN8840/41 devices can facilitate critical packet prioritization by providing high-speed time stamping that is then relayed between the various components to determine network latencies, accommodate for those latencies, and synchronize time amongst all connected devices. This functionality is key for process automation applications that require precise control production systems such as robotics, distributed sensors and cooling and mixing systems. Designed with robust applications in mind, the LAN8840/41 devices can withstand extended industrial temperatures ranging from -40 degrees C to +105 degrees C.
USAU

Hot Stocks

08:36 EST U.S. Gold sells interest in Maggie Creek Property for $2.75M - U.S. Gold (USAU) announced the execution on November 9 of a transaction related to the Maggie Creek Property among Nevada Gold Mines, Orogen Royalties, and U.S. Gold. Renaissance Exploration, a wholly-owned subsidiary of Orogen, and the company's wholly-owned subsidiary, Orevada Metals, are parties to an Exploration Earn-In Agreement pursuant to which Orevada, by making certain payments and incurring certain exploration expenditures, has the right to earn at least a 50% interest and up to a 70% interest in the Maggie Creek Property, owned by RenEx, in Eureka County, Nevada. U.S. Gold caused Orevada to assign its interest in the Original Earn-In Agreement to NGM. Simultaneous with that assignment, NGM and RenEx entered into an agreement pursuant to which NGM can earn a 100% interest in the Maggie Creek Property. As consideration for the assignment of the Original Earn-In Agreement to NGM, U.S. Gold received an upfront cash payment of $2.75M dollars from NGM, and NGM agreed that if it exercises the NGM Option and acquires the Maggie Creek Property, it will grant to U.S. Gold a 0.5% Net Smelter Returns royalty on all gold and other recovered and saleable minerals from the Maggie Creek Property, pursuant to a separate royalty agreement between NGM and U.S. Gold. Under the U.S. Gold Royalty Agreement, NGM will have the right to buy back one-half of the U.S. Gold Royalty for a fixed price of $500K. In addition, the U.S. Gold Royalty Agreement will provide that U.S. Gold waives the first $800K of production royalty payments owed to it, regardless of whether NGM exercises its buy-back rights. Under the U.S. Gold Royalty Agreement, NGM will also have a right of first refusal to purchase the U.S. Gold Royalty if U.S. Gold decides to sell that royalty.
TROW

Hot Stocks

08:35 EST T. Rowe Price reports preliminary AUM $1.28T at October 31 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $0.7B in October 2022 and $11B for the year-to-date period ended October 31, 2022. These client transfers include $0.6B and $7.7B, respectively, transferred to the target date retirement trusts during October and the year-to-date period.
STCGF

Hot Stocks

08:34 EST Stack Capital reports Q3 book value per share $11.75 - Book Value per Share of the Company was $11.75, as compared with $11.25 as at September 30, 2021, a 4% increase. The Company's cash position was $43.2 million, or $4.68 per share."We continue to diligently evaluate companies to add to our portfolio that we believe are market leaders with strong growth potential," said Jeff Parks, CEO of Stack Capital. "Given current market conditions, having 40% of our Book Value in cash is extremely beneficial and will enable us to opportunistically invest in attractive businesses that continue to grow in this economic environment. Scarcity of capital has resulted in better investment terms on recent deals that we have explored, with added benefits relating to downside protection. Overall, we remain excited for the future prospects of our existing portfolio companies."
BCLI

Hot Stocks

08:33 EST BrainStorm receives refusal to file letter from FDA regarding BLA for NurOwn - BrainStorm Cell Therapeutics announced that the company has received a refusal to file letter from the U.S. FDA regarding the company's New Biologics License Application for NurOwn for the treatment of ALS. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter. "While we are disappointed that the FDA has not accepted our BLA for NurOwn in ALS, we remain committed to NurOwn's advancement as a treatment for this devastating disease. The company intends to request a Type A meeting and looks forward to continued discussions with the FDA," said Chaim Lebovits, CEO of BrainStorm. "We continue to believe that NurOwn's Phase 3 trial represents a significant contribution to ALS therapy and will continue to work tirelessly to address the needs of people living with ALS by advancing science and partnering with researchers around the world."
DUK

Hot Stocks

08:31 EST Duke Energy to install microgrid at Marine Corps Base Camp Lejeune - Duke Energy has been awarded a $22M utility energy service contract by Marine Corps Base Camp Lejeune for the design and construction of a microgrid at the military base. The microgrid solution includes upgraded electrical infrastructure, 5 megawatts of on-site natural gas-fired generation, a 5.4-MW battery energy storage system, integration of an existing solar photovoltaic system, and a microgrid controller to provide integrated demand management, black start and islanding capability. Located in Onslow County, N.C., Camp Lejeune is home to the largest concentration of Marines in the Marine Corps.
DXR

Hot Stocks

08:30 EST Daxor announces its BVA-100 diagnostic will be featured in a webinar - Daxor Corporation announces Daxor's BVA-100 diagnostic will be featured in a MedAxiom Academy webinar - Best Practices for Using Blood Volume Analysis to Reduce Heart Failure LOS, Readmissions, Mortality and Costs on November 17, 2022. MedAxiom, with the support of Daxor, recently completed a project to identify best practices to build a blueprint of how to operationalize BVA through a care pathway that focuses on everything from patient selection to monitoring, and operationally from strategy to billing. Three customer sites who have implemented BVA into clinical practice, participated in the program review and data collection. The webinar panelists will be discussing first-hand how BVA has demonstrated notable improvements in patient outcomes, hospital savings and resource use.
BCRX

Hot Stocks

08:29 EST BioCryst presents real-world data on the effects of ORLADEYO on HAE attacks - BioCryst Pharmaceuticals announced new real-world data demonstrating rapid, sustained reduction of patient-reported HAE attacks and consistently low attack rates among patients 12 years and older who started on oral, once-daily ORLADEYO for the prophylactic treatment of hereditary angioedema, including patients who switched from other prophylactic therapies. The data are being presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, ACAAI. BioCryst ACAAI 2022 Presentation Highlights: Consistently Low Hereditary Angioedema Attack Rates Observed with Berotralstat Regardless of Previous Prophylaxis: This analysis assessed patient-reported HAE attack rates of patients on ORLADEYO 110 mg or 150 mg who were previously on another prophylactic therapy. Regardless of prior prophylaxis, a rapid reduction in median attack rates was observed early. The reduction of median attack rates was sustained throughout the 360-day treatment period. Upon initiating ORLADEYO treatment, the reduction in median attack rates from baseline over the 1-360 days period was consistent for patients regardless of their prior prophylaxis therapy. The reductions after starting ORLADEYO for each prior prophylactic therapy were: 77 percent reduction for patients previously on lanadelumab; 64 percent reduction for patients previously on SC C1-INH; 70 percent reduction for patients previously on danazol; and 72 percent reduction previously on IV C1-INH. The incidence of AEs reported was lower than the incidence reported in clinical trials. Rapid and Sustained Reductions in Hereditary Angioedema Attack Rates with Long-term Berotralstat: This analysis assessed the efficacy of ORLADEYO 110 mg or 150 mg in patients for a treatment period of more than 270 days. Patients reported a meaningful reduction in HAE attack rates when treated with ORLADEYO. An 80 percent average reduction from median baseline attack rate was observed during the initial 90-day treatment period.
ATGE

Hot Stocks

08:28 EST Adtalem Global Education elects Michael Malafronte as chairman - Adtalem Global Education announced that its board of directors has unanimously elected Michael W. Malafronte, as chairman, effective Nov. 9. Malafronte has been an independent director on Adtalem's board since 2016.
ALRN

Hot Stocks

08:25 EST Aileron Therapeutics announces 1-for-20 reverse stock split - Aileron Therapeutics announced that it will effect a 1-for-20 reverse stock split of its common stock. The reverse stock split will become effective at 5:00 p.m. ET today. Aileron's common stock will continue to be traded on the Nasdaq Capital Market under the symbol "ALRN" and will begin trading on a split-adjusted basis when the market opens on November 11, 2022. The reverse stock split, which was approved by Aileron's stockholders on June 15, 2022, is intended to bring the company into compliance with Nasdaq's minimum bid price requirement. The new CUSIP number for the company's common stock following the reverse stock split will be 00887A 204.
PEGY

Hot Stocks

08:25 EST Pineapple Energy announces acquisition of SUNation Energy - Pineapple Energy announced the acquisition of SUNation Energy, a New York-based installer of solar and battery energy storage systems for residential and small commercial customers. The transaction closed on November 9, 2022. The acquisition reinforces Pineapple's strategy as a customer-centric company, building long-term customer relationships through its "white-glove" customer experience. Founder Scott Maskin will continue to manage SUNation in New York. "We're thrilled to announce the SUNation acquisition, which is a fantastic complement to our Hawaii Energy Connection and E-Gear acquisitions which closed alongside our merger into a publicly traded company earlier this year," said Kyle Udseth, CEO of Pineapple Energy. "This acquisition is an indication of the growth potential inherent in our strategy of consolidating and building a nationwide solar, battery storage and home energy management business. We believe the acquisition will give us more scale, increase our revenue substantially, and move us toward achieving the important goal of reaching cash flow positive in 2023. Further, it expands our footprint into the northeastern United States, a region with strong demand for solar energy."
BCLI

Hot Stocks

08:25 EST BrainStorm trading halted, news pending
PHVS

Hot Stocks

08:23 EST Pharvaris to present PHVS416, PHVS719 clinical data - Pharvaris announced it will be presenting two in-person "ePoster - Meet the Author" presentations at the American College of Allergy, Asthma & Immunology, ACAAI, Annual Scientific Meeting 2022, being held from November 10-14, 2022, in Louisville, Ky. Title: Development of PHVS719: an Oral Extended-Release Bradykinin B2 Receptor Antagonist to Prevent Hereditary Angioedema Attacks. Pharmacokinetic properties of PHA121 were evaluated to support the intended therapeutic use of PHVS719 for the prophylactic treatment of HAE attacks using preclinical and clinical experimental models. In rodents, plasma concentrations following oral and intracolonic administrations of PHA121 were comparable, providing evidence that PHA121 can be systemically absorbed by colonic mucosa. In humans, high oral bioavailability and low fecal excretion further indicate almost-complete absorption in the gastrointestinal tract. Title: Pharmacokinetics of PHVS719, extended-release tablet formulation of PHA121, a first-in-class oral human bradykinin B2-receptor antagonist. In the Phase 1 pharmacokinetic study of PHVS719, 10 healthy subjects received, in a randomized order, two different doses of PHVS719 extended-release tablets, in fasting and in fed conditions, and one dose of PHVS416 20 mg in fasting conditions. Measurement of time-to-reach-therapeutic-exposure-levels for PHA121 above the EC85 of 13.8 ng/mL showed that after administration of XR1 and XR2, therapeutic plasma concentrations were achieved within approximately two hours. Food intake did not have significant effects on the time to reach therapeutic exposure of PHA121 nor on the time at which concentrations remained at therapeutic levels. Administration of both PHVS719 and of PHVS416 were well tolerated. No severe nor serious treatment-emergent adverse events were reported, with no specific safety pattern or trend in number or type of events.
ESTA

Hot Stocks

08:22 EST Establishment Labs announces Japan PMDA approval for Motiva Implants - Establishment Labs announced Motiva Implants and the Motiva Flora tissue expander have been approved for use in Japan by the Pharmaceuticals and Medical Devices Agency, or PMDA. The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System. The first reconstruction patient in Japan was successfully treated with Motiva in early November at Nagoya University Hospital.
INFN

Hot Stocks

08:21 EST Infinera receives TIP project award for open SDN transport requirements - Infinera has been awarded a Telecom Infra Project, TIP, Requirements Compliant Bronze Badge for its GX G42 Compact Modular Optical Transport Solution, validating its compliance with the open and standard software-defined networking, SDN, API requirements defined by the Mandatory Use Cases for SDN Transport, MUST, project group in TIP. The TIP MUST solution specifies the SDN technical requirements for an open optical terminal control and management API based on OpenConfig data models. The Requirements Compliant Bronze Badge acknowledges the Infinera GX G42's adherence to the MUST open and standard API and positions this solution as a suitable candidate for the open and disaggregated optical network architectures that operators would like to deploy. "The adoption of the MUST's open and standard API requirements by players such as Infinera reflects the huge impact TIP is having to enable open and disaggregated networks," said Hanson Tuang, Connectivity Technologies and Ecosystems Manager at Meta, and TIP OOPT Technical Lead. "We are excited about testing Infinera and other compliant MUST products, and we look forward to more compliant solutions getting listed on TIP Exchange soon."
TRU

Hot Stocks

08:21 EST TransUnion includes high-demand health audiences in TruAudience Data Marketplace - TransUnion announced the inclusion of high-demand health audiences from Veeva Crossix in its TruAudience Data Marketplace. Veeva Crossix is a top healthcare data provider and leader in health audience segments. The addition of this data will support more effective campaigns across streaming platforms.
VERB

Hot Stocks

08:20 EST Verb Technology completes financing transaction for $5M in gross proceeds - Verb Technology Company has completed a financing transaction with an accredited, family office investor, which provided gross proceeds to VERB of $5.0M. The transaction was structured as a non-convertible, unsecured term loan. The Loan accumulates interest at the rate of 9% per annum and matures on May 7, 2024. "It's no secret that the current economic conditions have impacted the capital markets, making fundraising a far more difficult process," stated Rory Cutaia, VERB CEO. "While there are limited options available to most companies, our Board members and management worked together in evaluating financing proposals, and determined that it was in the best interests of the Company and our stockholders to proceed with a non-convertible, unsecured term loan structure, with no warrant or other equity component, to provide funds for growth and working capital. This is the second financing the Company has completed in the past three weeks, bringing our aggregate gross proceeds from the financings to $9.0 million. We believe these financings, together with a recently implemented comprehensive cost reduction plan that I will discuss in greater detail during our upcoming earnings call, give VERB a solid basis to move forward through the fourth quarter and into 2023."
MYGN

Hot Stocks

08:19 EST Myriad Genetics announces launch of UroSuite - Myriad Genetics announced the launch of UroSuite, a comprehensive suite of genetic risk assessment tests that cover every stage of prostate cancer care. UroSuite includes Myriad's Prolaris Prostate Cancer Test, MyRisk Hereditary Cancer Test, BRACAnalysis CDx and Precise Tumor Molecular Profile Test. The combination of tests provides integrated genetic insights and makes it easier to tailor therapy and clinical trial selection for patients. "Today's launch of UroSuite reinforces Myriad Genetics' commitment to advancing health and well-being for all through a set of testing solutions for prostate cancer care, best-in-class support, and access to genetics and cancer specialists," said Paul J. Diaz, president and CEO, Myriad Genetics. "We continue to build on our efforts to elevate our products to their full potential and introduce new innovative solutions and analytics to help patients and healthcare providers with personalized genetic insights and data-driven medical information."
GRWG

Hot Stocks

08:19 EST GrowGeneration acquires St. Louis Hydroponic Company - GrowGeneration announced the acquisition of St. Louis Hydroponic Company. This store acquisition furthers the Company's strategic retail footprint and represents entry into a growing market, where voters approved adult-use ballot measures on Tuesday. The store officially began operating under the GrowGeneration name on Monday November 7. Currently, with over 200,000 medical patients, and the addition of 144 new micro licenses and home growing, the Missouri market is poised for growth.
ENPH

Hot Stocks

08:19 EST Enphase Energy expands IQ8 microinverter deployments in Oregon - Enphase Energy, announced that installers of Enphase products in Oregon have seen growing deployments of Enphase Energy Systems powered by IQ8 Microinverters. "We are pleased to be working with Oregon's leading installers to meet the state's growing demand for solar," said Dave Ranhoff, chief commercial officer at Enphase Energy. "Together, we will continue to provide homeowners in Oregon with access to reliable energy solutions to keep their homes up and running even if the grid is down."
AKTX

Hot Stocks

08:18 EST Akari Therapeutics announces FDA granted RPDD to nomacopan - Akari Therapeutics announced the U.S. Food and Drug Administration, FDA, has granted the Rare Pediatric Disease Designation, RPDD, to nomacopan for the treatment of pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy, HSCT-TMA. "Families with children who have a hematopoietic stem cell transplant-related TMA face grim prospects with high mortality rates and no approved treatment options," said Rachelle Jacques, President and CEO of Akari. "The Rare Pediatric Disease Designation was created by the FDA because families need so much more than hope for their children, they need meaningful treatment options. We are pleased the FDA has recognized the significant needs that exist for children with HSCT-TMA, and we will continue to urgently pursue our mission to advance nomacopan to approval on their behalf."
GNSS

Hot Stocks

08:17 EST Genasys signs Zonehaven SaaS contract with Riverside County, California - Genasys announced a new multi-year software-as-a-service contract with Riverside County, California for Zonehaven evacuation resources.
CYBN

Hot Stocks

08:17 EST Cybin announces dosing in CYB004-E trial - Cybin announced that its CYB004-E Phase 1 trial evaluating N,N-dimethyltryptamine, or DMT, has completed dosing for four out of five participant cohorts and The Safety Review Committee has confirmed no clinically significant safety or tolerability issues. The CYB004-E Phase 1 trial was acquired from Entheon Biomedical Corp. in July 2022.
AMTI

Hot Stocks

08:17 EST Applied Molecular Transport announces FDA ODD granted to AMT-101 - Applied Molecular Transport announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, for AMT-101 in patients with pouchitis, an indication with significant unmet medical need and no current FDA-approved products. AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT's proprietary carrier molecule, which is also in development for the treatment of ulcerative colitis and rheumatoid arthritis. "Pouchitis is a severe end-stage complication of ulcerative colitis with serious symptoms that have a tremendous negative impact on quality of life, including excessive stool frequency, urgency, fecal incontinence and chronic pain," said Bittoo Kanwar, M.D., chief medical officer of AMT. "Following the results observed in our FILLMORE trial demonstrating compelling activity of AMT-101 in pouchitis, we look forward to continued collaboration with the FDA as we remain focused on Phase 3 advancement in this patient population. If ultimately approved, AMT-101 may be the first product approved in the U.S. to treat pouchitis and potentially improve the lives of patients suffering from this condition."
NOVV

Hot Stocks

08:16 EST Nova Vision Acquisition announces extension of combination period - Nova Vision Acquisition announced that at its annual general meeting of shareholders on November 9, 2022, the Company's shareholders voted in favor of the proposal to amend its memorandum and articles of association, giving the Company the right to extend the date by which the Company has to complete a business combination up to nine times for an additional one month each time from November 10, 2022, to August 10, 2023. On November 9, 2022, Nova Pulsar Holdings Limited, the Company's initial public offering sponsor, deposited into the Company's trust account an aggregate of $75,030.26, in order to extend the period of time the Company has to complete a business combination for an additional one month period, from November 10, 2022 to December 10, 2022. The Company issued a promissory note to Sponsor with a principal amount equal to the amount deposited. The promissory note bears no interest and is convertible into the Company's units at a price of $10.00 per unit at the closing of a business combination by the Company. The purpose of the extension is to provide time for the Company to complete a business combination.
BNGO

Hot Stocks

08:13 EST Bionano Genomics appoints Donna Polizio as Global Head of Market Access - Bionano Genomics announced that it has appointed Donna Polizio as its global head of market access, further strengthening its leadership team. The appointment of a global head of market access reflects Bionano's focus on advancing the adoption of optical genome mapping and working to meet market needs. Ms. Polizio was most recently the vice president of U.S. managed care and reimbursement at Genomic Health, acquired by Exact Sciences in 2019. In this new position, Ms. Polizio will be responsible for being the company's advocate with government and private payors to drive global reimbursement for OGM-based tests, with a strong focus on the US market. In addition, Ms. Polizio will lead Bionano's government relations efforts in connection with legislation that impacts Bionano, its products, and the genomics industry generally.
EQ

Hot Stocks

08:12 EST Equillium initiates EQ101 open-label study - Equillium announced that it has initiated a Phase 2 open-label study of EQ101 to assess efficacy and safety in adult subjects with moderate to severe alopecia areata. The study is expected to enroll approximately 30 subjects at multiple clinical sites in Australia. This is a proof-of-concept study in adult subjects with at least 35% scalp hair loss due to alopecia areata where EQ101 will be administered intravenously once weekly over 24 weeks at a dose level of 2 mg/kg, with follow-up for an additional four weeks. The objectives of the study are to evaluate the efficacy, safety, tolerability, and pharmacokinetic/pharmacodynamic properties of EQ101 in adult subjects with moderate to severe AA.
BNTC

Hot Stocks

08:10 EST Benitec Biopharma reports Q1 EPS (47c) vs. (62c) last year - Reports Q1 revenue $0 vs. $0 last year."Following the receipt of a favorable decision from the Institutional Review Board of the lead clinical site for the OPMD Natural History Study in the United States and the formal completion of the Site Initiation Visit at this key clinical enrollment site, the screening of OPMD subjects for enrollment into the OPMD Natural History Study will begin this month. The initiation of subject screening for the OPMD Natural History Study represents a major milestone for Benitec, and we look forward to enrolling the first subjects into the OPMD Natural History Study this year. The enrollment of subjects into the OPMD Natural History Study in 2022 continues to support our central clinical development goal of administering the first dose of BB-301 in 2023," said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma. "The Principal Investigator of the OPMD Natural History Study in the United States expects high enrollment interest for this incurable genetic disease with no approved treatments, and we continue to work with regulators globally to open additional sites in geographies outside of the United States."
SKIN

Hot Stocks

08:10 EST Beauty Health announces $100M accelerated share repurchase agreement - Beauty Health announced that it has entered into an accelerated share repurchase agreement with JP Morgan Chase Bank, N.A., to repurchase an additional $100M of the Company's common stock. The ASR transaction was entered into pursuant to BeautyHealth's existing share repurchase program announced on September 27 of which $100M remained as of November 9. Under the ASR, the company will make a payment of $100M and will receive an initial delivery of approximately 9.5M shares of the company's common stock on November 14. The company expects to fund the repurchase with cash on-hand. The final number of shares to be repurchased will be based on the average of the daily volume-weighted average price of the company's common stock during the term of the ASR, less a discount and subject to adjustments pursuant to terms of the ASR. The final settlement of the ASR is expected to occur by the end of the second quarter of 2023.
VSAT

Hot Stocks

08:09 EST ViaSat and Cobham Satcom collaborate on maritime connectivity system - Viasat and Cobham Satcom, a global provider of satellite communications solutions to the maritime and land segments, are collaborating on a new, advanced satellite connectivity solution for the maritime and energy industries in preparation for the launch of Viasat's next generation satellite constellation, ViaSat-3. The connectivity system, which will include a portfolio of antenna systems from Cobham Satcom, is being designed to deliver high-speed connectivity that will leverage the satellite capacity expected from the ViaSat-3 constellation.
SPTN UBER

Hot Stocks

08:09 EST SpartanNash teams with Uber on grocery deliver in Midwest - Food solutions company SpartanNash ( SPTN) announced its new partnership with Uber Technologies (UBER) to offer on-demand and scheduled grocery delivery to shoppers across the Midwest."SpartanNash's focus on customer-centric innovation is core to our next stage of growth," said SpartanNash Executive Vice President and Chief Strategy and Information Officer Masiar Tayebi. "Partnering with Uber is an important marker of this, meeting our shoppers wherever they are - in stores or online. We are proud to expand our reach across the Uber and Uber Eats platform to new customers who are hungry for convenience delivered to their doorstep."Beginning this week, nearly 100 SpartanNash locations, including Family Fare, Martin's Super Markets and D&W Fresh Market storefronts, will be available to shop through Uber and Uber Eats. This upcoming holiday season, last-minute shoppers will be able to conveniently order their favorite must-haves, from fresh and frozen turkeys to baked goods, produce, household essentials and more-all delivered right to their home. The two companies are extending this service to SpartanNash's network of 2,100 independent grocery retail customers as part of their partnership to deliver customer-centric innovation. "
PEPG

Hot Stocks

08:08 EST PepGen announces upcoming milestones - PGN-EDO51: PepGen anticipates initiating a Phase 2a multiple ascending dose (MAD) trial evaluating PGN-EDO51 in DMD patients in the first half of 2023. PGN-EDODM1: PepGen anticipates initiating a Phase 1/2 clinical trial in DM1 patients in the first half of 2023. PGN-EDO53: PepGen anticipates reporting NHP exon skipping data by the end of 2022 for PGN-EDO53, the Company's program for the treatment of DMD patients who are amenable to an exon 53 skipping approach. Additional Pipeline Assets: PepGen anticipates that it will nominate lead candidates for PGN-EDO45 and PGN-EDO44 by the end of 2022, which target DMD patient populations amenable to an exon 45 and exon 44 skipping approaches, respectively.
LABP

Hot Stocks

08:07 EST Landos Biopharma expects cash to fund operations for at least next 12 months - As of September 30, 2022, the Company had cash, cash equivalents and marketable securities of $48.0 million, which it believes will be sufficient to fund its planned operations for at least the next 12 months. The Company plans to provide further details regarding its operating plans and capital resources upon completion of the portfolio review later this year.
MGTX

Hot Stocks

08:07 EST MeiraGTx expects cash to fund requirements into 4Q24 - In addition to the $25.0 million investment from JJDC, the Company had cash and cash equivalents of approximately $114.7 million as of September 30, 2022, as well as approximately $23.7 million in receivables due from Janssen from the third quarter of 2022. The Company believes it will have sufficient capital to fund operating expenses and capital expenditure requirements into the fourth quarter of 2024.
MGTX JNJ

Hot Stocks

08:06 EST MeiraGTx announces $25M investment from Johnson & Johnson Innovation - On November 9, 2022, JJDC purchased $25 million of MeiraGTx's ordinary shares in a private placement.
ACLS

Hot Stocks

08:05 EST Axcelis announces multiple shipments of its Purion ion implanter systems - Axcelis announced multiple new and follow-on shipments of the Purion Power Series ion implanter systems. The shipments went to multiple fabs in Asia and Europe operated by leading Si and SiC power device chipmakers. These shipments include the first SiC tool shipped from the Axcelis Asia Operations Center in South Korea.
BBBY BURL

Hot Stocks

08:02 EST Bed Bath & Beyond names Bart Sichel as EVP, Chief Marketing & Customer Officer - Bed Bath & Beyond (BBBY) announced the appointment of Bart Sichel as EVP, Chief Marketing & Customer Officer. Sichel will oversee fully integrated marketing and customer strategies for Bed Bath & Beyond, buybuy BABY and Harmon, reporting directly to Bed Bath & Beyond Inc. President and CEO, Sue Gove. Bart Sichel has more than 35 years of experience spanning marketing leadership, retail, and consulting. He was the Chief Marketing Officer at Burlington Stores (BURL) for eight years, and before that, he was with McKinsey & Company for 13 years.
AUY

Hot Stocks

07:59 EST Yamana Gold announces new exploration drilling results across its assets - YAMANA GOLD announces new exploration drilling results across its asset portfolio, underscoring its strategic outlook and efforts to meaningfully extend and expand its sustainable production platform. Exploration results at Canadian Malartic, Wasamac and Jacobina support strong organic growth in mineral reserves, mineral resources and production through successful brownfield exploration programs. Further success at El Penon, Minera Florida and Cerro Moro is expected to significantly replace or reduce depletion due to mining, extending mine life, increasing sustainable production and enhancing asset value. The Company reports that the strong operational performance seen throughout the nine month period ended September 30 continued in the month of October.
OTCM

Hot Stocks

07:58 EST OTC Markets completes acquisition of EDGAR Online - OTC Markets Group announced it has completed the acquisition of EDGAR Online, a premium supplier of real-time SEC regulatory data and financial analytics, from Donnelley Financial, LLC. EDGAR Online provides disclosure documents in multiple formats, company financials, structured data sets and mission-critical insights directly to exchanges, brokerage firms, data distributors and financial portals. Integrating the EDGAR Online data and domain expertise into OTC Markets' platform will provide investors, traders, and compliance teams with a more comprehensive view of an issuer and its securities. Our expanded data offering will now cover the full U.S. public company disclosure dataset, including SEC Reporting, Bank Reporting and OTCM's Disclosure and News Service. This acquisition includes substantially all of the assets of EDGAR Online, including proprietary technology, custom code, customer contracts and intellectual property.
WSR

Hot Stocks

07:55 EST Whitestone REIT releases 2022 ESG report - Whitestone REIT released its second Environmental, Social, and Governance, ESG, Report highlighting the Company's ESG strategic priorities and initiatives. Whitestone aligned its 2022 ESG Report with the Sustainability Accounting Standards Board industry standards and the Task Force on Climate-related Financial Disclosures recommendations. "We are proud to share Whitestone's second report on our environmental, social, and governance priorities and progress, demonstrating our commitments to our tenants, associates, and communities," says David Holeman, Chief Executive Officer. "We understand that managing our ESG responsibilities is critical to creating and sustaining long-term value."
NFYEF

Hot Stocks

07:54 EST NFI's Alexander Dennis announces order for 200 double deck buses - NFI Group, subsidiary Alexander Dennis announced that it has received an order for 200 low-emission Enviro400 double deck buses from Stagecoach. This represents the UK bus industry's largest single order by number of vehicles since 2019. Stagecoach's 200 new buses will be built in Britain and will have Alexander Dennis's SmartPack efficiency technology, giving them Low Emission Bus status and helping Stagecoach to cut emissions in the communities it serves. All are expected to be delivered in 2023 and to be allocated to depots across England, ranging from Torquay in the South West to Newcastle upon Tyne in the North East. The investment means that Stagecoach will remove older buses from its fleet, benefitting local air quality.
ANPC

Hot Stocks

07:53 EST AnPac Bio announces changes to board of directors - AnPac Bio-Medical Science announced the resignation of Yuyang Cui as the Co-Chair of the board of directors, and the Co-Chief Executive Officer, effective from November 7, 2022, and the resignation of Jiawen Kang from the position of a director of the Board, a member of the audit committee, and a member of the nominating and corporate governance committee, effective from November 4, 2022. Haohan Xu, the Co-Chairperson and Co-Chief Executive Officer of the Company, said, "On behalf of the Board of Directors and management team, I would like to express our sincere gratitude to them for all their contributions to the Company."
LIN

Hot Stocks

07:53 EST Linde Engineering, Vision Energy sign cooperation agreement - Vision Energy announced it has entered into a cooperation agreement with Linde Engineering to accelerate engineering efforts for the Company's pioneering Green Energy Terminal in North Sea Port of Vlissingen, the Netherlands. Vision Energy, through its wholly-owned subsidiary Evolution Terminals BV, has partnered with Linde Engineering, to deliver preliminary Front-End Engineering and Design services to the project for Phase 1 of Vision Energy's Green Energy Terminal. Scope includes design and engineering of 150,000 cubic meters of Green Ammonia storage, truck and barge loading facilities, ship loading and unloading facilities, and utilities, infrastructure and buildings. Engineering efforts under the agreement have commenced and are anticipated to conclude in April 2023 in support of the Company's target to reach Final Investment Decision by Q3 2023.
PYR

Hot Stocks

07:52 EST PyroGenesis announces conversion of methane into hydrogen production - PyroGenesis Canada announces that it has successfully produced hydrogen from methane using this revolutionary ZCE hydrogen production technology. PyroGenesis' plasma-based hydrogen production process converts this methane into a valuable solid carbon and hydrogen, thereby creating a ZCE hydrogen. The solid carbon is a byproduct that has many industrial applications, including the production of car tires, coatings, plastics, and batteries, and is considered an essential raw material. "Water Electrolysis has been around for many years and is considered to be a ZCE technology as well," said P. Peter Pascali, CEO and Chair of PyroGenesis. "The hydrogen generated from this process is generally referred to as "Green Hydrogen", however it is recognized to be expensive, require a lot of energy for its production, and uses rare earth materials. PyroGenesis' new technology is geared to combine the best of both worlds; it is expected to be cheaper than most existing hydrogen processes while at the same time producing ZCE hydrogen." Given today's results, PyroGenesis' plasma-based hydrogen production could become a solution/ alternative to the carbon-intensive hydrogen production technologies currently being used. If so, it could be instrumental in economically enabling the chemical industry to decarbonize production of chemicals such as ammonia or methanol.
BIOVF

Hot Stocks

07:51 EST Sobi announces FDA EUA for KINERET in COVID-19-related Pneumonia - Sobi North America announced that the U.S. Food and Drug Administration issued an emergency use authorization for KINERET for the treatment of Coronavirus Disease 2019 in adult patients who are hospitalized with positive results of direct SARS-CoV-2 viral testing with pneumonia, requiring supplemental oxygen, and are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain substance called urokinase plasminogen activator receptor that may be a sign of increased risk of worsening of the disease. The decision is based on results from the SAVE-MORE phase 3 study, which was the first large, pivotal randomized controlled trial to specifically evaluate a COVID-19 patient population at risk of progressing to critical state and demonstrate considerable benefit of earlier intervention for the prevention of disease progression and death. The study, conducted by the Hellenic Institute for the Study of Sepsis, found that early treatment of COVID-19-hospitalized patients with KINERET showed considerable efficacy, and reduced the risk of disease progression by 64 percent. In addition, treatment with KINERET reduced the risk of severe disease or death by 54 percent. Results were published in Nature Medicine on Sept. 3, 2021.
TLLTF

Hot Stocks

07:50 EST Tilt Holdings announces partnership with Coda Signature - TILT Holdings announced it has partnered with Coda Signature to launch the brand in Massachusetts. Expected to be available in the state within the first quarter of 2023 and in Ohio soon after, Coda is the ninth brand to join TILT's wide ranging brand portfolio that celebrates BIPOC- and women-owned brands. "Coda is a brand that stands out for its award-winning products and experience with operations in one of the country's most mature recreational markets," said Gary Santo, TILT's chief executive officer. "With our award-winning kitchen and Coda's proven products, TILT is well-equipped to develop a new following for Coda's fan-favorite chocolate bars and Fruit Notes with consumers and patients in Massachusetts."
NLCP

Hot Stocks

07:49 EST NewLake announces $10M share repurchase program, formation of ESG committee - NewLake Capital Partners announced that its Board of Directors authorized a $10M share repurchase program and the formation of an independent Environmental, Social & Governance, ESG, committee of the Board of Directors. The share repurchase program, which is effective immediately, allows for the repurchase of up to $10 million of the Company's common shares through December 31, 2023. "While there continues to be attractive investment opportunities across the cannabis real estate sector, we think there is also compelling value in our stock. The authorization of a $10 million share repurchase program underscores our confidence in the quality of our portfolio, robust pipeline and growth opportunity of the cannabis industry for many years to come," stated Anthony Coniglio, NewLake's President and Chief Executive Officer. "Additionally, the Board's formation of an independent ESG committee reaffirms our commitment to having the highest standard of oversight, strategy and management of all ESG matters. By making this a committee of the Board versus a subcommittee, we are elevating our focus and accountability on this important initiative."
UNCY

Hot Stocks

07:48 EST Unicycive Therapeutics completes enrollment of bioequivalence study for RENAZORB - Unicycive Therapeutics announced that it has completed the enrollment of subjects in the RENAZORB bioequivalence study. RENAZORB is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis. The study is a randomized, open-label, two-way crossover BE study to establish pharmacodynamic bioequivalence between RENAZORB and Fosrenol-the reference listed drug. Unicycive previously received confirmatory guidance from the U.S. Food and Drug Administration that this single BE study in healthy volunteers would satisfy the requirements and that no other clinical studies are required for a New Drug Application filing through the 505(b)(2) pathway. The study enrolled 40 subjects per treatment arm for 64 evaluable subjects. The study design, including the dose, primary endpoint, and sample size, was reviewed by, and aligned with the FDA before the initiation of the study. The primary endpoint of the study is LS mean change in urinary phosphate excretion from baseline to the evaluation period.
GILT

Hot Stocks

07:48 EST Gilat announces it entered into multi-year strategic framework agreement - Gilat Satellite Networks announced that it has entered into a multi-year, multimillion-dollar strategic framework agreement with a world-leading UAV manufacturer. High/Medium Altitude Long Endurance Unmanned Aerial Vehicles will be empowered with innovative capabilities enabled by next generation BRP60 satellite communication terminals from Gilat. "We are proud to have the latest generation of our satellite communication terminals in these UAVs, which are serving a variety of applications all over the world," said Michal Aharonov, Chief Commercial Officer at Gilat. "This new agreement represents an important milestone in our long-term partnership and continuing success in the industry."
TLRY

Hot Stocks

07:47 EST Tilray announces expansion of its CANACA cannabis brand portfolio - Tilray Brands announced the expansion of their CANACA cannabis brand portfolio. The brand's latest product release includes the launch of three new high-potency full-spectrum butane hash oil, BHO, infused products, along with expanded distribution of its current collection across Canada, for discerning cannabis enthusiasts, demanding boosted experiences.
CSTM

Hot Stocks

07:46 EST Constellium supplies aluminum auto body sheet for Maserati Grecale SUV - Constellium announced that it is supplying aluminium Auto Body Sheet for the all-new Maserati Grecale SUV. Constellium is the primary supplier of Auto Body Sheet solutions for the closures of the Maserati Grecale, including the hood, liftgate, and doors. For the outer surface of the hood and liftgate, Constellium provides Surfalex. Constellium also provides its high performing 5182 alloy for the inner of the hood, front and rear doors, and liftgate, delivering the required strength and formability for complex inner parts. "Constellium is proud to supply the all-new Maserati Grecale," said Dieter Hoell, Vice President, Global Automotive for Constellium's Packaging & Automotive Rolled Products business unit. "Aluminium is the material of choice for its lightweight and energy absorption properties. We have developed an integrated offer and unique solutions, both in Auto Body Sheet and extrusion-based components, to provide our customers with high-performance products that achieve both safety and efficiency."
TOVX

Hot Stocks

07:46 EST Theriva Biologics reschedules conference call for Q3 results - Theriva Biologics announced that it plans to host a conference call on Friday, November 11, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2022 and provide a corporate update. The call was originally scheduled for Thursday, November 10, 2022, at 8:30 a.m. ET.
VMAR

Hot Stocks

07:45 EST Vision Marine Technologies expands electric boat rental operations - Vision Marine Technologies announces the expansion plan of our high margin, profitable and rapidly growing electric boat rental operations into Portside Ventura Harbor, California. Vision Marine has entered into a Lease Agreement with Portside Ventura Harbor. Portside Ventura Harbor has secured office and slip space, which will enable Vision Marine to expand its growing electric boat rental operations. Portside Ventura Harbor is a new coastal community located on Pierpont Bay in Southern California, opening in March 2023. The new recreational marina will include 104 boat slips and a public dock. "We are excited to expand our continuing development of our electric boat rental operations with the expansion into Portside Ventura Harbor. The rental operations will create a unique experience for the residents and the general public," stated Alex Mongeon, co-Founder & CEO of Vision Marine.
SPTK

Hot Stocks

07:44 EST SportsTek Acquisition, Metavisio extend exclusivity period for discussions - SportsTek Acquisition Corp. announced that it has extended the exclusivity period under the non-binding letter of intent with Metavisio, a French company specializing in building, marketing, and selling laptops, whose securities are listed on Euronext Growth in Paris, with respect to a proposed business combination transaction. The Proposed Transaction is based on an enterprise value of Metavisio of USD 140 million to USD 160 million; however, such valuation is subject to due diligence by the Company of Metavisio. The exclusivity period for due diligence and the negotiation of a definitive agreement, as extended, will expire on December 9. 2022. A binding commitment with respect to the Proposed Transaction by the Company will only result from the execution of a definitive agreement and then only upon the terms and conditions set forth in the definitive agreement. There can be no assurance that the Company and Metavisio will enter into a definitive agreement with respect to the Proposed Transaction, or, if entered into, there is no certainty of the terms that will be contained in such definitive agreement.
BIIB

Hot Stocks

07:44 EST Biogen names Viehbacher president, CEO - Biogen announced that its Board of Directors has appointed Christopher Viehbacher as President and Chief Executive Officer, CEO, and a member of the Board of Directors, effective November 14. Viehbacher succeeds Michel Vounatsos, who has led the company since 2017. Viehbacher has extensive international experience in both large pharmaceutical companies and entrepreneurial biotech companies. More recently, Viehbacher and Ernesto Bertarelli co-founded Gurnet Point Capital, a Cambridge-based healthcare investment fund, which has led to the creation and continuing development of many companies.
SLDB

Hot Stocks

07:42 EST Solid Bioscience expects cash, cash equivalents to fund operations into Q2 2024 - Solid had $142.2 million in cash, cash equivalents and available-for-sale securities as of September 30, 2022, compared to $207.8 million as of December 31, 2021. The company expects that its cash, cash equivalents and available-for-sale securities will enable it to fund its operations and capital expenditures into the second quarter of 2024, without giving effect to the acquisition of AavantiBio and $75 million private placement.
TLSA

Hot Stocks

07:42 EST Tiziana announces near-term focus on intransal foralumab for CNS diseases - Tiziana Life Science announced a corporate update, including its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System such as non-active secondary-progressive Multiple Sclerosis, Alzheimer's disease and amyotrophic lateral sclerosis. Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana, remarked, "We look forward to leveraging the exciting clinical and preclinical results from our very promising formulation of intranasal foralumab that we have generated so far in CNS-based autoimmune diseases to guide our pipeline investment. Our near-term strategic focus to prioritize resources for the clinical development of this unique therapeutic candidate will allow Tiziana to focus on areas of greatest potential success, be highly efficient in our development timelines and maximize shareholder value while still maintaining optionality for our other research programs, including milciclib in oncology. We aim to become a leading company pioneering intranasal therapies for CNS-based diseases and have sufficient capital to fund our programs until the first quarter of 2024." To date, Tiziana's fully human anti-CD3 monoclonal antibody, foralumab, administered intranasally through Tiziana's proprietary drug delivery technology, has shown benefit in several different pre-clinical models of CNS-based inflammatory disease. These studies confirmed the uptake of the drug in the cervical lymph nodes of these animal models - an area rich in lymphocytes that is a key site of action to target since it then spurs the production of T-cells and reduces inflammation. Tiziana expects to announce the result of the six-month PET scan on patient EA2 and the nine-month PET scan on patient EA1 also in the first quarter of 2023. Additionally, Tiziana recently announced the completion of enrollment for the first cohort of its intermediate-size patient population to continue to evaluate the safety and activity of intranasal foralumab in non-active SPMS patients, as part of its Expanded Access Program. During the first quarter of 2023, the Company then plans to perform three-month PET scans on patients EA3 through EA6 anticipating the results to be available in Q2 2023. Separately, in the fourth quarter of 2022, Tiziana expects to request a "Type C" meeting with FDA to discuss its Phase 2 program for evaluating foralumab in non-active SPMS patients and receive feedback from FDA by the end of the first quarter of 2023.
CRMD

Hot Stocks

07:40 EST CorMedix expects cash to fund operations at least through 2023 - Total cash on hand and short-term investments as of September 30, 2022 was $59.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company's cash resources at September 30, 2022, it has sufficient resources to fund operations at least through 2023.
YETI

Hot Stocks

07:38 EST Yeti jumps 5% to $32.00 after Q3 results beat estimates
SIX

Hot Stocks

07:35 EST Six Flags amends pact with H Partners allowing boost to beneficial ownership - Six Flags Entertainment announced that the company and H Partners agreed to amend their existing Cooperation Agreement to permit H Partners to increase its beneficial ownership of Six Flags common stock to 19.9%, up from a cap of 14.9% in the original agreement. "H Partners has been a constructive and important partner to the company. We are pleased they continue to recognize the value potential of Six Flags and the progress management is making for our shareholders," said Ben Baldanza, Non-Executive Chairman of the Board. "We are excited about the company's strategy to deliver an exceptional guest experience and to drive sustainable, long-term earnings growth," said Arik Ruchim, a Partner at H Partners and director on the Six Flags Board. "We believe that meaningful change takes time to implement, and we are encouraged by the early signs of progress on this ambitious journey."
TGTX

Hot Stocks

07:34 EST TG Therapeutics expects cash to fund operations into 2024 - Cash, cash equivalents and investment securities were $197.7 million as of September 30, 2022. The Company believes its current cash, cash equivalents, investment securities and capital available under its debt facility on ublituximab's approval will be sufficient to fund our planned operations into 2024.
XP

Hot Stocks

07:33 EST XP Inc. to purchase 5.5M shares from Itausa for $105M - XP Inc. announced that it has signed a share purchase agreement with Itausa S.A. Under this agreement, XP will purchase 5,500,000 outstanding Class A common shares from Itausa S.A., equivalent to approximately $105M, in the same conditions for which Itausa sold 10,000,000 Class A shares on November 9. XP should utilize its existing cash to fund this share repurchase and the shares should be held in treasury. This transaction is not part of the share repurchase program announced by XP on May 11.
IPSC

Hot Stocks

07:32 EST Century Therapeutics sees cash runway into 2025 - The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $140 million and $145 million, including non-cash stock-based compensation expense of $10 million to $15 million. The Company expects its cash, cash equivalents, and investments will support operations into 2025.
ACHR UAL

Hot Stocks

07:31 EST Archer Aviation, United Airlines announce first airport to city center route - Archer Aviation (ACHR) and United Airlines (UAL) announced their first airport to city center route between United's hub at Newark Liberty International Airport, or EWR, and New York City. The Downtown Manhattan Heliport, located just above Battery Park on Pier 6, has been confirmed as the first planned takeoff and landing site as part of Archer's broader plan to launch an Urban Air Mobility, or UAM, network across the New York Metropolitan Area. The goal of Archer's electric air taxi network is to provide passengers with safe, quick, quiet and cost-effective transportation to and from EWR. Archer's proposed Manhattan to EWR route marks the first specific route that has been announced in the eVTOL industry. United's hub at EWR is ideally located to serve Manhattan and its surrounding boroughs, as well as communities in New Jersey. Archer estimates the journey from the Downtown Manhattan Heliport to EWR will take less than 10 minutes via its all-electric Midnight aircraft, a low noise, sustainable and safe alternative to helicopters. A similar journey by car can take upwards of an hour or more during rush hour traffic.
TFPM MMX

Hot Stocks

07:30 EST Elliott discloses voting support agreement with Triple Flag, Maverix Metals - Elliott Investment Management announces that on November 9, 2022, Triple Flag Co-Invest Luxembourg Investment Company S.a r.l. and Triple Flag Mining Aggregator entered into a voting support agreement with Triple Flag Precious Metals Corp. and Maverix Metals Inc. pursuant to which they agreed to, amongst other things, vote all of their common shares of Triple Flag in favour of the issuance of Common Shares pursuant to the acquisition of Maverix Metals by Triple Flag under a statutory plan of arrangement pursuant to the Canada Business Corporations Act. Under the terms of the arrangement agreement entered into between Maverix and Triple Flag, Maverix shareholders may elect to receive either US$3.92 in cash or 0.360 of a Common Share per common share of Maverix, subject to proration. The Support Agreement may be terminated by the Shareholders in certain circumstances, including if the Arrangement Agreement is terminated in accordance with its terms and if Maverix and Triple Flag amend the Arrangement Agreement in a manner that results in an increase in the amount of, or a change in the form of, the consideration payable for the common shares of Maverix to be acquired pursuant to the Transaction. In connection with the Transaction, the Shareholders have agreed to amend the investor rights agreement with Triple Flag dated May 26, 2021 effective upon closing of the Transaction to provide that the Shareholders will be entitled to nominate 33% of Triple Flag's directors, subject to reductions to the percentage of directors that may be nominated based on reductions in the percentage of Common Shares owned. The Shareholders are indirectly controlled by certain investment funds advised by Elliott Investment Management LP and its affiliates.
BGNE

Hot Stocks

07:29 EST BeiGene announces Brukinsa approval in Brazil - BeiGene announced Brukinsa has been approved in Brazil for the treatment of adult patients with Waldenstrom's macroglobulinemia, or WM, and adult patients with relapsed/refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen. Brukinsa was previously approved as a treatment in Brazil for adult patients with mantle cell lymphoma, or MCL, who have received at least one prior therapy. BeiGene is focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide.
SGEN

Hot Stocks

07:27 EST Seagen appoints David Epstein as CEO - Seagen announced that its board of directors has appointed David Epstein as CEO and a member of the board of directors. Epstein brings more than 30 years of experience in the biopharmaceutical industry, including more than 25 years at Novartis (NVS) where he built its oncology business unit from initiation to second largest in the world and then served as CEO of Novartis Pharmaceuticals, a division of Novartis AG.
SLI

Hot Stocks

07:27 EST Standard Lithium reports $124M cash on hand as of September 30 - "Q1 was an important quarter for Standard Lithium, in which we advanced our development strategy in meaningful ways - and have continued this momentum into the current quarter," said Robert Mintak, Chief Executive Officer and Director. "We achieved milestones, the most significant of which was awarding the Front-End Engineering and Design and Definitive Feasibility Study for our first commercial lithium plant. That work is successfully underway, with trade-off studies being completed, and the FEED and DFS for Phase 1A on schedule for delivery in the first half of 2023 and will be summarized in a NI 43-101 DFS report. We also added key personnel to the management team and to the workforce at our Arkansas facility, a team that I am proud to report now numbers 30 highly skilled operators, technicians, and engineers. We successfully commissioned a first-of-its-kind chloride-to-hydroxide conversion pilot plant in October. In November, we commenced a significant resource expansion program that includes re-drilling an existing production well into the deeper Smackover Formation at a location west of our South-West Arkansas Project. Additionally, we also received Notices of Allowance for Standard Lithium's first two U.S. patent applications." "The Company has had meaningful dialogue and hosted a number of site visits with groups over the past several months and we are evaluating potential strategic partnerships and supply agreements that will support the further development of our projects," concluded Mintak. "These initiatives, our continuing momentum toward key milestones, and our strong cash position will allow us to advance our commercial development strategy with confidence."
GHRS

Hot Stocks

07:24 EST GH Research expects cash to fund requirements into 2025 - Cash was $256.9 million as of September 30, 2022, compared to $276.8 million as of December 31, 2021. We believe that our existing cash will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2025.
FNCH

Hot Stocks

07:22 EST Finch Therapeutics expects cash to fund operations into 2Q24 - Finch's cash and cash equivalents as of September 30, 2022 were $85.3 million, compared to $133.5 million as of December 31, 2021. Finch believes its cash and cash equivalents on hand as of September 30, 2022, together with anticipated cash inflows from executed subleases for one of the Company's office and lab facilities, will fund its operations into Q2 2024.
FNCH

Hot Stocks

07:21 EST Finch Therapeutics to prioritize development of CP101 in recurrent CDI - Following a recent strategic review of its portfolio, which includes wholly-owned microbiome product candidates for recurrent CDI, inflammatory bowel disease and autism spectrum disorder, Finch is prioritizing the development of CP101 in recurrent CDI and exploring opportunities to potentially advance the development of its pre-clinical candidates for IBD through strategic partnerships. In connection with the strategic review, Finch has suspended efforts to initiate a Phase 1 trial of FIN-211 in ASD while the Company explores opportunities to leverage clinical data generated by ongoing third-party studies to inform its autism program strategy going forward, as previously announced.
HUMA

Hot Stocks

07:19 EST Humacyte expects cash to fund operations through 2024 - The Company reported cash, cash equivalents and short-term investments of $171.7 million as of September 30, 2022, compared to $225.5 million as of December 31, 2021. The $53.8 million net use of cash, cash equivalents and short-term investments for the first nine months of 2022 resulted from spending related to net operating activities for the period, including clinical and earlier-stage research and development programs, and preparation for the Company's anticipated commercial launch. The Company believes that its cash, cash equivalents and short-term investments are adequate to fund operations through 2024, past the Company's current expected timeline for potential approval of the HAV in vascular trauma.
SIOX

Hot Stocks

07:17 EST Sio Gene Therapies sees cash runway beyond December 2023 - As of September 30, 2022, we had $49.86 million of cash and cash equivalents. We hold no short-term or long-term debt on the balance sheet.
JNCE

Hot Stocks

07:15 EST Jounce Therapeutics expects cash to fund operating expenses into 1Q24 - Based on its current operating and development plans and cost containment efforts, Jounce is reiterating its financial guidance for 2022. Gross cash burn on operating expenses and capital expenditures for the full year 2022 is expected to be at the lower end of the range of $115.0 million to $130.0 million. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements into the first quarter of 2024.
ACM

Hot Stocks

07:15 EST Aecom's JV to supply California High-Speed Rail with management support - Aecom's joint venture has been selected by the California High-Speed Rail Authority to provide program management support for the California High-Speed Rail program, a first in the nation electrified high-speed rail line that will connect cities across California with frequent train service exceeding 200 miles per hour. The joint venture is expected to implement an operating model that facilitates the successful delivery of a full array of program delivery services in support of the Authority, such as program planning and strategy; environmental and engineering management; infrastructure delivery; supply chain management; and federal and state funding support. When complete, California High-Speed Rail will connect the 500-mile stretch between the Los Angeles region with the San Francisco Bay Area in less than three hours,
LRMR

Hot Stocks

07:14 EST Larimar Therapeutics sees cash runway into 2H24 - As of September 30, 2022, the Company had cash and marketable securities totaling $124.7 million which provides projected cash runway into the second half of 2024.
CMP

Hot Stocks

07:12 EST Compass Minerals signs multiyear agreement to supply lithium to LG Energy - Compass Minerals signed a binding, multiyear supply agreement to provide LG Energy Solution, a global manufacturer of lithium-ion batteries for electric vehicles and energy storage systems, with battery-grade lithium carbonate from its Ogden, Utah solar evaporation lithium brine development. Per the terms of the agreement, Compass Minerals would deliver up to 40% of its planned, phase-one battery-grade lithium carbonate production to LGES for an initial 6-year term from supply commencement. The company expects an annual commercial production capacity of approximately 35 kMT lithium carbonate equivalent - LCE - once fully operational, with an initial phase-one capacity of approximately 11 kMT battery-grade lithium carbonate coming online by 2025. Compass Minerals is pursuing the sustainable development of an approximately 2.4 mMT LCE resource on the Great Salt Lake. The supply agreement is subject to the successful start of commercial-scale, lithium carbonate production at Compass Minerals' Ogden facility and full product qualification.
ARAV

Hot Stocks

07:12 EST Aravive expects cash, cash equivalents to fund operations into Q4 of 2023 - As of September 30, 2022, cash and cash equivalents were $27.9 million, compared to $46.8 million as of June 30, 2022 and $59.4 million as of December 31, 2021. During October 2022, the Company received a $6 million milestone payment from the Company's licensee, 3D Medicines, and raised approximately $41.5 million in gross proceeds from a private placement offering. The Company believes that its existing cash and cash equivalents will be sufficient to sustain operations into the fourth quarter of 2023.
PASG

Hot Stocks

07:12 EST Passage Bio expects cash to fund operations into 1H25 - Cash, cash equivalents and marketable securities were $213.8 million as of September 30, 2022, as compared to $239.3 million as of June 30, 2022. The Company expects current cash and cash equivalents to fund operations into the first half of 2025.
PASG

Hot Stocks

07:11 EST Passage Bio to reduce workforce by 23%, focus on Imagine-1, upliFT-D programs - The company will decrease operating expenses by reducing the workforce by approximately 23 percent and prioritizing research and development investments. Moving forward, the company will focus on advancing its Imagine-1 and upliFT-D clinical programs for GM1 gangliosidosis and frontotemporal dementia, respectively. The company will stop further clinical development of PBKR03 for Krabbe disease and explore strategic alternatives to advance this program, as well as its program for metachromatic leukodystrophy, PBML04. The company will also prioritize advancing its programs for amyotrophic lateral sclerosis and Huntington's disease through its ongoing collaboration with the University of Pennsylvania's Gene Therapy Program.
OPTN

Hot Stocks

07:09 EST Optinose expects 2022 total GAAP operating expenses $127M-$131M - The Company expects total GAAP operating expenses for 2022 to be in the range of $127 - $131 million, of which the Company expects stock-based compensation to be approximately $9 million. Previously the Company expected total GAAP operating expenses for 2022 to be in the range of $129 - $134 million, of which the Company expected stock-based compensation to be approximately $9 million. In addition, the Company expects total GAAP operating expenses for full year 2023 to decrease materially compared to full year 2022 total GAAP operating expenses.
EQRX

Hot Stocks

07:09 EST EQRx expecst cash to fund operations into 2028 - Cash, cash equivalents and short-term investments totaled $1.5B at September 30, 2022. EQRx expects to maintain sufficient capital resources to fund anticipated operations into 2028, beyond its previous guidance of 2025.
TNGX

Hot Stocks

07:07 EST Tango Therapeutics announces upcoming milestones - Initial safety and efficacy data is expected from the Phase 1/2 clinical trial of TNG908, a synthetic lethal PRMT5 inhibitor, in patients with MTAP-deleted solid tumors during the first half of 2023. The IND filing for TNG462, a next-generation MTA-cooperative PRMT5 inhibitor, is on track for the first half of 2023. The IND filing for TNG260, a first-in-class CoREST inhibitor, is on track for the first half of 2023. The IND filing for TNG348, a novel USP1 inhibitor that is being developed for treatment of BRCA1 and BRCA2-mutant cancers, is on track for 2023.
BLRX

Hot Stocks

07:07 EST BioLineRx: FDA accepts for review NDA for APHEXDA - BioLineRx announced that the U.S. FDA has accepted for review and filed the company's New Drug Application for APHEXDA in stem cell mobilization for autologous transplantation in multiple myeloma patients. The FDA has assigned the NDA a Prescription Drug User Fee Act target action date of September 9, 2023.
CNTA

Hot Stocks

07:06 EST Centessa announces upcoming milestones - Q4 2022: SerpinPC - Initiate PRESent-5, an observation feeder study for the planned intervention studies, PRESent-2 and PRESent-3. Q4 2022: SerpinPC - Phase 2a OLE data readout at ASH on December 10, 2022. Q4 2022: LB101 - Investigational New Drug application submission.
TGT

Hot Stocks

07:06 EST Target debuts new larger-format store - Target revealed the next evolution of its new store strategy and store design created to better serve its guests and team members and drive continued growth. Target's new larger-format stores optimize additional space and new design elements and at nearly 150,000 square feet, the locations are more than 20,000 square feet larger than the chain average. While the retailer will continue to open stores of all sizes, it will focus on this larger footprint in the next few years. Target also will bring its reimagined store design - which features a more open layout and localized elements to inspire and serve its guests - to future remodels as well as new stores across its chain. The retailer recently debuted the new store design and larger store format in a new location outside Houston. Starting in 2023, more than half of Target's approximately 200 full store remodels and almost all the retailer's approximately 30 new stores will include elements of the new design. Beginning in 2024, all of Target's remodels and new stores will feature the majority of the reimagined store design elements.
SWIM

Hot Stocks

07:04 EST Latham Group announces cost reduction actions including workforce reduction - Building upon Latham's ongoing lean and value engineering initiatives, and in response to current market conditions, the Company has announced the implementation of several near-term cost reduction actions. These include optimizing production and shift schedules, implementing a workforce reduction, and streamlining its cover and liner manufacturing footprint with the closure of its Bossier City, Louisiana facility expected in the first quarter of fiscal 2023. As a result of these actions, the Company expects to incur approximately $2.0 million in total charges for employee severance and related costs and fixed asset and facility-related expenses. Latham expects to recognize these charges in the fourth quarter of fiscal 2022 into the first quarter of fiscal 2023. The cost reduction actions are expected to yield annualized cost savings of approximately $12 million beginning in fiscal 2023.
HOWL

Hot Stocks

07:02 EST Werewolf Therapeutics expects cash to fund operations through 2Q24 - As of September 30, 2022, cash and cash equivalents decreased to $140.5 million, compared to $157.5 million as of December 31, 2021. Based on updated forecasting, the Company has extended its runway to project that its existing cash and cash equivalents, together with anticipated collaboration revenue and access to the term loan agreement with Pacific Western Bank, will be sufficient to fund its operational expenses and capital expenditure requirements through at least the second quarter of 2024.
AURA

Hot Stocks

06:57 EST Aura Biosciences initiates startup activities for global Phase 3 trial - Aura Biosciences announced that it has initiated startup activities for the global Phase 3 trial. After presenting positive interim data at the American Academy of Ophthalmology from its ongoing Phase 2 trial, Aura has aligned with regulatory agencies and finalized the design of the global Phase 3 trial. The trial will evaluate the efficacy and safety of belzupacap sarotalocan with suprachoroidal administration, for the first-line treatment of early-stage choroidal melanoma. The Phase 3 trial has a three arm randomized and masked design, where the primary analysis will compare bel-sar to sham. Aura is planning to enroll approximately 75 adult patients with eary-stage CM, including patients with indeterminte lesions and small choroidal melanoma. Patients will be enrolled with documented growth as an enrichment strategy intended to increase the efficiency of the trial which will include an adaptive design to further increase the probability of success.
LAZ

Hot Stocks

06:55 EST Lazard reports preliminary AUM $204.6B as of October 31 - The month's AUM included market appreciation of $8B, net outflows of $1.8B, and foreign exchange appreciation of $0.6B.
SBH

Hot Stocks

06:48 EST Sally reports distribution center consolidation and store optimization plan - Sally Beauty stated: "Over the last several quarters, the company has been piloting store closures in various markets with the goal of maximizing the value of its large store portfolio and providing a seamless omni-channel experience to its customers. Based on positive sales recapture rates and improved profitability within those markets, the company is accelerating its store optimization plan, including the closure of approximately 350 stores with the majority closing in December 2022. Most of the store closings will be Sally Beauty locations in the U.S. In addition, the company will also be optimizing its supply chain by closing two small distribution centers in Oregon and Pennsylvania and transferring the volumes to larger distribution centers, effective in December 2022. As part of this optimization plan, the company incurred a $45.5M charge in the fourth quarter of 2022, which includes a $19.4M non-cash inventory write-down. The expense savings from this optimization plan is expected to be approximately $50M with an expected benefit of approximately $10M to adjusted operating earnings for fiscal year 2023."
USFD

Hot Stocks

06:46 EST US Foods announces $500M share repurchase program - The repurchase authorization does not have an expiration date.
EVTV

Hot Stocks

06:46 EST Envirotech Vehicles delivers two vans to Pick and Send Transportation - Envirotech Vehicles announced that the company has delivered two vans to Pick and Send Transportation., a Newark-based company in New Jersey, funded by New Jersey's Zero Emission Incentive Program.
HUT...

Hot Stocks

06:45 EST Hut 8 Mining mines 982 Bitcoin in Q3 - The company mined 982 Bitcoin in Q3, an 8.5% increase compared to Q3 2021 due to an increase in hashrate from the expansion of the company fleet of miners and mining activities. Hut 8's computing operations generated $4.4M of revenue in the quarter, the majority of which is monthly recurring revenue. The company installed an aggregate of 2,205 new MicroBT M30S, M30S+, M30S++ and M31S+ miners at its three mining sites during Q3. The installation of these miners brought Hut 8's operating capacity to 3.07 EH/s as of September 30, an increase of 10% in hashrate compared to June 30. "Our conservative approach to managing our balance sheet continues to be paramount for us at Hut 8," said Shane Downey, CFO of Hut 8. "Notably, we improved our mining capacity by 10% while reducing the average cost to mine each Bitcoin by 29%, when compared to the second quarter of 2022. We remain steadfastly committed to effectively managing capital in today's challenging environment and believe we are well positioned to deliver shareholder value in 2023 and beyond."
OB

Hot Stocks

06:44 EST Outbrain sees Q4 adjusted EBITDA $4M-$6M
OB

Hot Stocks

06:44 EST Outbrain raises 2022 adjusted EBITDA view to at least $23.2M from $18M - Raises FY22 Ex-TAC gross profit view to at least $232.5M from at least $228M.
IMOS

Hot Stocks

06:41 EST ChipMOS reports October revenue $48.8M, down 31.2%
SEV

Hot Stocks

06:29 EST Sono Motors partners with Bosch for Europe-wide car repair network - Sono Motors and German company Bosch have agreed to cooperate on a joint Europe-wide network of car repair shops. Owners of the Sion, Sono Motor's solar electric vehicle, will be able to use all services offered by participating car repair shops, including repair, servicing, maintenance, and warranty services. The overall 50 qualified Bosch Car Services to be trained in the launch phase will be distributed throughout Germany in such a way that both major cities and rural areas will be covered. Additional qualified service centers will be added in the subsequent rollout to create a comprehensive service network available in many European countries. The staff at Bosch partner workshops will receive comprehensive prior training from Sono Motors after which they will be authorized to perform repairs on high-voltage, photovoltaic, and safety systems with the assistance of, if necessary, Sono Motors Technical Field Service. The cooperation between Sono Motors and Bosch includes comprehensive repair, service, and proactive service work. As an accompanying measure, Sono Motors plans to provide tutorials for certain DIY maintenance on its website.
BDX

Hot Stocks

06:26 EST Becton Dickinson increases quarterly dividend 4.6% to 91c per share - The board of directors of Becton Dickinson has declared a quarterly dividend of 91c per common share, an increase of 4.6% from the previous quarter. The dividend will be payable on December 30 to holders of record on December 9. The indicated annual dividend rate for fiscal year 2023 is $3.64 per share.
TFPM...

Hot Stocks

06:15 EST Triple Flag to acquire Maverix Metals for $3.92 per share, sees accretion - Triple Flag (TFPM) and Maverix Metals (MMX) announced that they have entered into a definitive agreement in which Triple Flag will acquire all of the issued and outstanding common shares of Maverix pursuant to a plan of arrangement, positioning Triple Flag as the emerging senior streaming and royalty company. This combination is expected to be accretive on a NAV-per-share and cash-flow-per-share basis. Pursuant to the transaction, Maverix shareholders may elect to receive either $3.92 in cash or 0.360 of a Triple Flag share per Maverix share held, representing share consideration of $3.92 per Maverix share based on the closing price of Triple Flag shares on November 9 of $10.89. The shareholder election will be subject to pro-ration such that the cash consideration will not exceed 15% of the total consideration and the share consideration will not exceed 85% of the total consideration. Maverix shareholders who do not elect to receive either Triple Flag shares or cash will be deemed to elect default consideration of 0.360 Triple Flag shares per Maverix share. The exchange ratio implies a premium of 10% based on the closing share prices of Triple Flag and Maverix on the New York Stock Exchange on November 9 and a premium of 22% based on the 10-day volume-weighted average share prices of Triple Flag and Maverix on the NYSE as of November 9. The purchase price implies a total equity value for Maverix of $606M on a fully diluted basis. Upon completion of the Transaction, existing Triple Flag and Maverix shareholders would own approximately 77% and 23% of the combined company, respectively, on a fully diluted basis. Triple Flag shareholder Elliott Investment Management L.P. and Maverix shareholders Newmont Corporation, Pan American Silver Corp. and Kinross Gold Corporation are all supportive of the combination. The combined company will continue as Triple Flag Precious Metals headquartered in Toronto, Ontario, and will be led by Shaun Usmar as CEO. Following the completion of the transaction, it is expected that Geoff Burns, founder and chair of Maverix, and another nominee of Maverix will join the Triple Flag board of directors. The combined company will continue to pay an annualized dividend of 20c per Triple Flag share, resulting in an effective dividend increase of over 40% for Maverix shareholders pro forma, based on the exchange ratio. Under the terms of the agreement, the transaction will be carried out by way of a court-approved plan of arrangement under the Canada Business Corporations Act, and will require the approval of at least 66 2/3% of the votes cast by the shareholders of Maverix at a special meeting and if required, minority shareholder approval in accordance with Multilateral Instrument 61-101. Newmont Corporation (NEM) and Pan American Silver (PAAS), together with all of the officers and directors of Maverix, collectively control approximately 57% of the common shares of Maverix on a fully diluted basis and have entered into voting and support agreements pursuant to which they have agreed to vote their shares in favor of the transaction. As the Triple Flag shares to be issued to the shareholders of Maverix in the Transaction will exceed 25% of the issued and outstanding common shares of Triple Flag, Triple Flag shareholder approval of the transaction is required under Section 611(c) of the rules of the TSX. Triple Flag is relying on the exemption in Section 604(d) of the rules of the TSX, whereby instead of holding a shareholder meeting, Triple Flag has obtained the written consent for the Transaction of shareholders of Triple Flag holding greater than 50% of the issued and outstanding common shares of Triple Flag. Entities controlled by Elliott Investment Management L.P., which control approximately 83% of the issued and outstanding common shares of Triple Flag, have entered into voting and support agreements pursuant to which they have provided written consent to the transaction, and have agreed, if required, to vote their shares in favor of the Transaction at a Triple Flag shareholder meeting. Each of the officers and directors of Triple Flag have also entered into voting and support agreements, pursuant to which they have agreed to vote their shares in favor of the Transaction in the event of a Triple Flag shareholder meeting. Completion of the Transaction is also subject to regulatory and court approvals and other customary closing conditions. The agreement includes customary provisions, including non-solicitation by Maverix of alternative transactions, a right of Triple Flag to match superior proposals and an approximately $24M termination fee, payable under certain circumstances. Complete details of the transaction will be included in a management information circular to be delivered to Maverix shareholders in the coming weeks. Subject to receiving requisite court approval, the special meeting of shareholders of Maverix is expected to be held in early January 2023 and the transaction is also expected to close in January 2023. In connection with and subject to closing the Transaction, it is expected that the common shares of Maverix will be delisted from the TSX and the NYSE American and that Maverix will cease to be a reporting issuer under Canadian and U.S. securities laws.
YETI

Hot Stocks

06:14 EST Yeti CEO says 'expectations for the second half of the year have not changed' - CEO Matt Reintjes said, "We are maintaining and narrowing our Fiscal 2022 outlook, with all components remaining within our previous outlook. We expect full year 2022 sales growth of 16%, as our expectations for the second half of the year have not changed. This growth incorporates the strength of our third quarter performance, which did see an increase in wholesale orders that were backed by continued strong sell-through and the channel's effort to reach more optimal inventory levels earlier than we would normally see ahead of the holiday season. Our sales growth outlook for the year takes this into consideration, as well as a prudently cautious position for the fourth quarter. We also expect our adjusted operating margin to come in at approximately 17%, which is reflective of the supply chain cost challenges and our continued focus on balancing growth across our channels and categories. We remain confident in our ability to drive brand and product momentum, build out a great team, and strengthen an already sound balance sheet, as we look forward into the fourth quarter of 2022, Fiscal 2023, and beyond."
EYE

Hot Stocks

06:09 EST National Vision reports Q3 comparable store sales growth (8.0%) - Adjusted comparable store sales growth was (8.1%).
MMX TFPM

Hot Stocks

06:06 EST Maverix Metals, Triple Flag announce merger agreement - Triple Flag Precious Metals (TFPM) and Maverix Metals (MMX) announced that they have entered into a definitive agreement in which Triple Flag will acquire all of the issued and outstanding common shares of Maverix pursuant to a Plan of Arrangement, positioning Triple Flag as the leading emerging senior streaming and royalty company. Pursuant to the Transaction, Maverix shareholders may elect to receive either $3.92 in cash or 0.360 of a Triple Flag share per Maverix share held, representing share consideration of $3.92 per Maverix share based on the closing price of Triple Flag shares on November 9, 2022 of $10.89. The shareholder election will be subject to pro-ration such that the cash consideration will not exceed 15% of the total consideration and the share consideration will not exceed 85% of the total consideration. Maverix shareholders who do not elect to receive either Triple Flag shares or cash will be deemed to elect default consideration of 0.360 Triple Flag shares per Maverix share. The combined company will continue as Triple Flag Precious Metals Corp., headquartered in Toronto, Ontario, and will be led by Shaun Usmar as CEO. Following the completion of the Transaction, it is expected that Geoff Burns, founder and Chair of Maverix, and another nominee of Maverix will join the Triple Flag board of directors. The combined company will continue to pay an annualized dividend of $0.20 per Triple Flag share, resulting in an effective dividend increase of over 40% for Maverix shareholders pro forma, based on the exchange ratio. Completion of the Transaction is also subject to regulatory and court approvals and other customary closing conditions. The Agreement includes customary provisions, including non-solicitation by Maverix of alternative transactions, a right of Triple Flag to match superior proposals and an approximately $24M termination fee, payable under certain circumstances. Complete details of the Transaction will be included in a management information circular to be delivered to Maverix shareholders in the coming weeks. Subject to receiving requisite court approval, the special meeting of shareholders of Maverix is expected to be held in early January 2023 and the Transaction is also expected to close in January 2023. In connection with and subject to closing the Transaction, it is expected that the common shares of Maverix will be delisted from the TSX and the NYSE American and that Maverix will cease to be a reporting issuer under Canadian and U.S. securities laws.
RCL

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05:43 EST Royal Caribbean opens $125M cruise terminal in Galveston with Allure of the Seas - Royal Caribbean's new $125M cruise terminal in Galveston, Texas, opened its doors and welcomed the Lone Star State's largest cruise ship, Allure of the Seas. The cruise line held a ribbon cutting ceremony at the Port of Galveston to mark the facility's opening and the Texas debut of its revolutionary Oasis Class.
CVX

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05:39 EST Chevron, Mitsui O.S.K. to explore transportation of 2.5M tons per annum of CO2 - Chevron, through its Chevron New Energies International subsidiary, and Mitsui O.S.K. Lines, announced the signing of a joint study agreement, or JSA, on the feasibility of transporting liquified carbon dioxide, or CO2, from Singapore to permanent storage locations offshore Australia. Under the JSA, Chevron and MOL will explore the technical and commercial feasibility of initially transporting up to 2.5M tons per annum of liquified CO2 by 2030. The JSA will complement work to be advanced by a recently announced consortium to explore solutions for large-scale carbon capture, transport and permanent storage of CO2 from Singapore. Through its part in three joint ventures, Chevron was also recently granted an interest in three greenhouse gas assessment permits offshore Australia.
ESLT

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05:28 EST Elbit Systems subsidiary awarded $19M follow-on contract from British Army - Elbit Systems announced that its subsidiary Elbit Systems was awarded a follow-on contract $19M valued at approximately $19M to supply Night Vision Goggles, or NVG, and through-life support to the British Army. The contract will be executed over a 18-month period. Under the contract, Elbit Systems UK will supply the lightweight micro binocular XACT nv33 NVGs in a helmet-mounted configuration. XACT nv33 NVG are designed to enable troops to operate effectively in low-light conditions at a tactical level, maximizing their mission efficiency in both dismounted and mounted roles. Products from the XACT family are already in operational use with a number of NATO members including the Netherlands and Germany.
BA

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05:21 EST Boeing announces Japan's Skymark Airlines to add up to 12 737 MAX airplanes - Boeing and Japan's Skymark Airlines announced the airline's plan to add up to 12 737 MAX airplanes as part of its fleet modernization efforts. The carrier intends to order four airplanes including the 737-8 and 737-10 variants with options for two additional jets. Separately, the airline will add six lessor-owned 737-8s to its fleet. Based in Tokyo's Haneda Airport, Skymark Airlines is Japan's third largest carrier by revenue and currently operates an all-Boeing fleet of 29 Next-Generation 737-800s.
EVAX

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05:19 EST Evaxion Biotech intends to further increase focus on EVX-01, EVX-02/03 assets - Evaxion Biotech announced that it intends to further increase its focus on its lead oncology assets EVX-01 and EVX-02/03 to bring them to clinical proof of concept followed by out-licensing. The company further plans preclinical partnering of its early-stage programs under its infectious disease platforms. As previously announced by the company, the EVX-01 program recently started to enroll patients in the global Phase IIb trial in metastatic melanoma. At the same time, the Phase I/IIa trial of the DNA-based EVX-02 is progressing as planned, with data readout currently expected by mid-2023. The next-generation DNA vaccine, EVX-03, builds on EVX-02 and holds the potential for even stronger efficacy due to an integrated mechanism that boosts the immune system. The company plans to submit a regulatory filing of EVX-03, following EVX-02 data, which may allow Evaxion to advance EVX-03 faster to clinical proof of concept. "I am deeply impressed by the AI platforms and the quality of the innovative programs that Evaxion has developed. The Company holds several first-in-class assets within oncology and infectious diseases. In the current biotech market, however, we fully acknowledge the increasing need to center our activities. Consequently, our resources will be channeled into our leading clinical assets within personalized cancer immunotherapy," states Per Norlen, the company's new CEO. Norlen continues: "Our primary focus will be on our Phase IIb program for EVX-01 and our Phase I/IIa program for EVX-02/03. Regarding our early programs for infectious diseases, such as our Staphylococcus aureus vaccine, we aim to develop these in partnerships rather than bringing them into clinical development ourselves."
HTOO BLDP

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05:16 EST Fusion Fuel, Ballard Power commission H2Evora plant in Portugal - Fusion Fuel (HTOO) announced that it has completed the interconnection of its H2Evora plant to the Portuguese electric grid and has successfully commissioned the facility. The demonstration project, comprised of 15 HEVO-Solar units and associated balance of plant equipment, will produce 15 tons of green hydrogen per year and avoid the emission of 135 tons of CO2 annually. The facility includes a 200-kilowatt FCwave fuel cell module supplied by Ballard Power Systems (BLDP), which is used to convert its green hydrogen into electricity, enabling Fusion Fuel to sell power into the electric grid during periods of peak demand. The integration of Fusion Fuel's solar-to-hydrogen HEVO solution and Ballard's fuel cell technology is a powerful proof of concept for the use of hydrogen as a flexible energy storage vector and off-grid power supply.