Stockwinners Market Radar for October 20, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

TRKA

Hot Stocks

17:38 EDT Troika Media management sees 'substantial doubt' to continue as going concern - The company states: "As has been previously reported, the Company agreed with its senior lender, Blue Torch, to undertake a process with an investment banker to facilitate the repayment of Blue Torch's debt in full either through an acquisition or disposition involving the Company, a refinance of Blue Torch's debt, or some combination thereof. As a result, the Company engaged Jefferies LLC, a leading global full-service investment banking and capital markets firm, in December 2022 and the Board formed a Special Committee to, among other things, oversee a Potential Transaction. To date, no agreement for a Potential Transaction has been reached, and the Company is pursuing a long-term amendment of the Financing Agreement with Blue Torch. The current waivers with Blue Torch expire on October 20, 2023, subject to potential extension if a definitive written agreement is delivered on or prior to October 20, 2023, providing for cash repayment in full of all obligations owed to Blue Torch or which is otherwise acceptable to Blue Torch. There can be no assurance that the Company will be able to execute a Potential Transaction or reach agreement with Blue Torch by such date. If necessary, the Company will request additional waivers and extensions of the expiration date of the waivers from Blue Torch, but there can be no assurance that Blue Torch will agree to any requested waivers or extensions. The Company is currently in negotiations to extend that date. The issues with the Company's capital structure and the costs of the Blue Torch debt have materially impacted the liquidity of the Company and have negatively impacted the performance of the business given the Company's limited ability to invest in the business and the material amounts of time management has spent on the restructuring process. Pursuant to current projections of the Company's cash flow, the Company would fail to have enough cash to continue to fund operations for the next twelve months. Thus, management has concluded that there is substantial doubt that the Company will continue as a going concern."
BHC

Hot Stocks

17:23 EDT Bausch Health announces FDA approves Cabtreo in Acne Vulgaris - Bausch Health and its dermatology business, Ortho Dermatologics, announced that the FDA has approved the New Drug Application for CABTREO clindamycin phosphate, adapalene and benzoyl peroxide Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older. CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. CABTREO is expected to be available to patients in Q1 2024. CABTREO was studied in two Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12.
AKU

Hot Stocks

17:06 EDT Akumin reaches deal with Stonepeak to go private - Akumin announced that it has reached an agreement with Stonepeak, an alternative investment firm, and the company's stakeholders on the terms of a financial restructuring. The contemplated transaction will result in Akumin no longer being publicly listed. To effect the transaction, the company and certain of its subsidiaries will commence prepackaged chapter 11 cases in the Southern District of Texas. The company expects to obtain court approval of the transaction within the next 45 days and complete the transaction after receiving certain regulatory approvals. Throughout the process, Akumin's operations are expected to continue as normal. The company expects to continue to pay trade creditors, employees, and other partners in the ordinary course of business. The contemplated transaction will result in the existing Stonepeak Note, totaling approximately $470M, being cancelled and converted into common shares of the company. In addition, Stonepeak will invest $130M in new money into the company as a capital contribution. To facilitate the transaction, the company and Stonepeak have executed a restructuring support agreement with over one-third of the company's common equity, a supermajority of the company's bondholders, and all of the company's revolving lenders. The restructuring support agreement provides that, other than those notes which are exchanged for cash via the reverse Dutch election opportunity described below, the company's senior secured notes due 2025 will be exchanged for new senior secured notes with a maturity of August 1, 2027 and an increased interest rate, among other changes in terms. Additionally, the company's senior secured notes due 2028 will be exchanged for new senior secured notes with the same maturity date but an increased interest rate, among other changes in terms. As part of the transaction, Akumin's existing common stockholders will receive a total of $25M in cash as well as certain contingent value rights, or CVRs, for their shares. The transaction will be implemented through a court-supervised process and as such, the company and certain of its subsidiaries will commence prepackaged chapter 11 cases in the Southern District of Texas. In the event Stonepeak provides debtor-in-possession, or DIP, financing or any other new money contributions at or prior to the closing of the transaction, such DIP facilities and new money will convert to equity at closing and reduce the $130M investment amount on a dollar-for-dollar basis. Stonepeak will also make $60M of the proceeds from its investment available for a reverse Dutch election opportunity for the company's notes due 2025 and the notes due 2028.
REGN SNY

Hot Stocks

17:03 EDT Regeneron, Sanofi update on Dupixent sBLA in Chronic Spontaneous Urticaria - Regeneron (REGN) and Sanofi (SNY) announced that the FDA has issued a Complete Response Letter for the supplemental Biologics License Application for Dupixent, or dupilumab, in chronic spontaneous urticaria. CSU is an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin. The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An ongoing clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data.
ILAG

Hot Stocks

17:01 EDT Intelligent Living Application Group discloses Nasdaq minimum bid listing notice - Intelligent Living Application announced that, on October 19, 2023, the Company received a letter from the Nasdaq Stock Market notifying the Company that, because the closing bid price for the Company's ordinary shares listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company no longer meets the minimum bid price requirement for continued listing on Nasdaq under Nasdaq Marketplace Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share.
ARIZ

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16:47 EDT Arisz Acquisition extends deadline to complete business combination - Arisz Acquisition, a special purpose acquisition company, announced that Arisz Investments LLC, the Company's initial public offering sponsor, has timely deposited into the Company's trust account, an aggregate of $120,000, in order to extend the period of time the Company has to complete a business combination for an additional one (1) month period, from October 22, 2023 to November 22, 2023. The Extension is the sixth of up to nine (9) one-month extensions permitted under the May 12, 2023 amendment to the Amended and Restated Certificate of Incorporation of Arisz Acquisition Corp. The Extension provides Arisz with additional time to complete its proposed business combination with Finfront Holding Company.
F...

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16:47 EDT UAW says no new plants to go out on strike
F...

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16:43 EDT UAW says has 23% wage increase at all three companies on the table - Says extremely profitable companies have more to give. Says Kentucky strike dealt serious blow to Ford (F), but also meant to send a message to Stellantis (STLA) and General Motors (GM). Says days of UAW and Ford acting as a team is over. Says will not partner with Big 3 to match the low standard of non-union autoworkers. Says going to unionize autoworkers everywhere. Says Ford's dividends show the UAW that money is there, but they don't want the autoworkers to have it. Says Stellantis and Ford both have put more new money on the table. Says took Fords biggest plant out and they haven't come back with anything new. Says wages at all three companies we have a 23% raise on the table, up from 20% a couple days ago. Says killed massive wage tiers at all three major companies. Says in regards to cost of living, Ford back to where it was in 2009. Says fighting to end abuse of so called temp workers. Says won right to strike over plant closure at Ford and Stellantis, but GM won't grant it. Says wont two weeks of parental leave at Big 3. Says Ford and Stellantis agreed to 9% contribution to 401k with GM at 8%. Says not sticking to Friday expansions. Comments take from UAW livestream update.
F...

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16:36 EDT UAW President Shawn Fain says union has offers from two of big three in past day - Says past 24 hours got offers from two of the big three companies, Ford (F) General Motors (GM) and Stellantis (STLA). Says 1,000 UAW members walked out of casinos in Detroit this week. Says launched first ever wall-to-wall casino strike. Says General Dynamics (GD) won't agree to make Veterans day a paid holiday. Says bargaining team meant with Mack (VLVLY) this week. Says expects Mack to come back with something real and quick. Says companies are using fear to create doubt among UAW members. Says membership is highest authority and will always have final say. Says vote will be from a place of strength. Says there is more to be won. Says record contract offers from companies come off of record decline in the past two decades. Says there is room to move. Comments taken from UAW livestream update.
GBNH

Hot Stocks

16:32 EDT Greenbrook TMS names Peter Willett as interim CFO - Greenbrook TMS "announced the appointment of Mr. Peter Willett as Interim Chief Financial Officer, effective immediately. Over the past six years, Peter has been a key player on the Greenbrook finance team, serving as its senior vice president of finance. Peter brings over 11 years of finance experience, providing a broad base of experience and specialized knowledge about the financial and accounting matters that are unique to the mental health services industry. Peter assumes responsibilities from Erns Loubser as he pursues new opportunities. Greenbrook has retained an executive search firm and will consider Peter and other candidates as part of its process to identify the Company's next permanent Chief Financial Officer."
THFF

Hot Stocks

16:31 EDT First Financial announces Norman Lowery as new CEO on January 1st - First Financial "announced a leadership transition. Norman D. Lowery, Senior Vice President and Chief Operating Officer of the Company will succeed his father, Norman L. Lowery, as President and Chief Executive Officer on January 1, 2024. Norman L. Lowery, the Company's current Chairman, President and Chief Executive Officer, will serve as Executive Chairman of the Board through December 31, 2024, at which time he will transition to the role of non-executive Chairman of the Board."
GROW

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16:24 EDT U.S. Global Investors discloses late 10-Q filing from Nasdaq - U.S. Global Investors announces that it received a standard notification letter dated October 16, 2023, from the Nasdaq Listing Qualifications Department of Nasdaq notifying the Company that it is no longer in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of all required financial reports with the U. S. Securities and Exchange Commission, for failing to file its Form 10-K for the fiscal year ended June 30, 2023 within the prescribed timeframe.
MSEX

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16:17 EDT Middlesex Water raises quarterly dividend by 4% to 32.5c per share - Middlesex Water announced that its Board of Directors has declared a cash dividend of $0.325 per share on its common stock, an increase of 4.0% from the $0.3125 per share dividend last declared in July 2023. This increase raises the annual dividend rate to $1.30 from $1.25 per share of common stock and marks Middlesex's 51st consecutive year of dividend increases. The dividend at the new rate is payable December 1, 2023 to shareholders of record as of November 16, 2023.
SLCA

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16:16 EDT U.S. Silica announces CFO Donald Merril terminated without cause - U.S. Silica Holdings "announced that it has appointed Kevin Hough as interim Executive Vice President, Chief Financial Officer and Chief Accounting Officer, succeeding Donald A. Merril, who was terminated without cause effective as of October 20, 2023. Mr. Hough has served as the Company's Vice President and Corporate Controller since 2016. He previously served as the Company's Corporate Controller from 2011, when he joined the Company, to 2016. Mr. Hough holds a Bachelor of Science in Accounting from Le Moyne College."
EFC AJX

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16:16 EDT Ellington Financial, Great Ajax announce mutual termination of merger agreement - Ellington Financial (EFC) and Great Ajax Corp. (AJX) jointly announced they have agreed to terminate the merger agreement announced on July 3, effective immediately. "The termination was approved by both companies' boards of directors after careful consideration of the proposed merger and the progress made towards completing the proposed merger. In addition, Ellington Financial has agreed to pay Great Ajax $16M of which $5M is payable in cash and $11M was paid as consideration for approximately 1.666 million shares of Great Ajax common stock, which was purchased at a per share price of $6.60. Ellington Financial will now hold approximately 6.1% of Great Ajax's stock. In addition, an affiliate of the external manager of Ellington Financial owned 273,983 shares of Great Ajax common stock as of June 30, 2023. Ellington Financial remains a securitization joint venture partner as well. The two companies intend to continue to work together on mortgage loan opportunities," the companies stated.
DBX

Hot Stocks

16:14 EDT Dropbox amends lease agreement, to pay $79M in termination payments - In a regulatory filing, Dropbox disclosed that on October 17, it entered into a lease amendment to its office lease, dated October 6, 2017, as subsequently amended, with KRE Exchange Owner for its corporate headquarters in San Francisco, California, whereby the company will surrender to the landlord 165,244 square feet of office space and pay an aggregate of $79M in termination payments. The surrendering of space and payment of termination fees will occur in three tranches: 51,956 square feet and $28.1M paid in Q4 of 2023, 54,253 square feet and $14.9M paid in Q2 of 2024 and the remaining 59,035 square feet and $36M paid in Q1 of 2025. As a result of the amendment the company will avoid future cash payments related to rent and common area maintenance fees of $137M and approximately $90M, respectively, over the remaining 10 year lease term.
BMRN

Hot Stocks

16:09 EDT BioMarin reports FDA approves expanded indication for Voxzogo - BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application, or sNDA, for Voxzogo to increase linear growth in pediatric patients with achondroplasia with open epiphyses, or growth plates. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Previously, Voxzogo was indicated for children who were 5 years of age and older. This expanded indication now includes children of all ages with open growth plates, the company noted.
COMS

Hot Stocks

16:08 EDT COMSovereign Holding discloses Nasdaq de-listing determination, plans to appeal - COMSovereign Holdin "announced that on October 16, 2023, the Company received notice from the Nasdaq Listing Qualifications Staff indicating that the Staff had determined to delist the Company's securities from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel. The Company plans to timely request a hearing before the Panel, at which hearing the Company will present its plan to evidence compliance with Nasdaq's filing requirement and request an extension to do so. The Company will also request a further stay of any suspension action pending the Company's hearing and the expiration of any extension the Panel may grant to the Company following the hearing."
FSNB

Hot Stocks

16:06 EDT Fusion Acquisition Corp. II discloses NYSE notice of suspension of trading - On October 17, 2023, the New York Stock Exchange issued a press release announcing that the staff of NYSE Regulation determined to suspend trading immediately and commence proceedings to delist the shares of Class A common stock and units of Fusion Acquisition Corp. II because the Company is not in compliance with the NYSE's continued listing standard requiring a listed acquisition company to maintain an average aggregate global market capitalization attributable to its publicly-held shares over a consecutive 30 trading day period of at least $40,000,000. On the same day, the NYSE notified the Company in writing of the determination to suspend trading and commence proceedings.
PM

Hot Stocks

16:03 EDT Philip Morris submits applications to commercialize IQOS ILUMA to FDA - Philip Morris International submitted Premarket Tobacco Product Applications, PMTAs, and Modified Risk Tobacco Product Applications, MRTPAs, for IQOS ILUMA heated tobacco products with the FDA. A PMTA marketing order is required to commercialize any new tobacco product in the United States. The company is also seeking an order to market IQOS ILUMA products as modified risk products that reduce exposure to harmful, and potentially harmful chemicals, a claim authorized for previous versions of IQOS.
XTLB

Hot Stocks

16:02 EDT XTL Biopharmaceuticals discloses Nasdaq listing deficiency notice - XTL Biopharmaceuticals "announced that the Company received a written notification from the Nasdaq Stock Market LLC on October 18, 2023, notifying the Company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Rules for continued listing on the Nasdaq. The Notification Letter does not impact the Company's listing on the Nasdaq Capital Market at this time and the Company's ADSs continue to trade on the Nasdaq Capital Market under the symbol "XTLB". In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until April 15, 2024, to regain compliance. The Notice states that to regain compliance, the bid price for the ADSs must close at $1.00 per ADS or more for a minimum of ten (10) consecutive business days during the compliance period ending April 15, 2024."
XTLB

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16:00 EDT XTL Biopharmaceuticals confirms no disruption to business operations in Israel - XTL Biopharmaceuticals "addressed the status of the Company's continued and uninterrupted activity in Israel against the background of the recent severe terrorist attack in the south of the country and the subsequent declaration of war by the Israeli government against the Hamas terrorist organization. XTL's management confirms that to date the Company has not seen any adverse impact to its ongoing operations in Israel and continues to work as normal. At the same time, the Company continues to monitor its ongoing activities and make any needed adjustments to ensure a smooth continuity of its business. The Company notes that its headquarters are in the center of the country, near Tel Aviv, and not near any borders."
PFE

Hot Stocks

15:37 EDT Pfizer announces FDA approval of meningococcal disease vaccine - Pfizer announced that the Food and Drug Administration has approved Penbraya, the first pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. Penbraya combines the components from two meningococcal vaccines, Trumenba and Nimenrix "to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease globally," the company said in a statement. The CDC Advisory Committee on Immunization Practices will meet on October 25 to discuss recommendations for the appropriate use of Penbraya in adolescents and young adults.
OKTA

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15:20 EDT Okta sinks 10% to $76.58 after confirming customer files hacked
OKTA

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15:19 EDT Okta confirms threat actor viewed files uploaded by customers - Okta Chief Security Officer David Bradbury said in a blog post: "Okta Security has identified adversarial activity that leveraged access to a stolen credential to access Okta's support case management system. The threat actor was able to view files uploaded by certain Okta customers as part of recent support cases. It should be noted that the Okta support case management system is separate from the production Okta service, which is fully operational and has not been impacted. In addition, the Auth0/CIC case management system is not impacted by this incident. Note: All customers who were impacted by this have been notified. If you're an Okta customer and you have not been contacted with another message or method, there is no impact to your Okta environment or your support tickets. Within the course of normal business, Okta support will ask customers to upload an HTTP Archive file, which allows for troubleshooting of issues by replicating browser activity. HAR files can also contain sensitive data, including cookies and session tokens, that malicious actors can use to impersonate valid users. Okta has worked with impacted customers to investigate, and has taken measures to protect our customers, including the revocation of embedded session tokens. In general, Okta recommends sanitizing all credentials and cookies/session tokens within a HAR file before sharing it."
OKTA

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15:17 EDT Okta says identified stolen credential to access management system
OKTA

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15:10 EDT Okta slides 9% after report of hack - Shares of Okta are down 9%, or $7.73, to $77.73 in afternoon trading after noted security expert Brian Krebs said on his blog that the company had suffered a hack. Okta says the incident affected a "very small number" of customers, but it appears the hackers responsible had access to Okta's support platform for at least two weeks before the company fully contained the intrusion, according to Krebs' KrebsOnSecurity blog. In an advisory sent to some customers on October 19, Okta said it "has identified adversarial activity that leveraged access to a stolen credential to access Okta's support case management system. The threat actor was able to view files uploaded by certain Okta customers as part of recent support cases," Krebs reported.
ZJYL

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15:02 EDT Jin Medical International Ltd trading resumes
ZJYL

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14:57 EDT Jin Medical International Ltd trading halted, volatility trading pause
BKR

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13:01 EDT Baker Hughes reports U.S. rig count up 2 to 624 rigs - Baker Hughes reports that the U.S. rig count is up 2 from last week to 624 with oil rigs up 1 to 502, gas rigs up 1 to 118 and miscellaneous rigs unchanged at 4. The U.S. Rig Count is down 147 rigs from last year's count of 771 with oil rigs down 110, gas rigs down 39 and miscellaneous up 2. The U.S. Offshore Rig Count is up 2 to 24, up 9 year-over-year. The Canada Rig Count is up 5 from last week to 198, with oil rigs up 5 to 121 gas rigs up 1 to 77 and miscellaneous down 1. The Canada Rig Count is down 12 from last year's count of 210, with oil rigs down 23, and gas rigs up 11 and miscellaneous unchanged.
BKR

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13:01 EDT Baker Hughes reports U.S. rig count up 2 to 624 rigs
PHG

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12:26 EDT FDA says Philips recalling V60, V60 Plus Ventilators - Philips Respironics is recalling its V60 Ventilators and V60 Plus Ventilators, the FDA announced. Philips Respironics V60 Ventilators and V60 Plus Ventilators are used to provide breathing assistance to pediatric and adult patients. The ventilators contain power management printed circuit board assemblies that were distributed by a third-party warehouse and do not meet ventilators standards, the agency said. There have been no reports of death or injuries related to this recall.
GM

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12:19 EDT GM says 'record offer' given to UAW with 23% wage increases - General Motors said it made a "record offer" to the United Auto Workers, which includes 23% general wage increases. UAW represented employees at GM will make $40.39 per hour or $84,000 per year in base wages by the end of the agreement, GM said in a statement. All GM U.S. UAW-represented team members will receive an immediate wage increase upon ratification of the proposed offer, and all active seniority employees have the opportunity to reach max wages by the end of the proposed contract, it added.
ABBV

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12:12 EDT AbbVie receives approval from MHRA for Tepkinly in large B-cell lymphoma - The Medicines and Healthcare products Regulatory Agency has authorized new medicine called Tepkinly, a treatment for diffuse large B-cell lymphoma in adults. It can be used to treat patients when the cancer has returned after previous treatment, or who have not responded to at least two previous treatments, the MHRA said in a statement. Marketing authorization has been granted to AbbVie. Reference Link
RF

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12:00 EDT Regions Financial falls -11.4% - Regions Financial is down -11.4%, or -$1.88 to $14.61.
SMR

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12:00 EDT Nuscale Power falls -12.2% - Nuscale Power is down -12.2%, or -55c to $3.92.
HKD

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12:00 EDT AMTD Digital falls -13.8% - AMTD Digital is down -13.8%, or -75c to $4.70.
AKA

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12:00 EDT a.k.a. Brands rises 7.1% - a.k.a. Brands is up 7.1%, or 48c to $7.34.
MCW

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12:00 EDT Mister Car Wash rises 8.1% - Mister Car Wash is up 8.1%, or 44c to $5.84.
KNX

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12:00 EDT Knight-Swift rises 10.5% - Knight-Swift is up 10.5%, or $4.83 to $50.71.
RIVN

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11:02 EDT Rivian Automotive opens newest spaces location at Ponce City Market - Rivian announced the opening of its newest spaces location at Ponce City Market, using the occasion to showcase progress on its future Georgia manufacturing facility and upcoming milestones. The seventh public-focused Rivian space since June 2023, part of a nationwide rollout, visitors will have the opportunity to connect with the Rivian brand, get up-close with its electric adventure vehicles, and learn more about the company's plans in the Peach State. Rivian will build its next manufacturing facility-with an annual capacity of 400,000 units when fully complete-at the Stanton Springs North site about 40 minutes from Atlanta across Morgan and Walton Counties. For the past several months, the State of Georgia and Joint Development Authority of Jasper, Morgan, Newton & Walton Counties have worked with state and local partners to prepare the site for Rivian's arrival. At this time, the upper pad is 95 percent graded and is nearly ready for construction to begin. Rivian expects to hold a formal groundbreaking ceremony in early 2024, with start of vertical construction to begin thereafter. Rivian has opened an office in Covington, Georgia, a short drive from its future factory, and continues to grow its local presence with the addition of Tony Sanger, Vice President of Facilities-Georgia, as well as support functions designed to ensure a timely and innovative construction process.
GSK

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10:52 EDT GSK enters exclusive license agreement with Hansoh for HS-20089 - GSK and Hansoh Pharma announced that they have entered into an exclusive license agreement for HS-20089, a B7-H4 targeted antibody-drug conjugate, ADC, currently in phase I clinical trials in China. Under the agreement, GSK will obtain exclusive worldwide rights to progress development and commercialisation of HS-20089. Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: "Given early clinical data, we believe that HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours. This agreement is in line with our approach to advancing novel treatment options for patients with gynaecologic cancers." This agreement builds on GSK's strategic R&D focus on tumour-cell targeting modalities as well as expertise in gynaecologic cancers including a significant medical and commercial presence. GSK plans to begin phase I trials outside of China in 2024. Terms of the agreement: Under the terms of this agreement, GSK will pay an $85 million upfront payment. In addition, Hansoh will be eligible to receive up to $1.485 billion in success-based milestones for HS-20089. Upon commercialisation of HS-20089, GSK will also pay tiered royalties on global net sales outside of China's mainland, Hong Kong, Macau, and Taiwan.
JNJ

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10:32 EDT Janssen announces Phase 3b Week 16 results from Cohort A of VISIBLE trial - Janssen Pharmaceuticals, a Johnson & Johnson company, announced new Phase 3b topline Week 16 results from Cohort A of the VISIBLE trial. These data will be presented today at the 2023 Fall Clinical Dermatology Conference in Las Vegas, Nevada. Guselkumab Skin Clearance Data at Week 16 Poster: At Week 16, 74% of patients receiving TREMFYA achieved an Investigator's Global Assessment score of cleared or minimal disease and 57.1% achieved at least a 90% improvement in the Psoriasis Area Severity Index response, successfully meeting the study's co-primary endpoints versus placebo. After only three doses, significantly greater improvements in disease signs and symptoms were observed in patients receiving TREMFYA versus placebo. Significantly greater improvements in body surface area involvement were observed in patients receiving TREMFYA versus placebo. Approximately one-third of patients receiving TREMFYA achieved complete skin clearance PASI 100, IGA 0 versus none for placebo at week 16. Guselkumab Rapid and Significant Scalp Psoriasis Clearance Data at Week 16 Poster: As early as Week 4, after only one dose of TREMFYA, the mean percentage improvement from baseline Psoriasis Scalp Severity Index was 53.8% in patients treated with TREMFYA versus 12.3% for placebo. After one dose of TREMFYA, 26.3% of participants achieved complete scalp clearance versus none for placebo at Week 4. At Week 16, 71.9% of patients receiving TREMFYA achieved complete scalp clearance versus 10% for placebo. Guselkumab Health-Related Quality of Life and Post-Inflammatory Pigmentation Data Poster: At baseline, VISIBLE participants reported disease signs and symptoms have significant impact on HRQoL. They also reported moderate effect of skin discoloration on HRQOL. At Week 16, improvements in the Psoriasis Symptoms and Signs Diary, Dermatology Life Quality Index and Skin Discoloration Impact Evaluation Questionnaire were significantly greater in patients receiving TREMFYA versus placebo across all skin tones.
UPH

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10:29 EDT UpHealth subsidiary Thrasys files voluntary reorganization under Chapter 11 - UpHealth announced Thrasys, Inc. and its sole subsidiary Comprehensive Care Alliance, which has no operations, filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. Thrasys is a subsidiary of UpHealth Holdings, the subsidiary of UpHealth that filed for Chapter 11 protection on September 19, 2023 in the Bankruptcy Court. Holdings' Chapter 11 filing followed the September 14, 2023 decision by a trial court in New York to grant summary judgment in favor of Needham & Company in a lawsuit unrelated to the Company's operations. UpHealth and its direct and indirect subsidiaries, Cloudbreak Health, LLC and TTC Healthcare, Inc., respectively, have not filed for Chapter 11 protection and are operating in the normal course of business. The Company also announced that Behavioral Health Services, LLC, as well as the subsidiaries of Behavioral Health Services, filed for Chapter 11 protection. As previously disclosed, the Company discontinued operations of BHS earlier this year. Holdings, Thrasys and BHS have filed a motion with the Bankruptcy Court seeking to jointly administer their Chapter 11 cases under the caption In re UpHealth Holdings, Inc., Case No. 23 11476. Holdings, Thrasys and BHS have filed a number of customary first day motions that, once approved, will allow these entities to continue to operate in the normal course of business without interruption to their customers, vendors and employees. The Company expects to receive Bankruptcy Court approval for these requests and intends to pay vendors in full for all goods received and services provided after the filing date.
MRK DSNKY

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10:20 EDT Merck, Daiichi Sankyo announce development and commercialization collaboration - Daiichi Sankyo (DSNKY) and Merck (MRK) have entered into a global development and commercialization agreement for three of Daiichi Sankyo's DXd antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. All three potentially first-in-class DXd ADCs are in various stages of clinical development for the treatment of multiple solid tumors both as monotherapy and/or in combination with other treatments. Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor and platinum-based therapies. Ifinatamab deruxtecan is currently being evaluated as monotherapy in IDeate-01, a Phase 2 clinical trial in patients with previously treated extensive-stage small cell lung cancer. Under the terms of the agreement, Merck will pay Daiichi Sankyo upfront payments of $1.5B for ifinatamab deruxtecan due upon execution; $1.5B for patritumab deruxtecan, where $750M is due upon execution and $750M is due after 12 months; and $1.5B for raludotatug deruxtecan, where $750M is due upon execution and $750M is due after 24 months. Merck also will pay Daiichi Sankyo up to an additional $5.5B for each DXd ADC contingent upon the achievement of certain sales milestones. When combined with the additional refundable upfront payment of $1B total potential consideration across the three programs is up to $22B. Merck may opt out of the collaboration for patritumab deruxtecan and raludotatug deruxtecan and elect not to pay the two continuation payments of $750M each that are due after 12 months and 24 months, respectively. Merck will pay an additional upfront payment of $1B, a pro-rated portion of which may be refundable in the event of early termination of development with respect to each program. In aggregate, the three programs have multi-billion dollar worldwide commercial revenue potential for each company approaching the mid-2030s. In conjunction with this transaction, Merck will record an aggregate pretax charge of $5.5B, or approximately $1.70 per share, reflecting the $4B upfront payment and the $1.5B in continuation payments. The impact of this charge will result in a reduction in both fourth-quarter and full-year 2023 GAAP and non-GAAP results. In addition, Merck will invest in the pipeline assets and incur costs to finance the transaction, resulting in a negative impact to EPS of approximately 25c in the first 12 months following the close of the transaction.
FOUR

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10:18 EDT Shift4 Payments receives final approval for Credorax acquisition - Shift4 Payments said it received the final regulatory approval required to proceed with the closing of its previously announced European acquisition of Credorax. The company's management expects to consummate the transaction within the next three business days. Shift4 expects its guidance for the year ended December 31 to be within its previously issued ranges which were provided on August 3.
QTWO MA

Hot Stocks

10:03 EDT Q2 Holdings, MasterCard partner to bring card programs to Helix customers - Q2 Holdings (QTWO) announced a strategic partnership with Mastercard (MA), allowing fintechs, brands and financial institutions that use Helix's cloud-native core to issue Mastercard debit and prepaid cards to their account holders. The partnership with Q2 and Mastercard will also integrate Mastercom, Mastercard's dispute resolution service, to Q2's existing dispute intake capabilities, Centrix, to deliver an efficient solution to manage disputes, helping financial institutions mitigate chargebacks.
IOAC

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10:02 EDT Innovative International Aqstn Corp trading resumes
MRK

Hot Stocks

10:02 EDT Merck announces results from Phase 3 KEYNOTE-A18 trial - Merck announced results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, for newly diagnosed patients with high-risk locally advanced cervical cancer, stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease. Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, or PFS, compared to concurrent chemoradiotherapy alone for these patients. After a median follow-up of 17.9 months, the KEYTRUDA regimen reduced the risk of disease progression or death by 30% versus concurrent chemoradiotherapy alone in these patients. Median PFS was not reached in either group. The 24-month PFS rate was 67.8% for patients who received the KEYTRUDA regimen compared to 57.3% for those who received concurrent chemoradiotherapy alone. In addition to an improvement in PFS, a favorable trend in overall survival, or OS, the trial's other primary endpoint, was observed for the KEYTRUDA regimen versus concurrent chemoradiotherapy alone; with only 103 events across both groups, these OS data are not mature and did not reach statistical significance at the time of this interim analysis. The trial is continuing, and follow-up of OS is ongoing. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. The findings are being presented for the first time today at 10:45 a.m. ET during a late-breaking abstract proffered paper session at the European Society for Medical Oncology, or ESMO, Congress 2023, the company noted.
PINE

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10:00 EDT Alpine Income Property falls -10.5% - Alpine Income Property is down -10.5%, or -$1.74 to $14.81.
RTO

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10:00 EDT Rentokil Initial falls -11.2% - Rentokil Initial is down -11.2%, or -$3.40 to $27.02.
RF

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10:00 EDT Regions Financial falls -12.6% - Regions Financial is down -12.6%, or -$2.08 to $14.40.
BOWL

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10:00 EDT Bowlero rises 8.9% - Bowlero is up 8.9%, or 96c to $11.87.
MCB

Hot Stocks

10:00 EDT Metropolitan Bank rises 10.3% - Metropolitan Bank is up 10.3%, or $3.31 to $35.52.
KNX

Hot Stocks

10:00 EDT Knight-Swift rises 11.9% - Knight-Swift is up 11.9%, or $5.47 to $51.35.
IOAC

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09:53 EDT Innovative International Aqstn Corp trading halted, volatility trading pause
SLB

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09:48 EDT SLB sees pretax margins in Q4 at same level as Q3
RTO

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09:47 EDT Rentokil Initial falls -7.7% - Rentokil Initial is down -7.7%, or -$2.33 to $28.09.
NOVA

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09:47 EDT Sunnova Energy falls -9.6% - Sunnova Energy is down -9.6%, or -88c to $8.33.
RF

Hot Stocks

09:47 EDT Regions Financial falls -12.4% - Regions Financial is down -12.4%, or -$2.05 to $14.43.
BOWL

Hot Stocks

09:47 EDT Bowlero rises 8.5% - Bowlero is up 8.5%, or 93c to $11.83.
EAF

Hot Stocks

09:47 EDT GrafTech rises 12.1% - GrafTech is up 12.1%, or 41c to $3.80.
KNX

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09:47 EDT Knight-Swift rises 12.9% - Knight-Swift is up 12.9%, or $5.91 to $51.79.
SLB

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09:46 EDT SLB sees ending year by increasing revenue more than 15%, EBITDA in mid-20s
ULY

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09:44 EDT ULY Stock trading resumes
WBUY

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09:39 EDT Webuy Global Ltd trading resumes
ULY

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09:36 EDT ULY Stock trading halted, volatility trading pause
WBUY

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09:31 EDT Webuy Global Ltd trading halted, volatility trading pause
VLCN

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09:29 EDT Volcon enters initial low volume production for STAG UTV - Volcon has entered low-volume production and is conducting production validation testing for its flagship product, the Stag UTV. The Company's manufacturer, GLV Ventures, is currently building production validation units of Stag LTD, one of four trim levels being offered. Early production units are being put through the last phase of testing with compliance testing already complete, marking a major milestone for the Company.
GAN

Hot Stocks

09:28 EDT Gan Limited receives regulatory approval from Nevada Gaming Commission - Gan Limited announced that it has received regulatory approval from the Nevada Gaming Commission. The approval allows Gan to commence field trial operations of its Gab Sports betting platform with its Nevada customers after the platform is certified and approved. Gan Sports has built the infrastructure to deploy into the Nevada market, including mobile applications and retail sports betting.
CMA

Hot Stocks

09:14 EDT Comerica sees NII 'trough' in 1Q24, 'little bit of a slope up from there' - Comments taken from Q3 earnings conference call.
FNGR

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09:09 EDT FingerMotion files federal lawsuit against short selling research firm - FingerMotion announces that a federal lawsuit has been filed against Capybara Research in the United States District Court for the Southern District of New York. The Complaint filed against Capybara alleges that Capybara maliciously published a defamatory article in a premediated attempt to move the public market for FingerMotion's stock lower to benefit from their previously announced short position. The complaint alleges securities fraud violations, defamation, and interference with business under federal and state laws. The Company had announced on October 5, 2023 that it retained Mark R. Basile, Esq, and his securities and RICO litigation firm, The Basile Law Firm P.C., to assist the Company in investigating recent activities surrounding the Company's stock performance and to take the necessary legal action to prevent potential market participants utilizing unlawful means from further hurting the Company's shareholders.
HNRA

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09:08 EDT HNR Acquisition announces special meeting of shareholders - HNR Acquisition Corp has filed a definitive proxy statement with the Securities and Exchange Commission and has commenced mailing the Proxy Statement to stockholders with respect to its special meeting of shareholders to be held on October 30, 2023 at 1:30 pm EDT to approve, among other things, its business combination with Pogo Resources, LLC and its subsidiaries, and to acquire the Grayburg-Jackson oil field in the prolific Permian Basin in Eddy County, New Mexico. The Pogo fields comprise 13,700 contiguous leasehold acres, 343 producing wells and 207 injection wells for a total of 550 wells on the properties. Current production is approximately 1,400 barrels of oil and oil equivalent per day. Management expects to increase daily production to nearly 4,000 barrels of oil and oil equivalent in the next three years in accordance with the reserve report by William Cobb & Associates, a 3rd party engineering firm retained by Pogo.The special meeting will be conducted via a live web cast on October 30, 2023. Only holders of record of shares of the Company's common stock at the close of business on October 10, 2023, are entitled to vote. There will be voting on five proposals: The Purchase Proposal - To approve and adopt the various transaction documents to acquire Pogo; The Incentive Plan Proposal - To approve and adopt an omnibus incentive Plan attached to the Proxy Statement; The NYSE American Proposal - To approve, for purposes of complying with NYSE American Rule 713(a), the potential and likely issuance of more than 19.99% of the Company's outstanding shares of common stock in connection with the acquisition of Pogo; The Charter Proposal - To consider and vote upon a proposal to approve and adopt the form of second amended and restated certificate of incorporation attached to the Proxy Statement; The Adjournment Proposal - To approve the adjournment of the meeting to a later date, as necessary. The Company expects to close on its business combination as soon as possible following the special meeting; however, there are several closing conditions which must be met in addition to stockholder approval, including, without limitation, listing approval by the NYSE American.
PRST

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09:05 EDT Presto Automation president Dan Mosher departs - After nearly three years at Presto serving as both President and Chief Revenue Officer, Dan Mosher is leaving the company.
PRST

Hot Stocks

09:04 EDT Presto Automation names Justin Foster as chief revenue officer - Presto Automation promoted Justin Foster to Chief Revenue Officer, effective immediately. As Chief Revenue Officer, Mr. Foster will be responsible for all facets of the company's revenue generation, including growing Presto's footprint in the emerging voice AI market while retaining signed clients. Before joining Presto as SVP of Sales in 2022, Mr. Foster led all go-to-market activities for Liveclicker.
EDBL

Hot Stocks

09:04 EDT Edible Garden unveils new in-store displays - Edible Garden unveiled its new in-store displays, featuring a design for cut herbs at the Global Produce & Floral Show. Jim Kras, Chief Executive Officer of Edible Garden stated, "We are pleased to announce the new in-store, replenishable displays for our cut herbs in time for the 2023 holiday season, typically the busiest time of year in the herb business. These innovative displays house up to 144 clamshell packages including our most popular holiday herbs - rosemary, sage, and thyme. We plan to launch these displays starting at all Meijer retail locations. Each display contains three compartments, each of which can be easily restocked using a 48-count PDQ pallet. We will be showcasing these displays at the Show, and they will be available to all our major retail partners within our extensive distribution network as we reaffirm our dedication to providing flavor-forward, top-tier, sustainably cultivated, organic, fresh, and local produce."
NUE

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09:02 EDT Nucor explores potential sites in Pacific Northwest for new rebar micro mill - Nucor announced that it is exploring potential sites in the Pacific Northwest to build a new rebar micro mill with an annual capacity of 650,000 tons, subject to approval by Nucor's Board of Directors. The new mill would produce a full range of rebar sizes and have spooling capabilities. This would be Nucor's fourth rebar micro mill, joining its existing micro mills in Missouri and Florida and the mill currently under construction in North Carolina. "We have had great success with our rebar micro mills in Florida and Missouri and are on schedule to begin operating our third micro mill in the Q1 of 2025, which we are currently building in North Carolina," said Leon Topalian, Chair, President & CEO. Rebar is used primarily in the construction of roads, buildings, sidewalks and other structures. Nucor produces steel by recycling scrap metal into new steel products, making the Company one of the cleanest steel producers in the world.
HBAN

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08:48 EDT Huntington Bancshares sees Q4 average loans up 1% - Sees Q4 average deposits up 1%. Sees Q4 net interest income down 4%-5%. Sees Q4 noninterest income flat. Sees Q4 expense up 4%-5%. Sees FY23 net charge-offs up 20-30 basis points. Guidance taken from Q3 earnings conference call.
GATO

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08:45 EDT Gatos Silver announces filing of updated technical reports - Gatos Silver announced that it has filed a technical report summary prepared in accordance with subpart 1300 of Regulation S-K with the Securities and Exchange Commission and a corresponding technical report prepared in accordance National Instrument 43-101 - Standards of Disclosure for Mineral Projects on SEDAR+. The 2023 Technical Reports, titled "Mineral Resource and Mineral Reserve Update, Los Gatos Joint Venture, Chihuahua, Mexico" dated October 20, 2023, support the disclosure made by the Company in its September 6, 2023 press release announcing an updated Cerro Los Gatos mineral reserve, mineral resource, and life of mine plan.
DERM

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08:38 EDT Journey Medical announces data from bioavailability study of DFD-29 vs Solodyn - Journey Medical announced data from a comparative bioavailability study of DFD-29 vs. Solodyn. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy's Laboratories Ltd. The data were presented at the 43rd Annual Fall Clinical Dermatology Conference taking place in Las Vegas, NV. "The results of this bioavailability study successfully demonstrate that the systemic exposure of minocycline with DFD-29 was significantly lower than that of Solodyn," said Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. "We're also encouraged by DFD-29's safety profile demonstrated throughout our ongoing development program." Data highlights include: Bioavailability of minocycline was significantly lower after a single dose of DFD-29 under fasting and fed conditions vs. Solodyn following a single dose under fasting conditions. Food intake had no impact on maximum concentration of minocycline from DFD-29 but may delay absorption and may slightly increase exposure. Treatment-emergent adverse events were mostly mild, the most common being headache. No serious adverse events were reported in the study. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, "We continue to be encouraged by the growing body of clinical research evaluating DFD-29. Given the previously reported positive results from our two Phase 3 clinical trials of DFD-29, we anticipate submitting a New Drug Application to the FDA by the end of this year. If approved, DFD-29 will be the lowest-dose minocycline on the market and may create a paradigm shift in how rosacea is treated in the millions of patients suffering from this condition."
MGRM

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08:35 EDT Monogram Orthopaedics files updated presentation on Form 8-K - Monogram Orthopaedics announced the filing of an 8-K with the U.S. Securities and Exchange Commission that included an updated presentation regarding the business of the company. The presentation highlights the Company's vision, competitive differentiation, multi-stage product strategy, and market opportunities. "Monogram has come an incredibly long way over the past six years. Our system is moving quickly through verification and is now actively cutting without needing external fixation or custom holders with extremely tight accuracy and high speed. We believe our system is on track to be one of the most, if not most, advanced open platform systems internationally and highly competitive with the current state-of-the-art domestically. No high-performance autonomous active robot on the market today comes remotely close to the performance of market-leading semi-active systems in competitive markets," said Ben Sexson, Chief Executive Officer of Monogram Orthopaedics. "Monogram recently received FDA Clearance for Export with a Certificate to Foreign Government/Certificate of Exportability that advances us on our path to launch outside the U.S. for a Pilot Program with a Global Distributor. The system is performing at a high level, testing with pilot program implants is on schedule, and we remain on track to ship on or ahead of schedule pending overseas regulatory approvals that are in process."
ALLG

Hot Stocks

08:34 EDT Allego partners with Go'on Gruppen on fast charging ports - Allego announced its partnership with Go'on Gruppen, one of Denmark's largest fueling companies, under which Allego will install 168 fast charging ports with exclusive access to all 185 of Go'on's currently existing stations across the country. Allego views this partnership as another step in the strategic growth and optimization of its network and charging availability for electric vehicle, or EV, drivers. Go'on has positioned its fueling stations in smaller cities throughout Denmark where gasoline fueling stations are less ubiquitous and electric charging infrastructure is limited or even non-existent. Consequently, in these regions, EV drivers may need to drive long distances or plan their routes around charger availability. Allego strives to make charging accessible for all EV drivers to ensure the successful transition to e-mobility. Through this partnership, Allego and Go'on aims to provide EV drivers with the same convenience that they would have as if driving a combustion engine.
FRZA

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08:34 EDT Forza X1 begins to receive steel construction material for N. Carolina facility - Forza X1 announced that steel construction material has begun arriving to Forza's 11-acre property in Marion, North Carolina. This delivery marks a significant milestone in the construction of the Company's state-of-the-art manufacturing facility, which begins with the initial 60,000-square-foot factory with the capacity to build up to 550 boats annually. When all phases of the factory are eventually completed, Forza anticipates the manufacturing facility will be as large as 100,000 square feet with production capabilities for up to 1,000 boats annually. Once the factory is fully operational, the Company plans to integrate closed-molded composite boat-building techniques and electric motor assembly processes. This integration aligns with Forza X1's dedication to creating, engineering, and producing electric boats that are inspiring and operate with a strong focus on sustainability and eco-friendliness. Additionally, the Company expects to invest over $10.5 million in land, buildings, fixtures, infrastructure, and equipment and create as many as 170 jobs in McDowell County, North Carolina.
SDA LI

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08:33 EDT SunCar Technology launches online insurance solution Li Auto customers - SunCar Technology (SDA) announced that it has launched its online insurance solution for customers of Li Auto Inc.'s (LI) new energy vehicles. Accessible via the Li Auto car owners' app, SunCar can offer various online insurance solutions, including H5 on the mobile, so car owners can quickly and conveniently compare and purchase auto insurance and other services. YE Zaichang, Chairman and CEO of SunCar commented, "We are very pleased to announce this deal with Li Auto, one of the largest NEV manufacturers in China. Li Auto has delivered over 244,000 cars year-to-date through September 2023 and has recently received new orders for over 40,000 cars per month, representing a highly attractive potential market for our insurance products. SunCar has always been committed to solving substantive problems for customers with industry-leading products and services. Although there are many auto insurance options for drivers, including SunCar's insurance offerings in the Li Auto app should make it the default choice for all Li Auto customers. We believe that SunCar's continued cooperation with Li Auto will expand our customer base and begin a new avenue of significant potential growth for the Company."
TIO

Hot Stocks

08:32 EDT Tingo Group opens headquarters in Africa - Tingo Group announced the opening of a new Africa headquarters in Lagos, Nigeria. The new headquarters, which is located in the main business and financial center of Victoria Island, Lagos, becomes the Company's second office in the city, complementing its former headquarters, on Lagos Island, which has now become Tingo's commodity trading and operational support office. The new three-story 60,000 square foot headquarters building has capacity to accommodate a workforce of up to 500, which is in addition to the 100 employees and consultants that can be accommodated at the 12,000 square foot office space on Lagos Island. The new headquarters, incorporating the latest communications and information-technology infrastructure, will enable the Company to accelerate its growth, including through the expansion of Tingo Mobile, Tingo Foods, TingoPay and several new businesses currently under development.
SWAV

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08:32 EDT ShockWave Medical introduces enhanced coronary IVL catheter in the U.S. - Shockwave Medical announced the planned U.S. introduction of the Shockwave C2+ Coronary Intravascular Lithotripsy catheter following approval by the U.S. Food and Drug Administration. The Shockwave C2+ catheter provides 50 percent more pulses per catheter than the Shockwave C2 catheter that was approved in the U.S. in 2021. The enhanced C2+ catheter will make its U.S. debut at the 35th Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation, with the full commercial launch planned for the beginning of November. "The enhancements of Shockwave C2+ will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium," said Richard Shlofmitz, MD, Chairman, Department of Cardiology, St. Francis Hospital in Roslyn, New York, who performed the first U.S. commercial case with Shockwave C2+. "When additional pulses are added to the existing intuitive catheter design and simple-to-use system that are foundational to the success of Shockwave IVL, the result is an updated catheter that can enhance workflow and improve procedural efficiency."
NVTS

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08:31 EDT Navitas Semiconductor spotlights GaNSafe at CPSS conference - Navitas Semiconductor announced its continued sponsorship of the 2023 China Power Electronics and Energy Conversion Congress & the 26th China Power Supply Society Conference and Exhibition, revealing major next-generation gallium nitride and silicon carbide power semiconductor platforms, including GaNSafe. With GaNSafe, Navitas has optimized its 4th-generation GaN technology for demanding, high-power applications in data centers, solar / energy storage and EV markets, where efficiency, power density and robust & reliable operation are critical.
MRK

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08:28 EDT Merck announces results from KEYNOTE-756 trial at ESMO Congress - Merck announced the first presentation of results from the neoadjuvant part of the Phase 3 KEYNOTE-756 trial investigating Keytruda, Merck's anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by Keytruda plus endocrine therapy as adjuvant treatment, for patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Keytruda plus chemotherapy before surgery met one of its dual primary endpoints of pathological complete response, or pCR, demonstrating a statistically significant improvement in pCR rate compared to placebo plus chemotherapy. The pCR rate increased from 15.6% in patients treated with neoadjuvant chemotherapy alone to 24.3% in patients treated with neoadjuvant Keytruda plus chemotherapy, an estimated increase of 8.5 percentage points. A pCR rate is defined as a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery. The trial is currently continuing without changes to evaluate event-free survival, or EFS, the other dual primary endpoint of the study, per the trial design. These pCR results are being featured during a late-breaking proffered paper session at the European Society for Medical Oncology, or ESMO, Congress 2023. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies.
MRK

Hot Stocks

08:25 EDT Merck announces results from KEYNOTE-811 trial at ESMO Congress - Merck announced results from the Phase 3 KEYNOTE-811 trial evaluating Keytruda, Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with human epidermal growth factor receptor 2, or HER2,-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction, orGEJ, adenocarcinoma. These data are being presented during a proffered paper session at the European Society for Medical Oncology Congress 2023 and are being discussed with regulatory authorities worldwide. After a median follow-up of 28.4 months, the Keytruda regimen demonstrated a statistically significant improvement in progression-free survival, or PFS, in the intention-to-treat, or ITT, advanced HER2-positive study population, reducing the risk of disease progression or death by 28% compared to trastuzumab and chemotherapy alone. The Keytruda regimen also demonstrated a clinically meaningful improvement in PFS in patients whose tumors expressed PD-L1, reducing the risk of disease progression or death by 30% compared to trastuzumab and chemotherapy alone. Based on a pre-specified subgroup analysis, the improvement in PFS observed in the ITT population was limited to patients whose tumors expressed PD-L1. In the study, more than 80% of patients' tumors expressed PD-L1. At a subsequent interim analysis, a positive trend in overall survival, the trial's other primary endpoint, was observed for the Keytruda regimen versus trastuzumab and chemotherapy alone in the ITT population and the PD-L1 subgroup. Among patients whose tumors expressed PD-L1, median OS was 20 months for those receiving the Keytruda regimen versus 15.7 months for those receiving trastuzumab and chemotherapy alone. These OS results did not reach statistical significance at this interim analysis; follow-up is ongoing for a future planned OS analysis for this trial.
VFS

Hot Stocks

08:24 EDT VinFast Auto enters standby equity subscription agreement with Yorkville - VinFast Auto announced that it has entered into a standby equity subscription agreement with YA II PN, Ltd. VinFast has the option, but not the obligation, to require Yorkville to subscribe for up to $1B of ordinary shares in VinFast at any time during the term of the Subscription Agreement, subject to certain conditions and limitations. The Subscription Agreement has a term of 36 months.
F...

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08:24 EDT EU new car registrations up 9.2% in September - In September, new car registrations increased by 9.2%, reaching 861,062 units, "marking the EU car market's fourteenth consecutive month of growth," said the ACEA. Two of the EU's largest markets saw substantial gains, with Italy up 22.7% and France up 10.7%, the group noted. Germany's market was relatively steady, with a tiny 0.1% drop compared to September 2022, ACEA added. Publicly traded companies in the auto space include Ford (F), General Motors (GM), Honda (HMC), Mercedes-Benz Group (DDAIF), Nissan (NSANY), Stellantis (STLA), Tesla (TSLA), Toyota (TM) and Volkswagen (VWAGY).
CLMT

Hot Stocks

08:21 EDT Calumet Specialty Products provides operational update for Q3 - Calumet Specialty Products Partners provided an operational update for the Q3. As previously disclosed, Montana Renewables, identified a leak in the steam recovery system within its renewable hydrogen plant during the third quarter. After entering the unit, the company decided to replace the steam drum rather than repair it. The replacement is expected to be completed in November. Given the additional time, MRL will opportunistically pull forward its regularly scheduled turnaround into November, which was previously scheduled for early 2024. The facility is expected to continue to operate at reduced throughput until the turnaround begins. Upon scheduled completion, MRL expects to process over 12,000 barrels per day of predominantly untreated feed in December and continues to expect $1.25-1.45/gal of Adjusted EBITDA on untreated feed. Additionally, our Shreveport facility required maintenance during the quarter that resulted in a loss of approximately 300,000 barrels of lube oil and wax sales. The maintenance has been completed, and the facility is currently processing over 45,000 barrels per day of feed.
ET

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08:20 EDT Energy Transfer LP increases quarterly dividend to 31.25c per share - Energy Transfer LP announced a quarterly cash distribution of 31.25c per Energy Transfer common unit for the third quarter ended September 30. This cash distribution is an increase from 31c per Energy Transfer common unit for the second quarter and will be paid on November 20 to unitholders of record as of the close of business on October 30.
BSRR

Hot Stocks

08:17 EDT Sierra Bancorp announces new 1M share repurchase program - Sierra Bancorp announced that its board of directors has approved a new share repurchase program authorizing the company to repurchase up to 1M shares of its outstanding common stock, from time to time, commencing after the current share repurchase program expires on October 31 and continuing until October 31, 2024. This share repurchase program replaces and supersedes the prior share repurchase program. Shares may be repurchased in open-market transactions or privately negotiated transactions executed in compliance with applicable federal and state securities laws. The timing of the repurchases and the number of shares repurchased under the program will depend on a variety of factors, including price, trading volume, corporate and regulatory requirements, and market conditions. The Board further authorized Management to enter into a 10b5-1 Plan with a nationally recognized broker-dealer to facilitate share repurchases as appropriate. The company also announced that its board of directors has declared a regular quarterly cash dividend of 23c per share. The dividend was approved subsequent to the Board's review of the Company's financial performance and capital for the quarter ended September 30 and will be paid on November 14 to shareholders of record as of October 31. Counting dividends paid by Bank of the Sierra prior to the formation of Sierra Bancorp, the company has paid regular cash dividends to shareholders every year since 1987, comprised of annual dividends through 1998 and quarterly dividends thereafter.
INTE FLYB

Hot Stocks

08:15 EDT Flybondi to become public through Integral Acquisition Corporation 1 combination - Flybondi announced its plans to list on Nasdaq and its entry into a definitive business combination agreement with Integral Acquisition Corporation 1 (INTE). Shares of the airline are expected to be listed on Nasdaq under the symbol (FLYB). The planned transaction, structured as a share exchange and a subsidiary merger, has been approved by the boards of directors of both Integral 1 and Flybondi, and is expected to close during the first half of 2024, subject to regulatory approvals, the approval by the stockholders of Integral 1 and the shareholders of Flybondi, and the satisfaction of certain other customary closing conditions, including the review by the SEC of the proxy statement/prospectus relating to the proposed business combination and the listing approval by Nasdaq. Upon the closing of the proposed business combination, the combined company will continue to operate under the Flybondi name, and Flybondi's executive management team will continue to lead the combined company. All cash remaining on the combined company's balance sheet at the closing of the Business Combination, after the settlement of transaction-related expenses, is expected to be utilized by the combined company for working capital, growth, and other general corporate purposes. An affiliate of Flybondi recently formed FB Parent, a limited company incorporated under the laws of England and Wales, which in turn formed Gaucho MS, a Delaware corporation, as its wholly-owned subsidiary. Pursuant to the transactions contemplated by the business combination agreement, FB Parent shall acquire the outstanding shares of Flybondi from Flybondi's shareholders party to the business combination agreement, in exchange for ordinary shares of FB Parent and Merger Sub will merge with and into Integral 1, with Integral 1 continuing as the surviving entity and as a wholly-owned subsidiary of FB Parent.
APLS

Hot Stocks

08:11 EDT Apellis says journal published 24-month result from Phase 3 OAKS, DERBY studies - Apellis Pharmaceuticals announced that The Lancet published the positive 24-month results from the Phase 3 OAKS and DERBY studies evaluating SYFOVRE for geographic atrophy secondary to age-related macular degeneration. SYFOVRE is the only treatment approved for use beyond 12 months in GA, a chronic disease and leading cause of vision loss. In the publication, both every-other-month and monthly SYFOVRE showed a clinically meaningful reduction of GA lesion growth with increasing effects over time and a well-demonstrated safety profile in a broad population of more than 1,200 patients. "These 24-month data demonstrate that SYFOVRE is a clinically meaningful treatment for GA, and we are proud these results were published in one of the world's most prestigious peer-reviewed journals," said Caroline Baumal, M.D., chief medical officer, Apellis. "With SYFOVRE's approval in the United States and five additional applications under review globally, we are working urgently to bring this important treatment to patients in need worldwide."
MRK

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08:09 EDT Merck announces results from KEYNOTE-671 trial at ESMO Congress - Merck announced results from the Phase 3 KEYNOTE-671 trial evaluating Keytruda, Merck's anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery and after surgery, for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer, or NSCLC. These late-breaking data are being presented for the first time during a proffered paper session at the European Society for Medical Oncology, or ESMO, Congress 2023. At the trial's prespecified second interim analysis with a median follow-up of 36.6 months, neoadjuvant Keytruda plus chemotherapy followed by Keytruda as a single agent after surgical resection significantly improved overall survival, or OS, reducing the risk of death by 28%; one-sided in patients with resectable stage II, IIIA or IIIB NSCLC versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo, regardless of PD-L1 expression. For patients who received the Keytruda-based regimen, median OS was not reached versus 52.4 months for patients who received the chemotherapy-placebo regimen. The 36-month OS rates were 71.3% for patients who received the Keytruda-based regimen versus 64.0% for patients who received the chemotherapy-placebo regimen.
APLD

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08:09 EDT Applied Digital announces energization of its 200-megawatt datacenter in Texas - Applied Digital announced the energizing of its 200-megawatt facility in Garden City, Texas. The energization of the Garden City facility marks Applied Digital's third successful next-generation datacenter development within North America for blockchain hosting operations. Once fully energized, this location will bring Applied Digital to the full planned 480MW of total hosting capacity across its blockchain hosting facilities. "The successful energization of our third blockchain hosting facility, located in Garden City, Texas, represents a significant milestone for Applied Digital," said Applied Digital CEO and Chairman Wes Cummins. "We remain dedicated to providing digital infrastructure solutions for high-performance computing that redefines traditional data centers, including our existing blockchain hosting operations and other HPC applications."
ARQT

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08:07 EDT Arcutis Biotherapeutics announces new patient response data on ZORYVE cream - Arcutis Biotherapeutics announced new individual patient response data showing nearly all individuals treated with ZORYVE cream 0.3% had a measurable improvement in Psoriasis Area and Severity Index. Separately reported investigator and patient local tolerability assessment data confirms again that ZORYVE was well tolerated from first application. New analyses from two pivotal Phase 3 studies were presented in two posters at the 43rd Annual Fall Clinical Dermatology Conference held October 19-22, 2023, in Las Vegas, Nevada. At Week 8, a statistically significant greater percentage of patients achieved a 50% reduction in PASI scores, with 72.1% of patients treated with ZORYVE compared to 25.5% of those treated with vehicle. At the same 8 week endpoint, a 75% reduction in PASI scores was achieved in 40.3% of roflumilast-treated patients compared to 6.5% of vehicle-treated patients. PASI-90 was observed in 19.7% of patients treated with ZORYVE compared to 2.3% of vehicle-treated patients and a 100% reduction was observed in 12.3% of patients treated with ZORYVE compared to 0.8% of vehicle-treated patients. In other data shared as a poster at the conference, ZORYVE was shown to be very well tolerated in individuals with plaque psoriasis, as measured by both investigator- and patient-rated local tolerability assessed prospectively in the DERMIS-1 and DERMIS-2 clinical trials. Nearly no stinging and burning was reported by patients. At first application, Week 4 and Week 8 only 0.4%, 0.0% and 0.2% treated with roflumilast cream reported hot, tingling/stinging sensation vs 0.0%, 0.4% and 0.0% treated with vehicle respectively. There was no evidence of irritation per investigator assessment in approximately 99% of subjects at each of the post-baseline time points, Week 4 and Week 8. The findings included results in those with involvement in sensitive areas such as the face, genital, and intertriginous areas, where skin touches skin. ZORYVE safety and tolerability data were comparable with vehicle, with low rates of application site adverse events, treatment-related AEs, and discontinuations due to AEs. The most common adverse reactions include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.
AZN

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08:06 EDT AstraZeneca reports 'positive' results from interim analysis of MATTERHORN trial - AstraZeneca reports "positive" results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca's Imfinzi in combination with standard-of-care FLOT neoadjuvant chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response, or pCR, versus neoadjuvant chemotherapy alone for patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction, or GEJ, cancers. These results will be presented today at the European Society for Medical Oncology, or ESMO, Congress 2023 in Madrid, Spain, the company noted. Treatment with Imfinzi plus neoadjuvant FLOT chemotherapy resulted in a pCR rate of 19% versus 7% for patients treated with neoadjuvant chemotherapy alone as assessed by blinded independent central review. The rate of either complete or near-complete responses was 27% with the Imfinzi combination and 14% with neoadjuvant chemotherapy alone. The trial, which is assessing Imfinzi in combination with FLOT chemotherapy as a perioperative treatment, will continue as planned to assess the primary endpoint of event-free survival, or EFS, and the key secondary endpoint of overall survival, or OS, to which the trial team, investigators and participants remain blinded.
LLY

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08:05 EDT Eli Lilly announces results from Phase 3 monarchE study evaluating Verzenio - Eli Lilly and Company announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio, or abemaciclib, in combination with endocrine therapy, or ET, compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer, or EBC, at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology, or ESMO, Congress. The data presented include results from a pre-specified analysis reflecting a median follow-up of 4.5 years. All patients have completed the Verzenio treatment course, with more than 80% of patients having been followed for at least two years after completion. In the intent-to-treat, or ITT, population, the risk of developing invasive disease was reduced by 32%. The absolute increase in invasive disease-free survival, or IDFS, and distant relapse-free survival (DRFS) continued to deepen in magnitude at five years, to 7.6% and 6.7%, respectively, reflecting improvements from the two-, three-, and four-year rates. With the majority of the IDFS events being DRFS events, the DRFS benefit was also maintained with Verzenio reducing the risk of developing distant recurrence or death by 32.5%. In this five-year outcome analysis, the Kaplan-Meier curves continued to separate, confirming a sustained benefit beyond the two-year treatment period. IDFS and DRFS results for Cohort 1 were consistent with those for the ITT population. While overall survival, or OS, data remain immature, fewer deaths were observed in the Verzenio arm compared to the control arm. Nearly twice as many patients receiving ET alone developed and are living with metastatic disease compared to those receiving Verzenio.
LIPO

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08:05 EDT Lipella Pharmaceuticals announces FDA clearance of IND for LP-310 - Lipella Pharmaceuticals announces that the U.S. FDA has approved an Investigational New Drug application for a multi-center, phase-2a, dose-escalation clinical trial to assess the safety and efficacy of LP-310 in patients with symptomatic oral lichen planus, a highly morbid condition with no effective treatment.
AMGN

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08:03 EDT Amgen presents data from global Phase 2 DeLLphi-301 study - Amgen announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 targeting BiTE molecule, in patients with advanced stage small cell lung cancer who had failed two or more prior lines of treatment. The data are being presented Oct. 20 at 3:20 PM CEST at a Proffered Paper session as a late-breaking oral presentation during the European Society for Medical Oncology Congress 2023 in Madrid, Spain, with publication in the New England Journal of Medicine. With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose for tarlatamab demonstrated an objective response rate of 40%. For key secondary endpoints, median progression-free survival was 4.9 months and median overall survival was 14.3 months. Median response duration was not reached. Of the patients who responded to treatment with tarlatamab at 10 mg dose, 58% experienced at least six months of response and 55% of responses were ongoing at data cutoff. There were no new safety signals observed compared to Phase 1 study. Discontinuations due to treatment-related adverse events were infrequent. The most common treatment-emergent adverse events reported among patients in the tarlatamab 10 mg group, were cytokine release syndrome, pyrexia, decreased appetite and dysgeusia. CRS was largely confined to the first and second dose, predominantly grade 1 or 2 and were generally managed with supportive care. At the tarlatamab 10 mg dose, grade 3 CRS was low and grade 3 immune effector cell-associated neurotoxicity syndrome and associated neurologic events were not observed. There were no reported grade 4 or 5 cases for either of these two adverse events.
GNS

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08:03 EDT Genius Group board implements 10-year performance plan for CEO - Genius Group announces that its Board has approved a 10 year performance plan for the Founder & CEO, Roger James Hamilton, to earn share awards across 10 tranches based on achieving market capitalization targets for Genius Group up to $1 billion within 10 years or less. Qualifying for each of the tranches requires Hamilton to achieve each of the 10 market capitalization targets, together with achieving an additional operational goal related to either annual revenue, from 10 goals up to $500 million, or annual adjusted EBITDA, from 10 goals up to $25 million. Richard Berman, Chairman of Genius Group's Audit & Compensation Committees, said "The Board has a strong belief in Roger Hamilton's ability to grow Genius Group into a billion dollar company delivering a positive, global impact to the future of education. We believe this plan aligns our CEO, management and investors with our long term growth prospects and the value Genius Group can deliver to all long term shareholders."
AVDL

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08:03 EDT Avadel Pharmaceuticals announces data supporting clinical profile for LUMRYZ - Avadel Pharmaceuticals announced new and encore data supporting the clinical profile for LUMRYZ for extended-release oral suspension and patient preference for a once-nightly oxybate in 15 poster presentations and two oral presentations, at World Sleep 2023, being held from October 20-25, 2023 in Rio de Janeiro, Brazil. LUMRYZ is a U.S. Food and Drug Administration approved extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting. Highlights from the presentations include: Post-hoc analyses reinforcing data from the completed pivotal Phase 3 REST-ON trial, demonstrating that treatment with LUMRYZ resulted in statistically significant and clinically meaningful improvement in EDS as measured by the Epworth Sleepiness Scale, a patient reported outcome, with the median score in the range considered normal at the end of the study. A poster from the open-label RESTORE study demonstrating long-term tolerability and clinically significant improvement in symptoms, including EDS, cataplexy, nighttime awakenings and severity of narcolepsy, with LUMRYZ, providing insight into its real-world use. Two posters including new post-hoc analyses that demonstrate the robust clinical efficacy of LUMRYZ and provide further insight into the improvements on measures of EDS and cataplexy compared with placebo in different demographic and clinical subgroups based on age, sex, race, body mass index, narcolepsy subtype and alerting agent use. A poster presenting demographic differences between patients with narcolepsy subtypes NT1 and NT2, with data from objective measures of EDS showing identical sleep latency, comparable subjective assessments of sleep quality and refreshing nature of sleep, with some other baseline parameters suggestive of more severe disease in NT1. A poster with results from a survey of people living with narcolepsy describing their significant daytime and nighttime symptoms and primary focus on treatment of daytime symptoms in discussions between clinicians and patients, highlighting the need for comprehensive discussion and understanding of the full range of symptoms experienced by people with narcolepsy.
WTM

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08:02 EDT White Mountains to acquire majority stake in Bamboo - White Mountains Insurance Group announced that it has entered into an agreement to acquire a majority stake in Bamboo Ide8 Insurance Services, an MGA focused on the California homeowners insurance market. White Mountains expects to invest approximately $285M, including primary capital to support Bamboo's growth, and to acquire approximately 70% of Bamboo basic shares outstanding. Bamboo was launched in 2018 by John Chu, a seasoned insurance executive. Bamboo provides homeowners' insurance for over 100,000 California policyholders, using its technology-enabled underwriting platform to select and manage risk. Bamboo has grown profitably and rapidly in the challenging California market, and is now poised to expand into other states. John and the current Bamboo management team will continue to lead the business through its next phase and will retain a significant equity stake. The transaction is expected to close in the Q1 of 2024. The closing is subject to regulatory approvals and other customary closing conditions. The closing is not subject to a financing condition. The exact ownership to be acquired by White Mountains, and the resulting amount that will be invested, will be determined based on Bamboo unitholder elections made prior to closing. Howden Tiger Capital Markets & Advisory acted as financial advisor to White Mountains, while Cravath, Swaine & Moore provided legal advice. Evercore Group acted as financial advisor to Bamboo and selling equityholders, while Willkie Farr & Gallagher provided legal advice.
RMBL

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07:48 EDT RumbleON appoints Michael Kennedy as CEO - RumbleOn announced that Michael Kennedy has been appointed CEO effective November 1. In connection with his appointment as CEO, Kennedy will also join the RumbleOn board of directors as of that date. Kennedy succeeds Mark Tkach, who has served as Interim CEO since June.
GP

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07:08 EDT GreenPower Motor announces record delivery of all-electric school buses in Q2 - GreenPower Motor Company announced record delivers of its all-electric school buses during the Q2. GreenPower delivered a record 16 purpose-built school buses in the Q2. Of that total, 13 were BEAST school buses and three were the award-winning Nano BEAST school buses. Michael Perez, GreenPower's Vice President of School Bus, Contracts and Grants referenced an increasing number of states that are either mandating the switch to all-electric school buses, providing funds and incentives to change, or both. California is the most recent state to join Connecticut, Maine, Maryland and New York in mandating the purchase of zero-emission school buses when Governor Gavin Newsom signed legislation providing funding of up to $5B to complete the state's transition to zero-emission school buses by 2035. The California HVIP program has also extended the date for submissions for the public-school bus set-aside funding of $285,000 for a Type A eligible school bus without a wheelchair lift and $310,000 with a wheelchair lift and $370,000 for a Type D eligible school bus without a wheelchair lift and $395,000 with a wheelchair lift. Model 1 Commercial Vehicles is GreenPower's exclusive dealer for its Type A Nano BEAST and Type D BEAST school buses in California. In addition to school bus deliveries, GreenPower also delivered 14 commercial vehicles consisting of 12 EV Star passenger vehicles, an EV Star Cargo and an EV Star specialty vehicle. While there were no deliveries of EV Star Cab and Chassis in the quarter, GreenPower presently has more than 50 ready for delivery.
PEV

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07:08 EDT Phoenix Motor announces award of California DGS contract - Phoenix Motor announced the Company's award of a contract by the California Department of General Services, enabling school districts to procure and purchase Phoenix Motorcars' Z600 zero emission Type A with a Cutaway Chassis school buses. This awarded contract will be valid for two years with an option to extend it to three years. This DGS contract will give any school district in California the ability to purchase zero-emission school buses quickly and easily at a competitive price, without having to go through a bid process. Phoenix Motorcars is the sole awardee in the category of Zero Emission Type A with a Cutaway Chassis school buses. Phoenix's Z600 school bus is offered with both 90kWh as well as 141kWh battery pack options and can be purchased with or without an ADA-compliant wheelchair lift.
EMOTF

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07:06 EDT Emerita Resources commences drilling program at Nuevo Tintillo Project - Emerita Resources is commencing with the previously announced diamond drill program at its wholly owned Nuevo Tintillo project. Due to an unusually hot and dry summer, the restrictions related to fire prevention in the area were extended to mid-October. During the hottest weather in this region of Spain, heavy equipment is not permitted to operate during the daytime hours. Construction of drill access roads and platforms at the Project are completed. The drill campaign will start with one rig that will be mobilized next week. Permits for the program and agreements with local landowners are in place. The initial Drill Program at Nuevo Tintillo will focus on targets that have been identified on the west side of the Project, nearest to the Rio Tinto mine. The Drill Program will evaluate six priority targets and comprise approximately 3,000 meters in the initial target testing phase. Subsequent drilling will be budgeted based on results. Targeting is based on a combination of airborne electromagnetic surveying, detailed and archived gravity data, detailed mapping and a compilation of historical geology. The area has abundant evidence of base metal mineralization in surface outcrops as well as small historical mines and is situated on trend from large Volcanogenic Massive Sulfide deposits such as Rio Tinto mine, Aznalcollar mine and Cobre Las Cruces mine. In addition to the drilling at Nuevo Tintillo, the Company has continued to evaluate the potential along strike to the east, towards the center of the property. The exploration team has been mapping and characterizing the lithologies and alteration types in this area. The geological interpretation indicates the stratigraphy correlates well with the western area in the Project and by extension the stratigraphy hosting the Rio Tinto mine further to the west.
RRC

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07:04 EDT Range Resources appoints Charles Griffie to board of directors - RANGE RESOURCES CORPORATION announced the appointment of Charles Griffie to its Board of Directors. Mr. Griffie's appointment is effective October 17 and he will serve on Range's Governance and Nominating and ESG and Safety committees. Griffie previously served as the Senior Vice President of Engineering and Operations at Western Midstream Partners.
VNDA

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07:03 EDT Vanda to petition Supreme Court in HETLIOZ ANDA litigation - Vanda Pharmaceuticals announced its intention to file a petition for a writ of certiorari in its HETLIOZ Abbreviated New Drug Application, or ANDA, litigation against Teva Pharmaceuticals USA, Apotex Inc. and Apotex Corp. Vanda seeks to demonstrate that the United States Court of Appeals for the Federal Circuit applied a flawed standard in assessing obviousness when it affirmed a lower court decision finding several of Vanda's HETLIOZ patents invalid. Vanda's petition seeks to show that the Federal Circuit's approach to obviousness has deviated materially from KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, which trains the obviousness inquiry on whether the claimed innovations "do more than yield a predictable result." Vanda believes that the Federal Circuit's approach improperly invalidates critical patent rights, which are necessary to ensure robust pharmaceutical research and development. Chief Justice Roberts extended the time for the filing of Vanda's forthcoming petition, which Vanda expects to file by January 12.
LLY

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06:55 EDT Eli Lilly to present results from ADjoin long-term extension study - Patients with moderate-to-severe atopic dermatitis who continued treatment with investigational lebrikizumab for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing as demonstrated in the ADjoin long-term extension study from Eli Lilly. Results from ADjoin will be presented at the 43rd Annual Fall Clinical Dermatology Conference happening from October 19-22 in Las Vegas, Nevada. Lebrikizumab is an interleukin-13, or IL-13, inhibitor that specifically blocks IL-13 signaling. The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. ADjoin is the two-year extension of the lebrikizumab monotherapy trials ADvocate 1 and ADvocate 2 and ADhere, the combination trial with topical corticosteroids. Patients taking lebrikizumab who achieved IGA 0,1 or EASI-75 at 16 weeks in ADvocate 1 and 2 and ADhere were enrolled in ADjoin. Patients in the long-term extension trial received either lebrikizumab 250-mg every two weeks or monthly. In ADjoin, lebrikizumab provided durable efficacy in skin and itch outcomes through two years of treatment with both monthly and two-week dosing. The safety profile of lebrikizumab in ADjoin was consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed up to two years of treatment. In ADjoin, 62% of patients reported adverse events, or AEs, most of which were mild or moderate in severity. The most common side effects of lebrikizumab were conjunctivitis, injection site reactions and shingles. Less than three percent of patients experienced AEs leading to treatment discontinuation. Lilly's partner Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including eczema, in Europe.
SLB

Hot Stocks

06:52 EDT SLB sees 'continued sequential revenue growth' in Q4 - "In the fourth quarter, we expect continued sequential revenue growth driven by year-end sales in Digital & Integration and seasonal product and equipment sales in Production Systems. In addition, the fourth quarter will reflect the results of the OneSubsea joint venture."
SLB

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06:51 EDT SLB reports Q3 cash flow from operations $1.68B; free cash flow $1.04B
ALV

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06:46 EDT Autoliv sees FY23 organic sales up 17% - Sees FY23 adjusted operating margin 8.5%-9%. Sees FY23 operating cash flow $900M.
JPM...

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06:43 EDT JPMorgan Payments' Pay-by-bank solution now live - J.P. Morgan (JPM) Payments' Pay-by-bank solution, which provides billers with the ability to allow their customers to pay bills directly from their bank account, is now live. Leveraging Mastercard's (MA) open banking technology to enhance J.P. Morgan Payments' ACH capabilities, Pay-by-bank offers payment choice and provides a simple, secure and frictionless experience for billers to offer to their customers. Verizon (VZ) is planning to pilot J.P. Morgan Payments' Pay-by-bank offering with U.S. customers in the coming months. Pay-by-bank is a payment option that gives merchants the ability to allow their customers to conveniently pay directly from their bank account using traditional ACH banking rails.
GEHI

Hot Stocks

06:39 EDT Gravitas Education announces ADS ratio change - Gravitas Education announced that it plans to change the ratio of its American Depositary Shares, or ADS, to its Class A ordinary shares from one ADS representing twenty 20 shares to one ADS representing 10 shares. The company anticipates that the ADS Ratio Change will be effective on or about October 31.
FSR

Hot Stocks

06:32 EDT Fisker to offer over-the-air software updates in coming weeks - Fisker is pursuing its strategy of offering customers frequent over-the-air software updates by adding or upgrading new features in the coming weeks. Fisker will release its next two OTA updates over the coming weeks and will continue upgrading software for Fisker Ocean SUVs in the future. The first update will address areas of customer feedback, general bug fixes, enhance the drivetrain and 12-volt battery performance, along with several other areas of fine tuning. The second update will include a much-anticipated addition of analytics to the SolarSky roof. Owners can use the user interface of their vehicle to easily track live and historical solar analytics from their Fisker Ocean's central touchscreen, where they can view up-to-date solar gain totals and averages from the past day, week, month, year or lifetime in both watt-hours and miles/km gained. An update to trip stats will enable owners to stay in the know about how much distance they've covered. They can view their current trip, trip meter, and distance since their last charge or dive deeper with the energy metrics for any of those drives. Energy consumption will also be able to be monitored. Owners will be able to track and compare their recent driving metrics to other Fisker Ocean drivers as well as to their vehicle's expected energy usage. This feature has been designed to help energy-minded drivers understand how their driving impacts battery consumption so they can learn better driving habits and improve range.
NVS

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06:27 EDT Novartis says NATALEE analysis reinforces reduction in risk of recurrence - Novartis announced it will present late-breaking results from a prespecified exploratory subgroup analysis of invasive disease-free survival, or iDFS, from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology, or ESMO, Congress 2023. After 27.7 months of follow-up, the iDFS benefit with Kisqali plus endocrine therapy was consistent across key prespecified subgroups, compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer, the company announced. Results were also consistent with those in the overall trial population, reinforcing that the benefit was not driven by a specific patient subgroup. Further analysis of the NATALEE trial is ongoing. Additional data, including the final efficacy analysis of the NATALEE trial, will be shared at upcoming medical meetings. "This analysis further reinforces the potential of ribociclib to address the need for a new adjuvant option that reduces the ongoing risk of recurrence consistently across many types of at-risk patients," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "These results from the NATALEE trial add to the wealth of efficacy, safety and quality of life data suggesting that ribociclib, if approved, could provide healthcare providers with a new option to help keep their patients living well and cancer-free."
HTHT

Hot Stocks

06:19 EDT H World Group sees Q3 Legacy-Huazhu RevPAR 129% of 2019 level - H World Group announced preliminary results for hotel operations in the Q3. For the Legacy-Huazhu business, RevPAR in Q3 recovered to 129% of the 2019 level, supported by the strong travel demand. Breaking down into monthly numbers, RevPAR in July, August and September 2023 recovered to 132%, 128% and 128% of the 2019 levels, respectively. While the RevPAR growth continued to be primarily driven by ADR growth, the occupancy rate recovery also improved sequentially this quarter. In Q3 2023, hotel openings picked up with a gross openings of 545 hotels, and hotel closures amounted to 139 hotels. Steigenberger Hotels GmbH and its subsidiaries continued its promising business recovery trend and its RevPAR recovered to 107% of the 2019 level.
RF

Hot Stocks

06:02 EDT Regions Financial reports Q3 net interest margin 3.73% vs. 3.53% last year - Down from 4.04% in Q2.
GILD

Hot Stocks

05:16 EDT Gilead announces new Sunlenca data from CAPELLA trial - Gilead presented new data supporting Sunlenca as an important treatment option for adults with multi-drug resistant, or MDR, HIV who have extensive treatment history. These findings highlight the significance of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its potential to help transform the future of coordinated HIV clinical care. The data were presented at the 19th European AIDS Conference, or EACS 2023, in Warsaw, Poland, from October 18-21. The latest results include two-year data from the Phase 2/3 CAPELLA trial, which demonstrate that resistance to Sunlenca occurred in a minority of participants and only among those with inadequate adherence to their optimized background regimen, or OBR, or without fully active antiretrovirals as part of their OBR. Furthermore, a survey of healthcare professionals and coordinators conducting the CAPELLA trial reveal positive perceptions of Sunlenca, suggesting its potential to help improve clinical outcomes and health-related quality of life for adults who are heavily treatment experienced. CAPELLA is an ongoing Phase 2/3 study evaluating the safety and effectiveness of Sunlenca in combination with other antiretrovirals as an optimized background regimen, or OBR, for people with multi-drug resistant HIV who are heavily treatment experienced. CAPELLA investigators enrolled 72 participants with advanced HIV disease. Of the 27 participants who met the resistance analysis criteria, 13 did not develop resistance to Sunlenca. Fourteen participants developed Sunlenca resistance-associated mutations; importantly, all 14 either had inadequate adherence to their OBR or an OBR lacking fully active antiretrovirals, 7 of the 14 participants with Sunlenca resistance resuppressed upon re-adherence to their OBR or with OBR change. These findings emphasize the importance of including more than one fully active agent whenever possible when creating a treatment regimen for people with multi-drug resistant HIV who have limited therapy options. In an additional survey conducted amongst 25 CAPELLA healthcare professionals and study coordinators, the majority of respondents believed Sunlenca would be easy to integrate into real-world clinical practice. Respondents reported that Sunlenca has strong potential to improve clinical outcomes and health-related quality of life for heavily treatment-experienced adults. All respondents perceived that injection site reactions did not affect participants' willingness to continue Sunlenca treatment. Lenacapavir is being developed as a foundation for future HIV therapies. The goal is to offer both long-acting oral and injectable options with various dosing frequencies in combination with other antiretroviral agents for treatment or as a single agent for prevention. This approach aims to help address the individual needs and preferences of people with HIV and people who would benefit from pre-exposure prophylaxis, or PrEP. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Sunlenca is approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom or the United States for the treatment of people with multi-drug resistant HIV in combination with other antiretrovirals.
PAC

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05:11 EDT GAP Airports announces government action to amend tariff regulation rules - GAP Airports announced that the Federal Civil Aviation Agency, or AFAC, a decentralized entity of the Mexican Secretary of Infrastructure, Communications and Transport, or SICT, notified us of a new document that modifies the Rules for Tariff Regulation received last October 4. These new rules have immediate application, however, the master development plan and the current maximum tariffs, approved in the last tariff review for the period 2020-2024, will remain in place. Any modification to the tariffs based on the new Rules for Tariff Regulation will apply to tariffs starting on January 1, 2025, once the ordinary review process of the joint maximum tariff and master development plan for the period 2025-2029 is completed.
PRFT

Hot Stocks

05:07 EDT Perficient to acquire Smedix, terms undisclosed - Perficient announced it has entered into a purchase agreement to acquire Smedix, an approximately $12M revenue healthcare software engineering firm headquartered in San Diego, California, with offshore operations located in Cluj-Napoca, Romania. The parties are targeting a closing in January 2024, subject to customary closing conditions and regulatory approval. The agreement includes customary representations, warranties and covenants by the parties and customary termination rights for the company and the selling shareholder.
RIO

Hot Stocks

05:05 EDT Rio Tinto, YEC sing MOU to explore projects on Yindjibarndi country - Rio Tinto and Yindjibarndi Energy Corporation, or YEC, have signed a memorandum of understanding, or MOU, to explore opportunities to collaborate on renewable energy projects on Yindjibarndi country in the Pilbara region of Western Australia. Rio Tinto and YEC will study and evaluate a range of opportunities including wind and solar power as well as battery energy storage systems. The initial focus is on rapidly exploring the potential development of a solar power generation facility for the supply of energy to Rio Tinto. Rio Tinto operates four gas-fired power stations in the Pilbara. About 600MW to 700MW of renewable generation is estimated to be required to displace the majority of gas use across its network. The company is currently assessing the development of approximately 300MW of solar projects. The collaboration opportunities currently being explored by Rio Tinto and YEC if progressed, would be complementary to renewable energy developments on Rio Tinto Iron Ore's electricity grid.