Stockwinners Market Radar for October 18, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:27 EDT Allergan's BOTOX Cosmetic gets FDA approval in jaw-neck bands - The company states: "Allergan Aesthetics, an AbbVie company, announced the U.S. FDA approval of BOTOX Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults.1 BOTOX Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face. The platysma muscle is a thin muscle that covers the neck and extends over the lower face. When this muscle is contracted it can cause the appearance of bands on the neck, which can also create a less defined jawline. Treatment with BOTOX(R) Cosmetic works beneath the surface to temporarily reduce the underlying muscle activity and improves the appearance of the bands connecting the neck and jaw.1 By injecting along the jawline and the vertical bands connecting the jaw and neck with one of the FDA-approved doses of BOTOX(R) Cosmetic based on severity-26, 31, or 36 units-BOTOX(R) Cosmetic temporarily reduces underlying muscle activity. Patients are encouraged to speak to their licensed aesthetic specialist to determine if treatment is right for them."

20:08 EDT T-Mobile exec sells $9.2M in common stock - In a regulatory filing, T-Mobile disclosed that its General Counsel Mark Nelson sold 42.8K shares of common stock on October 16th in a total transaction size of $9.2M.

20:05 EDT Cathie Wood's ARK Investment bought 162K shares of Intellia Therapeutics today

18:00 EDT Amentum awarded $142.03M Army contract modification - Amentum was awarded a $142.03M modification to contract for logistics support services. Work will be performed in Kuwait, with an estimated completion date of November 20, 2025. Fiscal 2010 and 2025 operation and maintenance, Army funds in the amount of $142.03M were obligated at the time of the award. Army Contracting Command is the contracting activity.

17:14 EDT PS5 game 'Spider-Man 2' coming to PC January 30, 2025 - Sony's 2023 video game "Marvel's Spider-Man 2," which released exclusively on PlayStation 5 consoles last year, will arrive on PC via Steam on January 30, 2025. Reference Link

17:03 EDT Genentech announces topline one-year results from ELEVATUM study - Genentech, a member of the Roche, announced topline one-year results from the open-label, single-arm Phase IV ELEVATUM study evaluating Vabysmo for the treatment of diabetic macular edema, or DME, in people from racial and ethnic groups that are often underrepresented in clinical trials. Initial data from 124 participants in the United States showed that after one year of treatment with Vabysmo, administered every eight weeks, participants could read an additional 12.3 letters on average - equivalent to about two and a half lines on an eye chart. Results among major racial and ethnic groups represented in this study were similar. Hispanic and Latino participants started the study with the most severe disease and had an average vision gain of 14.1 letters from baseline at one year, equivalent to nearly three lines on an eye chart. African American and Black participants gained an average of 11.3 letters from baseline at one year. Vabysmo was well tolerated, with no new safety events identified. These data were presented in a late-breaking oral presentation at the American Academy of Ophthalmology, or AAO, 2024 Annual Meeting in Chicago on October 18. The study is the first retina trial for historically underrepresented populations. Results were consistent with the Phase III YOSEMITE and RHINE DME studies. A secondary endpoint showed robust retinal drying with Vabysmo across these racial and ethnic groups, who, on average, achieved a decrease of 206.3 microns in central subfield thickness, or CST, from baseline. Reducing CST indicates retinal drying, which is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision. Among the 124 patients, 45% self-identified as Hispanic or Latino, and 48% as Black or African American. The study was designed to facilitate enrollment and promote retention of underrepresented patients. For example, ELEVATUM was conducted at sites that treat a high proportion of these populations, in urban, rural, and community-based locations. In addition, eligibility criteria allowed participants with a hemoglobin A1c (HbA1c) level up to 12%. An HbA1c test measures a person's average blood sugar levels over the past three months and is used to diagnose diabetes. Typically, the threshold for DME trials is an HbA1c level of 10%. However, HbA1c levels can be higher in Black, African American, Hispanic and Latino populations compared with Caucasians, meaning a lower HbA1c threshold can inadvertently lead to the exclusion of patients from various ethnic and racial groups.

16:06 EDT Public Storage names Chris Sambar COO - Public Storage (PSA) announced that Chris Sambar has joined the company as COO. Most recently, he was president at AT&T (T) and led approximately 27,000 employees across network operations.

16:04 EDT Boston Scientific launches next-gen cardiac mapping for FARAPULSE - Boston Scientific Corporation announced it has received U.S. Food and Drug Administration approval for the navigation-enabled FARAWAVE NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation and FDA 510(k) clearance for the new FARAVIEW Software, which will combine to provide visualization for cardiac ablation procedures with the FARAPULSE Pulsed Field Ablation System. These technologies are compatible exclusively with Boston Scientific's existing cardiac mapping technology and the company's latest offering, the OPAL HDx Mapping System. Today, physicians may utilize a separate mapping catheter prior to a cardiac PFA procedure to examine and analyze the heart's electrical patterns and plan the therapeutic applications for each patient. The FARAWAVE NAV Ablation Catheter builds upon the current FARAWAVE catheter by adding magnetic navigation capabilities, enabling cardiac mapping and PFA therapy delivery within a single integrated catheter, while minimizing the need for additional device exchanges. Mapped procedures with the FARAPULSE PFA System are visually depicted for physicians via the FARAVIEW Software, which offers a dynamic view of catheter placement, shape and rotation. "The addition of the FARAWAVE NAV Ablation Catheter and FARAVIEW Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the FARAPULSE PFA System," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "Built on this safe and clinically-proven platform - which has been used to treat more than 125,000 patients globally - the visualization capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures."

14:54 EDT Acadia Healthcare falls 4% to $56.70 following NY Times report

14:14 EDT Roche receives FDA approval for Ventana CLDN18 RxDx Assay - Roche announced that the VENTANA CLDN18 RxDx Assay is the first U.S. Food and Drug Administration approved immunohistochemistry companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOY. "Patients who are diagnosed with gastric or gastroesophageal junction cancer are often diagnosed in an advanced stage as early symptoms can be similar across several conditions," said Jill German, Head of Pathology Lab at Roche Diagnostics. "Our companion diagnostic for CLDN18 can help identify patients eligible for targeted treatment and provide them with additional therapeutic options. With the launch of this test, Roche continues to advance personalised healthcare by expanding our innovative companion diagnostic portfolio."

13:55 EDT Starbucks hires former Chipotle executive as Chief Brand Officer - Starbucks (SBUX) has hired a former Chipotle Mexican Grill (CMG) executive, Tressie Lieberman, to join on Nov. 4 as Chief Brand Officer, the company announced in an emailed statement. Lieberman, who was most recently Chief Marketing Officer at Yahoo, has also worked at Chipotle, where Niccol was previously CEO, and at Yum! Brands (YUM), where Niccol led the Taco Bell brand. In the statement, Niccol said Lieberman will help "reintroduce Starbucks to the world" and will lead marketing, product development, digital, creative and analytics.

12:45 EDT Richtech Robotics to bring robot-run restaurants to certain Walmart stores - Richtech Robotics (RR) said that it is bringing robot-run restaurants to Walmart (WMT) stores across Arizona, Colorado, and Texas. "Our new signed agreement with Ghost Kitchens Brands will introduce 20 new locations," the company said. Reference Link

12:19 EDT Orange delists from New York Stock Exchange, moves to OTC market - Orange announces that its voluntary delisting of American depositary shares representing its ordinary shares from the New York Stock Exchange has become effective. Orange maintains a level 1 American depositary receipt program, which will enable investors to retain their ADRs and facilitate trading on the over-the-counter market, under the symbol "ORANY." Orange's shares will remain listed on Euronext Paris.

12:00 EDT Telephone and Data rises 15.6% - Telephone and Data is up 15.6%, or $3.95 to $29.21.

12:00 EDT Fabrinet falls -7.0% - Fabrinet is down -7.0%, or -$18.71 to $248.16.

12:00 EDT CVS Health falls -9.2% - CVS Health is down -9.2%, or -$5.88 to $57.79.

11:53 EDT XCHG Ltd (ADR) trading resumes

11:10 EDT Top Wealth Group Holding Ltd trading resumes

10:49 EDT BioNTech: FDA puts partial clinical hold on Phase 3 PRESERVE-003 trial - In a regulatory filing, BioNTech said that it has been informed by its partner OncoC4 that the U.S. FDA has placed a partial clinical hold on the companies' two-stage, open-label, randomized Phase 3 trial, PRESERVE-003. BioNTech and OncoC4 understand that the partial clinical hold in the ongoing Phase 3 trial with BNT316/ONC-392 in non-small cell lung cancer is due to varying results between the squamous and non-squamous NSCLC patient populations. The trial evaluates the efficacy and safety of the antibody candidate BNT316/ONC-392 as monotherapy in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. A recent assessment of the trial data by the independent data monitoring committee identified a possible variance in population results. Consequently, OncoC4 and BioNTech decided to proactively pause enrollment of new patients and informed the FDA of the possible variance for further alignment. While the companies are assessing next steps for the ongoing trial with BNT316/ONC-392 in NSCLC, patients already enrolled in the trial will continue to receive treatment. Trials evaluating BNT316/ONC-392 in other indications remain unaffected.

10:08 EDT Focus Impact Acquisition Corp trading resumes

10:03 EDT Orangekloud to invest S$1M in Evvo Labs - Orangekloud Technology announced the signing of an Investment Agreement with Evvo Labs, an established Cybersecurity company in Singapore. Investment and Collaboration Highlights: Orangekloud to invest S$1,000,000 (approximately $761,000) for a 3.23% shareholding stake in Evvo Labs. The strategic collaboration will enable OrangeKloud to leverage Evvo Labs' cybersecurity capabilities to elevate ORKT's offerings of digital transformation solutions, benefitting the Company's end-user enterprise customers. Orangekloud's investment will contribute to Evvo Labs' product enhancement and market expansion into Singapore and Vietnam. Orangekloud and Evvo Labs said they expect the strategic agreement to produce "positive synergies" enabling both parties to strengthen the competitive positions in their respective product markets, as well as facilitate the development of additional products and services.

10:01 EDT Spirit AeroSystems announces employee furloughs in response to Boeing strike

10:00 EDT Bunge falls -4.8% - Bunge is down -4.8%, or -$4.62 to $90.98.

10:00 EDT CVS Health falls -7.5% - CVS Health is down -7.5%, or -$4.76 to $58.91.

10:00 EDT Telephone and Data rises 10.8% - Telephone and Data is up 10.8%, or $2.73 to $27.98.

09:56 EDT Pineapple Energy Inc trading halted, volatility trading pause

09:52 EDT Arqit Quantum trading resumes

09:48 EDT Autoliv rises 7.3% - Autoliv is up 7.3%, or $6.82 to $100.71.

09:48 EDT Cheetah Mobile rises 7.9% - Cheetah Mobile is up 7.9%, or 30c to $4.11.

09:47 EDT Ally Financial falls -6.4% - Ally Financial is down -6.4%, or -$2.30 to $33.54.

09:47 EDT CVS Health falls -6.5% - CVS Health is down -6.5%, or -$4.15 to $59.52.

09:43 EDT Sobr Safe Inc trading resumes

09:38 EDT Sobr Safe Inc trading halted, volatility trading pause

09:33 EDT ORIS Stock trading halted, volatility trading pause

09:31 EDT DRAGON PHARMA INC trading halted, volatility trading pause

09:24 EDT E-Home Household Service establishes resource recycling department - E-Home Household Services established a new Resource Recycling Department in response to the current national policy guidance coupled with the advantages of its own business. It recovers used home appliances, unused and old materials and waste classification and recycling business through home maintenance technicians, cleaners, nannies and caretakers' door-to-door service at the same time, and co-operates with professional resource recycling companies. The Resource Recycling Department first operates as an independent business department, and then registers a subsidiary company to operate independently in parallel.

09:11 EDT Can-Fite BioPharma reports results from osteoarthritis clinical study in dogs - Can-Fite BioPharma announced that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite's veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study. Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325M to Can-Fite over the next 10 years. The study looked at the effect of 90 days treatment with Piclidenoson at 100 undefined/kg and 500 undefined/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs questionnaire for the assessment of symptoms severity evaluated on dog's mobility. The secondary objectives included Visual Analog Scale for pain assessment by pet parents and Numerical Rating Score for lameness and pain assessment by the veterinarian. The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 microgram/kg dose.

09:06 EDT Procter & Gamble says No. America organic sales up 4% in Q1 vs. up 7% last year - Says growing, holding volume share in most regions. Expects strong product innovation in 2H25. Says opportunity in U.S. is "still huge." Says main driver of gross margin progress will be productivity. Does not expect any impact from recent port strike.

09:03 EDT Theravance Biopharma's revefenacin improves bronchodilation in published study - Theravance Biopharma announced the publication of a sub-study of the registrational revefenacin Phase 3 trials for Yupelri, the first and only FDA approved once-daily nebulized long-acting muscarinic antagonist, evaluating the area under the curve lung function effects in moderate-to-very-severe chronic obstructive pulmonary disease - COPD - patients. These data and analyses, published in the International Journal of Chronic Obstructive Pulmonary Disease, reinforce that Yupelri provides consistent and durable improvements in lung function, as compared with placebo, over a full 24-hours. Analysis of a retrospective, pooled sub-study from Phase 3 studies demonstrated that revefenacin improved bronchodilation versus placebo in patients with moderate-to-very-severe COPD when assessed by FEV1 AUC. Rapid onset of bronchodilation was observed, with a mean FEV1 difference of 145 mL achieved at 15 minutes, exceeding the accepted Minimal Clinically Important Difference of 100 mL with approximately 97.5% confidence. Day 84 bronchodilation improvements were sustained over 24 hours vs. placebo.As patients depend on the magnitude of sustained bronchodilation to address COPD symptoms, combined use of both trough FEV1 and FEV1 AUC may allow for a more comprehensive assessment of bronchodilator efficacy to support clinical decision-making.

09:02 EDT FIS, Fulham Football Club announce new partnership - FIS and Fulham Football Club have together announced a new partnership, unveiling the Markers, presented by FIS, an innovation space and technology hub at the new Fulham Pier. Fulham Pier, which is part of the redevelopment of Fulham's riverside stand, is London's newest riverfront destination, with restaurants and cafes, a hotel, spa and members' club all overlooking the Thames.

08:42 EDT MidCap Financial amends, extends senior secured revolving credit facility - MidCap Financial Investment Corporation has amended and extended its senior secured, multi-currency, revolving credit facility. Lender commitments under the Facility total $1.66B, excluding non-extending lender commitments, an increase of $110M. Lender commitments under the Facility total $1.815B, including $155M of commitments from non-extending lenders which are set to terminate on December 22, 2024. The final maturity date under the Facility for extending lenders was extended from April 19, 2028, to October 17, 2029. The remaining material business terms of the Facility will remain substantially the same. JPMorgan Chase Bank, N.A., Truist Securities, Inc., BMO Capital Markets Corp., and MUFG Bank, LTD. are Joint Bookrunners and Joint Lead Arrangers on the Facility. JPMorgan Chase Bank, N.A is the Administrative Agent on the Facility.

08:37 EDT SeaStar announces enrollment in NEURTALIZE-AKI trial passes halfway point - SeaStar Medical announces that 51 subjects have been enrolled in its NEUTRALIZE-AKI pivotal trial, passing the halfway point toward the target of 100 subjects for performing an interim analysis on the trial's 90-day primary endpoint. The trial is evaluating the safety and efficacy of SeaStar Medical's proprietary therapeutic Selective Cytopheretic Device, SCD, in adults with acute kidney injury, AKI, in the intensive care unit, ICU, receiving continuous kidney replacement therapy, CKRT.

08:35 EDT Norwegian Cruise Line announces time change for Q3 results - Norwegian Cruise Line Holdings announced changes to the timing of the previously announced release of its third quarter 2024 results and the associated webcast, in order to minimize conflicts with other industry earnings announcements. Financial results will now be announced on Thursday, October 31 at approximately 7:00 a.m. Eastern Time with a conference call and webcast to discuss results at 9:00 a.m. Eastern Time. There is no change to the date or webcasting information.

08:35 EDT Sealsq, Allion Japan partner to assist IoT device manufacturers - SEALSQ announced a strategic partnership with Allion Labs Japan Inc., a leading certification consulting laboratory with over 30 years of experience. The partnership aims to assist IoT device manufacturers in creating secure and standard-compliant products, meeting key protocols such as Matter, and complying with new international IoT security regulations like the EU Cyber Resilience Act and the US Cyber Trust Mark. With Allion Japan serving as SEALSQ's Sales Representative in the Japan region and an Authorized Test Laboratory for CSA Matter certification, the collaboration seeks to provide comprehensive support to manufacturers, from product development to certification, with the aim to reduce time-to-market and technology costs for IoT manufacturers by providing a complete scalable security solution.

08:20 EDT Bradley Radoff issues letter to GSE Systems board in opposition to Pelican sale - Bradley Radoff, who collectively with his affiliates owns approximately 9.9% of the outstanding shares of GSE Systems, sent the below letter to GSE Systems' board indicating its opposition to the proposed take-private merger with Pelican Energy Partners. "I am one of GSE's largest shareholders, with an approximately 9.9% stake in the Company. After reviewing the Company's belated and limited disclosures, I believe the proposed sale to Pelican significantly undervalues the Company and puts leadership's interests ahead of shareholders' best interests. The Board, which collectively has limited public company experience and de minimis share ownership, appears to have allowed the Company to develop liquidity issues that have become the basis for what is seemingly a fire sale. Now, with this deal, the Board is seemingly doubling down on its missteps by giving up on the Company right as the nuclear power industry is entering a renaissance that should be a significant tailwind for GSE and its prospects for enhanced value creation. Despite GSE's apparent runway for improved financial performance, you have refused to provide a view on the business for 2025. As a result, shareholders are unable to appropriately analyze the Company's prospects and evaluate a standalone future relative to the current deal. The Board's contention that it cannot provide projections because management's forecasts have historically been unreliable simply serves as an acknowledgment of your failures when it comes to governing the business and overseeing the executive leadership you put in place. With respect to your decision to deprive shareholders of relevant information, it is highly unusual that the Company's definitive proxy statement for the merger did not contain forward-looking business projections. I appear to be one of the many shareholders who are disappointed with this insufficient disclosure. The Company's Form-8-K filed on October 8th, 2024 - just two weeks prior to the shareholder vote - was purportedly only put out in response to "demand letters alleging similar deficiencies and/or omissions regarding the disclosures made in the Preliminary Proxy Statement or the Definitive Proxy Statement." In the October 8th 8-K, GSE provided a mere glimpse of very encouraging and positive projections that implied more than $0.30 of quarterly earnings for a Company that currently trades at around $4. The projections, while incomplete, appear to show that the Company is beginning to materially benefit from the nuclear resurgence. Given this context, I am calling on you to provide the market with customary disclosures regarding the Company's forward-looking projections so shareholders can make the most informed decision on the transaction. If the Company continues to provide such limited disclosures as it did in the October 8th 8-K, then it should at least reset the record date for the Pelican merger to enable the investment community to sufficiently digest this new, albeit limited, information. While the Company's legal counsel and bankers - who stand to make millions if the deal goes through - may have signed off on the disclosures to this point, the Board should know that this deal fails the smell test. Nothing in the merger agreement prevents you from providing more information and transparency to shareholders. I believe your decision to effectively keep GSE shareholders in the dark will define your directorship at GSE and be a black mark for any of you who intend to pursue other director opportunities. Shareholders have long memories. While you have trumpeted Institutional Shareholder Services' recent report as an endorsement, I don't believe shareholders should give it any credence. The report neglects to mention the lack of initial projections, the magnitude of the late projections and the recent trading activity indicating that shareholders believe there is more value than is being offered by Pelican. In fact, approximately 30% of the Company's outstanding shares have traded at or above the deal price this week. In closing, I believe an independent GSE has significant upside potential. The Board failed to provide projections prior to the record date and then reluctantly offered limited disclosure just two weeks prior to the shareholder meeting. This set of circumstances, combined with a comical fairness opinion and egregious transaction expenses, are very troubling. I once again demand normal course forward projections so that shareholders, who are the owners of the business, can fairly evaluate the Pelican transaction."

08:06 EDT Sierra Bancorp announces new 1M share stock repurchase program - Sierra Bancorp announced that its board of directors has approved a new share repurchase program authorizing the company to repurchase up to one million 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, 2025. This share repurchase program replaces and supersedes the prior share repurchase program.

08:03 EDT Simmons First National reports Q3 net interest margin 2.74%, up 5 bps vs. Q2

08:02 EDT Valvoline announces CFO retirement and transition plan - Valvoline announces the planned retirement of its CFO Mary Meixelsperger. Meixelsperger will continue as CFO until a successor is hired and will remain with the company through the subsequent transition period. The company has initiated a comprehensive search with the assistance of an executive search firm to identify a successor for this position, which will include both internal and external candidates. Meixelsperger joined Valvoline in 2016 as CFO just prior to the initial public offering and spinoff from Ashland Global Holdings.

07:37 EDT Avangrid subsidiary awarded $31.8M in federal funding - Avangrid announced that Central Maine Power, or CMP, has been awarded $31.8 million in federal funding to deploy technologies to create a more modern and dynamic power grid to support the deployment of renewable energy in Maine. This grant was awarded through the U.S. Department of Energy's Grid Resilience and Innovation Partnerships program and is funded by the Bipartisan Infrastructure Law. These initiatives are being driven at the state-level in Maine by the Flexible Interconnections and Resilience for Maine project, led by the Governor's Energy Office, part of the administration of Governor Janet Mills. Specifically, this funding will be used to deploy Active Network Management and Dynamic Line Rating (DLR). Together, these smart grid technologies will help connect more renewable energy to the power grid while also protecting it from overloading.

07:32 EDT Antelope Enterprise announces first phase of planned energy production sold out - Antelope Enterprise Holdings announced that its first phase of its planned supply project in Midland, Texas, has been sold out. The Company's energy supply project will be further developed to increase its power generation output. Will Zhang, CEO of Antelope Enterprise, commented "We are pleased to announce that our first phase of 9 MW of electricity generation has been sold out. Natural gas can achieve significantly higher thermal efficiencies than other fossil fuels and considered a reliable fuel source allowing for consistent power generation with predictable output.

07:09 EDT Allegion acquires SOSS Door Hardware, terms undisclosed - Allegion has acquired SOSS Door Hardware. A manufacturer of premium hinges and door hardware, SOSS primarily sells its solutions in North American non-residential markets. Founded in 1903, the company invented the concealed hinge, it's SOSS Invisible Hinge as well as fire-rated, heavy-duty and other specialty hinges are popular across industrial, commercial and institutional spaces. SOSS will report into the Allegion Americas segment, led by Allegion Senior Vice President Dave Ilardi. Terms of the transaction were not disclosed.

07:04 EDT CVS Health falls 11% to $56.28 after weak Q3 guidance, CEO change

06:59 EDT Novartis receives positive CHMP opinion for Kisqali - Novartis announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion and recommended granting marketing authorization for Kisqali for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer, EBC, at high risk of disease recurrence, including those with node-negative disease.

06:58 EDT TreeHouse announces recall of certain frozen waffle products - TreeHouse is voluntarily recalling certain frozen waffle products due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women. The recalled products were distributed throughout the United States and Canada and packed in various formats.

06:51 EDT Autoliv reports Q3 adjusted EPS $1.84, consensus $1.95 - Reports Q3 revenue $2.56B, consensus $2.53B. The company said, "Light vehicle production was weak in the third quarter, declining by close to 5% globally. This was driven by a combination of inventory reductions, especially in the Americas and a high comparison base, especially in China. In this tough environment, Autoliv managed to outgrow LVP by 4pp, enabling almost unchanged sales and operating income. This is despite a $14 million cost item related to a supplier settlement. We were able to achieve these results mainly due to our cost control, including a continued reduction of our indirect workforce. We accelerated our efficiency improvements, contributing to a reduction of direct headcount by 3,100 compared to a year earlier, which is a reduction of 6%. I am pleased that we outgrew LVP on a global basis following substantial outperformance in Europe and Asia excl. China. Our sales underperformed LVP in China due to a substantial negative market mix, however, our position with Chinese OEMs continues to improve."

06:41 EDT Comerica sees maintaining capital well above CET1 target of 10% through year-end

06:37 EDT PTC Therapeutics announces negative CHMP opinion on Translarna authorization - PTC Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has maintained its negative opinion on the renewal of the conditional marketing authorization of Translarna for the treatment of nonsense mutation Duchenne Muscular Dystrophy, or nmDMD, following re-examination. The opinion will now be reviewed by the European Commission which is expected to decide on opinion adoption in approximately 67 days.

06:31 EDT CVS Health CEO Karen Lynch steps down, David Joyner succeeds - CVS Health announced that David Joyner was appointed president and CEO effective October 17, replacing Karen Lynch, who stepped down from her position in agreement with the company's board of directors. Joyner also joined the board of directors. In addition, current chairman of the board, Roger Farah, will now be executive chairman. Joyner was most recently executive vice president, CVS Health, and president, CVS Caremark.

06:09 EDT Better Choice Company issues letter to shareholders on SRx Health acquisition - Better Choice Company Chairman Issues Letter to Shareholders as Company Continues to Make Progress Towards the Closing of its SRx Health Acquisition Combined company will emerge as a leading global health and wellness company by providing better products and solutions for pets, people, and families Combined 2025 revenue and EBITDA expected to be approximately +$270 million, and +$10 million, respectively1 Better Choice net tangible book value is $4.07 per share2 and net current asset value per share is $3.943 Transaction is expected to close in late Q4 2024 or early Q1 2025 Better Choice Company issued a letter to shareholders as the company continues to make progress towards the closing of its acquisition of SRx Health Solutions, a provider of healthcare solutions, in an all-stock transaction for approximately $125M. The letter states that: "...The combination of the two companies is expected to generate significant cash flow, yield operational efficiencies, and cost savings, while providing large growth opportunities that will drive sustainable organic growth for each respective business. We expect the transaction to close in late Q4 of this year or early Q1 of 2025...Better Choice has established its premium pet food brand Halo through our omni-channel distribution model. Gross sales of the brand totaled approximately $49M in 2023...For Q2 2024, Better Choice generated close to break-even adjusted EBITDA of less than ($0.03M)...SRx Health generated approximately C$180M in revenue and generated positive adjusted EBITDA in 2023...The combined companies for the trailing twelve months have generated $235M in revenue, increasing approximately 25% quarter-over-quarter. From an operational perspective, we expect to achieve immediate cost savings estimated to be approximately $1.7M annually, with potential for further upside as we continue to integrate the two companies...On a pro forma basis, we project 2025 combined revenue and EBITDA to be over $270M and over $10M, respectively...From a valuation perspective, net tangible book value is $4.072 per share and net current asset value per share is $3.943, both well below the current price of our equity."

06:00 EDT Robinhood announces the launch of Robinhood Legend - Roobinhood announced Robinhood Legend, a desktop trading platform built specifically for active traders. The company is also launching futures trading and index options on mobile. "With Robinhood Legend, futures, and index options, we're helping customers harness the full power of the markets so they can take control of their financial future," said Vlad Tenev, Chairman and CEO of Robinhood. Robinhood Legend is fully customizable and available at no additional cost to anyone with a Robinhood account. The platform gives active traders: advanced trading tools; deeper analysis; real-tome data; customer and present layouts; make trades; and dynamic linking.

05:38 EDT Nokia announces changes to group leadership team - Nokia announced changes to its group leadership team. Its corporate affairs function will be divided into two parts: Geopolitics and Government Relations; and Communications. Former Finland ambassador to the U.S. Mikko Hautala has been appointed chief geopolitical and government relations officer and member of the group leadership team, effective November 1. Louise Fisk has been promoted to chief communications officer, and member of the group leadership team, effective immediately. Chief corporate affairs officer, Melissa Schoeb, has decided to leave the company, effective December 31 and step down from the group leadership team immediately. In addition, President of Nokia Technologies, Jenni Lukander, has decided to leave the company, effective December 31 and will step down from the group leadership team immediately. Patrik Hammaren, who is currently chief licensing officer, Wireless Technologies, will assume an interim role leading Nokia Technologies and will be a member of the group leadership team as the search commences for Lukander's successor.

05:27 EDT Philip Morris affiliate announces $23.5B CCAA plan to resolve Canada litigation - Philip Morris has been informed by its deconsolidated Canadian affiliate, Rothmans, Benson & Hedges, or RBH, that the court-appointed mediator and monitor in RBH's Companies' Creditors Arrangement Act, or CCAA, proceeding filed a proposed plan of compromise and arrangement outlining certain terms of a resolution of tobacco product-related claims and litigation in Canada against RBH and its affiliates. The court-appointed mediator and monitors also filed substantially similar proposed plans for Imperial Tobacco Canada and Imperial Tobacco Company and JTI-Macdonald Corp. Under the proposed plan, if ultimately approved and implemented, RBH, ITL and JTIM would pay an aggregate settlement amount of $23.5B. This amount would be funded by an upfront payment equal to the companies' cash and cash equivalents on hand in Canada plus certain court deposits of $540M for working capital inclusive of cash pledged as collateral and annual payments based on a percentage of the companies' net income after taxes until the aggregate settlement amount is paid. As stated in the proposed plan, the issue of allocation of the C$32.5B aggregate settlement as between the companies in the CCAA proceedings remains unresolved. The proposed plan, broadly speaking, would release claims against RBH and its affiliates, including PMI and its indemnitees, relating to the manufacture, marketing, sale, or use of or exposure to, RBH's combustible and traditional smokeless tobacco products based on conduct prior to the effective date of the proposed plan; related litigation would also be dismissed - bringing an end to all pending tobacco product litigation in Canada, including class actions brought in different provinces and, beginning in 2001, health care cost recovery actions brought by each of the Provinces. If the proposed plan is approved and implemented, RBH, ITL, and JTIM would pay an aggregate amount of $23.5B into trusts for the benefit of claimants, comprising two primary components: upfront contribution equal to the companies' cash and cash equivalents on hand plus certain court deposits, with a withholding of $540M for working capital inclusive of cash pledged as collateral; the proposed plan projects that the total industry upfront contribution would be C$12.5B as at December 31, after the C$750M withheld working capital amount is deducted. annual contributions determined by reference to a percentage of the companies' Canadian affiliates' only "net after-tax income" until the aggregate amount is paid in full. Annual contributions start at 85% of NATI, with a five-percentage point reduction in NATI every five years until reaching 70%. Annual contributions are contingent on positive NATI of the companies. Such payments and obligations concern only the Canadian affiliates and not the ultimate parent company PMI. As stated in the proposed plan, the issue of allocation of the C$32.5B aggregate settlement as between the companies in the CCAA proceedings remains unresolved. Alternative product businesses would be transferred to an RBH affiliate and not factored into the calculation of the annual contribution payments described above. The proposed plan, including the terms described above, remains subject to any further negotiation by the parties and CCAA court orders, voting by claimants, and approval by the CCAA court. According to a schedule proposed by the court-appointed mediator and monitors, voting on the proposed plan would occur in December. If accepted by claimants, a hearing to consider approval of the proposed plan would then be expected in the first half of 2025. The carrying value of PMI's equity interest in RBH is in line with the fair value determined at the date of deconsolidation, $3.28B, subject only to ongoing adjustments for the effect of foreign currency exchange rates. If the proposed plan is approved and implemented, the fair value of PMI's continuing investment in RBH will be dependent on its final terms, and any allocation of responsibility for funding the aggregate settlement amount among the companies. These or similar or related developments may have a material adverse impact on the fair value of PMI's continuing investment in RBH and may result in non-cash impairment charges, which could be material to PMI.

05:12 EDT Kaspi.kz to acquire 65.41% of Hepsiburada for $1.13B - Kaspi.kz (KSPI) has announced that it has signed a definitive agreement with Hanzade Dogan, the founder and controlling shareholder of Hepsiburada (HEPS), and Vuslat Dogan Sabanci, Begum Dogan Faralyali, Arzuhan Dogan Yalcindag and Isil Dogan to acquire 65.41% of all the total outstanding Class A and Class B shares of Hepsiburada. Founded in 2000 by Hanzade Dogan, Hepsiburada has long been one of Turkiye's e-commerce platforms. For FY23, the company recorded around $4B in gross merchandise value, served around 12M consumers and 101,000 merchants. For first half of 2024, Hepsiburada was EBITDA positive and equivalent to 2.4% of GMV. The aggregate consideration for the transaction is approximately $1.13B, payable in cash in two installments. The transaction is subject to customary closing conditions and regulatory approvals in Turkiye, with closing expected in the first quarter 2025. Kaspi.kz signed a stock purchase agreement with Hanzade Dogan, Vuslat Dogan Sabanci, Begum Dogan Faralyali, Arzuhan Dogan Yalcindag and Isil Dogan to purchase Class A and Class B shares representing 65.41% of the total outstanding share capital of Hepsiburada. The aggregate consideration for the transaction is approximately $1.13B, payable in cash in two tranches: $600M at closing, and $526.9M no later than in six months post-closing. To finance the investment, Kaspi.kz intends to use its own cash from operations and cash at hand. Kaspi.kz may explore opportunities in debt capital markets, subject to terms and market conditions; however, no such arrangements or commitments are currently being negotiated or contemplated. Subject to customary closing conditions and receipt of regulatory approval by certain Turkish government agencies, the transaction is expected to close in the first quarter 2025.