Workflow
Xenon Showcases New 48-Month Azetukalner OLE Study Data in Epilepsy at AES 2025
Globenewswire· 2025-12-05 14:00
Core Insights - Xenon Pharmaceuticals Inc. announced new data on its commitment to epilepsy treatment, including interim 48-month data from the X-TOLE open-label extension study of azetukalner, real-world studies on depression burden, and pre-clinical data for Dravet syndrome [1][2] Group 1: Azetukalner Efficacy and Safety - The interim data from the X-TOLE study showed a monthly seizure frequency reduction of over 90% at 48 months, with a 100% reduction in patients on 1-2 anti-seizure medications (ASMs) at baseline [2][4] - Among participants treated for 48 months, 38.2% achieved at least 12 months of seizure freedom, while 10.7% maintained seizure freedom for 48 months [4] - The long-term safety profile of azetukalner was consistent with that observed during the double-blind period, indicating a favorable tolerability [5] Group 2: Real-World Studies on Depression in Epilepsy - A study found that 80.6% of patients with focal seizures reported depressed mood, highlighting the significant mental health burden among this population [7] - Newly diagnosed epilepsy patients with depression had a higher prevalence of comorbidities and an increased risk of treatment failure, emphasizing the need for tailored treatment strategies [8] - Patients with moderate to severe depression symptoms experienced a lower quality of life and higher healthcare resource utilization, reinforcing the necessity for routine depression screening in epilepsy care [9] Group 3: Pipeline and Future Directions - Xenon is preparing to share Phase 3 data from the X-TOLE2 study in early 2026, which is anticipated to be a significant milestone for the company and the epilepsy community [2] - The company is also advancing early-stage programs targeting potassium and sodium channels for potential pain treatment, indicating a broadening of its therapeutic focus [15]
Freight Technologies Announces Strategic Partnership with Solvento to Integrate Financial Workflows
Globenewswire· 2025-12-05 14:00
Core Insights - Freight Technologies, Inc. has announced a strategic partnership with Solvento to integrate Fleet Rocket TMS with Solvento's financial solutions platform, enhancing invoicing and payment capabilities for logistics operators [1][2] - The collaboration aims to create a unified ecosystem that streamlines logistics execution and financial settlement, benefiting brokers, carriers, and shippers [2][3] Company Overview - Freight Technologies, Inc. (Fr8Tech) is a logistics management innovation company that offers a diverse portfolio of technology-driven solutions, including Fleet Rocket TMS, which is designed to optimize and automate supply chain processes [5] - Solvento is an AI-powered fintech platform that transforms logistics operations in Latin America through automation and smart financing solutions, having processed over 150,000 invoices and financed more than MXN 4.5 billion in freight operations [4] Partnership Details - The integration allows users of Fleet Rocket TMS to connect shipment and operational data to Solvento's financial management tools, simplifying various financial processes [2] - Both companies are launching a mutual referral program and plan to introduce additional collaborative features and joint offerings in the future [3]
Allied Gaming and Entertainment Issues Statement to Shareholders and the Investment Community
Globenewswire· 2025-12-05 14:00
Core Viewpoint - The company reaffirms its financial strength and strategic progress despite elevated short-selling activity, emphasizing a significant disconnect between its market valuation and intrinsic value [1][2][3]. Financial Position - Total assets exceed US$106.7 million, with cash, cash equivalents, and short-term investments totaling approximately US$53.8 million, and shareholders' equity at around US$56.9 million [3]. - The current market capitalization is approximately US$14 million, representing about 25% of net asset value and less than 30% of cash and short-term investments [3]. Expense Management - Increased operating expenses are attributed to a prolonged shareholder control dispute, which is exceptional and non-recurring, not indicative of operational weakness [4]. - The company has optimized its cost structure and improved the efficiency of strategic capital deployment while maintaining stable operational progress [4]. Income Generation - The company generated over US$3.5 million in interest and investment income during the first nine months, showcasing a resilient financial foundation [5]. Strategic Focus - The company aims to expand higher-margin experiential and live entertainment businesses, advance monetization models, and pursue selective investment opportunities [6]. - With liquidity exceeding US$53 million, the company is positioned to execute its growth strategy without pressure from short-term market fluctuations [6]. Shareholder Guidance - The company advises shareholders to exercise caution regarding unverified commentary and to evaluate based on official disclosures and long-term value rather than short-term price movements [7]. - Management remains confident in delivering sustainable value to long-term shareholders and is committed to transparent communication and disciplined execution [8].
Biogen and Stoke Therapeutics Present Data that Further Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 2025 American Epilepsy Society (AES) Annual Meeting
Globenewswire· 2025-12-05 14:00
Core Insights - Zorevunersen shows potential as a disease-modifying therapy for Dravet syndrome, demonstrating durable seizure reductions and improvements in cognition, behavior, and quality of life in patients [1][3][4] Clinical Data - Long-term Phase 1/2a and open label extension (OLE) studies indicate significant reductions in seizure frequency and increased seizure-free days for patients treated with zorevunersen alongside standard anti-seizure medicines [1][3][4] - A propensity score weighted analysis revealed that patients receiving zorevunersen experienced statistically significant reductions in major motor seizure frequency at six months, consistent with the ongoing Phase 3 EMPEROR study [5][6] - Improvements in cognition and behavior were observed at 18 months, with several assessments reaching statistical significance [5][6] Mechanism of Action - Analysis of electroencephalogram (EEG) data supports a disease-modifying mechanism of action for zorevunersen, showing dose-dependent effects in decreasing abnormal brain activity associated with Dravet syndrome [2][7] Safety Profile - Zorevunersen has been generally well tolerated, with 30% of patients in Phase 1/2a studies and 53% in OLE studies experiencing treatment-emergent adverse events (TEAEs) [8] - The most common TEAE was CSF protein elevations, occurring in 14% of patients in Phase 1/2a and 45% in OLE studies, with no related clinical manifestations observed [8] Future Directions - The ongoing Phase 3 EMPEROR study aims to further evaluate the efficacy and safety of zorevunersen in children with Dravet syndrome, with a focus on seizure frequency and improvements in behavior and cognition [12] - The collaboration between Biogen and Stoke Therapeutics is expected to advance the development and commercialization of zorevunersen for Dravet syndrome [11][16]
XOMA Royalty Announces Closing of Transaction to Acquire Mural Oncology plc
Globenewswire· 2025-12-05 14:00
Core Viewpoint - XOMA Royalty Corporation has successfully completed the acquisition of Mural Oncology plc, with shareholders receiving $2.035 in cash per share as part of the transaction [1][2]. Acquisition Details - The acquisition was approved by Mural shareholders during a special meeting on October 24, 2025, and was sanctioned by the Irish High Court on December 3, 2025 [2]. - The acquisition became effective on December 5, 2025, following the delivery of the court order to the Irish Companies Registration Office [2]. Trading and Delisting - Mural's shares ceased trading on Nasdaq prior to the market opening on December 5, 2025, and the company plans to delist and deregister its shares under the Securities Exchange Act of 1934 [3]. Advisory Information - XOMA Royalty was advised by Gibson, Dunn & Crutcher LLP and Mason Hayes & Curran LLP, while Davy Corporate Finance UC acted as its financial advisor [4]. - Mural was advised by Lucid Capital Markets, LLC, with legal support from Wilmer Cutler Pickering Hale and Dorr LLP and Arthur Cox LLP [4]. Company Overview - XOMA Royalty Corporation operates as a biotechnology royalty aggregator, acquiring future economic rights associated with therapeutic candidates licensed to pharmaceutical or biotechnology companies [5]. - The company provides non-dilutive funding to sellers, enabling them to advance their internal drug candidates or for general corporate purposes [5].
Strategic Partnership with Leading UAE Family Office to Build a New Growth Engine in the Middle East and North Africa
Globenewswire· 2025-12-05 14:00
Core Insights - LZ Technology Holdings Limited has entered into a partnership with Red Dune Capital Holding Limited to establish its regional headquarters in the MENA region and commercialize its smart access control systems and IoT technologies [1][2][4] - This partnership signifies the launch of LZ Technology's global second growth curve, aiming to replicate its successful business model from China in the MENA region [2][4] - The MENA region is experiencing rapid growth in smart-city development and digital infrastructure investment, creating a favorable environment for LZ Technology's expansion [2][4] Company Strategy - The collaboration aims to build a full-scale operational platform in MENA, focusing on smart access control, community-service digitalization, and integrated business-service ecosystems [2][3] - LZ Technology plans to leverage Red Dune's extensive local networks and capital capabilities to accelerate its expansion in the Middle East [3][4] - The goal is to create "another LZ Technology" in the MENA region, establishing a strong regional presence and a second global growth engine [4] Market Potential - The MENA region is witnessing strong growth in urban digital governance, property management modernization, and digital public service upgrades, indicating a robust market potential for LZ Technology [2][4] - LZ Technology intends to progressively expand into key markets such as Saudi Arabia, Qatar, Kuwait, and Egypt, aiming to build a region-wide smart-community digital network [4] Company Overview - LZ Technology operates primarily in three verticals: Smart Community, Out-of-Home Advertising, and Local Life, providing intelligent access control and safety management systems across thousands of residential communities in China [5] - The Out-of-Home Advertising division offers multi-channel advertising solutions through a vast network of monitors in approximately 120 cities in China [5]
Edible Garden’s Pickle Party™ Line Starts to Ship at King Kullen, Expanding Access to Fresh, Fermented, Functional Kosher Pickles
Globenewswire· 2025-12-05 14:00
Core Insights - Edible Garden AG Incorporated has launched its Pickle Party™ product line in King Kullen supermarkets, enhancing its presence in the New York Metro region as demand for clean-label foods grows [1][3]. Product Overview - Pickle Party™ is the world's first functional pickle line, featuring raw, refrigerated, fermented, Kosher, and Non-GMO products made through traditional fermentation methods that support digestive wellness [2]. - The product line includes a variety of pickles and krauts with unique flavor profiles, free from artificial preservatives, stabilizers, and added sugars, aligning with the company's commitment to better-for-you foods [2]. Market Strategy - The partnership with King Kullen, a well-established supermarket chain, reflects Edible Garden's strategy to collaborate with respected regional grocers that prioritize fresh, responsibly sourced foods [3]. - The introduction of Pickle Party™ is positioned to meet the growing consumer interest in fermented and health-forward products, thereby strengthening the company's market presence [3]. Company Background - Edible Garden is a leader in controlled environment agriculture (CEA), providing sustainable, locally grown organic produce through its Zero-Waste Inspired® farming model, available in over 5,000 retail locations [4]. - The company utilizes advanced safety protocols, sustainable packaging, and patented technologies to optimize growing conditions and reduce environmental impact [5]. Additional Offerings - In addition to Pickle Party™, Edible Garden markets a range of nutrition and specialty food products, including plant and whey protein powders, and gourmet sauces [6][7].
Toro Corp. Reports Net Income of $1.3 Million for the Three Months Ended September 30, 2025 and $4.3 Million for the Nine Months Ended September 30, 2025
Globenewswire· 2025-12-05 13:55
Core Insights - Toro Corp. reported its financial results for the third quarter and nine months ended September 30, 2025, highlighting a stable performance despite some declines in revenue and net income compared to the previous year [1][2]. Financial Performance - Third Quarter - Total vessel revenues from continuing operations increased to $5.4 million, a 1.9% increase from $5.3 million in the same period of 2024 [5][6]. - Net income from continuing operations rose to $1.3 million, reflecting a 30% increase from $1.0 million in the third quarter of 2024 [5][6]. - EBITDA from continuing operations was $1.6 million, compared to a loss of $0.1 million in the same period last year [5][6]. - The average Daily TCE Rate improved to $13,363 from $11,426 in the same period of 2024 [6][41]. Financial Performance - Nine Months - Total vessel revenues from continuing operations decreased to $15.0 million, a 12.8% decline from $17.2 million for the nine months ended September 30, 2024 [5][28]. - Net income from continuing operations was $4.2 million, down 6.7% from $4.5 million in the same period last year [5][28]. - Net income overall dropped significantly to $4.3 million, an 82.2% decrease from $24.2 million for the nine months ended September 30, 2024 [5][28]. - EBITDA for the nine months was $3.8 million, up from $1.7 million in the same period of 2024 [5][28]. Operational Developments - The company acquired two MR tanker vessels and sold two LPG carriers during the third quarter, indicating ongoing fleet management activities [4]. - The spin-off of the Handysize tanker segment to Robin Energy Ltd. was completed on April 14, 2025 [5]. Cash Flow and Liquidity - Cash position decreased by $12.1 million to $25.1 million as of September 30, 2025, primarily due to net operating cash flows used in continuing operations and financing activities [15][38]. - The company made a capital contribution of $10.4 million to Robin in connection with the spin-off [15]. Recent Business Developments - On October 15, 2025, Toro received dividends from Castor and Robin, amounting to $1.25 million and $0.125 million, respectively [16]. - An "at-the-market" offering agreement was established on November 13, 2025, allowing the company to sell common shares valued up to $12.5 million for various corporate purposes [18].
Jeffs’ Brands Enters into a Definitive Agreement with Scanary, Marking Entry into the Global Homeland Security Market
Globenewswire· 2025-12-05 13:32
Core Insights - Jeffs' Brands Ltd has entered into a distribution agreement with Scanary Ltd, marking its strategic entry into the global homeland-security sector [1][2] Company Overview - Jeffs' Brands is a data-driven e-commerce company focused on transforming products into market leaders through advanced technology and management insights [4] Agreement Details - KeepZone AI Inc., a subsidiary of Jeffs' Brands, will market and distribute Scanary's AI-radar screening systems, which can scan up to 25,000 people per hour without stopping [2] - The agreement includes a one-time payment of $1 million to Scanary, payable in five monthly installments of $200,000 [3] - Scanary will provide a free demonstration unit and technical support for pre-sales activities [3] Market Potential - The security scanning equipment market was valued at over $11.4 billion in 2022 and is expected to grow at a CAGR of over 7% from 2023 to 2032 [3] Distribution Rights - KeepZone has exclusive distribution rights for the systems in Canada, Germany, and the UAE for an initial 24-month period, extendable upon achieving a purchase target of 20 systems [6] - Non-exclusive distribution rights are granted in Spain and Italy [6]
New Cretostimogene Grenadenorepvec Data Highlight its Potential to Become the Backbone Therapy for High-Risk Non-Muscle Invasive Bladder Cancer
Globenewswire· 2025-12-05 13:30
Core Insights - CG Oncology, Inc. announced promising topline data from BOND-003 Cohort P and CORE-008 Cohort A, indicating efficacy, safety, and tolerability of cretostimogene for bladder cancer treatment [1][2][3] BOND-003 Cohort P Results - The BOND-003 trial demonstrated High-Grade Event-Free Survival (HG-EFS) rates of 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months among 51 evaluable patients [4][9] - No Grade 3 or greater treatment-related adverse events (TRAEs) were reported, and no patients progressed to muscle-invasive bladder cancer (MIBC) [5][9] - The study included 56 patients across 35 clinical sites in the U.S. and Japan [6] CORE-008 Cohort A Results - CORE-008 Cohort A showed an overall Complete Response (CR) rate of 83.7% in evaluable patients, with an 88.0% CR rate for optimized administration compared to 79.2% for original administration [7][10] - The safety profile was consistent with previous trials, with no serious adverse events or treatment-related discontinuations reported [8][10] Cretostimogene Overview - Cretostimogene is an investigational oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC), with over 400 patients involved in its clinical development [11] - The company is conducting two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [11] Company Background - CG Oncology focuses on developing and commercializing bladder-sparing therapies for bladder cancer patients, aiming to improve their quality of life [12]