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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]
Soligenix Inc. (NASDAQ: SNGX) Advancing Rare-Disease Therapies Positioned at Pivotal Crossroad
Globenewswire· 2025-12-05 13:30
Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing therapies for rare diseases with significant unmet medical needs [3][4] - The U.S. healthcare system faces increasing challenges from chronic illnesses and rare disorders, particularly among older populations, with over 30 million Americans affected by rare diseases [2][3] - Soligenix is advancing several therapies, including HyBryte(TM) for cutaneous T-cell lymphoma, and is positioned to align with national healthcare goals under the current administration [3][4] Company Overview - Soligenix Inc. specializes in developing and commercializing products for rare diseases, with a focus on HyBryte(TM) as a novel photodynamic therapy for cutaneous T-cell lymphoma [4] - The company is also expanding its pipeline to include treatments for psoriasis and inflammatory diseases, as well as vaccine candidates for bioterrorism threats and COVID-19 [5] Industry Context - The increasing burden of rare diseases among aging populations highlights the urgent need for innovative treatments, as many conditions lack FDA-approved therapies [2][3] - The company's initiatives are supported by government grants and contracts from agencies such as NIAID, DTRA, and BARDA, indicating a strong alignment with public health objectives [5]
Lead Real Estate Co., Ltd to Present at Sidoti's Year End Virtual Investor Conference on December 10-11, 2025
Globenewswire· 2025-12-05 13:30
Core Viewpoint - Lead Real Estate Co., Ltd will participate in Sidoti & Company's Year End Virtual Investor Conference on December 10-11, 2025, with a presentation scheduled for December 11 at 10:00 a.m. ET [1][2][3] Company Overview - Lead Real Estate Co., Ltd is a Japanese developer specializing in luxury residential properties, including single-family homes and condominiums, primarily in Tokyo, Kanagawa prefecture, and Sapporo [4] - The company also operates the ENT TERRACE brand of extended-stay hotels and leases apartment units in Japan and Dallas, Texas [4] Conference Participation Details - The conference will take place virtually on December 10-11, 2025, with a corporate presentation by Eiji Nagahara and Daisuke Takahashi on December 11 from 10:00 a.m. to 10:30 a.m. ET [3] - One-on-one meetings with investors will be available throughout both days of the conference [3] Company Mission and Vision - The company's mission is to provide stylish, safe, and luxurious living [5] - It aims to adopt a Kaizen approach for continuous improvement and leverage its strong market position in luxury residential properties to create a global transaction platform for prime Japanese and overseas condominiums [5] Brand Recognition - The ENT TERRACE brand has received accolades, including the "Luxury Apartments of the Year in Kanto" at the Travel & Hospitality Awards 2025, highlighting its service excellence in the international tourism industry [7][8]
Clinical Data on Effect of Sotagliflozin on Adipose Distribution in Non-Diabetic Patients will be Presented at the 2025 Cardio Vascular Clinical Trialists Forum
Globenewswire· 2025-12-05 13:30
Core Insights - Lexicon Pharmaceuticals, Inc. announced the presentation of clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025) [1] - The data comes from the SOTA-P-CARDIA trial, which focused on patients with heart failure with preserved ejection fraction (HFpEF) [2] - Craig Granowitz, M.D., Ph.D., highlighted that the new data supports sotagliflozin's differentiated benefits compared to SGLT2 inhibitors [3] Sotagliflozin Overview - Sotagliflozin is an oral inhibitor of SGLT2 and SGLT1, which are involved in glucose regulation [4] - The drug has been studied in various patient populations, including approximately 20,000 patients across heart failure, diabetes, and chronic kidney disease [4] - Sotagliflozin is also under investigation for hypertrophic cardiomyopathy (HCM) [4] Company Background - Lexicon Pharmaceuticals aims to pioneer medicines that transform patients' lives through its Genome5000™ program, which has identified over 100 protein targets with therapeutic potential [5] - The company has a pipeline of drug candidates in various stages of development, focusing on neuropathic pain, HCM, metabolism, and other indications [5]
Alpha Modus Signs Pilot With Major National Retailer to Deploy ~100 AlphaCash Kiosks, Opening Scalable Pathway Toward 1,000s Of Targeted Locations Nationwide
Globenewswire· 2025-12-05 13:13
Core Insights - Alpha Modus Holdings, Inc. has signed a pilot agreement with a major national retail chain to deploy approximately 100 AlphaCash financial service kiosks across Texas, marking the first entry of AlphaCash into retail stores [1][4] - The pilot aims to address the needs of underbanked consumers, with a significant portion of the population in areas like Houston being underbanked [4][6] - Alpha Modus has identified over 4,000 additional U.S. retail locations for potential expansion of AlphaCash, contingent on the pilot's success [3][7] Company Strategy - The pilot represents a material inflection point for Alpha Modus's financial services platform, with a conservative estimate of $2,000 in monthly revenue per kiosk [4] - The rollout will include coordinated joint-marketing efforts between Alpha Modus and the retailer, providing a unified public launch strategy [1][6] - AlphaCash kiosks will initially offer services such as Check Cashing, Money Transfer, Event Tickets, and Mobile Top-Up, with plans for additional services as adoption increases [5][6] Market Opportunity - The underbanked population in the U.S. is estimated at 4.2% of households, indicating a substantial market opportunity for accessible financial services [4] - The pilot will span both rural and metropolitan regions, targeting areas with high concentrations of underbanked consumers [1][4] - Alpha Modus is positioned for accelerated national-scale growth and expanded financial-access impact, leveraging its AI-driven fintech platform [7]
XBP Global Holdings, Inc. Announces 1-for-10 Reverse Stock Split
Globenewswire· 2025-12-05 13:02
Core Viewpoint - XBP Global Holdings, Inc. has announced a 1-for-10 reverse stock split, effective December 12, 2025, to enhance its stock price and market perception [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split was authorized by stockholders at the Annual Meeting on July 25, 2025, where every ten shares will be combined into one share [2]. - No fractional shares will be issued; stockholders entitled to fractional shares will receive cash based on the closing price on the effective date [2]. - Post-split, XBP Global will have approximately 11.75 million shares of common stock outstanding, with adjustments made to outstanding warrants, stock options, and other derivative securities [3]. Group 2: Company Overview - XBP Global is a multinational technology and services company specializing in intelligent workflows, with operations in 20 countries and around 11,000 employees [5]. - The company partners with over 2,500 clients, including many Fortune 100 companies, to facilitate hyper-automation and digital transformation [5][6].
EBZT Reduces Float and Advances AI Stablecoin & Sports Trading Platforms
Globenewswire· 2025-12-05 13:00
Core Insights - Everything Blockchain Inc. (EBZT) is focusing on developing AI-driven products for digital asset markets, including a stablecoin engine and an AI Sports Odds Engine [1][3][9] Financial Filings and Share Structure - EBZT plans to file its Q3 2025 financial statements by December 15, 2025 - Approximately 6.5 million common shares were voluntarily surrendered, reducing total outstanding shares from 33.4 million to 26.7 million - No new shares were issued during the quarter, indicating no dilution for existing shareholders [2][3] Shift to AI-Powered Finance - The company is transitioning from a digital treasury model to an AI-powered finance platform to optimize capital movement in digital markets - The CloverMint platform is being developed to automate the management of digital dollars [3][4] CloverMint Stablecoin Engine - CloverMint targets the expanding stablecoin market, estimated at $250 billion in 2025, with potential growth to $500–750 billion and high-end projections nearing $2 trillion by 2028 - Capturing just 0.1% of a $1 trillion stablecoin market could manage approximately $1 billion in assets, presenting a significant growth opportunity for EBZT [5] AI Sports Odds Engine - EBZT has initiated the development of an AI Sports Odds Engine to price and trade sports prediction markets on Polymarket - The AI models analyze major sporting events to identify mispriced odds and build hedged positions to capitalize on these discrepancies - Historical strategies have shown annualized returns of up to 250% on limited capital allocations, indicating early proof-of-concept for AI in sports trading [6][7][8] Market Positioning - With a lean share structure and a pipeline of AI-driven products, EBZT is positioned as a differentiated early-stage AI investment in the OTC markets [9]
Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson's Disease
Globenewswire· 2025-12-05 13:00
Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapiesCREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each doseFindings highlight CREXONT as a key therapy in a category with limited innovationELEVATE-PD study is ongoing with longer-term data expected in 2026 BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) ...
Reed's, Inc. Announces Pricing of $10 Million Public Offering and Uplisting to NYSE American Stock Exchange
Globenewswire· 2025-12-05 13:00
NORWALK, Conn., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Reed’s, Inc. (NYSE American: REED) (“Reed’s” or the “Company”), owner of the nation’s leading portfolio of handcrafted, natural ginger beverages, today announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock and warrants to purchase 2,500,000 shares of common stock (collectively, the “Securities”). Each share of common stock and accompanying warrant to purchase one share of common stock are being sold together at a co ...
Vertex and CPA.com Announce AI-Driven Expansion of Tax Compliance Services for Accounting Firms
Globenewswire· 2025-12-05 13:00
KING OF PRUSSIA, Pa., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Vertex Inc. (NASDAQ:VERX) (“Vertex” or the “Company”), a leading global provider of indirect tax solutions, and CPA.com, the trusted partner in accounting and finance transformation, today announced an expansion of their partnership to include an AI-driven solution in collaboration with Kintsugi. The application helps accounting firms of all sizes and tax expertise deliver automated, accurate, and scalable sales tax compliance for clients. Building on ...