Additional Confirmed Response Reported as Part of Amplia Investor Presentation
Globenewswire· 2025-12-12 13:45
Core Insights - Amplia Therapeutics Limited has reported an additional confirmed partial response in the ongoing ACCENT trial for metastatic pancreatic cancer, indicating progress in their clinical research [1][6] - The confirmed objective response rate (ORR) has reached 35% (19 out of 55 patients), which is significantly higher than the 23% ORR observed in the benchmark MPACT trial for gemcitabine and nab-paclitaxel alone [2][5] Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing a pipeline of Focal Adhesion Kinase (FAK) inhibitors targeting cancer and fibrosis, particularly in fibrotic cancers like pancreatic and ovarian cancer [4] - The company is advancing its lead candidate, narmafotinib, which is a potent and selective FAK inhibitor, currently being tested in the ACCENT trial in combination with gemcitabine and Abraxane for advanced pancreatic cancer [5] Clinical Trial Details - The ACCENT trial has achieved its primary endpoint with a confirmed response rate of 35%, surpassing the benchmark of 23% from the MPACT study [5] - An interim median progression-free survival (PFS) of 7.6 months has also been reported in the trial [5] - A second trial, AMPLICITY, is underway, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients [5]
Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Globenewswire· 2025-12-12 13:42
Final Decision from European Commission Expected in Q1 2026 SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III ...
Rail Vision: Quantum AI Powers Next-Gen Rail Safety Breakthroughs
Globenewswire· 2025-12-12 13:37
Core Viewpoint - Rail Vision Ltd. has announced a strategic acquisition of 51% ownership in Quantum Transportation Ltd., aiming to enhance railway safety and data-related technologies through quantum computing and AI innovations [1][3]. Group 1: Acquisition Details - The acquisition is expected to close between late December 2025 and early January 2026, pending customary closing conditions [1]. - Rail Vision will issue ordinary shares representing approximately 4.99% of its issued and outstanding share capital to certain Quantum Transportation shareholders in exchange for their full holdings [4]. - A convertible loan of up to $700,000 will be extended to Quantum Transportation at an 8% annual interest rate to support its operations and development roadmap for the next 18 months [5]. Group 2: Technology and Innovation - Quantum Transportation holds an exclusive sublicense for a pending patent application in quantum error correction, which addresses challenges in noisy intermediate-scale quantum devices [2]. - The machine learning-based universal decoder technology from Quantum Transportation is expected to significantly improve quantum error correction, making it adaptable across various hardware platforms [6]. - Rail Vision aims to leverage this technology for transportation applications, enhancing capabilities in anomaly detection, predictive maintenance, and autonomous rail operations [7]. Group 3: Strategic Goals - The combination of Rail Vision's advanced vision and railway safety technologies with Quantum Transportation's quantum-AI based IP is anticipated to create technological synergies and accelerate innovation [3]. - The strategic acquisition is positioned to support long-term value creation for stakeholders by enhancing Rail Vision's current and future product lines [3].
WELLE Environmental Group and Primech Holdings Enter Strategic Cooperation to Advance Intelligent Industrial Robotics and Sustainable Operations
Globenewswire· 2025-12-12 13:36
Core Insights - The partnership between WELLE Environmental Group and Primech Holdings aims to innovate in industrial robotics and sustainable environmental technologies through a Joint Venture in Singapore [1][2][3] Group 1: Strategic Cooperation - WELLE and Primech Holdings will establish a Joint Venture to combine WELLE's environmental governance and bioenergy capabilities with Primech's operational experience and robotics expertise [2][3] - The Joint Venture will focus on developing specialized industrial robots for high-risk and complex environments, contributing to global carbon reduction goals [2][3] Group 2: Investment and Vision - WELLE has an option to invest in Primech AI until September 2026, highlighting a shared long-term vision for scaling robotics solutions across Asia [5] - Both organizations recognize the increasing global demand for intelligent automation in environmental and industrial operations, aiming to enhance safety, efficiency, and environmental performance [6] Group 3: Company Profiles - WELLE Environmental Group specializes in energy conservation and environmental protection, focusing on areas such as food waste utilization and biogas development [7] - Primech AI is dedicated to innovation in robotics, aiming to revolutionize the industry with impactful solutions [8] - Primech Holdings provides technology-driven facilities services, integrating eco-friendly practices and smart technology to enhance operational efficiency [10]
Clearmind Medicine's MEAI Spotlighted in Prestigious Review: Leading Experts Affirm Transformative Potential for Alcohol Use Disorder Treatment
Globenewswire· 2025-12-12 13:32
Core Insights - Clearmind Medicine Inc. has published a review article validating the therapeutic potential of its candidate MEAI in treating alcohol use disorder (AUD) [1][2] - The review highlights MEAI's advantages over classical psychedelics, including a milder subjective experience and lower abuse potential [2] Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel neuroplastogen-derived therapeutics for under-treated health issues, particularly AUD [4] - The company holds an intellectual property portfolio consisting of 19 patent families and 31 granted patents, with plans to seek additional patents [5] Therapeutic Effects of MEAI - Recreational users typically take MEAI in doses of 1 to 2 mg/kg, reporting positive effects such as reduced desire to consume alcohol within 4 hours [6] - MEAI's receptor interaction profile suggests it may stimulate serotonin release while having a lower risk of abuse compared to other substances like MDMA [6] Adverse Effects - Users of MEAI have not reported serious adverse events, and it is expected to have milder toxicity compared to MDMA due to its receptor interactions [6]
iOThree Limited Chairman and CEO Letter to Shareholders
Globenewswire· 2025-12-12 13:30
Core Insights - 2025 was a pivotal year for the company, marking its first year as a Nasdaq-listed entity and demonstrating the strength of its business model and team resilience [1] Financial Performance - For the financial year ending March 31, 2025, revenue increased by 22.3% to US$10.5 million, driven by sales momentum and disciplined execution [2] - Gross profit rose to US$1.9 million, supported by steady project delivery and recurring revenues from software and solutions [2] - For the half-year ending September 30, 2025, revenue continued to grow, increasing by 39.6% to US$7.3 million, indicating the underlying health and scalability of the business [2] Strategic Developments - The company achieved ISO 9001 and ISO 14001 certifications, validating its commitment to quality and environmental responsibility [3] - Relocation to a larger, purpose-built headquarters improved team integration, workflow efficiency, and future growth capacity [3] Innovation and Technology - Three proprietary digital solutions received classification approval from a leading international classification society, enhancing the company's competitive position [4] - The F.R.I.D.A.Y. Planned Maintenance System (PMS) was highlighted for its role in improving operational efficiency and supporting carbon reporting [4] Market Outlook - The maritime connectivity and digital solutions market is projected to grow at a compounded annual rate of 5.6% through 2028, driven by digitalization, increasing vessel numbers, and demand for automation [6] - Asia Pacific is identified as a key growth area, with strong demand and digitalization momentum in countries like Taiwan, Singapore, Japan, and Korea [7] Future Strategy - The company aims to deepen technology capabilities, scale its global footprint, pursue M&A opportunities, and deliver sustainable growth [8] - Planned use of IPO proceeds includes accelerating product innovation, obtaining further classification approvals, and enhancing marketing visibility [8] Conclusion - The company expresses confidence in its trajectory moving into 2026, supported by a resilient business model, a committed team, and a strong balance sheet [9]
VisionWave Holdings, Inc. Announces Intention to Launch Up to £500,000 Autonomous Ground Vehicle Program with Evie Autonomous
Globenewswire· 2025-12-12 13:30
Core Insights - VisionWave Holdings, Inc. has entered into a non-binding letter of intent with Evie Autonomous Limited to explore a £500,000 Proof-of-Concept program for integrating autonomous vehicle technology into VisionWave's Unmanned Ground Vehicle platforms [1][3] - The collaboration marks VisionWave's first strategic initiative following its de-SPAC listing on Nasdaq in July 2025, aiming to enhance its multi-domain autonomy strategy and address European demand in 2026 and beyond [4][5] Company Developments - Discussions and technical evaluations between VisionWave and Evie Autonomous began around August 2025, coinciding with VisionWave's expansion of its UGV R&D team in London [2] - The proposed POC program, if agreed upon, is expected to commence in 2026, focusing on advanced navigation, mission execution, and multi-sensor fusion capabilities [3] Strategic Goals - VisionWave is actively pursuing additional acquisitions and integrations, including negotiations to acquire Monte drones and related robotics technologies to complement its RF-perception and autonomy engine [4] - The collaboration with Evie Autonomous aligns with VisionWave's strategy to enhance its capabilities in defense technology and autonomous systems [5]
Alliance Entertainment's Handmade by Robots™ Welcomes Seasoned Sales Executive Brian Maggio to Drive Next Phase of Growth
Globenewswire· 2025-12-12 13:30
Core Insights - Alliance Entertainment Holding Corporation has appointed Brian Maggio as Vice President of Sales for its Handmade by Robots™ brand, aiming to accelerate commercial growth following strong performance since joining the Alliance portfolio last year [1][2][3] Company Overview - Alliance Entertainment is a leading distributor and omnichannel fulfillment partner in the entertainment and pop culture collectibles industry, offering over 340,000 unique SKUs across various categories including music, video, and collectibles [1][5] - The company serves over 35,000 retail and e-commerce storefronts, providing a vast catalog that includes licensed merchandise and exclusive collectibles [5] Brand Development - Handmade by Robots™ is recognized for its unique vinyl figures that resemble knitted and crocheted characters, gaining traction among major retailers and fan communities [2][4] - The brand has established licensing partnerships with iconic entertainment franchises and has a loyal global collector base, positioning it for expanded retail penetration and product innovation [2][3] Leadership and Strategy - Brian Maggio brings extensive experience in sales strategies for licensed products across various channels, which is expected to enhance retail partnerships and support the brand's roadmap of character franchises and new product formats [3][4] - The appointment of Maggio is seen as a strategic move to deepen engagement with licensors and strengthen the brand's market presence [3][4]
CCC Announces $500 Million Share Repurchase Authorization and $300 Million Accelerated Share Repurchase Program
Globenewswire· 2025-12-12 13:30
CHICAGO, Dec. 12, 2025 (GLOBE NEWSWIRE) -- CCC Intelligent Solutions Holdings Inc. (“CCC” or the “Company”) (NASDAQ: CCC), a leading SaaS platform provider for the multi-trillion-dollar insurance economy, today announced that its Board of Directors has authorized a new share repurchase program of up to $500 million of the Company’s outstanding common stock. This new authorization follows the $300 million program announced in December 2024, which has been fully utilized. Under this authorization, the Company ...
Meet the New Benchmark in Global Automotive Safety, GEELY OPENS WORLDS LARGEST VEHICLE TESTING CENTRE
Globenewswire· 2025-12-12 13:30
Ningbo, Dec. 12, 2025 (GLOBE NEWSWIRE) -- New Geely Safety Centre sets five new Guinness World Records for size, scope and capability Geely Safety Centre offers fully capability for new tests for the electrified and intelligent vehicle eraCybersecurity, data privacy protection, health, and environmental protection included in Geely’s new concept of Comprehensive SafetyGeely Safety Centre becomes new platform for collaboration with global partners on safety technologies and standards Ningbo— Geely Auto Gro ...