Peijia Medical Submits EU MDR CE Mark Registration Application for GeminiOne® TEER System
Prnewswire· 2026-02-09 06:00
Core Viewpoint - Peijia Medical Limited has submitted the CE Mark registration application for its GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System, marking a significant step in its globalization strategy and commitment to expanding in international markets [2][4]. Group 1: Product Development - The GeminiOne TEER device features a unique sliding groove mechanism for longer coaptation length while maintaining a smaller implant size and delivery system [3]. - It incorporates an independent leaflet grasping design to reduce procedural complexity, an auto-locking mechanism to prevent repeated locking and unlocking, and a multi-angular detachment capability for accommodating various anatomical variations [3]. - The design has been patented globally and has passed multiple freedom-to-operate analyses [3]. Group 2: Regulatory Progress - In addition to the EU submission, the GeminiOne registration application has been accepted by the National Medical Products Administration (NMPA) of China and is under review [4]. - The system has received Investigational Device Exemption (IDE) approval from the U.S. FDA for an Early Feasibility Study in the United States [4]. Group 3: Company Overview - Peijia Medical, established in 2012 and headquartered in Suzhou, China, focuses on the interventional procedural medical device market and aims to become a leading global medical device platform for structural heart and neurovascular diseases [8]. - The company currently has four TAVR systems and nearly twenty neurointerventional devices registered in China, along with various innovative product candidates at different development stages [8].
Evinova and Bristol Myers Squibb Forge Strategic Collaboration to Optimize Clinical Development with Artificial Intelligence
Businesswire· 2026-02-09 06:00
Core Insights - Bristol Myers Squibb has signed an agreement with Evinova to optimize clinical trials using Evinova's AI-native clinical development platform, specifically the Cost Optimizer module [1][2] - The partnership aims to enhance decision-making, identify productivity opportunities, and create more efficient trial designs to accelerate innovation and improve experiences for sites and patients [2][3] Evinova's AI-Native Platform - Evinova's platform utilizes agentic AI to enhance study design, streamline processes, and ensure seamless digital data flow in compliance with USDM standards [4] - The platform has delivered hundreds of millions of dollars in multi-year savings for customers, showcasing its effectiveness in clinical development [4] Unified Trial Solution - Evinova's Unified Trial Solution integrates essential study elements to create a connected trial experience for sponsors, sites, and patients, incorporating eCOA with telehealth and remote patient monitoring [5] - This solution aims to improve data collection for novel endpoints and innovative trial designs while reducing friction points [5] Proven Outcomes - Evinova's solutions have demonstrated significant improvements, including up to 60% enhancement in patient experience, a 6-month acceleration in trial delivery, and a 32% reduction in costs [8][9] - The platform is designed to accelerate timelines, reduce costs, improve data quality, and enhance patient experiences [6]
Markets Are Turning Up — These Stocks Could Ride the Upswing
The Smart Investor· 2026-02-09 06:00
Group 1: Market Overview - Markets are cyclical, and sentiment can shift quickly, indicating a potential return of risk appetite [1] - Leadership in stocks is crucial during market upswings, as not all stocks will rise equally [1] Group 2: Singapore Exchange Limited (SGX) - SGX is recognized as a long-term dividend income player and is Singapore's sole approved stock exchange, allowing it to generate strong cash flows with low capital expenditure [2] - In the first half of fiscal year 2026, SGX reported a net revenue increase of 10.1% YoY to S$636.6 million and an adjusted net profit rise of 11.6% YoY to S$357.1 million [3] - The interim quarterly dividend declared is S$0.110 per share, contributing to a total dividend of S$0.2175 for 1HFY2026, a 20.8% YoY increase [4] Group 3: SATS Ltd - SATS is positioned as a cyclical recovery play, benefiting from the rebound in global air travel and increased cargo volumes, with a revenue increase of 9.1% YoY to S$3.08 billion in 1HFY2026 [5] - The net profit for SATS in 1HFY2026 was S$149.8 million, up 11.2% from the previous year [5] - An interim dividend of S$0.02 represents a 33% increase from the previous year, although inflation and economic slowdown may pose challenges [6] Group 4: Frasers Centrepoint Trust (FCT) - FCT is a quality REIT focused on suburban retail malls, which comprise 97.3% of its portfolio, providing stable income from essential services [7][8] - The trust has a debt of S$421.3 million due in FY2026 and benefits from refinancing at lower rates, with an average borrowing cost of 3.5% [8][9] - FCT has consistently paid dividends since 2006, with a 0.6% YoY increase in distribution per unit to S$0.12113 for FY2025 [9] Group 5: iFAST Corporation - iFAST is a rapidly growing fintech company in Singapore, driven by increasing assets under administration and recurring fee income [10] - In 3Q2025, gross revenue reached S$135.82 million, a 37% YoY increase, with net profit rising 54.7% YoY to S$26.01 million [11] - The company announced a third interim dividend of S$0.023 per share, a 53% increase from the previous year, with guidance suggesting a potential payout of S$0.082 for FY2025, indicating confidence in cash flow stability [11]
Press Release: Sanofi's rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia
Globenewswire· 2026-02-09 06:00
Core Viewpoint - Sanofi's rilzabrutinib has received breakthrough therapy designation from the FDA and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia (wAIHA), highlighting the urgent need for effective treatments for this rare autoimmune disorder [1][3][4]. Group 1: Designations and Studies - The FDA's breakthrough therapy designation aims to expedite the development of medicines for serious conditions, indicating rilzabrutinib may show substantial improvement over existing treatments [3]. - Rilzabrutinib is currently being evaluated in the LUMINA 2 phase 2b study and the new LUMINA 3 phase 3 study, which compares rilzabrutinib with placebo for wAIHA patients [2]. - There are no approved treatments specifically targeting the underlying causes of wAIHA, which can lead to severe health complications [2]. Group 2: Rilzabrutinib Overview - Rilzabrutinib is a novel oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, already approved for immune thrombocytopenia (ITP) in the US, EU, and UAE, and under review in Japan [4][8]. - The drug addresses immune system dysregulation through multi-immune modulation, making it a potential treatment for various rare diseases [7][8]. - Rilzabrutinib has received multiple regulatory designations, including orphan drug status for autoimmune hemolytic anemia and other rare diseases [5][9]. Group 3: About wAIHA - Warm autoimmune hemolytic anemia is a rare and potentially life-threatening condition, affecting 4 to 24 individuals per 100,000 in the US and EU, and 3 to 10 per million in Japan [6]. - Symptoms include fatigue, dizziness, and serious complications like thromboembolism, emphasizing the need for effective treatments [6]. Group 4: Company Overview - Sanofi is an R&D-driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [10].
Press Release: Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia
Globenewswire· 2026-02-09 06:00
Core Insights - Sanofi's rilzabrutinib has received breakthrough therapy designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and orphan drug designation in Japan for the same condition [1][2][3] Group 1: Designations and Studies - The breakthrough therapy designation is based on clinical data from the ongoing LUMINA 2 phase 2b study, which assesses the efficacy and safety of rilzabrutinib for wAIHA patients [2] - A new LUMINA 3 phase 3 study is also underway, comparing rilzabrutinib with placebo in wAIHA patients [2] - There are currently no approved treatments specifically targeting the underlying cause of wAIHA, which can lead to anemia and serious organ damage [2] Group 2: Rilzabrutinib Overview - Rilzabrutinib is a novel oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that aims to restore immune balance through multi-immune modulation [7][8] - It is already approved in the US, EU, and UAE for treating immune thrombocytopenia (ITP) and is under regulatory review for ITP in Japan [4][8] - Rilzabrutinib has received multiple designations, including orphan drug status for autoimmune hemolytic anemia and other rare diseases [5] Group 3: About wAIHA - wAIHA is a rare autoimmune disorder characterized by the destruction of red blood cells, affecting 4 to 24 people per 100,000 in the US and EU, and 3 to 10 people per million in Japan [6] - Symptoms include fatigue, dizziness, palpitations, and shortness of breath, with potential complications such as thromboembolism [6] Group 4: Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [10]
WISeKey's WISe.Art and GMA Once Again Revolutionize the Future of Art and Technology in an Extraordinary Event in Venice
Globenewswire· 2026-02-09 06:00
Core Viewpoint - WISeKey International Holding Ltd and its subsidiary WISe.Art are organizing the Art&DeepTech Convergence event in Venice, Italy, in September 2026, focusing on the intersection of art, advanced technologies, and space [2] Group 1: Event Overview - The Art&DeepTech Convergence will serve as a milestone in merging art with advanced technologies, showcasing how technological innovation can enhance artistic expression and human values [2] - The event will feature a next-generation technological infrastructure that includes generative AI, cognitive robotics, advanced blockchain, certified tokenization, post-quantum cybersecurity, and satellite connectivity [3] Group 2: Art Protection and Registration - Both digital and physical artworks will be registered and protected through certified digital identity systems, ensuring authenticity, traceability, copyright protection, and continuity over time [4] Group 3: Space and Art Integration - A key feature of the event will be the Art in Space program, utilizing WISeKey's WISeSat satellite constellation to create a cultural archive of 21st-century art associated with space missions [5][6] Group 4: AI and Visitor Interaction - WISeRobots will act as intelligent cultural mediators, engaging visitors through conversational AI, adapting language to context, and collecting real-time feedback to enhance the visitor experience [7] - The AI will follow a human-centric and ethical approach, promoting cultural diversity, creativity, and critical thinking [8] Group 5: Digital Immersion and Exhibition Paradigm - The exhibition will include advanced digital immersion environments generated by AI, allowing visitors to interact with evolving artistic universes [9][10] Group 6: Cultural Finance Initiatives - The event will launch the Renaissance Coin and the Artech Fund, introducing new models of transparent cultural finance to support high-tech artistic projects [11] Group 7: Global Artist Participation - Thousands of artists on the WISe.ART platform will present works that integrate AI, data, robotics, and immersive media, establishing Venice as a hub for a global creative network [12] Group 8: Vision for the Future - The Art&DeepTech Convergence aims to symbolize a new Renaissance, where technology and creativity converge to foster a more open, secure, and universal cultural future [13]
Abitibi Metals Delivers 124% Resource Growth at B26, Defining a High-Grade Copper-Gold System of Meaningful Scale
Prnewswire· 2026-02-09 05:57
VANCOUVER, BC, Feb. 9, 2026 /PRNewswire/ -- Abitibi Metals Corp. (CSE:AMQ) (OTCQB:AMQFF) has taken a major step forward in establishing itself as a serious emerging copper-gold developer in Québec's Abitibi Greenstone Belt. The updated estimate shows a 124% increase in total mineral resources since Abitibi optioned the project in 2023, reflecting the results of successive drilling campaigns completed over the past two years. Continue Reading Abitibi Metals Delivers 12.83% CuEq at B26 as High-Grade Zone Cont ...
Innovent Biologics Strikes Partnership Deal With Eli Lilly
WSJ· 2026-02-09 05:57
Chinese drugmaker Innovent Biologics and Eli Lilly plan to target cancer and immune system diseases under the partnership. ...
ARC Resources: When The Market And Logic Part Ways
Seeking Alpha· 2026-02-09 05:55
I analyze oil and gas companies like ARC Resources and related companies in my service, Oil & Gas Value Research, where I look for undervalued names in the oil and gas space. I break down everything you need to know about these companies -- the balance sheet, competitive position and development prospects. This article is an example of what I do. But for Oil & Gas Value Research members, they get it first and they get analysis on some companies that is not published on the free site. Interested? Sign up her ...
Everybody: Coinbase Is Back Again, with a Karaoke Ode to Crypto in Sunday's Big Game
Businesswire· 2026-02-09 05:33
Group 1 - Coinbase created a shared, high-energy karaoke experience for its community to engage with during America's most anticipated football game [1]