监管审评进展 - 公司已向美国FDA提交了cytisinicline新药申请审评所需的120天安全更新数据[1][7] - FDA已接受该新药申请并指定PDUFA目标日期为2026年6月20日[5] - 数据安全监测委员会完成对ORCA-OL长期安全性试验的第四次也是最后一次审查 未发现任何药物安全问题[1][7] 临床试验成果 - ORCA-OL长期安全性试验成功完成 共有334名参与者完成了为期一年的累积治疗 显著超过FDA要求的100名参与者标准[3][7] - 该试验旨在满足FDA对NDA审评的要求 即至少300名参与者提供6个月累积安全数据 至少100名参与者提供一年数据[4][7] - 截至2025年6月4日的数据截止点 安全更新数据包含411名至少有6个月累积cytisinicline暴露的参与者和214名至少有一年暴露的参与者[7] 产品与市场潜力 - Cytisinicline是一种植物基生物碱 具有高尼古丁乙酰胆碱受体结合亲和力 通过减少尼古丁渴求症状和产品满足感来帮助治疗尼古丁成瘾[9] - 美国约有2900万成年吸烟者和1700万成年电子烟使用者 2024年约有160万中学生报告使用电子烟[6][8] - 目前尚无FDA批准的专门用于辅助尼古丁电子烟戒断的治疗方法 该产品有望成为近二十年来首个获FDA批准的戒烟新疗法[2][8]

DUBLIN and BRIDGEWATER, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular care, today announced it will be presenting new findings at the American Heart Association's Scientific Sessions 2025 scheduled for November 7-10 in New Orleans, Louisiana. These new data supported by Amarin will further reinforce the robust efficacy of VASCEPA®/VAZKEPA® (icosapent ethyl) in cardiovascular risk reduction (CVRR) as well as highl ...

Dr. Siri Jirapongphan Joins PureCycle Board; Jeffrey R. Fieler Resigns as DirectorORLANDO, Fla., Nov. 03, 2025 (GLOBE NEWSWIRE) -- PureCycle Technologies, Inc. (Nasdaq: PCT), a U.S.-based company revolutionizing plastic recycling, announced today the appointment of Dr. Siri Jirapongphan to its board of directors, effective October 28, 2025. Dr. Jirapongphan currently serves as an independent director and Chairman of the Audit Committee of Bangkok Bank PLC. Additionally, he has served as Director and Treasur ...

Announces Regular Quarterly Cash Dividend of $0.17 Per Share and Raises Full-Year GuidanceReports record revenue of $21.2 million for the third quarter of 2025, an increase of $2.9 million, or 16%, compared to the same period in 2024.Reports record GAAP diluted EPS of $0.43 and non-GAAP diluted EPS of $0.47 for the third quarter of 2025, which are increases of 8% and 9%, respectively, compared to the same period in 2024.Raises full-year guidance to revenue of $82.5 million to $83.5 million and GAAP diluted ...

SHENZHEN, China, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Aurora Mobile Limited (NASDAQ: JG) ("Aurora Mobile" or the "Company"), a leading provider of customer engagement and marketing technology services in China, recently showcased its flagship platforms, EngageLab and GPTBots.ai, at DXPO Fukuoka 2025 (October 10–11), Japan’s premier Sales & Marketing Digital Transformation Expo held at Marine Messe Fukuoka. The Company demonstrated how its innovative solutions help Japanese enterprises enhance efficiency, custo ...

VANCOUVER, Washington, Nov. 03, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), today announced that it has secured a $30 million funding commitment from Yorkville Advisors Global. Under the terms of the ...

收购交易核心条款 - ECGI控股公司签署具有约束力的意向书 以全股票交易方式收购RezyFi Inc 交易价值约为3000万美元[1] - ECGI将通过发行优先股收购RezyFi 100%的已发行股权 该交易为非现金交易 旨在维护股东价值[2] - 尽职调查完成并签署最终协议后 RezyFi将成为ECGI控股公司的全资子公司[2] 战略意义与业务协同 - 此次收购标志着ECGI战略性地进入金融科技行业[3] - 合并后的实体将利用人工智能驱动的贷款处理和区块链支持的碎片化抵押贷款投资 以简化贷款操作并提高效率[3] - 公司旨在创建一个融合机构级合规性与尖端数字金融基础设施的下一代抵押贷款平台[3] - 公司计划成为首批在合规平台上对抵押贷款进行代币化的企业之一 为投资者创造获取房地产支持收益产品的新机会[4] 管理层观点与技术整合 - ECGI总裁指出 此次收购将弥合传统抵押贷款与下一代金融技术之间的差距 结合RezyFi的全国性牌照和运营基础设施与ECGI的资本市场及技术专长具有巨大潜力[5] - RezyFi首席执行官表示 加入ECGI将加速其向技术驱动型抵押贷款平台的演变 合作实施人工智能和区块链解决方案将使贷款对投资者和借款人更快、更智能、更易获得[5] - 公司将在后续发布中分享技术整合路线图的更多更新 包括引入专业的人工智能和区块链开发团队 这些举措预计将开辟新的收入来源[5] 公司背景与投资组合 - ECGI控股公司是一家技术驱动的投资和开发公司 专注于构建具有可持续长期收入模式的技术驱动型创新企业[6] - 公司的投资组合和战略利益涵盖人工智能、金融科技、时尚科技和体验式酒店等高增长行业[6] - 公司当前的投资和合作伙伴包括Entrepreneur Ventures Fund I TCA Venture Group AuraChat ai Payday Fantasy TrueToForm Pacific Saddlery以及Vintner's Caldera Ranch等[7]

November 3, 2025 Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US - European Market Put at $7 Billion Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced the approval of a Clinical Trial Application (CTA) by the European Medicines Agen ...

-- Successful completion of first trial phase enables continued pivotal trial of FemBloc, the only non-surgical permanent birth control, toward U.S. FDA approval -- -- $12 million senior secured convertible notes for total potential proceeds of $58 million, if all warrants are exercised for cash, reflecting strong investor confidence in Femasys’ women’s health mission -- ATLANTA, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical ...

BEIJING, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Global Mofy AI Limited (the “Company” or “Global Mofy”) (Nasdaq: GMM), a generative AI-driven technology solutions provider engaged in virtual content production and the development of 3D digital assets for use in the broader digital content industry, today announced that representatives from the Chinese Academy of International Trade and Economic Cooperation under the Ministry of Commerce (“CAITEC”) and the Commercial Circulation Promotion Division of the Chaoyang ...