Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence
Newsfilter· 2024-07-31 20:00
关于Achieve Life Sciences公司 - 公司为致力于全球开发和商业化用于戒烟和尼古丁依赖的cytisinicline的后期制药公司[1] - 美国食品药品监督管理局(FDA)已授予cytisinicline用于尼古丁电子烟(或 vaping)戒烟的突破性疗法认定[1] - 公司总裁兼首席医疗官称美国有超1300万吸电子烟且努力克服成瘾的人目前没有FDA批准的专门用于戒烟的药物cytisinicline有潜力成为一流治疗方法[2] - 突破性疗法认定旨在加快用于治疗严重疾病药物的开发和审查且初步临床证据表明该药物可能比现有疗法有显著改善[2] - 公司计划在今年年底前与FDA多学科团队举行2期结束会议[2] - FDA认为烟草依赖是严重或危及生命的状况长期使用电子烟也被认为是严重状况[3] - 青少年和年轻成人使用电子烟存在风险包括对大脑发育的潜在风险和尼古丁成瘾风险[3] - 公司的2期ORCA - V1试验结果表明接受cytisinicline治疗的参与者戒烟的可能性是接受安慰剂的2.6倍[4] - 在其他次要终点也发现了有利于cytisinicline的趋势且cytisinicline治疗耐受性良好无严重不良事件报告依从性良好[4] - 2期ORCA - V1临床研究部分由美国国立卫生研究院(NIH)国家药物滥用研究所支持[5] - 2期ORCA - V1试验评估了美国5个临床试验点的160名吸电子烟的成年人[6] - 参与者随机接受3mg cytisinicline或安慰剂并结合标准戒烟行为支持为期12周[6] - ORCA - V1研究中cytisinicline的剂量和给药方式与3期注册试验相同[6] - 公司专注于通过cytisinicline的开发和商业化解决全球吸烟健康和尼古丁成瘾流行问题[7] - 美国约有2900万成年人吸食可燃香烟烟草使用是全球可预防死亡的主要原因[7] - 美国有超过1100万成年人使用电子烟2023年美国约有210万中学生和高中生报告使用电子烟[7] - 目前没有FDA批准的专门用于尼古丁电子烟戒烟的治疗方法[8] - cytisinicline是一种植物性生物碱与烟碱型乙酰胆碱受体有高亲和力[8] - 它被认为可通过与大脑中的尼古丁受体相互作用减轻戒断症状降低尼古丁产品的奖励和满意度来帮助治疗尼古丁成瘾[8] - cytisinicline是一种正在开发的用于治疗尼古丁成瘾的候选产品尚未在美国获得FDA批准用于任何适应症[8]
Diamond Equity Research Releases Update Note on Viomi Technology Co., Ltd. (NASDAQ: VIOT)
Newsfilter· 2024-07-31 20:00
NEW YORK, July 31, 2024 (GLOBE NEWSWIRE) -- Diamond Equity Research, an equity research firm with a focus on small capitalization public companies released an Update Note on Viomi Technology Co., Ltd. (NASDAQ:VIOT). The update note includes detailed information on the Viomi Technology's business model, services, industry, financial results, valuation, and risks. The update note is available here. Highlights from the note include:  Strategic Divestiture of IoT@Home Portfolio: Viomi Technology Co., Ltd has an ...
Luxury home values are rising faster than typical homes for the first time in years
Prnewswire· 2024-07-31 20:00
Listings for luxury homes are seeing relatively more competition than homes in the market's midrange Luxury home values are up 3.9% year over year.  Inventory of luxury homes remains 46.9% below pre-pandemic levels, a bigger deficit than in the housing market overall.  Richmond has the hottest luxury housing market in the country. Austin is the only major market where luxury home values have declined throughout the past year.  SEATTLE, July 31, 2024 /PRNewswire/ -- Luxury home value growth, which has consis ...
Vivo Worldwide Productions Taps Harmonic to Power Caliente TV Sports Channel
Prnewswire· 2024-07-31 20:00
Harmonic's VOS360 Media SaaS-based Solution Simplifies Media Processing, Playout and Primary Distribution for New Sports Channel in Mexico SAN JOSE, Calif., July 31, 2024 /PRNewswire/ -- Harmonic (NASDAQ: HLIT) today announced that Vivo Worldwide Productions is powering Caliente TV, a new sports TV channel in Mexico, with Harmonic's comprehensive playout and distribution solution. Simplifying all stages of media processing, playout and distribution to affiliates and partners, Harmonic's VOS®360 Media SaaS a ...
Ardmore Shipping Corporation Announces Financial Results For The Three and Six Months Ended June 30, 2024
Prnewswire· 2024-07-31 20:00
HAMILTON, Bermuda, July 31, 2024 /PRNewswire/ -- Ardmore Shipping Corporation (NYSE: ASC) ("Ardmore", the "Company" or "we") today announced results for the three and six months ended June 30, 2024. Highlights and Recent Activity Reported net income of $61.8 million for the three months ended June 30, 2024, or $1.48 earnings per basic share and $1.47 earnings per diluted share, compared to net income of $23.7 million, or $0.57 earnings per basic and diluted share for the three months ended June 30, 2023. W ...
Sun Life appoints Patrick Cronin and Stacey Madge to Board of Directors
Prnewswire· 2024-07-31 20:00
TORONTO, July 31, 2024 /PRNewswire/ - Sun Life Financial Inc. (TSX: SLF) (NYSE: SLF) is pleased to announce the appointments of Patrick Cronin and Stacey Madge to the Sun Life Board of Directors, effective July 31, 2024. Mr. Cronin is a seasoned financial executive with a distinguished career spanning over 30 years in the banking and financial services industries across Canada, U.S. and international markets. Most recently, Mr. Cronin served as Special Advisor to the CEO for BMO Financial Group. Prior to th ...
GigaGen Receives FDA Clearance of IND Application for Phase 1 Trial of Recombinant Polyclonal for HBV Treatment, GIGA-2339
Newsfilter· 2024-07-31 20:00
文章核心观点 - 公司开发了首个用于治疗和功能性治愈慢性乙型肝炎病毒(HBV)感染的重组多克隆治疗药物GIGA-2339 [1][4][5] - GIGA-2339包含超过1,000种完全人源化的重组抗HBV抗体,可复制人体自然免疫反应 [2][7] - GIGA-2339是公司重组多克隆抗体药物平台的一部分,是Grifols公司创新战略和致力于为患者和医疗专业人员提供下一代抗体药物的一部分 [3][5] 行业概况 - 目前现有疗法和疫苗仍无法治愈HBV,全球仍有2.96亿人感染HBV,每年导致超过80万人死亡 [6] - 现有药物只能抑制病毒复制,但无法显著降低病毒蛋白水平,无法彻底治愈 [6][7] 公司情况 - 公司利用行业领先的单细胞技术,开发用于治疗免疫缺陷、传染病和难治性肿瘤的创新性抗体药物 [16] - 公司的重组多克隆抗体技术平台可以捕获和重现完整的免疫细胞谱系,从而创造出首创的重组多克隆抗体治疗药物 [9] - 公司的主要股东是Grifols公司,Grifols是一家全球性的医疗保健公司,致力于改善全球人民的健康和福祉 [10][14] - Grifols专注于治疗免疫学、肝病、重症监护、肺病、血液病、神经病和传染病等多个治疗领域 [11] - Grifols拥有全球最大的血浆捐赠中心网络,在北美、欧洲、非洲、中东和中国设有超过390个捐赠中心 [12] - Grifols还提供输血医学解决方案、生命科学研究用生物原料以及医院、药房和医疗专业人员所需的工具、信息和服务 [13]
Milestone® Pharmaceuticals to Present at the Upcoming BTIG Virtual Biotechnology Conference
Newsfilter· 2024-07-31 20:00
MONTREAL and CHARLOTTE, N.C., July 31, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST) today announced that President and CEO, Joe Oliveto, will participate in the BTIG Virtual Biotechnology Conference, to take place from August 5-6, 2024. The presentation will be in the form of a Fireside Chat to take place on August 6th at 8 AM EDT. The webcast will be available to watch both live and as a replay for approximately 90 days following the presentation in the News & Events section of Mi ...
American Oncology Network Announces Second Quarter 2024 Earnings Release Date and Conference Call
Newsfilter· 2024-07-31 20:00
FORT MYERS, Fla., July 31, 2024 (GLOBE NEWSWIRE) -- American Oncology Network ("AON" or the "Company") (OTCQX:AONC), one of the fastest growing community-based oncology practices, announced today that the Company will release its second quarter 2024 financial results on Wednesday, August 14, 2024, prior to market open. The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time on the same day. To access the call through a conference line, dial 1-877-704- ...
Inuvo Secures $10 Million Credit Line from SLR Digital Finance
Newsfilter· 2024-07-31 20:00
LITTLE ROCK, Ark., July 31, 2024 (GLOBE NEWSWIRE) -- Inuvo, Inc. (NYSE:INUV), a leading provider of marketing technology, powered by its proprietary IntentKey® artificial intelligence (AI) that serves brands and agencies, has announced that it has secured a new $10 million asset-based credit facility to support its continued growth and operations. The credit facility, provided by SLR Digital Finance, provides Inuvo with enhanced liquidity and the financial flexibility to accelerate the adoption of its large ...