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GRI Bio Participates in the Virtual Investor “What's Your Story” Summer Spotlight On-Demand Conference
Globenewswire· 2025-07-22 20:45
– Video webcast now available on-demand LA JOLLA, CA, July 22, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced Marc Hertz, PhD, President, Chief Executive Officer and Director of GRI BIO, participated in the Virtual Investor “What’s Your Story” Summer Spotlight On-Demand Conference. As part ...
Palisade Bio Participates in the Virtual Investor “What's Your Story” Summer Spotlight On-Demand Conference
Globenewswire· 2025-07-22 20:45
– Video webcast now available on-demand Carlsbad, CA, July 22, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced JD Finley Chief Executive Officer of Palisade Bio, participated in the Virtual Investor “What’s Your Story” Summer Spotlight On-Demand Conference. As part ...
Outlook Therapeutics Participates in the Virtual Investor “What's Your Story” Summer Spotlight On-Demand Conference
Globenewswire· 2025-07-22 20:45
文章核心观点 Outlook Therapeutics公司新任命的首席执行官Bob Jahr参加虚拟投资者会议并深入探讨相关内容,该公司专注视网膜疾病治疗药物开发与商业化 [1][2] 公司动态 - 新任命的首席执行官Bob Jahr参加虚拟投资者“你的故事是什么”夏季聚焦按需会议 [1] - 会议按需视频网络直播可在virtualinvestorco.com及公司网站投资者板块活动页面查看 [2] 公司业务 - 公司是专注开发和商业化ONS - 5010/LYTENAVA™以提高贝伐珠单抗治疗视网膜疾病护理标准的生物制药公司 [3] - LYTENAVA™是首个获欧盟委员会和英国药品和保健品管理局上市许可用于治疗湿性AMD的贝伐珠单抗眼科制剂,已在德国和英国商业推出 [3] - 在美国,ONS - 5010/LYTENAVA™处于研究阶段,生物制品许可申请已重新提交给FDA,若获批将是首个用于视网膜适应症包括湿性AMD的获批贝伐珠单抗眼科制剂 [4] 投资者咨询信息 - 联系人Jenene Thomas,首席执行官,JTC Team, LLC [5] - 电话908.824.0775,邮箱OTLK@jtcir.com [5]
SRPT DEADLINE: Lose Money on Sarepta Therapeutics, Inc. (NASDAQ:SRPT)? You may have been Affected by Fraud and are Urged to Contact BFA Law by August 25
GlobeNewswire News Room· 2025-07-22 20:36
NEW YORK, July 22, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Sarepta Therapeutics, Inc. (NASDAQ: SRPT) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Investors have until August 25, 2025, to as ...
Veru to Participate in the 2025 BTIG Virtual Biotech Conference
Globenewswire· 2025-07-22 20:30
文章核心观点 Veru公司作为临床后期生物制药公司,专注开发治疗心脏代谢和炎症疾病创新药物,其两款后期小分子药物enobosarm和sabizabulin分别在肥胖和动脉粥样硬化炎症项目中展现积极进展和潜力 [1][2] 公司参会信息 - 公司将参加2025年7月29 - 30日举行的2025 BTIG虚拟生物技术大会,与投资者进行一对一会议和炉边谈话展示 [1] 公司概况 - 公司是临床后期生物制药公司,专注开发治疗心脏代谢和炎症疾病创新药物,药物开发项目包括两款后期小分子药物enobosarm和sabizabulin [2] 肥胖项目 - Enobosarm 临床研究情况 - 公司公布2b期QUALITY临床研究积极顶线和安全结果,该研究是多中心、双盲、安慰剂对照、随机、剂量探索临床试验,旨在评估enobosarm 3mg、6mg或安慰剂辅助接受司美格鲁肽慢性体重管理的168名老年患者(≥60岁)减脂和防肌肉流失的安全性和有效性 [3] - 完成2b期QUALITY临床试验疗效剂量探索部分后,参与者进入2b期维持扩展研究,所有患者停用司美格鲁肽,但继续双盲接受安慰剂、enobosarm 3mg或6mg单药治疗12周 [4] 研究结果 - 2025年6月24日,公司公布2b期QUALITY和维持扩展临床研究积极结果,显示enobosarm显著减少司美格鲁肽停药后体重反弹、防止脂肪反弹并保留瘦体重 [4] - 2b期QUALITY研究16周积极减重期结束时,各治疗组体重减轻情况相似,司美格鲁肽加安慰剂组平均减重11.88磅;12周维持扩展研究期(第112天至第196天)所有治疗组停用司美格鲁肽后,安慰剂单药治疗组体重反弹之前减重的43%,体重平均百分比变化为2.57%(5.06磅),而3mg enobosarm组为1.41%(2.73磅)(p = 0.038),6mg enobosarm组为2.87%(5.29磅);3mg enobosarm单药治疗显著减少46%的体重反弹 [4] - 平均而言,安慰剂单药治疗组脂肪量反弹2.27%,而enobosarm单药治疗组3mg剂量脂肪量减少 - 0.27%,6mg剂量减少 - 0.50%;安慰剂组体重反弹的平均组织构成为28%脂肪和72%瘦体重,而3mg和6mg enobosarm组均为0%脂肪和100%瘦体重 [4] - 到28周研究结束时(第1天至第196天),安慰剂加司美格鲁肽后接安慰剂单药治疗组瘦体重流失,而enobosarm加司美格鲁肽后接enobosarm单药治疗组(3mg和6mg剂量)显著保留超过100%的瘦体重(enobosarm 3mg p < 0.001和enobosarm 6mg p = 0.004) [5] - enobosarm加司美格鲁肽后接enobosarm单药治疗患者与安慰剂加司美格鲁肽后接安慰剂单药治疗相比,3mg enobosarm组脂肪减少多58%(p = 0.085),6mg enobosarm组脂肪减少多93%(p = 0.008) [5] - 2b期QUALITY维持扩展临床试验(第112 - 196天)中,enobosarm单药治疗有积极安全状况 [5] 后续计划 - 公司获FDA会议批准讨论其3期项目 [7] 动脉粥样硬化炎症项目 - Sabizabulin 开发策略 - 公司调整sabizabulin药物开发策略,探索其作为新型口服广谱抗炎剂治疗动脉粥样硬化心血管疾病炎症的临床开发可能性 [8] 开发依据 - 动脉粥样硬化性冠状动脉疾病是全球主要死亡原因,炎症和高胆固醇共同导致动脉粥样硬化心血管疾病,即使采用最大程度降胆固醇疗法,仍存在大量未治疗的残余炎症风险,联合使用积极降脂和抗炎疗法或可进一步降低动脉粥样硬化风险,促使寻找可降低CAD患者动脉粥样硬化事件风险的抗炎药物 [8] - sabizabulin药代动力学稳定,药物相互作用可能性低,可作为辅助疗法与他汀类药物联合使用以减少炎症,减缓动脉粥样硬化心血管疾病进展或促进其逆转;体外和体内炎症研究的临床前数据显示sabizabulin治疗可抑制所有测试的细胞因子和趋化因子;在2期和3期肺部炎症COVID - 19临床研究中,sabizabulin已证明具有广泛抗炎活性;安全数据库包含来自之前sabizabulin临床开发项目的266名给药患者 [8] 决策原因 - 公司探索这一重大心脏代谢适应症的决策基于治疗动脉粥样硬化心血管疾病炎症的重大未满足医疗需求、巨大全球市场机会、现有266名患者的sabizabulin临床和安全数据库、鉴于其作用机制与秋水仙碱相似的高成功概率、强大知识产权地位,且符合公司对心脏代谢疾病的关注 [9] 后续计划 - 公司认为可在小型2期剂量探索概念验证研究中评估sabizabulin对高敏C反应蛋白的影响 [9]
Hoth Therapeutics Signs VA Research Deal to Advance GDNF as Breakthrough Therapy for Obesity and Fatty Liver - Side-by-Side Study vs. Semaglutide Begins
Prnewswire· 2025-07-22 20:19
NEW YORK, July 22, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, today announced a CRADA (Cooperative Research and Development Agreement) with the U.S. Department of Veterans Affairs and Foundation for Atlanta Veterans Education and Research (FAVER) to evaluate GDNF (glial cell-derived neurotrophic factor) as a novel metabolic therapy targeting obesity and hepatic steatosis (fatty liver disease).The study, conducted at the Atlanta VA Medical Center, will ...
Hoth Therapeutics Signs VA Research Deal to Advance GDNF as Breakthrough Therapy for Obesity and Fatty Liver - Side-by-Side Study vs. Semaglutide Begins
Prnewswire· 2025-07-22 20:19
NEW YORK, July 22, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, today announced a CRADA (Cooperative Research and Development Agreement) with the U.S. Department of Veterans Affairs and Foundation for Atlanta Veterans Education and Research (FAVER) to evaluate GDNF (glial cell-derived neurotrophic factor) as a novel metabolic therapy targeting obesity and hepatic steatosis (fatty liver disease). The study, conducted at the Atlanta VA Medical Center, will ...
Catalyst Pharmaceuticals to Report Second Quarter 2025 Financial Results on August 6, 2025
Globenewswire· 2025-07-22 20:03
The Company will Host a Conference Call and Webcast on Thursday, August 7, 2025, at 8:30 AM ETCORAL GABLES, Fla., July 22, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it will release its second quarter 2025 financial results after the market close on Wedne ...
Reunion Neuroscience Announces Publication of RE104 Phase 1 Data in The Journal of Clinical Psychopharmacology
GlobeNewswire News Room· 2025-07-22 19:30
-- Phase 1 Data Highlight RE104 Favorable Safety Profile and Short Duration Psychoactive Experience -- -- Topline Results from RECONNECT Phase 2 Trial of RE104 in Postpartum Depression (PPD) Anticipated in Q3 2025 -- MORRISTOWN, N.J., July 22, 2025 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, toda ...
Beyond Air Awarded Therapeutic Gases Agreement with Premier, Inc.
Globenewswire· 2025-07-22 19:30
文章核心观点 - 超越空气公司获得与Premier的全国团体采购协议,有助于其LungFit PH系统在美国医院和医疗保健供应商网络中扩大销售 [1][2] 公司合作 - 超越空气公司获得与Premier的治疗气体全国团体采购协议,自7月15日起,Premier成员可自行选择利用Premier预先协商的LungFit PH系统和一次性NO2智能过滤器的特殊定价和条款 [1] - 此Premier合同是在超越空气战略合作伙伴HealthCare Links的支持下协商达成 [4] 公司产品 LungFit PH系统 - 采用专利Ionizer™技术,可从环境空气中按需产生无限量一氧化氮,仅使用相当于60瓦灯泡的功率,电离氮和氧分子形成一氧化氮,副产物二氧化氮极少,内置智能过滤器可有效去除内部回路中的NO₂,确保安全输送给患者 [2] - 设计用于治疗PPHN,能为通气患者提供与当前20 ppm NO护理标准一致的剂量,范围为0.5 ppm - 80 ppm(低浓度NO),每个智能过滤器可提供12小时治疗,可在数秒内更换以实现不间断治疗 [2] - 已在美国、欧盟、澳大利亚、泰国、沙特阿拉伯、中国台湾和新西兰获得商业使用批准 [7] 其他LungFit系统 - 可产生浓度为1 ppm至80 ppm的一氧化氮输送到肺部,有可能取代大型高压NO气瓶,减少库存和存储要求,消除NO2净化步骤以提高整体安全性,并提供其他运营优势 [5] - 还能以80 ppm或更高浓度输送NO,用于治疗医院环境中的严重急性肺部感染(如COVID - 19、细支气管炎)和家庭环境中的慢性难治性肺部感染(如NTM),公司有意在家庭环境中提供NO治疗,但其他LungFit系统仅用于研究,未获商业使用批准 [6][7] 公司介绍 - 是一家商业阶段的医疗设备和生物制药公司,致力于利用内源性和外源性一氧化氮的力量改善呼吸系统疾病、神经系统疾病和实体肿瘤患者的生活 [8] - 首款系统LungFit® PH已获得FDA批准和CE认证,用于治疗足月和近足月新生儿的低氧性呼吸衰竭 [8] - 目前正在推进其他革命性LungFit系统的临床试验,用于治疗严重肺部感染,如病毒性社区获得性肺炎(包括COVID - 19)和非结核分枝杆菌(NTM) [9] - 与耶路撒冷希伯来大学合作推进针对自闭症谱系障碍(ASD)和其他神经系统疾病治疗的临床前项目;附属公司Beyond Cancer正在临床前阶段研究超高浓度NO和专有输送系统以靶向某些实体肿瘤 [10] 合作方介绍 - Premier是一家领先的技术驱动型医疗保健改善公司,为美国三分之二的医疗保健供应商提供解决方案,联合供应商、供应商、付款人和政策制定者,利用集成数据和分析、协作、供应链解决方案、咨询和其他服务,以更低成本实现更好的护理和结果 [3]