Oral presentation will highlight the results from the randomized Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 cancer vaccine plus pembrolizumab for first-line (1L) advanced melanomaPoster presentation will share final data from Phase 2 basket trial (IOB-022/KN-D38) of IO102-IO103 cancer vaccine plus pembrolizumab for 1L treatment of solid tumors NEW YORK, Sept. 23, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-she ...

SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) today announced the Company will be presenting an update on its application for Orphan Drug status to the U.S. Food and Drug Administration (FDA) for HemaXellerate. This therapy is anticipated being used in treating aplastic anemia. Additionally the Company anticipates HemaXellerate may be used in addressing the side effects of Chemotherapy, a market of several billions of dollars. The Company’s Chairm ...

CUPERTINO, Calif., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will present and host one-on-one investor meetings at the Lytham Partners Fall 2025 Investor Conference, ...

BRISTOL, Tenn., Sept. 23, 2025 (GLOBE NEWSWIRE) -- VanderbiltReport.com, a financial news and content platform, reports that Coeptis Therapeutics (NASDAQ: COEP) is pioneering a dual-track model designed to sustain innovation while reducing reliance on dilutive funding. The biotech industry is known for high burn rates and long timelines. Companies often face an impossible choice between continuous capital raises or scaling back scientific ambitions. Coeptis is demonstrating that hybrid business models can p ...

Phio Pharmaceuticals Announces Participation in the Renmark Financial Communications Live Virtual Non-Deal Roadshow SeriesRegistration Link Below for September 30, 2025 12 PM EST Presentation and Live Q&ASeptember 23, 2025 7:45 AM EDT | Source: Phio Pharmaceuticals Corp.King of Prussia, Pennsylvania--(Newsfile Corp. - September 23, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene si ...

公司人事任命 - 公司任命Tomas J Philipson博士为战略顾问 该顾问在美国经济政策特别是医疗政策领域具有专长 并曾在特朗普政府担任白宫经济顾问委员会副主席及代理主席 在FDA和CMS担任高级经济顾问 并参与多项政府医疗政策倡议[1][2] - 该顾问目前担任风险投资公司MEDA Ventures管理合伙人 曾共同创立Precision Health Economics公司(2015年被黑石集团收购) 并担任多家公司董事会成员[2] - 公司首席执行官表示将利用该顾问在政府高层的广泛经验和关系网络 特别是在FDA和CMS方面的专长 推动主要候选产品HyBryte及其他罕见病管线的审批和商业化进程[3] 核心产品HyBryte临床进展 - HyBryte是一种新型首创光动力疗法 使用安全可见光激活 活性成分为合成金丝桃素 通过局部涂抹后24小时用可见光激活 可穿透皮肤更深层治疗病变[4] - 在III期FLASH试验中 169名患者(166名可评估)参与研究 第一治疗周期HyBryte组16%患者达到至少50%病变减少 显著优于安慰剂组的4%(p=0.04)[5] - 第二治疗周期所有患者接受HyBryte治疗 12周治疗组反应率达40%(p<0.0001) 且继续治疗显示更好疗效(p<0.0001)[6] - 第三治疗周期66%患者选择继续治疗 在所有3个周期都接受治疗的患者中 49%显示阳性治疗反应(p<0.0001)[7] - 产品安全性表现良好 无系统性可用性证据 机制不涉及DNA损伤 避免了现有疗法相关的黑色素瘤和其他恶性肿瘤风险[8] 监管审批计划 - FDA和EMA要求进行第二次成功的III期试验以支持上市批准 确认性研究FLASH2预计2024年底前启动[9] - FLASH2将招募约80名早期CTCL患者 采用随机双盲安慰剂对照多中心设计 主要终点评估延长至18周连续治疗[9] - FDA倾向要求更长期的对比研究而非安慰剂对照试验 但公司基于EMA已接受的方案启动研究 同时继续与FDA讨论开发路径修改[10] 市场与疾病背景 - CTCL是一种非霍奇金淋巴瘤 影响约4%的170万NHL患者 美国估计有31,000例患者(年新增3,200例) 欧洲估计有38,000例患者(年新增3,800例)[14] - 该疾病目前无法治愈 早期阶段中位生存期约12年 晚期降至2.5年 现有疗法均存在严重安全风险且仅批准用于其他治疗失败后的情况[13] 公司业务概况 - 公司是专注于罕见病治疗的后期生物制药公司 主要业务包括专科生物治疗和公共卫生解决方案[15] - 专科生物治疗板块除HyBryte外 还包括银屑病扩展项目(SGX302) 先天防御调节剂技术dusquetide(SGX942)治疗炎症疾病 以及Behçet病项目(SGX945)[15] - 公共卫生解决方案板块包括蓖麻毒素疫苗RiVax 针对丝状病毒(马尔堡和埃博拉)的疫苗项目 以及新冠疫苗CiVax 采用专有热稳定平台技术ThermoVax[16] - 公共卫生业务部分获得美国政府资助 包括NIAID、DTRA和BARDA的赠款和合同资金[16] 额外支持性数据 - 额外研究证明更长治疗时间的效用 局部应用后金丝桃素无显著系统性暴露 以及与Valchlor相比的相对疗效和耐受性[11] - FDA授予260万美元孤儿产品开发赠款 支持宾夕法尼亚大学开展研究者发起的研究 评估HyBryte在家庭使用环境中的扩展治疗[12]

GAITHERSBURG, Md., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that members of the Company’s management team will participate and be available for 1x1 meetings at the following investor conferences: Stifel 2025 Virtual Cardiometabolic ForumTuesday, September 30, 2025Fireside Chat at 10:30 a.m. Eastern Time H.C. Wainwright Liver Disease Virt ...

Open-label study evaluated a two-dose induction regimen of BPL-003 (8 mg followed by 12 mg two weeks later) in patients with treatment-resistant depression and demonstrated rapid, clinically meaningful and durable antidepressant effects, which are sustained for up to 3 monthsThe second dose of BPL-003 led to further reductions in MADRS scores from baseline, indicating that this regimen has the potential to enhance the clinical response beyond what is observed with a single administrationFindings will be us ...

Global Biopharmaceutical Company Bristol Myers Squibb is in Munich, Upper Bavaria, Bavaria, Germany, on April 13, 2025. (Photo by Michael Nguyen/NurPhoto via Getty Images)NurPhoto via Getty ImagesBristol-Myers Squibb (NYSE: BMY) has considerably lagged behind the overall market, with its stock decreasing by 20% this year, while the S&P 500 index has risen by 14%. This drop can be attributed in part to recent challenges in the company’s drug pipeline, including underwhelming late-stage results for its cardio ...

MAINZ, Germany, September 23, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”), alongside its artificial intelligence (“AI”) company InstaDeep Ltd. (“InstaDeep”), will host its second AI Day, an edition of BioNTech’s “Innovation Series”, at 09:00 a.m. EDT (3:00 p.m. CEST) on Wednesday, October 1, 2025, in London, United Kingdom. The event will provide an overview of BioNTech’s AI strategy and capabilities, and the application of AI in BioNTech’s pipeline and internal processes. The live webca ...