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Dogwood Therapeutics Secures Exclusive Worldwide, Royalty Free License to Develop and Commercialize SP16 as a Treatment for Cancer Related Pain in an All-Stock Transaction Underscoring the Company's Dedication to Improving the Lives of Cancer Patients
Globenewswire· 2025-09-29 11:15
-A first-in-class LRP1 agonist, SP16 phase 1b Chemotherapy Induced Neuropathy (CIPN) Study fully funded by the National Cancer Institute, with projected patient enrollment beginning in the first half of 2026- -SP16 has demonstrated both anti-inflammatory and neural repair activity that has the potential to treat CIPN, synergistically complementing Halneuron®, the Company’s late stage NaV1.7 inhibitor, which has demonstrated significant pain reduction in previous Phase 2 studies- -Webcast today, September 29 ...
REGENXBIO Announces Presentation at the World Muscle Society
Prnewswire· 2025-09-29 11:05
Accessibility StatementSkip Navigation ROCKVILLE, Md., Sept. 29, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced Chief Medical Officer, Steve Pakola, M.D., will present at the International Congress of the World Muscle Society taking place in Vienna, Austria, October 7-11, 2025. The podium presentation will share new analysis of previously presented 12-month functional data from the Phase I/II trial of RGX-202, including individual patient improvement on the North Star Ambulatory Assessme ...
Genmab (NasdaqGS:GMAB) Earnings Call Presentation
2025-09-29 11:00
业绩总结 - Genmab计划收购Merus,以推动未来十年的可持续增长[1] - 收购Merus的现金报价为每股97美元,交易总值约为80亿美元[24] - 预计通过现金和55亿美元的新非可转换债务融资收购,预计将获得强劲的非投资级评级[24] - 预计在2026年保持显著盈利能力,同时投资于petosemtamab和其他后期项目[24] - 预计到2029年底将对EBITDA产生增益,持续的收入增长将延续到下一个十年[24] - 预计在收购完成后两年内,目标总杠杆率低于3.0倍[24] - 2024年和2025年将实施生产力计划,预计运营利润增长26%[28] - 收购ProfoundBio的现金交易额为18亿美元,预计将加速Rina-S的开发[28] - Genmab的目标是到2030年实现盈利增长,增强后期管道[33] 用户数据与产品研发 - Petosemtamab在复发/转移性头颈鳞状细胞癌(HNSCC)中有两个正在进行的三期研究,预计在2026年将有初步结果发布[7] - Petosemtamab的年峰值销售潜力预计为数十亿美元[7] - Epkinly®在2L滤泡淋巴瘤的PDUFA日期为2025年11月30日,1L和2L+ DLBCL的三期结果预计在2026年底之前发布[9] - Petosemtamab在1L和2L+ HNSCC中均获得FDA突破性疗法认证[18] - Petosemtamab与pembrolizumab联合治疗的客观缓解率(ORR)为63%,而单药治疗为19%[19] - Petosemtamab的安全性良好,100%的患者报告至少有一种不良事件[21] - Genmab的目标是到2027年在多个适应症中实现首次上市[7] - 预计到2026年将有两项三期临床试验的初步结果发布[33] - 预计2027年初步推出新产品,并有扩展潜力[33] 市场扩张与未来展望 - Genmab的资本配置优先事项与2030愿景一致,推动可持续的长期增长[7]
Tonix Pharmaceuticals Plans to Initiate Prader-Willi Syndrome Phase 2 Trial of TNX-2900 (Intranasal Potentiated Oxytocin) in 2026
Globenewswire· 2025-09-29 11:00
Phase 2 randomized, double-blind, placebo-controlled trial planned to evaluate TNX-2900 in children and adolescents (ages 8 to 17.5 years) with Prader-Willi Syndrome under a cleared IND TNX-2900 granted Orphan Drug and Rare Pediatric Disease Designations by the FDA, providing the potential for a Priority Review Voucher upon approval Magnesium-potentiated intranasal oxytocin formulation designed to reduce dose-related inconsistencies in receptor activity CHATHAM, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Toni ...
沃森生物(300142.SZ):子公司收到13价肺炎球菌多糖结合疫苗约旦药品注册证
格隆汇APP· 2025-09-29 10:46
登录新浪财经APP 搜索【信披】查看更多考评等级 (JordanFood&DrugAdministration)签发的《药品注册证》。本次获得约旦的《药品注册证》,标志着 公司在中东市场的战略布局取得关键进展,是公司13价肺炎球菌多糖结合疫苗在国际化进程中取得的重 要突破。因公司产品首次在约旦市场实现准入,关于该疫苗的实际上市时间与销售业绩尚存在一定的不 确定性。公司将积极推进后续相关工作,并及时履行信息披露义务。 格隆汇9月29日丨沃森生物(300142.SZ)公布,子公司玉溪沃森生物技术有限公司(简称"玉溪沃森")生 产的13价肺炎球菌多糖结合疫苗于近日收到约旦食品与药品监督管理局 ...
Enanta Pharmaceuticals Reports Positive Topline Results from its Phase 2b Study of Zelicapavir for the Treatment of Respiratory Syncytial Virus (RSV) in High-Risk Adults
Businesswire· 2025-09-29 10:30
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced positive topline data from RSVHR, a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of zelicapavir in outpatient adults with acute RSV infection who are at high risk of complications including the elderly and/or those with. ...
Hanmi's Oral Delivery Platform Compound Licensed to Gilead
Prnewswire· 2025-09-29 09:45
Accessibility StatementSkip Navigation Hanmi and HHP will grant Gilead an exclusive license to Encequidar and provide access to drug supply. Orascoveryâ"¢ is an innovative oral drug delivery proprietary platform owned by Hanmi that enables the conversion of injectable medicines into oral formulations. Encequidar is a P-gp inhibitor that was discovered through Hanmi's Orascoveryâ"¢ platform and originally developed by Hanmi. Under this agreement, Hanmi and HHP will grant Gilead exclusive global rights to Enc ...
Viva Biotech Receives Frost & Sullivan's 2025 APAC Technology Innovation Leadership Recognition in the Integrated Intelligent Drug Discovery Industry
Prnewswire· 2025-09-29 09:00
公司荣誉与行业认可 - 公司荣获Frost & Sullivan 2025年亚太地区技术创新领导力奖 表彰其在集成智能药物发现行业的卓越成就 [2] - 该奖项是Frost & Sullivan最高荣誉 认可公司在临床前研发中推动变革性效率的突出表现 [2] - 公司在战略制定与执行方面表现突出 在严格的基准测试中脱颖而出 [3] 技术创新与平台优势 - 公司通过多模态人工智能与广泛湿实验室验证结合 建立行业最多功能发现平台之一 [4] - AI驱动药物发现平台包含V-Scepter、V-Orb和V-Mantle三大模块 结合预测建模、物理模拟和生成式AI [5] - V-Scepter提供生物系统自动化参数化功能 支持小分子和肽类包括非经典氨基酸 [9] - V-Orb包含物理驱动建模 专有FEP计算套件优化非共价/共价结合剂及生物制剂 [9] - V-Mantle具备生成式AI能力 包括蛋白质大语言模型和抗体工程工作流 [9] 平台性能与客户成果 - 平台支持超过50家全球客户的150多个项目 实现发现速度提升30-50%和成本降低高达70% [6] - 平台支持多种治疗模式 包括小分子、抗体以及PROTACs、分子胶和RNA靶向化合物等新兴疗法 [4] - 平台在广泛靶点包括挑战性靶点上保持持续高成功率 [6] 商业模式与服务范围 - 公司提供从早期基于结构的药物研发到商业化生产的一站式服务 [10] - 技术平台涵盖X射线结晶、冷冻电镜、DEL、ASMS、SPR、HDX、AIDD/CADD等前沿技术 [10] - 通过子公司Langhua Pharma提供从临床前到商业化生产的CMC一站式服务 [10] - 采用服务换股权模式支持高潜力初创公司解决未满足医疗需求 [10] 战略愿景与行业影响 - 公司致力于构建真正整合AI驱动药物发现与基于结构药物发现的平台 [8] - 通过AI驱动建模和基于结构的药物发现加速全球客户决策支持 [7] - 公司投资无缝实验室闭环系统 支持全球客户的首创项目 [7]
美股异动|Merus盘前涨超38% Genmab以每股97美元全现金将其收购
格隆汇APP· 2025-09-29 08:56
格隆汇9月29日|荷兰制药商Merus(MRUS.US)盘前暴涨超38%,现报95.29美元。此前丹麦生物技术公 司Genmab同意以每股97美元的价格全现金收购Merus,交易价值约为80亿美元。 ...
Angle PLC Announces Presentation of Data on Glioblastoma
Accessnewswire· 2025-09-29 06:00
CLINICAL study SHOWS DETECTION OF CTCs in glioblastoma Patients GBM CTC isolation only possible with Parsortix label-free methodology Data presented at the 7th ACTC meeting GUILDFORD, SURREY / ACCESS Newswire / September 29, 2025 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company with innovative circulating tumour cell (CTC) solutions for use in research, drug development and clinical oncology, is pleased to announce the presentation of new data from a proof-of-concept study in gliobl ...