Enanta Pharmaceuticals (NASDAQ:ENTA) shares rose on Monday despite the company reporting it did not achieve the primary objective in a mid-stage trial for its antiviral drug, zelicapavir, which is aimed at treating respiratory syncytial virus infections. The stock is up ...

Enanta Pharmaceuticals (NasdaqGS:ENTA) Update / Briefing September 29, 2025 08:30 AM ET Company ParticipantsJennifer Viera - VP - IR & Corporate CommunicationsJay Luly - President, CEO & DirectorScott Rottinghaus - Chief Medical OfficerJonathan Miller - MD - Biotech & Pharma Equity ResearchMazahir Alimohamed - Biotech Equity ResearchConference Call ParticipantsBrandon Folkes - MD & Senior Healthcare AnalystEd Arce - Senior Research Analyst - BiotechnologyBrian Skorney - Senior Research AnalystRoy Buchanan - ...

Phase 2b Study of Zelicapavir in High-Risk Adults: RSVHR Topline Results September 29, 2025 Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our research and development programs, our business and the industry in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be forward-loo ...

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. ...

Shares of Merus NV (NASDAQ: MRUS) rose sharply in today's pre-market trading.Genmab announced plans to acquire Merus for $8 billion in all-cash deal adding breakthrough therapy Petosemtamab to its late-stage pipeline.Merus shares jumped 38.2% to $95.21 in the pre-market trading session.Here are some other stocks moving in pre-market trading.GainersSteakholder Foods Ltd – ADR (NASDAQ: STKH) rose 92% to $8.32 in pre-market trading. Steakholder Foods recently announced signing of agreement for the acquisition ...

Several small- and mid-cap biotech and medical stocks saw notable after-hours price action on Friday, September 26, following a mix of clinical updates, investor presentations, and strategic announcements.Enanta Pharmaceuticals Inc. (ENTA) surged sharply in after-hours trading on Friday, September 26, following a modest gain during the regular session. The stock closed the day at $7.90, up 1.94%, before vaulting another 20% after hours to reach $9.48. This dramatic post-close rally was driven by investor r ...

Enanta Pharmaceuticals Inc. (ENTA) will hold a conference call and webcast on Monday, September 29, 2025, at 8:30 a.m. ET to share topline results from its RSVHR study.RSVHR is a phase 2b trial evaluating its lead drug candidate Zelicapavir for the treatment of respiratory syncytial virus (RSV) in high-risk adults.Respiratory syncytial virus (RSV) causes severe lung infections, including bronchiolitis and pneumonia. High-risk populations include premature babies, young infants, and children. In the U.S. al ...

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 the company will hold a conference call and webcast on Monday, September 29 at 8:30 a.m. ET to share topline results from RSVHR, a Phase 2b study evaluating zelicapavir for the treatment of respiratory syncytial virus (RSV) in high-risk adults. Conference Call and Webcast. ...

公司概况 * 公司为Enanta Pharmaceuticals (NasdaqGS:ENTA) 一家历史悠久的抗病毒药物研发公司 现已拓展至免疫学领域[4][9] * 公司最初专注于丙型肝炎领域 并与艾伯维合作将药物成功商业化 其产品MAVERIT是唯一一款8周治愈丙肝的药物 也是目前唯一同时获批用于慢性和急性丙肝治疗的治愈性方案[4] * 公司研发策略已从病毒学扩展至免疫学 拥有针对KIT和STAT6的研发项目 并计划在今年宣布第三个免疫学项目[9][25] 核心研发管线与进展 **呼吸道合胞病毒(RSV)项目** * 公司拥有两个RSV抗病毒项目 均针对病毒复制过程 而非病毒进入 分别是N蛋白抑制剂(zelicapavir)和L蛋白抑制剂(病毒聚合酶 EDP-323)[6][7] * **Zelicapavir (N蛋白抑制剂)** * 已公布儿科研究数据 研究达到了证明药物安全性 耐受性 抗病毒效果和确定合适剂量的所有目标[14] * 针对高风险成人(主要为75岁以上 患有COPD或充血性心力衰竭)的Phase IIb研究(研究代号未明确)已完成 略超募至约180名患者 所有患者均在症状出现72小时内入组 主要终点为症状缓解时间的缩短[14][15][16] * 预期结果参照流感及新冠药物的注册研究 目标是观察到约1天的症状持续时间缩短 数据预计本月晚些时候公布[17][19][20] * 若结果积极 该研究将支持进入Phase III注册研究[25] * **EDP-323 (L蛋白抑制剂)** * 更早期的RSV治疗药物 人类挑战研究数据优异 单次给药后12小时内通过培养测得的活病毒载量即消失 显示其起效迅速[43][44] * 公司正在考虑为其中一个或两个RSV资产寻求合作伙伴关系 以进行全球上市[25] **免疫学项目** * **KIT抑制剂项目** * 针对肥大细胞驱动疾病 如慢性自发性荨麻疹(CSU) 通过抑制KIT诱导肥大细胞凋亡并下调其活性[22][48] * 候选药物显示出高效力和高选择性 目前正在进行IND enabling研究 药物规模化生产以及临床试验准备 目标是最早在明年进入临床[21][23][25] * **STAT6抑制剂项目** * 目标是开发一种口服的Dupixent 通过抑制IL-4和IL-13信号通路下游的STAT6来发挥作用[9][24] * 候选药物在效力和选择性方面表现优异 并有良好的临床前体内模型数据 预计在今年下半年确定开发候选药物 目标明年进入临床[24][25] * 公司计划在今年宣布第三个免疫学项目[9][25] **新冠病毒(COVID-19)项目** * 公司拥有3CL蛋白酶抑制剂EDP-235 已获得Phase II数据[8] * 公司在美国和欧盟拥有覆盖nirmatrelvir(辉瑞Paxlovid的活性成分)的专利[53] * 公司于2022年6月在美国提起诉讼 该案目前在美国联邦上诉法院 并于2024年8月通过统一专利法院(UPC)在欧盟对辉瑞提起了诉讼 UPC的程序时间线约为12个月[54][55] 市场策略与行业洞察 * **RSV治疗市场机会** * 目前市场上尚无针对活动性RSV感染的治疗药物 存在重大未满足的医疗需求[6] * 即使有疫苗 其接种率并不理想(约不到20%) 且存在突破性感染 大多数患者未接种疫苗 因此治疗市场空间巨大[40][41] * 标准风险的健康成年人可能无法从治疗中获益 因此研发重点集中在高风险患者群体(儿科和高龄成人)[30][32] * **合作策略** * 公司从丙肝领域的合作中汲取经验 正在评估为RSV资产寻找全球合作伙伴的可能性[25] 其他重要细节 * **研发策略** * 公司专注于小分子药物研发 在此领域拥有深厚的化学和临床前开发专业知识[46] * 对于STAT6等新靶点 公司认为需要等待临床数据来比较直接抑制剂和降解剂等不同模态的价值[45][47] * **临床试验设计** * 在抗病毒试验中 早期治疗至关重要 高风险成人RSV研究要求患者在症状出现72小时内入组[15] * 症状改善是可行的注册终点 仅病毒载量降低不足以支持注册[16] * 高风险成人研究 deliberately限制了较低风险患者(65-74岁及哮喘患者)的入组比例(总计20%) 以确保80%的参与者是75岁以上或患有COPD/心力衰竭的高风险人群 从而预期更长的安慰剂症状持续时间[14][37]

Enanta Pharmaceuticals (NasdaqGS:ENTA) FY Conference September 09, 2025 02:00 PM ET Company ParticipantsTara L. Kieffer - Chief Product Strategy OfficerDr. Jay R. Luly - President and CEOOperatorThank you. All right. Good afternoon, everyone. Thank you very much for joining us here for this afternoon session with Enanta Pharmaceuticals, Inc. and a fireside chat with President and Chief Executive Officer Jay R. Luly and Chief Product Strategy Officer Tara L. Kieffer. Jay, Tara, thanks very much for joining u ...