核心观点 - Altimmune公司宣布其药物pemvidutide在治疗MASH的IMPACT 2b期临床试验中获得积极的24周数据，显示出显著的MASH缓解、抗纤维化活性和体重减轻，且耐受性良好 [1][3][5] 临床试验结果 - **主要终点**：在24周时，1.2mg剂量组和1.8mg剂量组分别有58%和52%的患者实现MASH缓解且纤维化未恶化，显著优于安慰剂组的20% [6] - **纤维化改善**：1.8mg剂量组有36%的患者实现纤维化改善且MASH未恶化，安慰剂组为28% [6] - **肝硬度测量**：1.2mg和1.8mg剂量组肝硬度分别改善-3.7 kPa和-2.2 kPa，安慰剂组为-0.7 kPa [6] - **增强肝纤维化评分**：1.2mg和1.8mg剂量组分别改善-0.6和-0.5，安慰剂组为0.03 [6] - **肝脏脂肪归一化**：1.2mg和1.8mg剂量组分别有31%和44%的患者肝脏脂肪含量恢复正常，安慰剂组为4% [6] - **体重减轻**：1.2mg和1.8mg剂量组体重相对基线分别减少4.8%和5.8%，安慰剂组减少0.5% [6] 安全性与后续计划 - **安全性**：药物耐受性良好，各治疗组因不良事件停药率及严重不良事件发生率低，与安慰剂组相当 [6] - **数据发布**：试验数据已在《柳叶刀》发表，并将在美国肝病研究协会2025年肝脏会议上进行最新突破性口头报告 [2][4] - **未来节点**：IMPACT试验的48周数据预计在2025年第四季度公布 [7][8][10] 药物机制与公司信息 - **作用机制**：Pemvidutide是一种平衡的1:1 glucagon/GLP-1双重受体激动剂，旨在同时针对MASH的肝脏和代谢驱动因素 [9] - **研发进展**：该药物针对MASH和酒精使用障碍已获美国FDA快速通道资格，其针对AUD和ALD的2期试验也已启动 [10] - **公司定位**：Altimmune是一家处于临床研发后期的生物制药公司，专注于开发治疗肝脏和心血管代谢疾病的肽类疗法 [11]

Citizens JMP analyst Jonathan Wolleben lowered the firm’s price target on Altimmune (ALT) to $14 from $15 and keeps an Outperform rating on the shares. The firm says it looks forward to the oral late-breaking presentation of pemvidutide’s Phase 2b data at the Liver Meeting with 48-week data on track for this quarter. Meet Your ETF AI Analyst Discover how TipRanks' ETF AI Analyst can help you make smarter investment decisions Explore ETFs TipRanks' users love and see what insights the ETF AI Analyst re ...

AI-based digital pathology analysis provides high-resolution quantification of hepatic fibrosis and objective measurement of fibrosis improvement Pemvidutide demonstrated significant reductions in liver fibrosis and improvements in non-invasive tests vs. placebo at 24 weeks GAITHERSBURG, Md., Nov. 07, 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 resu ...

48-week Data from Phase 2b IMPACT Trial of Pemvidutide in MASH Expected Before Year End End-of-Phase 2 Meeting with FDA for MASH Program Scheduled in Fourth Quarter Executive Leadership Strengthened with Appointments of Chief Medical Officer, Chief Commercial Officer, and Chief Legal Officer Cash, cash equivalents and short-term investments of $211 million as of September 30, 2025 Webcast to be held today, November 6, 2025, at 8:30 a.m. ET GAITHERSBURG, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. ...

Enrollment completed ahead of schedule, underscoring strong interest from patient community in a potential new therapeutic option On track to complete the 24-week treatment period and announce topline results in 2026 GAITHERSBURG, Md., Nov. 03, 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 the completion of patient enrollment in RECLAIM, a Phase 2 clin ...

Altimmune, Inc. ( ALT ) has multiple trials of pemvidutide underway providing it with the ability to differentiate its asset, but it hasn't yet landed a partner or been bought out. In July I rated ALT a hold, noting theScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure:I/we have no stock, ...

GAITHERSBURG, Md., Oct. 30, 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 it will report its third quarter 2025 financial results on Thursday, November 6, 2025. Altimmune management will host a conference call at 8:30 a.m. ET on November 6 to discuss financial results and provide a business update. The conference call will be webcast live on Altim ...

Altimmune (NasdaqGM:ALT) Conference October 21, 2025 07:00 AM ET Company ParticipantsChristophe Arbet-Engels - CMOScott Harris - Senior Strategic AdvisorVipin Garg - CEOConference Call ParticipantsPatrick Trucchio - AnalystPatrick TrucchioHello everyone, and welcome to the first annual H.C. Wainwright Virtual Liver Disease Conference. My name is Patrick Trucchio. I'm a Senior Health Care Analyst at HC Wainwright. This year, for the first time, we've combined our viral hepatitis and MASH conferences, expandi ...

Oral presentation to highlight 24-week efficacy and safety data Poster to feature results of AI-based analyses of liver fibrosis reduction GAITHERSBURG, Md., Oct. 20, 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 24-week data from its Phase 2b IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) will be presented ...

涉及的行业或公司 * 公司为Altimmune 专注于开发治疗MASH的GLP-1/glucagon双重激动剂pemvidutide [1][2] * 行业为生物制药 特别是代谢性疾病领域 如MASH 肥胖 酒精使用障碍和酒精性肝病 [1][36][38] 核心观点和论据 **药物疗效与优势** * 24周二期数据显示出类领先的MASH缓解率 以及纤维化改善的明确迹象 所有评估指标均指向药物的快速强效活性 [2][5] * 药物显示出强劲的减重效果 24周时体重减轻约6% 并且减重趋势仍在持续 未出现平台期 [2][20] * 药物具有多重作用机制 结合了glucagon的直接肝脏作用和GLP-1的代谢益处 可多方位治疗MASH 对血清脂质和血压等也有益处 [2][3][29] * 药物起效迅速 在非侵入性测试中早期就显示出变化 例如肝脂肪减少在12周时已与24周时相当 ALT改善在第4周就具有统计学显著性 [12][23] **耐受性与患者依从性** * 药物耐受性良好 在MASH研发药物中拥有最低的不良事件停药率 且无需剂量滴定 [3][12] * 良好的耐受性和早期疗效对于维持患者治疗依从性至关重要 而当前其他GLP-1药物存在高停药率问题 [14][15][16] **监管策略与三期试验设计** * 公司的基本策略是以基于活检的终点进入三期试验 但同时为监管变化预留灵活性 如采用AI组织学评估或非侵入性测试终点 [11][25][26] * 预计FDA会要求为期52周的三期试验终点和安全性数据 但非侵入性测试可以更早显示疗效 [22][23] * 采用AI评估和非侵入性测试可使试验更高效 成功概率更高 成本更低 [27] **市场定位与竞争格局** * 药物定位为可治疗从F1到F4的广泛MASH患者 结合了直接肝脏作用和减重益处 相比需要联合两种疗法的方案 单一分子更具优势 [32][34] * 与semaglutide相比 pemvidutide起效更快 72周的起效时间对于会进展为肝硬化的患者群体来说难以接受 [13][33] * 公司战略是专注于治疗MASH等具有高价值的难治性疾病 而非直接竞争肥胖适应症 肥胖是作为共病被治疗 [38] 其他重要内容 **AI组织学评估进展** * 欧洲已批准使用AI方法读取活检切片 提供该分析服务的PathAI公司已向FDA提交提案 预计FDA将在今年第四季度做出回应 [8][9] * AI评估被认为比人眼更准确 公司对此持乐观态度 并已获得优秀的AI读取结果 [8][9] **其他研发管线** * 公司在酒精使用障碍领域拥有快速通道资格 预计该试验将在2026年下半年读出结果 [36] * 酒精性肝病研究也已开始 对成功抱有高度信心 [36] **财务状况与合作** * 公司正在改善资产负债表 并评估所有选项为三期试验提供资金 [39] * 大型药企对MASH领域的兴趣回归 公司是战略讨论的一部分 但未透露具体细节 [29][31]