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北京时间·🕒 发布 21:36:34时区推断·⟳ 抓取 21:37:44·⚡ 决策 07-30 21:40:08 +2m24s·88.9 天前
Capricor的DMD心肌病疗法deramiocel遭FDA顾问委员会否定疗效证据
FDA顾问委员会以9:3认为现有证据不支持deramiocel治疗DMD心肌病的有效性，对Capricor核心疗法审批概率构成直接负面。
📄 原文Investing.com↗ 原文
FDA advisory panel votes against Capricor’s DMD therapy
U.S. launches fresh strikes on Iran as fighting intensifies across Middle East SAN DIEGO - Capricor Therapeutics (NASDA…
不做 Capricor Therapeutics（CAPR.US）
近72小时已处理过同一具体催化，命中CAPR.US news_center/twitter多条deramiocel遭FDA顾问委员会否决记录；为避免重复推卡和重复风险信号，本条不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
🔎 新鲜度:最早出现 2026-07-30 · 扩散 medium · price-in 风险 high ↗
关键理由
- FDA顾问委员会以9:3认为现有证据不支持deramiocel治疗DMD心肌病的有效性，对Capricor核心疗法审批概率构成直接负面。
- 但近72小时已处理过同一具体催化，多条CAPR.US决策记录已覆盖该FDA顾问委员会否决事件，本条不应重复出卡或重复生成风险。
- Capricor Therapeutics（CAPR.US）盘中已大跌约52%，重复处理不会新增可执行信息。
主要风险
- 若FDA后续仍在8月22日前批准或给出意外正面路径，当前负面判断会被反转。
反向证据
- 做空前查反向 · 来源 kb_search · 日期 2026-07-30 · 影响 none
内部KB未命中足以反转FDA顾问委员会9:3负面投票的近期利好证据。
检索:Capricor Deramiocel FDA advisory committee DMD therapy recent bullish bearish - 做空前查反向 · 来源 kb_search · 日期 2026-07-30 · 影响 supports
内部KB命中FDA会议通知与BLA 125842背景，未显示顾问委员会负面投票前已有同等最终结果。
检索:Capricor Therapeutics CAPR Deramiocel revenue cash runway FDA PDUFA August 22 2026 原文 ↗
工具调用 · 历史记录,结果未知(3 种)
- search_processed_events · 结果未知
- stock_quote · 结果未知
- kb_search · 结果未知
原文全文
展开原文 · 1,955 字
U.S. launches fresh strikes on Iran as fighting intensifies across Middle East
SAN DIEGO - Capricor Therapeutics (NASDAQ:CAPR) announced today that a U.S. Food and Drug Administration advisory committee voted 9 to 3 that available evidence did not support the effectiveness of Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy.
The Cellular, Tissue and Gene Therapies Advisory Committee’s vote is non-binding, according to a press release statement. The committee’s voting question addressed a narrower indication than Capricor had proposed and did not include a vote on the therapy’s overall benefit-risk profile.
The committee provided feedback on upper limb function that was directionally supportive of clinical evidence from the Phase 3 HOPE-3 trial, including results on its primary endpoint, PUL 2.0.
Duchenne muscular dystrophy is a severe genetic disorder affecting approximately 15,000 individuals in the United States, primarily boys. The disease causes progressive muscle degeneration, and cardiomyopathy is the leading cause of death. No approved cardiomyopathy treatment currently exists for the condition.
Deramiocel consists of allogeneic cardiosphere-derived cells that have been administered to over 250 human subjects across multiple clinical trials. The therapy has received Orphan Drug Designation from the FDA and European Medicines Agency, as well as Regenerative Medicine Advanced Therapy designation in the U.S.
The FDA’s target action date for Deramiocel is August 22, 2026.
"We remain committed to Deramiocel and to the patients who could benefit from it," said Linda Marbán, Chief Executive Officer of Capricor. "We remain confident in the strength of the HOPE-3 data."
The company stated it will continue working with the FDA toward potential approval ahead of the August deadline.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
SAN DIEGO - Capricor Therapeutics (NASDAQ:CAPR) announced today that a U.S. Food and Drug Administration advisory committee voted 9 to 3 that available evidence did not support the effectiveness of Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy.
The Cellular, Tissue and Gene Therapies Advisory Committee’s vote is non-binding, according to a press release statement. The committee’s voting question addressed a narrower indication than Capricor had proposed and did not include a vote on the therapy’s overall benefit-risk profile.
The committee provided feedback on upper limb function that was directionally supportive of clinical evidence from the Phase 3 HOPE-3 trial, including results on its primary endpoint, PUL 2.0.
Duchenne muscular dystrophy is a severe genetic disorder affecting approximately 15,000 individuals in the United States, primarily boys. The disease causes progressive muscle degeneration, and cardiomyopathy is the leading cause of death. No approved cardiomyopathy treatment currently exists for the condition.
Deramiocel consists of allogeneic cardiosphere-derived cells that have been administered to over 250 human subjects across multiple clinical trials. The therapy has received Orphan Drug Designation from the FDA and European Medicines Agency, as well as Regenerative Medicine Advanced Therapy designation in the U.S.
The FDA’s target action date for Deramiocel is August 22, 2026.
"We remain committed to Deramiocel and to the patients who could benefit from it," said Linda Marbán, Chief Executive Officer of Capricor. "We remain confident in the strength of the HOPE-3 data."
The company stated it will continue working with the FDA toward potential approval ahead of the August deadline.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
决策记录链 · 只追加
每次领取产生一条记录,重新决策追加一条并以 supersedes 指向被替代的记录(ADR 0014)。
这条决策早于决策账本(2026-10-08 起逐条追加),没有追加记录。