--- title: "周二 Replimune 的股票发生了什么情况？" type: "News" locale: "zh-CN" url: "https://longbridge.com/zh-CN/news/285246812.md" description: "Replimune Inc.（纳斯达克代码：REPL）面临显著的股价下跌，跌幅为 15.18%，至 2.58 美元，此次下跌与 FDA 领导层受到的批评有关，批评者为专员 Marty Makary。FDA 拒绝 Replimune 的黑色素瘤治疗方案引发了对审查流程不一致和患者获得潜在救命疗法机会有限的担忧。Makary 为 FDA 的决定辩护，表示多个独立审查团队支持这些拒绝决定。过去一个月，Replimune 的股价下跌了约 63.5%，而标准普尔 500 指数则上涨了 10.3%" datetime: "2026-05-05T17:44:00.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/285246812.md) - [en](https://longbridge.com/en/news/285246812.md) - [zh-HK](https://longbridge.com/zh-HK/news/285246812.md) --- # 周二 Replimune 的股票发生了什么情况？ U.S. Food and Drug Administration (FDA) Commissioner **Marty Makary** defended his leadership in a CNBC interview aired Tuesday, growing criticism with concerns centering on drug approval decisions and internal leadership disputes that have sparked political and public backlash. Among the companies affected by the FDA decisions is **Replimune Inc.**. **• Replimune Group ( REPL ) stock is showing notable weakness. Why is REPL stock dropping?** ## **Makary Responds To Mounting Criticism Over FDA Leadership** A Bloomberg report published Monday characterized Makary's tenure at the FDA as marked by internal disruption, leadership instability, and increasing frustration across the pharmaceutical industry. Reports of staff conflicts, frequent leadership turnover, and an inconsistent drug review process have unsettled biotech companies and drawn attention from lawmakers. While no immediate removal is planned, insiders say another major misstep could jeopardize his position, despite his efforts to implement reforms and defend his record. The Wall Street Journal report highlighted that a series of FDA rejections involving rare-disease and cancer treatments has drawn sharp reactions. Critics argue the agency has reversed prior guidance and relied on technical grounds to deny access to potentially life-saving therapies. **Read Also: Controversial FDA Vaccines Chief Vinay Prasad To Leave Agency In April** ## **Replimune Case Fuels Debate Over FDA Review Practices** One such case involves a melanoma treatment by **Replimune Inc.**, where roughly one-third of patients unresponsive to other immunotherapies reportedly achieved remission. After FDA rejection in April, Replimune ( REPL ) highlighted what it described as inconsistencies in the FDA’s review process. According to the company, a new review team was assigned during the resubmission phase, replacing the original team that had engaged with the company earlier. Critics contend the FDA's decision limits patient access despite promising outcomes. Similarly, a gene therapy developed by **uniQure N.V.** for Huntington's disease showed a 75% slowing in disease progression during trials. The FDA has called for an additional study involving a control group undergoing sham brain surgery, a requirement some experts have labeled unethical. ## **Makary Defends FDA Scientists and Decision Integrity** "I think that article in The Wall Street Journal is the ninth article they've posted in that opinion section, begging for Replimune's ( REPL ) approval," Makary said in the CNBC interview. "I don't work for Replimune ( REPL ), I work for the American people, and I stand by the scientists at the FDA." Makary told CNBC that three independent review teams reached the same conclusion and rejected claims that the FDA engaged in "corrupt sweetheart deals." Replimune ( REPL ) has alleged unfair treatment by the agency. He added that he supports the FDA's scientific review teams, arguing that commissioner-level overrides have historically led to poor outcomes. He pointed to past decisions, including the approval of **Biogen Inc.’s** Alzheimer's drug Aduhelm and authorization of a COVID-19 booster for low-risk children, as examples. **REPL Price Action:** Replimune Group ( REPL ) shares were down 15.18% at $2.58 at the time of publication on Tuesday, according to Benzinga Pro. Over the past month, REPL has declined about 63.5% versus a 10.3% rise in the S&P 500 and is down roughly 69% year-to-date compared to the index’s 5.5% gain. **Read Also: How Corporate Bitcoin Adoption Has Created New BTC Investment Vehicles** _Image via Shutterstock_ ### 相关股票 - [REPL.US](https://longbridge.com/zh-CN/quote/REPL.US.md) - [BBH.US](https://longbridge.com/zh-CN/quote/BBH.US.md) - [LABD.US](https://longbridge.com/zh-CN/quote/LABD.US.md) - [FBT.US](https://longbridge.com/zh-CN/quote/FBT.US.md) - [LABU.US](https://longbridge.com/zh-CN/quote/LABU.US.md) - [XBI.US](https://longbridge.com/zh-CN/quote/XBI.US.md) - [IBB.US](https://longbridge.com/zh-CN/quote/IBB.US.md) - [BIB.US](https://longbridge.com/zh-CN/quote/BIB.US.md) - [PBE.US](https://longbridge.com/zh-CN/quote/PBE.US.md) - [SBIO.US](https://longbridge.com/zh-CN/quote/SBIO.US.md) - [QURE.US](https://longbridge.com/zh-CN/quote/QURE.US.md) - [BIIB.US](https://longbridge.com/zh-CN/quote/BIIB.US.md) - [.SPX.US](https://longbridge.com/zh-CN/quote/.SPX.US.md) ## 相关资讯与研究 - [CAR-T 迎接新时代](https://longbridge.com/zh-CN/news/286999381.md) - [创胜集团医药-B 合作伙伴 INHIBRX 报告 OZEKIBART 的 CRC 最新积极数据并宣布就治疗软骨肉瘤提交美国 BLA 申请](https://longbridge.com/zh-CN/news/287126678.md) - [Tevogen Bio Q1 运营亏损收窄 48%，推进 AI 平台与细胞疗法管线](https://longbridge.com/zh-CN/news/287086570.md) - [Scholar Rock 将出席杰富瑞全球医疗保健大会，聚焦 SMA 新药 apitegromab 关键审批](https://longbridge.com/zh-CN/news/287069556.md) - [默沙东 ADC 药物达 III 期主要终点](https://longbridge.com/zh-CN/news/286929703.md)