Sangamo Therapeutics Stock Plunges As Pfizer Terminates Hemophilia Gene Therapy Pact
Sangamo Therapeutics Stock Plunges As Pfizer Terminates Hemophilia Gene Therapy Pact
In July 2024, Pfizer announced topline results from the Phase 3 AFFINE trial of giroctocogene fitelparvovec, which demonstrated that the trial met the primary and key secondary objectives of superiority compared to prophylaxis.On Monday, Sangamo Therapeutics, Inc. (NASDAQ:SGMO) regained the development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for moderately severe to severe hemophilia A that it has co-developed with and licensed to Pfizer Inc (NYSE:PFE).
周一，Sangamo Therapeutics, Inc.（纳斯达克：SGMO）重新获得了giroctocogene fitelparvovec的开发和商业化权利，这是一种针对中重度到重度血友病A的试验性基因治疗产品候选者，该产品与辉瑞公司（纽交所：PFE）共同开发并授权。
Pfizer decided to terminate the global collaboration and license agreement between the parties. Sangamo intends to explore all options to advance the program, including seeking a potential new collaboration partner.
辉瑞决定终止双方之间的全球合作和许可协议。Sangamo计划探索所有可能的选项以推进该项目，包括寻找可能的新合作伙伴。
Also Read: FDA Approves Pfizer's Second Hemophilia Drug With Six Months
另见：FDA批准辉瑞的第二款血友病药物，时隔六个月
In July 2024, Pfizer announced topline results from the Phase 3 AFFINE trial of giroctocogene fitelparvovec, which demonstrated that the trial met the primary and key secondary objectives of superiority compared to prophylaxis.
在2024年7月，辉瑞公布了giroctocogene fitelparvovec的3期AFFINE试验的顶线结果，显示该试验达到了与预防治疗相比的主要和关键次要优越性目标。
"...we believe it is well positioned for regulatory submissions and potential commercialization," said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. "While we were surprised and extremely disappointed by Pfizer's decision to end our collaboration so close to the anticipated BLA and MAA submissions..."
“……我们认为它在监管提交和潜在商业化方面处于良好位置，”Sangamo Therapeutics首席执行官Sandy Macrae表示。“虽然我们对辉瑞决定在预期的BLA和MAA提交前终止我们的合作感到惊讶和非常失望……”
The collaboration and license agreement with Pfizer will terminate effective April 21, 2025. All trial participants will continue to be monitored as planned during the transition period.
与辉瑞的合作和许可协议将于2025年4月21日终止。所有试验参与者将在过渡期间继续按计划接受监测。
Sangamo believes that its recently announced partnerships with Roche Holdings AG's (OTC:RHHBY) Genentech and Astellas Pharma Inc (OTC:ALPMF) (OTC:ALPMY) and advanced business development discussions for its Fabry gene therapy program will allow it to chart a path forward for its neurology genomic medicine pipeline.
Sangamo相信，它最近宣布与罗氏控股有限公司（场外交易：RHHBY）的Genentech和安斯泰莱制药(ADR)（场外交易：ALPMF）（场外交易：ALPMY）建立的合作关系，以及其Fabry基因治疗项目的先进业务发展讨论，将使其能够为其神经科学基因治疗管道制定前进路径。
The company prepares to initiate the expected enrollment of patients in the Phase 1/2 study of ST-503 for idiopathic small fiber neuropathy in mid-2025 and file an anticipated Clinical Trial Authorisation submission for the prion disease program in Q4 2025, each subject to securing additional funding.
该公司准备在2025年中期启动针对特发性小纤维神经病的St-503 1/2期研究患者的预期入组，并计划在2025年第四季度提交朊病毒病项目的预期临床试验授权申请，这些都需获得额外资金的保障。
Price Action: SGMO stock is down 54.70% at $1.106 during the premarket session at last check Tuesday.
价格行动：SGMO股票在周二盘前交易时下跌54.70%，报1.106美元。
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