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).
週一，Sangamo Therapeutics, Inc.（納斯達克：SGMO）重新獲得了giroctocogene fitelparvovec的開發和商業化權利，這是一種針對中重度到重度血友病A的試驗性基因治療產品候選者，該產品與輝瑞公司（紐交所：PFE）共同開發並授權。
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.
輝瑞決定終止雙方之間的全球合作和許可協議。Sangamo計劃探索所有可能的選項以推進該項目，包括尋找可能的新合作伙伴。
Also Read: FDA Approves Pfizer's Second Hemophilia Drug With Six Months
另見：FDA批准輝瑞的第二款血友病藥物，時隔六個月
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，輝瑞公佈了giroctocogene fitelparvovec的3期AFFINE試驗的頂線結果，顯示該試驗達到了與預防治療相比的主要和關鍵次要優越性目標。
"...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..."
「……我們認爲它在監管提交和潛在商業化方面處於良好位置，」Sangamo Therapeutics首席執行官Sandy Macrae表示。「雖然我們對輝瑞決定在預期的BLA和MAA提交前終止我們的合作感到驚訝和非常失望……」
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.
與輝瑞的合作和許可協議將於2025年4月21日終止。所有試驗參與者將在過渡期間繼續按計劃接受監測。
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，它最近宣佈與羅氏控股有限公司（場外交易：RHHBY）的Genentech和安斯泰萊製藥(ADR)（場外交易：ALPMF）（場外交易：ALPMY）建立的合作關係，以及其Fabry基因治療項目的先進業務發展討論，將使其能夠爲其神經科學基因治療管道制定前進路徑。
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.
該公司準備在2025年中期啓動針對特發性小纖維神經病的ST-503 1/2期研究患者的預期入組，並計劃在2025年第四季度提交朊病毒病項目的預期臨牀試驗授權申請，這些都需獲得額外資金的保障。
Price Action: SGMO stock is down 54.70% at $1.106 during the premarket session at last check Tuesday.
價格行動：SGMO股票在週二盤前交易時下跌54.70%，報1.106美元。
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譯文內容由第三人軟體翻譯。