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.（納斯達克股票代碼：SGMO）重新獲得了giroctogene fitelparvovec的開發和商業化權。giroctogene fitelparvovec是與輝瑞公司（紐約證券交易所代碼：PFE）共同開發並授權給輝瑞公司（紐約證券交易所代碼：PFE）的中重度至重度A型血友病的研究性候選基因療法產品。
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打算探索推進該計劃的所有選擇，包括尋找潛在的新合作伙伴。
Also Read: FDA Approves Pfizer's Second Hemophilia Drug With Six Months
另請閱讀：美國食品藥品管理局批准輝瑞在六個月內推出的第二種血友病藥物
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.
2024年7月，輝瑞公佈了giroctogene fitelparvovec的3期AFFINE試驗的主要結果，該結果表明，與預防相比，該試驗達到了優勢的主要和關鍵次要目標。
"...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..."
Sangamo Therapeutics首席執行官桑迪·麥克雷表示：「... 我們認爲它完全有能力提交監管申報和潛在的商業化。」「雖然輝瑞決定在接近預期的BLA和MAA提交文件時結束合作，但我們對此感到驚訝和極度失望...」
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。在過渡期間，將繼續按計劃對所有試驗參與者進行監測。
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.
桑加莫認爲，其最近宣佈與羅氏控股股份公司（場外交易代碼：RHHBY）基因泰克和安斯泰來製藥公司（場外交易代碼：ALPMF）（場外交易代碼：ALPMY）的合作伙伴關係以及就其法布里基因療法項目進行深入的業務發展討論，將使其能夠爲其神經病學基因組醫學產品線規劃前進方向。
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ST-503特發性小纖維神經病的1/2期研究的預期患者入組，並預計在2025年第四季度提交朊病毒病項目的臨牀試驗授權申請，每份申請均需獲得額外資金。
Price Action: SGMO stock is down 54.70% at $1.106 during the premarket session at last check Tuesday.
價格走勢：在週二最後一次盤前交易中，SGMO股價下跌54.70％，至1.106美元。
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