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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).
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.
Also Read: FDA Approves Pfizer’s Second Hemophilia Drug With Six Months
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.
“...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...”
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.
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.
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.
Price Action: SGMO stock is down 54.70% at $1.106 during the premarket session at last check Tuesday.
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This article Sangamo Therapeutics Stock Plunges As Pfizer Terminates Hemophilia Gene Therapy Pact originally appeared on Benzinga.com
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