On Monday, Sangamo Therapeutics, Inc. (NASDAQ:SGMO) has regained development and commercialization rights to giroctocogene fitelparvovec, a gene therapy product candidate for moderate to severe hemophilia A, which it co-developed and in-licensed Pfizer Inc (NYSE:PFE).
Pfizer decided to terminate the global collaboration and licensing agreement between the parties. Sangamo plans 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, showing that the trial met its primary and key secondary objectives of superiority. compared to prophylaxis.
“…we believe it is well positioned for regulatory filings 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 partnership so close to the expected BLA and MAA submissions….”
The collaboration and licensing agreement with Pfizer will be terminated with effect from 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 (OTC:RHHBY) Genentech And Astellas Pharma Inc (OTC:ALPMF) (OTC:ALPMY) and advanced business development discussions for its Fabry gene therapy program will enable the company to chart a path forward for its neurology genomic drug pipeline.
The company is preparing to begin anticipated patient recruitment in the Phase 1/2 study of ST-503 for idiopathic small fiber neuropathy in mid-2025 and to submit an anticipated clinical trial authorization for the prion disease program in the fourth quarter of 2025, each subject to securing additional financing.
Price promotion: SGMO shares are down 54.70% to $1,106 during the premarket session at last check Tuesday.
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This article Sangamo Therapeutics Stock Plummets as Pfizer Ends Hemophilia Gene Therapy Pact originally appeared on Benzinga.com
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