News Summary
* Pfizer Ends Global Collaboration and License Agreement with Sangamo for the Development and Commercialization of Giroctocogene fitelparvovec.* Sangamo Regains Full Rights to Giroctocogene fitelparvovec.* SGMO plunges over 60% to $0.92.
Shares of Sangamo Therapeutics Inc. (SGMO) plunged more than 60% in after-hours trading Monday, following Pfizer Inc.'s (PFE) decision to terminate their collaboration agreement regarding Giroctocogene fitelparvovec, a gene therapy for Hemophilia A.
Giroctocogene fitelparvovec was being developed as part of a collaboration between Sangamo and Pfizer, under an agreement signed in 2017.
Hemophilia A is a rare bleeding disorder caused by mutations in the F8 gene, leading to insufficient clotting factor VIII (FVIII) in the bloodstream. FVIII is crucial for normal blood clotting, and the severity of Hemophilia is determined by its deficiency. Lower levels of FVIII increase the likelihood of bleeding, potentially resulting in significant health complications. Giroctocogene fitelparvovec is intended to deliver a working copy of the F8 gene to the liver so that liver cells can start producing functional FVIII clotting factor.
In a phase III trial that evaluated the efficacy and safety of a single infusion of Giroctocogene fitelparvovec in 75 adult (ages 18-64 years) male participants with moderately severe to severe Hemophilia A, dubbed AFFINE, the primary and key secondary objectives of superiority compared to prophylaxis were met. The results of the AFFINE trial were reported in July of this year.
Pfizer had initially planned to submit a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for Giroctocogene fitelparvovec in early 2025. However, with Pfizer exiting the collaboration, Sangamo is now planning to seek a potential new collaboration partner to continue the development of Giroctocogene fitelparvovec.
The termination of the collaboration and license agreement with Pfizer will take effect on April 21, 2025.
SGMO has traded in a range of $0.30 to $3.18 in the last 1 year. The stock closed Monday's trading at $2.34, down 8.59%. In after-hours, the stock plunged 60.38% to $0.92.
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