- A phase 3 trial of Pfizer ( NYSE: PFE ) and Sangamo Therapeutics ( NASDAQ: SGMO ) Therapeutics' giroctocogene fitelparvovec, a gene therapy for hemophilia A, has reopened recruitment .
- Dosing is expected to begin next month with all trial sites operational by the end of the year. A pivotal readout is expected in 1H 2024.
- The US FDA earlier this year lifted a clinical hold on the study, named AFFINE.
- The trial is expected to enroll 60 adult male participants and evaluate a single dose of giroctocogene fitelparvovec.
- The primary endpoint is impact on annualized bleeding rate 15 months after receiving treatment.
- Seeking Alpha's Quant Rating views Sangamo ( SGMO ) as a buy with high marks for momentum and revisions .
For further details see:
Pfizer, Sangamo reopen recruitment for late-stage trial of hemophilia A gene therapy