Biotech Values

[DewDiligence]

PFE/SGMO re-open phase-3 hemophilia-A GT trial_after_FDA_lifts clinical hold:

https://www.pfizer.com/news/announcements/pfizer-and-sangamo-therapeutics-announce-phase-3-trial-investigational-gene

Pfizer and Sangamo Therapeutics announced that the Phase 3 AFFINE study evaluating giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A, has re-opened recruitment. Trial sites will begin to resume enrollment this month, with dosing expected to resume in October. All trial sites are anticipated to be active by the end of 2022 and a pivotal readout is expected in the first half of 2024.

I.e., the FDA clinical hold set back the program two years.

Trial listing:
https://www.clinicaltrials.gov/ct2/show/NCT03587116