Pfizer Inc ((PFE)) announced an update on their ongoing clinical study.
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Pfizer Inc. is conducting a Phase 3 study titled ‘A Phase 3, Non-Investigational Product, Multi Country Cohort Study to Describe the Long-Term Safety and Effectiveness of a Prior Single-Dose Treatment with Investigative Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Participants with Hemophilia A or Hemophilia B, Respectively.’ The study aims to assess the long-term safety and efficacy of these treatments in patients who have previously participated in Pfizer-sponsored trials. This research is significant as it could provide critical insights into the lasting impacts of these gene therapies on hemophilia patients.
The interventions being tested are giroctocogene fitelparvovec for Hemophilia A and fidanacogene elaparvovec for Hemophilia B. These are diagnostic tests evaluating hepatic AAV vector integration, which is crucial for understanding the gene therapy’s long-term effects.
The study is designed as a non-randomized, single-group intervention model with no masking. It is not an investigational study but focuses on observing the long-term outcomes of previously administered treatments.
The study began on October 3, 2022, and is currently recruiting participants. The last update was submitted on August 12, 2025. These dates are important as they indicate the study’s ongoing nature and commitment to gathering comprehensive data over time.
The update on this study could influence Pfizer’s stock performance positively, as successful long-term results may boost investor confidence in the company’s gene therapy pipeline. In the competitive landscape of hemophilia treatments, Pfizer’s advancements could set a new benchmark, potentially impacting competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.