Bluebird bio Inc ((BLUE)) announced an update on their ongoing clinical study.
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Bluebird bio Inc. is conducting a study titled ‘A Postmarketing, Prospective, Multicenter, Observational, Long-Term Safety and Effectiveness Registry Study of Patients With Cerebral Adrenoleukodystrophy (CALD) Treated With Elivaldogene Autotemcel (Stargazer)’. The study aims to evaluate the long-term safety and effectiveness of Elivaldogene Autotemcel (Skysona) in treating CALD, focusing on safety outcomes and major functional disability-free survival over time.
The intervention being tested is Elivaldogene Autotemcel, a gene therapy product designed to treat CALD. This study is non-interventional, meaning no new drug will be administered; it will observe patients already treated with the therapy.
The study is observational, following a cohort model with a prospective time perspective. It will track 120 participants over 15 years to gather real-world data on the therapy’s outcomes.
The study began on March 27, 2024, with an estimated completion date 15 years later. The latest update was submitted on June 30, 2025, indicating ongoing recruitment and data collection.
This study update could positively impact Bluebird bio’s stock performance as it underscores the company’s commitment to long-term safety and effectiveness, potentially boosting investor confidence. The study’s findings may also influence the competitive landscape in gene therapy for rare diseases.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.