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# Bluebird Bio Suspends 2 Gene Therapy Studies
- URL: https://www.fdaweb.com/bluebird-bio-suspends-2-gene-therapy-studies/
- Published: 2021-02-16T12:00:00.000Z
- Updated: 2026-09-14T16:46:48.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148668

Bluebird Bio has temporarily suspended its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease due to a reported “suspected unexpected serious adverse reaction” (SUSAR) of acute myeloid leukemia (AML). The [company says](https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-temporary-suspension-phase-12-and-phase-3?ref=fdaweb.com) it received a report last week that a patient who was treated more than five years was diagnosed with AML. It is investigating the case to determine if there is any relationship to the therapy. Additionally, Bluebird says a second SUSAR involving myelodysplastic syndrome was reported last week and is currently being investigated.