Dive Insight:

Bluebird is in the midst of an investigation that carries substantial consequences for both its sickle cell gene therapy, and for the broader field of companies and researchers that use similar technology in other treatments.

While initial findings indicated the virus Bluebird uses for its therapy was “very unlikely” the cause of a leukemia case, the diagnosis has renewed concerns over cancer risk. Follow-up on the second case — reportedly myelodysplastic syndrome — remains ongoing.

Simultaneously, the biotech is moving forward with a plan to split itself in two, separating its cancer drug research into a new company while retaining its work in severe genetic diseases under the Bluebird bio name.

Davidson’s exit is another significant change, although it’s not clear how much recent events tied into his planned departure.

“Per the company, Dr. Davidson made an independent decision to transition away from his role as Bluebird embarks on separating the [severe genetic disease] and oncology programs into two distinct businesses,” wrote Benjamin Burnett, an analyst at Stifel, in a note to clients.

Bluebird did not return BioPharma Dive’s request for comment.

According to the form Bluebird filed with regulators, Davidson’s employment will end April 16, after which he’ll consult with the company for six months. In particular, Bluebird said he will “provide ongoing guidance and support for bluebird’s late-stage development programs in severe genetic disease, particularly as it navigates the regulatory interactions following the safety events reported to the Company in February 2021.”

Davidson’s duties as CMO will be passed on an interim basis to Richard Colvin, who most recently served as senior vice president of clinical research in severe genetic diseases, Stifel’s Burnett wrote.

Shares in Bluebird fell 5% on Wednesday.