The submission of U.S. BLA for ide-cel (bb2121) remains on track for H1 2020.
Bluebird bio does not anticipate completing the rolling BLA submission for LentiGlobin for β-thalassemia until mid-2021 (Q2/Q3).
The company is currently on track to submit the
marketing authorization application in the EU for Lenti-D for CALD by
year-end 2020. BLUE anticipates the submission of U.S. BLA for Lenti-D
in CALD in mid-2021.
Bluebird bio continues to engage in discussions
with the FDA about the regulatory path for LentiGlobin for Sickle Cell
Disease. The company reiterates guidance for a regulatory update by the
end of 2020.
In January 2020, the company launched ZYNTEGLO in
Germany. Treatment of the first patient in Germany is expected to be
shifted to H2 2020.
The company is re-evaluating its operating plan.
Bluebird bio will be adjusting priorities and overall expenses. An
update will be provided by the company’s Q1 2020 earnings release.
As a partner in development of ide-cel,
Bristol-Myers Squibb has temporarily suspended screening, enrollment and
apheresis in their cellular therapy clinical studies, which includes
the KarMMa-2, KarMMa-3 and KarMMa-4 studies.
Planned data disclosures for 2020 remain on track.
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