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bluebird bio, inc

Company Namebluebird bio, inc
Stock SymbolBLUE
Class PeriodMay 11, 2020 to November 04, 2020
Lead Plaintiff Motion DeadlineApril 13, 2021

In May 2020, in the midst of the COVID-19 pandemic, bluebird announced that the Company expected to submit a U.S. Biologics Licensing Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for LentiGlobin for sickle cell disease in the second half of 2021.

On November 4, 2020, post-market, bluebird disclosed that it would delay its BLA submission to late 2022 due to “feedback” from the FDA that requires the Company to provide additional data “to demonstrate drug product comparability” for LentiGlobin for sickle cell disease, as well as “COVID-19 related shifts and contract manufacturing organization COVID-19 impacts.”

On this news, bluebird’s stock price fell $9.72 per share, or 16.6%, to close at $48.83 per share on November 5, 2020.

 

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