bluebird bio (BLUE) Lyfgenia FDA Approval Case

D. Massachusetts

Court

1:24-cv-10803

Case number

04/24/2023

Class period Start

12/08/2023

Class period End

05/28/2024

Lead Plaintiff motion deadline

$BLUE stockholder filed a claim vs. bluebird bio Inc. for overstating chances to obtain FDA approval and priority review voucher without any black box warnings. 
On December 8, 2023, unfavorable details about FDA approval caused $BLUE to fall 40.5%, losing $375M+ in shareholder value.
On December 8, 2023, Bluebird bio (BLUE) announced that it had received approval from the FDA for its ex-vivo gene therapy drug Lyfgenia for sickle cell disease. 
Along with the approval came a black box warning for hematological malignancies with a requirement to monitor patients for cancer through complete blood counts at least every six months for at least 15 years. 
Plus viral vector integration site analysis every six months as warranted. 
Additionally, the Company’s anticipated priority review voucher was denied by the FDA.
On this news, $BLUE fell 40.5% and lost over $375 million of its market capitalization, seriously injuring investors.

On March 26, 2024, bluebird announced that it would restate several financial statements for 2022 and 2023 concerning the identification of embedded leases and the treatment of non-lease components contained in lease agreements with contract manufacturers. The Company further stated that it expects an increase in lease assets and lease liabilities, as well as an increase in non-cash interest expense in the restated periods.

On this news, $BLUE fell 11.8%, further damaging investors.

Now, investors have reasons to suspect bluebird of overstating its chances to obtain FDA approval without any black box warnings and to be granted the FDA's priority review voucher.

The first investor has filed the initial claim over this situation in a Massachusetts court to recover thier losses. 

Details: https://11thestate.com/cases/bluebird-bio-investor-suit

Case Status

Motion to dismiss

Alleged Offence

Misleading Statements,

Failure to Disclose,

Omissions

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

12/08/2023

Filing date

03/28/2024

Lead Plaintiff Deadline

05/28/2024

Judge

Hon. Patti B. Saris

bluebird bio (BLUE) Lyfgenia FDA Approval Case

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