Sign In
Step 1
Unite with Fellow Investors
Step 2
Choose the Best Attorney
Step 3
Provide Documents
Step 4
Follow Case Progress
Step 5
Get Payout
BLUE.US
id: 1170

bluebird bio (BLUE) Lyfgenia FDA Approval Case

D. Massachusetts
Court
1:24-cv-10803
Case number
24 Apr 2023
Class period Start
08 Dec 2023
Class period End
28 May 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
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
08 December 2023
Filing date
28 March 2024
Lead Plaintiff Deadline
28 May 2024
Judge
Hon. Patti B. Saris
Collecting participants…

Bluebird bio Inc

bluebird bio, Inc., a biotechnology company, researches, develops, and commercializes gene therapies for severe genetic diseases. Its product candidates for severe genetic diseases include ZYNTEGLO...

    Ticker
    BLUE.US
    ISIN
    US09609G1004
    CIK
    1293971
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    455 Grand Union Boulevard, Somerville, MA, United States, 02145