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Tuesday, April 16, 2024 5:45:31 PM
IMO, Blue has not committed the securities law violations alleged (which have not been named or enumerated, btw), and any lawsuit going forward should be filed against the FDA for their issuance of the "Blackbox" warning. Blue stated previously they intend to address the non-award of the PRV with the FDA. They should also be pursuing removal of the "Blackbox" warning; if the Blackbox warning had teeth, the clinical trial hold should never have been lifted in the first place - but the FDA vindicated BLUE from this previously. Furthermore, if BLUE did commit securities fraud (again, unspecified how), then that falls onto the regulatory agency moreso than BLUE, IMO.
Honestly - if not a single analyst anticipated the Blackbox warning, this is all a malignant waste of time by the FDA.
[ALLEGATIONS: According to the complaint, on December 8, 2023, Blue announced that the Food and Drug Administration (FDA) approved its drug Lyfgenia (lovotibeglogene autotemcel), also known as lovo-cel for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs). However, the Lyfgenia approval came with a black box warning for haematological malignancies after two patients developed AML during the clinical trials. Analysts noted that they did not expect the black box warning or the absence of a priority review voucher. Following this news, Blue's stock price fell by $1.95 per share, or approximately 40% to close at $2.86 per share.]
Recent BLUE News
- Form 8-K - Current report • Edgar (US Regulatory) • 07/11/2024 11:38:42 AM
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- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 06/13/2024 09:00:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:22:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/29/2024 11:06:00 AM
- bluebird bio Appoints O. James Sterling as Chief Financial Officer • Business Wire • 05/29/2024 11:00:00 AM
- Investors in bluebird bio, Inc. Should Contact The Gross Law Firm Before May 28, 2024 to Discuss Your Rights - BLUE • PR Newswire (US) • 05/21/2024 09:45:00 AM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2024 08:05:45 PM
- Class Action Filed Against bluebird bio, Inc. (BLUE) Seeking Recovery for Investors - Contact The Gross Law Firm • PR Newswire (US) • 05/14/2024 09:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 11:01:50 AM
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- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 28, 2024 in bluebird bio, Inc. Lawsuit - BLUE • PR Newswire (US) • 05/07/2024 09:45:00 AM
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- Class Action Filed Against bluebird bio, Inc. (BLUE) - May 28, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 05/03/2024 09:45:00 AM
- bluebird bio Announces Receipt of Expected Notice from Nasdaq • Business Wire • 04/26/2024 08:05:00 PM
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- Shareholders that lost money on bluebird bio, Inc.(BLUE) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 04/12/2024 09:45:00 AM
- bluebird bio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 04/11/2024 12:00:00 PM
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- Shareholders that lost money on bluebird bio, Inc.(BLUE) should contact The Gross Law Firm about pending Class Action - BLUE • PR Newswire (US) • 04/05/2024 09:45:00 AM
- bluebird bio Reports Fourth Quarter and 2023 Annual Results and Highlights Operational Progress and 2024 Guidance • Business Wire • 03/26/2024 11:01:00 AM
- bluebird bio to Host Fourth Quarter and 2023 Annual Results Conference Call • Business Wire • 03/25/2024 08:05:00 PM
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