EMA accepts Bluebird Bio's MAA for LentiGlobin gene therapy [Seeking Alpha]
bluebird bio, Inc. (BLUE)
Last bluebird bio, inc. earnings: 2/18 04:05 pm
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US:NASDAQ Investor Relations:
investor.bluebirdbio.com/investor-overview
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Source: Seeking Alpha
The European Medicines Agency (EMA) accepts Bluebird Bio's (NASDAQ: BLUE ) marketing authorization application (MAA) for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent ß-thalassemia (TDT) and a non-ß 0 /ß 0 genotype. LentiGlobin was previously granted an accelerated assessment by the CHMP of the EMA in July 2018, reducing the EMA’s review time of the MAA from 210 days to 150 days. The MAA is supported by data from the completed Phase 1/2 Northstar (HGB-204) study and the ongoing Phase 1/2 HGB-205 study as well as available data from the Phase 3 Northstar-2 (HGB-207) study and the long-term follow-up study LTF-303. Click to subscribe to real-time analytics on BLUE Now read: Emergent Biosolutions completes acquisition of PaxVax » Subscribe for full text news in your inbox
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News
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- BLUE INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Reminds bluebird bio, Inc. Investors to Join the Class Action LawsuitAccesswire
BLUE
Earnings
- 11/7/23 - Beat
BLUE
Sec Filings
- 4/16/24 - Form 8-K
- 4/10/24 - Form SC
- 3/26/24 - Form 8-K
- BLUE's page on the SEC website