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Share Name | Share Symbol | Market | Type |
---|---|---|---|
bluebird bio Inc | NASDAQ:BLUE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.1254 | 12.87% | 1.10 | 1.10 | 1.11 | 1.23 | 1.01 | 1.02 | 11,517,879 | 00:58:46 |
By Colin Kellaher
Bluebird bio has won U.S. Food and Drug Administration approval of its Lyfgenia gene therapy for sickle-cell disease, making it one the first two cell-based gene therapies to win a U.S. green light for the inherited blood disorder.
The FDA on Friday said the approval covers Lyfgenia for the treatment of patients 12 years of age and older with sickle-cell disease and a history of vaso-occlusive events.
The FDA nod, nearly two weeks ahead of the target action date of Dec. 20, comes on the same day the agency cleared the Casgevy gene-therapy from CRISPR Therapeutics and Vertex Pharmaceuticals, marking the first U.S. approval for a drug using the gene-editing technology known as Crispr.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 08, 2023 11:48 ET (16:48 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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