BLUE - Is bluebird bio's Surge a Bellwether for Gene Editing Stocks?
Pioneering biotech bluebird bio (NASDAQ: BLUE) has resumed clinical trials for its blood disorder gene therapies after getting clearance from the U.S. Food and Drug Administration (FDA). The stock is up more than 10% over the past five days in response, and the FDA's move bodes well for other gene therapy companies.
In February, two patients in separate studies using the company's lentiviral vector (a type of gene-therapy delivery system) came down with suspected cases of blood cancer. After further review, bluebird bio said that multiple independent analyses found it was unlikely either diagnosis was linked to the company's BB305 lentiviral. The FDA, after looking at the company's analysis, agreed, and last week the agency lifted the embargo on the trials .
This means that bluebird can go back to selling Zynteglo (a therapy to fight blood disorder transfusion-dependent beta-thalassemia (TDT)) in Europe, where it already has European Medicines Agency approval, which makes it more likely the drug will be approved in the United States. It also means that the company's phase 3 trials of LentiGlobin to fight sickle cell disease (SCD) and elivadogen autotemcel to fight cerebral adrenoleukodystrophy (ALD, a genetic condition where the myelin sheath that covers nerve cells in the brain is damaged, causing behavioral and neurological symptoms), can continue as well.
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Is bluebird bio's Surge a Bellwether for Gene Editing Stocks?