What happened
Shares of Bluebird Bio (BLUE +0.00%) had popped by more than 34.3% at 10:58 ET Friday morning amid a wider rally in the cell and gene therapy segments of the biotech industry. The jump in its shares appears to have been caused by two things: an upbeat video message presented by its CEO Andrew Obenshain late on June 16 at the European Hematology Association Hybrid 2022 Congress and another earlier presentation by CRISPR Therapeutics describing excellent results with its exa-cel therapy for beta thalassemia and sickle cell disease.
NASDAQ: BLUE
Key Data Points
So what
Bluebird is currently working to commercialize a pair of cell therapies for beta thalassemia and sickle cell disease. While its beti-cel candidate for beta thalassemia got the green light from the Food and Drug Administration's (FDA) advisory committee on June 10 and could be commercialized by the end of this year, its sickle cell program called lovo-cel is a bit further behind in the pipeline.
The positive data presented by CRISPR Therapeutics suggest that the company's therapies could be a functional cure for both conditions. That's highly relevant to Bluebird, as it's another piece of supporting evidence indicating that it's possible to make a similarly potent pair of medicines. Likewise, the CEO's comments at the conference are a sign that management thinks its programs are on track for approval.
Now what
Beti-cel will go before the FDA's binding committee for a final ruling on whether it can be commercialized on August 19, and the company is aiming to submit the regulatory package for lovo-cel around Q1 of 2023. Today's news indicates that the market is growing increasingly confident in the prospect of Bluebird getting beti-cel out the door, and the stock may continue to surge if regulators give it the final OK.
