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What happened
bluebird bio (BLUE +0.00%) ended Monday up 10% on no apparent news -- at least, none that came today.
So what
The spike might be a carryover from last week, when the biotech announced that it was starting a phase 3 trial called HGB-207, testing its LentiGlobin gene therapy in patients with a blood disorder called beta-thalassemia with non-β0/β0 genotypes.
Starting a phase 3 trial doesn't usually send a stock up by double digits, but along with the announcement, the company said that it'll be using a new manufacturing process for the trial. The company had previously disclosed that it was working on a new process that would improve expression of LentiGlobin, which should increase the cure rate in harder-to-treat beta-thalassemia patients as well as patients with sickle cell disease, which the gene therapy has also been tested on with mixed results.
There was some worry that the Food and Drug Administration would make the company submit a new Investigational New Drug (IND) application for the new process, but it appears Bluebird will be able to use the old IND, saving it some time.
Now what
Investors can look forward to seeing clinical trial data for LentiGlobin under the old manufacturing process at the American Society of Hematology (ASH) meeting in early December. Hopefully, Bluebird will also have some data on how much the new manufacturing process is increasing expression, although that would just be in test tubes, not patients, as it's unlikely clinical data from the trial that stated last week would be available that soon.
Abstracts for the ASH meeting will be available on Nov. 3, so investors won't have to wait too long to know what's being presented. Just keep in mind that the abstracts for medical meetings are often light on data, allowing companies to present the most up-to-date data at the meeting.
