What happened?
Shares of biotech company Gamida Cell (GMDA +0.00%) are blasting higher on Wednesday following the company's release of data from a phase 3 clinical trial for one of its leading pipeline candidates, Omidubicel. As of 2:12 p.m. EST, Gamida's stock was up by 25.9%, after jumping by as much as 51.7% earlier in the day.
So what
The phase 3 study in question tested the safety and efficacy of Omidubicel in patients with high-risk hematologic malignancies, that is, blood-based cancers. Bone marrow transplant is the only potential treatment for many of these patients, but about 40% of those eligible never receive a transplant for various reasons. For those lucky enough to receive a transplant, the procedure is rife with potential pitfalls, including medical complications and lengthy hospitalizations.
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Omidubicel can potentially address these problems for cancer patients when used in stem cell transplants. Gamida revealed data showing that Omidubicel resulted in faster hematopoietic recovery (blood count recovery), fewer bacterial and viral infections, and fewer days in the hospital during the phase 3 trial. Mitchell Horwitz, the principal investigator of the study, said these results "represent potentially important advancements in care when considering the patient experience following transplant."
Now what
Gamida is planning to submit a Biologics License Application to the U.S. Food and Drug Administration for Omidubicel in the second half of this year. And given the data the healthcare company released today, the future looks bright for this therapy as it tackles a critical unmet need. With that said, investors should exercise caution. Gamida currently has no products on the market, a thin pipeline, and it does not generate any revenue. These factors make this biotech stock particularly risky.
