What happened
Iovance Biotherapeutics (IOVA +5.75%) is being shifted to the fast track in its current approval process for an investigational drug. On news that the Food and Drug Administration (FDA) is willing to make the process faster, enthusiastic investors traded the biotech's stock up by more than 13%. That was more than good enough to top the performance of the S&P 500 index, which dipped by slightly over 1%.
So what
At first glance, Iovance's announcement about the FDA's review wasn't positive. The company wrote that the regulator requires additional time to complete its priority review of Iovance's biologics license application (BLA). The biotech is seeking the FDA's nod for lifileucel, an investigational drug that targets advanced melanoma. The FDA extended its target action date for its decision to Feb. 24, 2024.
However, in a sign that it is considering the drug favorably, the FDA has agreed to expedite what remains of lifileucel's review process. This could result in the agency rendering a decision earlier than the new target action date.
Iovance said that the date extension is due to the FDA's "insufficient resources."
NASDAQ: IOVA
Key Data Points
Now what
So far, the FDA's review has been going well. The agency told the company that there are no major issues so far, and every preapproval inspection of clinical trial sites, as well as manufacturing and testing facilities, have been successfully finalized.
The company sounded a positive note on the current state of the review, and waxed enthusiastic about lifileucel's potential. It quoted CEO Frederick Vogt as saying, "With the strength of our clinical data, manufacturing capabilities, and commercial readiness efforts, Iovance is well positioned to rapidly serve the U.S. melanoma community immediately following an approval."
