Iovance Declines Following FDA Feedback On Its Melanoma Drug Lifileucel

Shares of Iovance Biotherapeutics, Inc. (IOVA) are down more than 14% Friday morning after the company said it received feedback from the Food and Drug Administration on the rolling Biologics License Application for Lifileucel, the company's investigational drug for melanoma.

The company said that as part of an amendment to the ongoing investigational new drug application submitted during the third quarter of 2022, it received recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel.

Iovance will address these FDA comments promptly and will now complete its rolling BLA submission during the first quarter of 2023, the company added.

IOVA, currently at $6.07, has traded in the range of $5.43-$20.60 in the last 1 year.

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