Shares of Iovance Biotherapeutics (NASDAQ: IOVA) jumped in pre-market trading on Monday after the late-stage biotechnology company announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel.
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Lifileucel is a tumor-infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced (unresectable or metastatic) melanoma – a type of skin cancer.
Frederick Vogt, Ph.D., J.D., Interim President, and CEO stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. Our preparations for commercialization remain on track to support a launch later this year. “
Analysts are bullish about IOVA stock with a Strong Buy consensus rating based on nine Buys and one Hold.