Iovance (NASDAQ:IOVA) Rises on New FDA Action Date

Iovance Biotherapeutics (NASDAQ:IOVA) shares are up nearly 16% in the pre-market session today. This comes after the U.S. Food and Drug Administration (FDA) extended the decision date for the company’s biologics license application (BLA) for its lead candidate lifileucel. However, it also agreed to expedite the review process for a potentially earlier approval date.

The health regulator has sought additional time for the priority review owing to resource constraints. Iovance is seeking accelerated approval for lifileucel for the treatment of advanced melanoma by February 24, 2024, under the Prescription Drug User Fee Act (PDUFA). The PDUFA allows the FDA to collect fees from drug manufacturers to fund the new drug approval process faster without compromising the thoroughness of the review.

Importantly, the FDA has noted that there are no major issues with the review, and it is not planning to hold an advisory committee meeting. Furthermore, the company’s TILVANCE-301 confirmatory trial in frontline advanced melanoma remains on track to be well underway by the February PDUFA date, and the FDA has not expressed any concerns about its status.

If approved, Lifileucel could become the first and only tumor-infiltrating lymphocyte (TIL) therapy for the treatment of advanced melanoma and the first one-time cell therapy in a solid tumor cancer.

Overall, the Street has a consensus price target of $23.70 on Iovance, alongside a Strong Buy consensus rating. This implies a mouth-watering 410.2% potential upside in the stock.

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