- Iovance Biotherapeutics Inc IOVA has received regulatory feedback from the FDA on its potency assays for lifileucel.
- Following FDA feedback, Iovance will have to submit additional assay data and meet with the FDA in the second half of 2021.
- Meanwhile, the company will continue its ongoing work developing and validating its potency assays.
- The company's marketing application submission for lifileucel is now expected to occur during the first half of 2022. Earlier the submission was expected during 2021.
- Lifileucel is a Tumor-infiltrating lymphocyte (TIL) therapy that uses a patient's immune cells to attack cancer.
- Price Action: IOVA shares are down 8.68% at $24.63 in the premarket session on the last check Wednesday.
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