Iovance's Lifileucel US Application Submission Pushed To 2022

by Vandana Singh, Benzinga Editor

May 19, 2021 7:26 AM | 1 min read | Make a Comment

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.