Additional Assay Data Holdup Delays Iovance's Lifileucel Filing Again, CEO Resigns; Shares Plunge

In a brief statement, Iovance Biotherapeutics Inc IOVA company divulged that the FDA wants to see more data on the assays used to ensure each batch of its tumor-infiltrating lymphocyte therapy (TIL) is up to standard, in addition to what was already submitted.
This FDA holdup pushed the submission of the lifileucel marketing application for melanoma in the first half of 2022, which amounts to a delay of more than a year from the original timeline of submitting in 2020.
Last year in October, regulators wanted more data on the current assays or potentially see different assays in the marketing application.
After the setback, the company’s CEO & President Maria Fardis said she would be resigning to pursue other opportunities, as per SEC filing.
The company will immediately begin a search for a successor.
In the meantime, Frederick Vogt, the company’s current General Counsel, will act as the interim President and CEO.
Chardan Capital analyst Geulah Livshits maintained Iovance Biotherapeutics with a Buy rating and lowered the price target from $54 to $51.
Price Action: IOVA shares are down 40.2% at $16.14 during the market session on the last check Wednesday.
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