Iovance Shares Fall Premarket on Lifileucel FDA Filing Delay

By Colin Kellaher

Shares of Iovance Biotherapeutics Inc. slipped in premarket trading Friday after the biotechnology company said it has pushed back its targeted completion of a rolling submission to the U.S. Food and Drug Administration for its proposed cancer treatment lifileucel.

The San Carlos, Calif., company, which is seeking FDA approval of lifileucel for patients with advanced melanoma, said it recently received FDA feedback regarding supplemental assay validation information and comparability data for the drug.

Iovance said it plans to address the FDA comments promptly, and that it will expects to complete the rolling submission during the first quarter of 2023. The company had previously targeted a completion by the end of 2022.

Shares of Iovance, which closed Thursday at $7.10, were recently down 9.2% to $6.45 in light premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

11-18-22 0711ET