Shares of Iovance Biotherapeutics, Inc. (IOVA) slipped over 10% on Tuesday extended session after the late-stage biotechnology company developing cancer therapies announced receipt of regulatory feedback from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel.
Previously, the company reported the submission of assay data to the FDA and recently the FDA provided comments regarding the data package.
Iovance said it will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet with the FDA in the second half of 2021. The company's biologics license application (BLA) submission for lifileucel is now expected to occur during the first half of 2022.
IOVA closed Tuesday's trading at $26.97, up $0.48 or 1.81%, on the Nasdaq. The stock, however, slipped $2.91 or 10.79%, in the after-hours trading.
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