Iovance’s stock tumbles over questions about regulatory submission for melanoma drug

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Shares of Iovance Biotherapeutics Inc. were down 20.0% in premarket trading on Tuesday, the day after the biotechnology company said it plans to now submit an application to the Food and Drug Administration next year after the regulator took issue with its current application. Iovance, which is seeking approval for an experimental metastatic melanoma drug, said it does not agree with the FDA on the required potency assays, which is required for its biologics license apppliation submission. As a result, it expects the appliation to now occur in 2021. “We have agreement with the FDA regarding the amount of clinical follow up for the BLA, and we will work closely with the FDA to reach alignment on our assays,” Iovance CEO Maria Fardis said in a news release. Iovance’s stock is up 15.8% for the year, while the S&P 500 is up 5.5%.
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