What happened
Shares of Iovance Biotherapeutics (IOVA 0.09%) were crashing 31.1% lower as of 11:57 a.m. EDT on Wednesday. The steep decline came after the company announced a delay in the U.S. regulatory filing for approval of cell therapy lifileucel.
So what
Iovance previously submitted data to the U.S. Food and Drug Administration (FDA) for its potency assay for lifileucel. The company received feedback from the FDA, prompting it to push back its planned filing for approval of the cell therapy from later this year to the first half of 2022.
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Investors were understandably disappointed, causing the biotech stock to fall even more after already sinking nearly 50% below its highs from earlier this year. However, a delay isn't the same thing as a death knell. Iovance CEO Maria Fardis noted that the "FDA recognizes the unmet need for patients with metastatic melanoma who progress after anti-PD1 therapy."
Now what
Iovance now plans to continue developing and validating its potency assays. The company expects to submit additional assay data to the FDA and meet with the agency in the second half of this year.
