IOVA - Why Iovance Biotherapeutics Is Crashing Today
Shares of biopharma company Iovance Biotherapeutics (NASDAQ: IOVA) are down 8.7% as of 12:31 p.m. ET Friday after the company announced it had received feedback from the U.S. Food and Drug Administration (FDA) regarding its new drug application for cancer treatment lifileucel. While the FDA's request for clarified information regarding the drug's effectiveness is in no way a rejection of lifileucel, it could potentially prolong the approval process.
But not by much.
The FDA's feedback is more procedural than not. The regulator is simply looking for more "supplemental assay validation information and comparability data for lifileucel." In that its Biologics License Application for the therapy is a so-called rolling application that can be updated while it's being considered for approval, providing the requested information doesn't force the company to restart the licensing process for lifileucel once the data is collected. The company only has to amend its request. Iovance Biotherapeutics believes this entire addendum can be completed and submitted during the first quarter of the coming year.
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Why Iovance Biotherapeutics Is Crashing Today