Iovance Surges after U.S. FDA Approval for Lifileucel

Shares of Iovance Biotherapeutics (NASDAQ: IOVA) surged in pre-market trading after the biotech company announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for lifileucel for patients with advanced melanoma. The company stated that the FDA has granted lifileucel a “Priority Review” and assigned November 25 as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA).

Iovance added, “The FDA is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues.”

Analysts are bullish about IOVA stock with a Strong Buy consensus rating based on nine Buys and two Holds.