H.C. Wainwright still sees approval for Iovance despite PDUFA delay

H.C. Wainwright analyst Joseph Pantginis keeps a Buy rating on Iovance Biotherapeutics with a $38 price target after FDA, citing insufficient resources, sets a new action date of February 24, 2024 for lifileucel in advanced melanoma. The previous PDUFA date was set for November 25, 2023. While this represents a setback for the approval timeline, it is important to note that the FDA has agreed to work closely with Iovance to expedite the remaining review with the potential of an earlier date; the analyst tells investors in a research note. The agency also reiterated there are no major review issues and there are no new plans to hold an advisory committee meeting, says the firm. Wainwright restates its confidence that lificeucel should be approved on the new PDUFA date.