Ademi LLP is investigating possible securities fraud claims against Iovance (NASDAQ: IOVA). The investigation results from inaccurate statements Iovance may have made regarding its financial results, business operations and prospects.
The investigation focuses on whether Iovance properly disclosed the facts underlying its submissions of potency assays for lifileucel to the FDA. On May 19, 2021, Iovance disclosed that its assay data package submitted in the first quarter was insufficient to fully satisfy FDA reviewers, and would require Iovance to submit additional assay data and meet with the FDA in the second half of 2021. Iovance’s biologics license application submission for lifileucel is now expected to occur during the first half of 2022. Later that day, Iovance CEO Maria Fardis resigned.