Shares of Iovance Biotherapeutics, Inc. (IOVA) plunged around 15% in early trading on Wednesday as the company provided a regulatory update from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel. Iovance is a late-stage biotechnology company that develops immune cell-based cancer immunotherapies.
Lifileucel is a tumor-infiltrating lymphocyte (TIL) immunotherapy used in the treatment of metastatic melanoma, that is, skin cancer. Following the feedback from the FDA, the company will continue to develop and validate potency assay data for lifileucel and will meet the FDA in the second half of this year. IOVA now expects to file a biologics license application (BLA) for lifileucel during the first half of next year.
Iovance Biotherapeutics’ President and CEO, Maria Fardis, Ph.D., MBA said, “TIL is a first-in-class, one-time administration cell therapy and the first potential BLA for a cell therapy in solid tumors. As such, TIL product is complex by nature and alignment with FDA on a potency assay is an important step toward BLA submission. With a regenerative medicines advanced therapy (RMAT) designation for lifileucel, FDA recognizes the unmet need for patients with metastatic melanoma who progress after anti-PD1 therapy.” (See Iovance Biotherapeutics stock analysis on TipRanks)
Following the regulatory update, Oppenheimer analyst Mark Breidenbach lowered the price target from $57 to $51 (126% upside) but reiterated a Buy on the stock. Breidenbach said in a research note to investors, “Unfortunately, the assay data package submitted in 1Q was insufficient to fully satisfy FDA reviewers, and Iovance plans to submit additional assay data and meet with the agency in 2H. Management offered revised guidance for lifileuce’s BLA filing and now expects to file in 1H22 instead of later this year.”
“Given lifileucel’s RMAT/Fast Track designations, we model launches in melanoma and cervical cancer in 1H23. Given the strength of lifileucel’s clinical data, we would add to IOVA positions on expected near-term weakness,” Breidenbach added.
Overall, consensus among analysts is that IOVA is a Strong Buy based on 10 Buys. The average analyst price target of $47.67 implies upside potential of about 111% from current levels.