Why Iovance Biotherapeutics shares rose today

29.12.2023

Shares of Iovance Biotherapeutics (NASDAQ: IOVA) rose 18.7 percent on Thursday as investors assessed the impact of yesterday’s U.S. Food and Drug Administration ban on its cancer treatment clinical trial.

Today’s gains nearly offset the nearly 20 percent drop in Iovance stock that occurred after the U.S. Food and Drug Administration (FDA) decided to suspend the IOV-LUN-202 clinical trial due to the death of a patient. The trial was evaluating Iovance’s experimental LN-145 TIL therapy for the treatment of non-small cell lung cancer (NSCLC).

Iovance issued a press release explaining that the deaths were “potentially related to the nonmyeloablative lymphodepletion preconditioning regimen” in the trial. At the same time, Iovance cited an urgent need for the therapy in such cases, noting that patients in the trial have “poor prognosis, limited treatment options, and an actual overall survival of less than six months.”

In any case, Iovance has suspended enrollment of new patients during the clinical pause and will continue to follow up with patients who were previously treated according to the study protocol. The company says patients who have already undergone tumor resection will continue to receive the LN-145 TIL regimen “with additional precautions and risk reduction.”

From an investor’s perspective (and potentially contributing to today’s upside), the following should be noted: LN-145 TIL is not Iovance’s lead drug. Rather, more important to the company’s near-term survival is its melanoma drug lifileucel, which could generate peak annual sales of $900 million and for which the company expects to receive an FDA approval decision by February 24, 2024.

The potential approval of lifileucel is not related to the LN-145 TIL clinical trial. It’s a potentially huge revenue stream for a company whose market cap today is just $2.2 billion. And opportunistic shareholders appear to have taken advantage of yesterday’s drop to invest accordingly.