Shares of Iovance Biotherapeutics (IOVA 0.87%) popped 18.7% on Thursday as investors assessed the fallout of a clinical hold placed on a cancer-therapy trial yesterday by the U.S. Food and Drug Administration (FDA).
A setback for a much-needed treatment
Today's rebound nearly recouped an almost 20% drop yesterday for Iovance, which came on the heels of a U.S. Food and Drug Administration (FDA) decision to place a clinical hold on its IOV-LUN-202 clinical trial following a patient's death. The trial was evaluating Iovance's LN-145 TIL experimental therapy to treat non-small-cell lung cancer (NSCLC).
Iovance issued a press release explaining that the death was "potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen" of the trial. At the same time, Iovance pointed out the dire need for therapies in cases such as these, noting that the patients in the trial "have a poor prognosis, limited treatment options, and a real-world overall survival of less than six months."
What's next for Iovance investors?
In any case, Iovance has paused enrollment in the treatment regimen for new patients during the clinical hold, and it will continue to monitor and follow patients previously treated according to the trial protocol. The company says patients who have already undergone tumor resection will continue to receive the LN-145 TIL treatment regimen "with additional precautions and risk mitigations."
Of note from an investor's standpoint (and potentially contributing to today's rebound): LN-145 TIL isn't Iovance's lead drug candidate. Rather, more important to the company's near-term survival is its lifileucel advanced melanoma treatment, which could generate peak annual sales of as much as $900 million and for which the company expects to receive an FDA-approval decision by Feb. 24, 2024.
The potential approval of lifileucel is unrelated to LN-145 TIL's clinical trial. That's a potentially massive revenue stream for a company whose entire market cap sits at just $2.2 billion today. And opportunistic shareholders appear to be taking advantage of yesterday's drop to invest accordingly.
