Shares of clinical-stage company Iovance Biotherapeutics (NASDAQ:IOVA) nosedived over 20% in the early session today after the U.S. Food and Drug Administration (FDA) placed a clinical hold on its IOV-LUN-202 trial.
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The trial is evaluating Iovance’s product candidate, LN-145, for the treatment of advanced non-small cell lung cancer. Subjects in the trial have progressed during or after chemotherapy and anti-PD-1 therapy and have limited treatment options (overall real-world survival of less than six months).
The healthcare regulator placed the clinical hold on the trial following a fatal serious adverse event. Consequently, Iovance is pausing enrolment and treatment regimens for new patients. Last month, data analysis pointed to a response duration of over six months for 71% of the confirmed respondents in the trial. The company now plans to work with the FDA to safely resume the trial.
Additionally, Iovance noted that its other clinical programs remain unaffected. Further, its biologics license application (BLA) for lifileucel, an advanced melanoma treatment, remains on track for the February 24, 2024 action date.
Is IOVA a Good Stock to Buy?
Today, Mizuho’s Mara Goldstein reiterated a Buy rating on Iovance alongside a $30 price target. Overall, the Street has a Strong Buy consensus rating on Iovance, and the average IOVA price target of $22 points to a 147% potential upside in the stock. That’s on top of a nearly 60% rise in the company’s share price over the past month.
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