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Shares of Iovance (IOVA) plunged 15% on Thursday after the biotech firm’s first-quarter report fell short of Wall Street estimates and amid deepening investor concerns over mounting delays in securing U.K. and European approvals for its cancer therapy.
Iovance’s flagship Amtagvi cell therapy is already approved in the U.S. for patients with melanoma that has spread or cannot be removed with surgery after prior treatment. The drug received accelerated approval in February 2024.
In the United Kingdom, Iovance withdrew its initial marketing authorization application (MAA) for Lifileucel, sold as Amtagvi, earlier this month, citing procedural issues. The company said it is in talks with the Medicines and Healthcare Products Regulatory Agency (MHRA) to resubmit the application with updated information for an expedited review.
Iovance also plans to resubmit a marketing authorization application to the European Medicines Agency (EMA) in 2026.
In Q1, Iovance posted a 45% increase in revenue to $71.4 million, which fell below Wall Street’s estimates of $75.6 million, according to Fiscal.ai data. Loss came in at $0.19 per share, compared to an estimated loss of $0.15 per share.
The company forecast its total product revenue for the second quarter (Q2) between $86 million and $88 million and for FY26 between $350 million and $370 million.
Retail sentiment for IOVA on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘high’ message volumes.
One user said the company overpromised but underdelivered.
Another user said Iovance’s Amtagvi is a great product, but needs proper management.
The stock has gained 23% so far in 2026.
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