IOVA Stock Clocks Best Session Since February As Retail Awaits FDA Decision On Rival Drug

• FDA is slated to decide on potential rival Replimune’s application for RP1 in the treatment of advanced melanoma by April 10.
• Iovance’s Amtagvi cellular therapy is already approved as a treatment for people with previously treated melanoma that has spread or cannot be removed by surgery.
• The company recorded Amtagvi revenue of about $220 million for the full year 2025 in the U.S.

Shares of Iovance Biotherapeutics (IOVA) closed up 16% on Thursday as investors await the U.S. Food and Drug Administration’s decision on its aspiring competitor Replimune’s (REPL) skin cancer drug.

IOVA stock has closed in the green for three consecutive days and recorded its best single-day gain on Thursday since late February.

The FDA is slated to decide on Replimune’s application for RP1 in the treatment of advanced melanoma by April 10. RP1 is Replimune’s lead product candidate.

Iovance’s Amtagvi cellular therapy is already approved as a treatment for people with previously treated melanoma that has spread or cannot be removed by surgery. The drug was granted accelerated approval in February 2024.  The company recorded Amtagvi revenue of about $220 million for the full year 2025 in the U.S.

Retail Chimes In

A Stocktwits user said that rejection for Replimune’s drug will be the “end of the last anchor” holding IOVA down.

Another expressed anticipation for the decision.

RP1’s Past Issues

In late July 2025, the FDA issued a complete response letter regarding the application for RP1 in combination with Nivolumab for the treatment of advanced melanoma.

The agency said in the letter that it is unable to approve the application in its present form, and indicated that the trial conducted by the company for the drug is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.

Following months of engagement between the company and the FDA, Replimune subsequently resubmitted its application in October with additional information, data, and analyses.

How Did Retail Traders React?

On Stocktwits, retail sentiment around IOVA stock jumped from ‘bearish’ to ‘bullish’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘normal’ levels.

Meanwhile, sentiment around REPL trended in ‘extremely bearish’ territory at the time of writing.  

IOVA stock has gained 23% over the past 12 months while REPL stock fell 19%. 

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