REPL Vs IOVA: FDA Decision Day Could Test Biotech Bulls’ Conviction On These Melanoma Plays

• Analysts estimate about 116% upside for REPL, compared to a 124% upside for IOVA from current levels.
• Amtagvi, already approved for melanoma, helped Iovance generate about $264 million in product revenue in 2025.
• RP1, in combination with Nivolumab, shrank tumors in about one-third of PD-1-failed melanoma patients.

Shares of Replimune Group, Inc. (REPL) and Iovance Biotherapeutics, Inc. (IOVA) are back in focus on Friday ahead of an FDA decision on the former's lead immunotherapy candidate RP1, as investors compare a near-term approval catalyst with an already approved melanoma therapy.

REPL stock is on track for its worst weekly decline in nearly seven months after logging its biggest single-session drop in over six months on Wednesday. Meanwhile, IOVA shares are poised to snap a four-week losing streak after jumping 16% on Thursday, marking their best session in over a month.

Koyfin estimates give Iovance the early lead on upside, but today’s RP1 verdict could determine whether Replimune closes the gap in a single catalyst move.

RP1 Decision Looms For Replimune

Replimune’s lead candidate RP1, in combination with Nivolumab, an immunotherapy that helps the immune system attack cancer cells, is under U.S. Food and Drug Administration (FDA) review for patients with advanced melanoma whose disease has progressed after prior PD-1 therapy, with the Prescription Drug User Fee Act (PDUFA) decision due Friday.

The company’s commercial readiness activities are already underway to support the launch if approval is granted. Trial results from last year showed that RP1 combined with Nivolumab shrank tumors in about one-third of patients whose melanoma had already stopped responding to standard PD-1 immunotherapy, including complete tumor disappearance in 15% of patients.

Consensus estimates tracked by Koyfin place Replimune’s average price target at $12.86, implying a 116% upside from current levels. The stock is covered by seven analysts, with one rating it ‘Strong Buy’, four ‘Buy’, and two ‘Hold’, resulting in an overall consensus rating of ‘Strong Buy’.

Several analysts turned bullish after the FDA accepted the BLA resubmission in October. H.C. Wainwright raised its probability of approval to 85% from 50%, while Piper Sandler expects a potential mid-2026 launch. JPMorgan added that the “totality of the RP1 data in the refractory melanoma setting is compelling and warrants approval.”

Amtagvi Gives Iovance Commercial Edge

Unlike Replimune, Iovance already has an approved therapy on the market. The FDA approved Amtagvi in 2024 as the first therapy made from a patient’s own tumor-fighting immune cells for people with advanced melanoma that cannot be removed with surgery or has spread after earlier PD-1 immunotherapy stopped working.

The company reported $264 million in total product revenue in 2025, including $220 million from Amtagvi, marking its first full calendar year of launch. The company flagged increasing treatment-center adoption and manufacturing improvements expected to continue this year.

Consensus estimates place Iovance’s average analyst price target at $9, representing a 124% upside from the stock’s last close. The stock is covered by 11 analysts, with two rating it ‘Strong Buy’, six ‘Buy’, and three ‘Hold’, supporting a consensus rating of ‘Strong Buy’.

Iovance is also expanding its tumor-infiltrating lymphocyte, or TIL, therapy platform into several cancers beyond melanoma. Updated data in February showed that 44% of melanoma patients responded to Amtagvi, while additional trials are underway in non-small-cell lung cancer, sarcoma and frontline melanoma combinations. The FDA has also granted Fast Track designation to Amtagvi in advanced non-small-cell lung cancer.

How Do Retail Traders Feel About REPL, IOVA?

On Stocktwits, retail sentiment for REPL was ‘bearish’ amid ‘extremely high’ message volume, while sentiment toward IOVA was ‘bullish’ amid ‘high’ message volume.

One user warned that approval appeared unlikely ahead of the decision, saying "Take off the blinders, the stock [REPL] tanked this week on no news, IOVA had a surge, the trial design was basically picked apart at the joints in the last CRL."

Another user said, “Why gamble with REPL when you have a sure thing with IOVA at a lower price?”

Over the past year, shares of REPL have fallen 19%, while IOVA stock has risen 23%.

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