REPL Stock Tracks Best Day Ever: This Analyst Sees Higher Approval Odds For Replimune’s Melanoma After ‘Overwhelmingly Positive’ Panel Outcome

• Cantor Fitzgerald upgraded Replimune to Overweight from Neutral without a price target
• The Adcom panel voted 10-3 in favor of RP1 ahead of the FDA’s official decision on Aug 2.
• The panel said the efficacy results from the IGNYTE trial were evaluable and clinically meaningful

Replimune Group (REPL) drew renewed investor attention after the biotech company received a major boost from a favorable U.S. Food and Drug Administration (FDA) advisory committee review of its melanoma therapy RP1, prompting Cantor Fitzgerald to upgrade the stock to ‘Overweight’ from ‘Neutral’.

At the time of writing, REPL stock surged 140% in pre-market trading on Wednesday, on track for its biggest ever single-day gains.

RP1 Therapy: Cantor Says Approval Odds Have Improved

Cantor Fitzgerald’s upgrade follows a closely watched meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, which reviewed Replimune’s resubmitted Biologics License Application (BLA) for RP1 in combination with Nivolumab in patients whose melanoma had progressed after anti-PD-1 treatment, a type of immunotherapy.

The committee examined whether the single-arm IGNYTE study was capable of providing a reliable assessment of response rates and durability of response, and whether the responses were clinically meaningful.

After extensive discussions, the panel voted 10-3 in favor of the view that the efficacy results from the trial were evaluable and clinically meaningful. Cantor Fitzgerald described the outcome as “overwhelmingly positive” and said testimony from patients and physicians strengthened the case for an accelerated approval.

Third Time Lucky?

The positive vote is particularly notable because the FDA had previously issued Complete Response Letters in July 2025 and in April 2026. Earlier this week, FDA staff reviewers said Replimune had not provided clear evidence that RP1 works as claimed and argued that aspects of the IGNYTE trial design make the results difficult to interpret.

However, it is important to note that the advisory panel’s support does not guarantee approval. The FDA is expected to convey its official position on the drug’s application on Aug. 2, 2026.

Separately, Replimune said its existing cash and investments are expected to fund operations into the first quarter of 2027.

Retail Expects RP1 Approval

Retail sentiment surrounding REPL on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid a 360% jump in message volumes.

One user said that it’ll be “very hard for the FDA to deny REPL now.”

Another user cited historical data to show why the FDA is likely to approve the drug.

One user highlighted why the high short interest could push the stock to $20. According to Koyfin data, short interest on REPL stock stands at 28.2% of the float.

As of Thursday’s close, the stock has tanked more than 39% so far this year.

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