Replimune’s Melanoma FDA Decision Pending: This Analyst Sees 40% Upside, ‘High Conviction’ For Approval

• Leerink upgraded Replimune to ‘Outperform’ from ‘Market Perform’ and raised its price target to $17 from $11, according to The Fly.
• The firm added that several factors have significantly strengthened RP1’s regulatory case, leaving the FDA ‘boxed into approval’
• Retail investors have mixed views on the delay in the FDA’s decision, ranging from a third rejection to discussions over the drug’s label.

Replimune (REPL) remained on investors’ radar on Tuesday as the U.S. Food and Drug Administration’s (FDA) decision on its melanoma therapy remained pending beyond the Aug. 2 verdict date, with Leerink expressing ‘high conviction’ that the treatment will secure accelerated approval.

REPL stock gained 1.5% in premarket trading, building on three consecutive sessions of gains that have increased its value by more than 120%.

Leerink Sees 40% Upside Potential For REPL

Leerink upgraded Replimune to ‘Outperform’ from ‘Market Perform’ and raised its price target to $17 from $11, according to The Fly. This represents a roughly 40% upside potential from current levels.

The brokerage expects the treatment to see strong demand if approved, citing its relative ease of access and favorable safety profile. However, Replimune’s biggest near-term hurdle will be rebuilding its manufacturing and commercial infrastructure, the firm noted.

Why Leerink Says FDA Is ‘Boxed Into Approval’

Leerink argued that several factors have significantly strengthened RP1’s regulatory case, leaving the FDA “boxed into approval.”

The firm pointed to last week’s 10-3 advisory committee vote supporting the treatment, the panel’s agreement that patients have a significant unmet medical need, and the current and political environment favoring faster access to therapies.

The positive vote marked a sharp turnaround after FDA staff reviewers had questioned whether Replimune had provided sufficient evidence that the therapy was effective. The FDA had twice rejected the therapy, first in July 2025 and again in April 2026, arguing that the single-arm IGNYTE study did not provide sufficient evidence of effectiveness.

Retail Traders Debate The FDA Delay

Retail sentiment surrounding REPL on Stocktwits turned ‘neutral’ from ‘extremely bullish’ with chatter discussing the potential implications of the delayed FDA response.

One user said the delay could be due to the FDA issuing yet another complete response letter, indicating that the application is rejected.

However, another user said the delay is likely due to REPL negotiating with the FDA over the label.

The stock has gained around 34% so far this year.

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