Cantor Fitzgerald has started coverage on Replimune (REPL, Financial) with an Overweight rating as the company approaches a critical FDA decision for its RP1 treatment in advanced melanoma, set for July 22. The firm highlights promising regulatory indicators that could pave the way for accelerated approval, including breakthrough therapy designation, the absence of a panel meeting, and a completed late-cycle inspection.
According to Cantor Fitzgerald, physicians regard RP1 as offering a strong competitive advantage in terms of risk and benefit when compared to existing treatments. The firm anticipates substantial financial growth from RP1, projecting adjusted sales to hit $497 million by 2030 and $828 million by 2040.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 7 analysts, the average target price for Replimune Group Inc (REPL, Financial) is $22.71 with a high estimate of $31.00 and a low estimate of $17.00. The average target implies an upside of 139.35% from the current price of $9.49. More detailed estimate data can be found on the Replimune Group Inc (REPL) Forecast page.
Based on the consensus recommendation from 8 brokerage firms, Replimune Group Inc's (REPL, Financial) average brokerage recommendation is currently 1.6, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
REPL Key Business Developments
Release Date: May 22, 2025
- Cash and Cash Equivalents: $483.8 million as of March 31, 2025.
- Research and Development Expenses: $54 million for Q4 2025; $189.4 million for the fiscal year ended March 31, 2025.
- Selling, General and Administrative Expenses: $25.4 million for Q4 2025; $72.2 million for the fiscal year ended March 31, 2025.
- Net Loss: $74.1 million for Q4 2025; $247.3 million for the fiscal year ended March 31, 2025.
- Cash Runway: Expected to fund operations into Q4 2026.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Replimune Group Inc (REPL, Financial) is on track for the potential approval and launch of RP1, with a PDUFA date set for July 22, 2025.
- The company has made significant regulatory progress, including recognition of RP1 as a breakthrough therapy with priority review.
- Replimune's US manufacturing facility is prepared to support the RP1 launch with commercial inventory and capacity for long-term global demand.
- The IGNYTE study data shows that approximately one-third of patients achieve durable responses in a high unmet need setting.
- Replimune is well-capitalized, with cash and cash equivalents totaling $483.8 million, expected to fund operations into the fourth quarter of 2026.
Negative Points
- Replimune Group Inc (REPL) reported a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025.
- Research and development expenses increased to $54 million for the fiscal fourth quarter, reflecting higher personnel-related and facility costs.
- The company's selling, general, and administrative expenses rose to $25.4 million for the fiscal fourth quarter, indicating increased operational costs.
- The IGNYTE-3 confirmatory trial is expected to take a couple of years to complete enrollment, potentially delaying further validation of RP1.
- Despite regulatory progress, the company faces challenges in ensuring broad and rapid adoption of RP1 across diverse healthcare settings.
