Replimune's (REPL, Financial) stock experienced a significant drop in premarket trading, plummeting 78% to $2.75, following Cantor Fitzgerald's downgrade of the stock to Neutral from Overweight. This action came after the FDA issued a complete response letter regarding Replimune's RP1 treatment for advanced melanoma. The FDA highlighted that there was not an "adequate and well-controlled clinical investigation" for RP1, raising concerns over the approval process.
The downgrade reflects expectations that the FDA will demand a randomized controlled trial to support RP1's approval, a process anticipated to take several years. This delay could erode RP1's lead time in reaching the market. Cantor Fitzgerald expressed doubts about RP1's future market presence, citing the lengthy approval pathway ahead.
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 728.99% from the current price of $2.74. More detailed estimate data can be found on the Replimune Group Inc (REPL) Forecast page.
Based on the consensus recommendation from 9 brokerage firms, Replimune Group Inc's (REPL, Financial) average brokerage recommendation is currently 1.7, 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.
