Replimune Group, Inc. (REPL) AI Stock Summary

Snapshot

Replimune is a clinical-stage biotech with no revenue, burning through cash at a rapid pace. The company lost $247.3M in FY 2025 and generated $198.9M in negative free cash flow. It holds $483.8M in cash against $76.2M in debt, but with zero revenue and a $199M annual burn rate, the cash runway is effectively zero months at current spending levels. The share count grew 21% year-over-year, diluting existing holders significantly. The stock trades at $4.68, which is in the lower portion of its 52-week range, having fallen sharply after a recent FDA rejection of its lead drug candidate.

What's Happening Right Now

• Fri 29th May '26 · FDA Update: Replimune announced it will resubmit its application for RP1 to the FDA, which agreed to prioritize the review after productive discussions.
• Thu 23rd Apr '26 · Lawsuit: Bronstein, Gewirtz & Grossman opened a shareholder investigation into Replimune over disclosures related to the FDA rejection.
• Fri 10th Apr '26 · Regulatory Setback: The FDA issued a Complete Response Letter rejecting Replimune's application for RP1 in advanced melanoma, citing insufficient data.

Ownership

Institutions hold 94.0% of the shares, while insiders hold 3.6%.

Bottom Line

Replimune is in a precarious position. The company has no revenue and is burning nearly $200M a year, leaving it with a cash runway of zero months at current burn rates. While it holds $484M in cash, that buffer is shrinking fast against a backdrop of regulatory failure and legal investigations. The recent FDA rejection of its lead drug was a major setback, though the company says it will resubmit the application. The stock is down significantly from its highs, but the combination of heavy cash burn, no sales, and pending lawsuits creates a high-risk profile. A reader needs to believe the drug gets approved quickly and generates massive revenue to justify the current price.