Replimune stock rating upgraded by BMO Capital on improved FDA outlook

Investing.com - BMO Capital upgraded Replimune Group (NASDAQ:REPL) from Underperform to Market Perform and raised its price target to $11.00 from $2.00. The stock currently trades at $9.73, with the broader analyst community maintaining a consensus recommendation of 2.11 (between Buy and Hold).

The upgrade follows what BMO describes as "cautious optimism" regarding potential FDA approval for Replimune’s RP1 treatment for advanced melanoma.

BMO Capital had previously downgraded Replimune shares following a Complete Response Letter (CRL) from the FDA in July, when regulatory approval options appeared limited and the company faced cash constraints. Despite these concerns, InvestingPro data shows Replimune maintains a healthy current ratio of 6.94, with liquid assets exceeding short-term obligations.

The firm now believes current share prices appropriately reflect the risk profile for the RP1 program.

According to BMO Capital, Replimune appears to have achieved "better alignment with regulators on a path forward" for its melanoma treatment candidate.

In other recent news, Replimune Group has made significant strides with the U.S. Food and Drug Administration’s acceptance of its resubmitted Biologics License Application (BLA) for the RP1 treatment in combination with nivolumab. This combination therapy targets advanced melanoma patients who have not responded to anti-PD-1 regimens. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, following a Class II resubmission timeline. This development has prompted several analyst upgrades for Replimune. H.C. Wainwright upgraded the stock from Neutral to Buy, setting a price target of $12.00. Leerink Partners also upgraded Replimune from Market Perform to Outperform with a price target of $13.00. Additionally, Wedbush raised its rating from Neutral to Outperform, significantly increasing its price target from $4.00 to $18.00. These upgrades reflect growing confidence in Replimune’s potential following the FDA’s acceptance of the BLA.

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