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On Thursday, H.C. Wainwright analyst Raghuram Selvaraju increased the price target on Replimune Group (NASDAQ:REPL), currently trading at $13.79 with a market cap of $1.06 billion, to $22.00, up from the previous $21.00, while maintaining a Buy rating on the stock. The revision reflects the analyst’s optimism regarding the potential FDA approval of RP1 in combination with Opdivo for the treatment of advanced melanoma. According to InvestingPro data, REPL has shown impressive momentum with a 92.7% return over the past year.
The FDA has granted the Biologics License Application (BLA) for RP1 Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date set for July 22, 2025. Replimune has been informed by the FDA that it does not currently plan to hold an Advisory Committee meeting regarding this application, and no potential review issues have been identified thus far. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 10.11, indicating robust financial flexibility during this crucial regulatory phase.
The BLA submission is supported by data from the IGNYTE trial, which evaluates the efficacy of RP1 in combination with Opdivo in patients with melanoma who have not responded to anti-PD1 therapies. Selvaraju’s optimism is based on these clinical results and the regulatory progress.
After adjusting the discounted cash flow (DCF)-based valuation to a more current timeline, the analyst reiterated the Buy rating. The slight increase in the price target to $22 represents confidence in Replimune’s prospects and the anticipated approval of its melanoma treatment.
In other recent news, Replimune Group, Inc. has been making significant strides with the U.S. Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for RP1, the company’s leading oncolytic immunotherapy for advanced melanoma. The FDA has granted RP1 Priority Review status, with a decision expected by July 22, 2025. This development is a crucial step forward for Replimune, as it sets the stage for a potential commercial launch in 2025.
Analysts have responded positively to these developments. Barclays (LON:BARC)’ Peter Lawson reiterated an Overweight rating and a $17.00 price target on Replimune stock, citing the potential FDA approval of RP1 as "increasingly de-risked." Similarly, BMO Capital has raised its price target for the company to $27.00 from $18.00, maintaining an Outperform rating. Jefferies also increased its price target to $19.00, maintaining its "Buy" rating on the stock.
In addition to the FDA’s acceptance of the BLA, Replimune’s IGNYTE-3 confirmatory trial is progressing, with plans to enroll more than 100 sites worldwide. This trial is a key component of the company’s clinical development strategy and will further support the potential of RP1. These are some of the recent developments that have been shaping Replimune’s journey in the biotech industry.
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