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Investing.com - Cantor Fitzgerald initiated coverage of Replimune Group (NASDAQ:REPL) with an overweight rating on Friday. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 7.95x, though it’s currently experiencing rapid cash burn.
The firm’s initiation comes ahead of the July 22 PDUFA date for Replimune’s RP1 therapy in advanced melanoma. Shares have experienced volatility following FDA and CBER leadership changes since May 2025, according to Cantor Fitzgerald’s research note. The stock currently trades at $9.49, down about 24% over the past six months.
Cantor Fitzgerald sees a clearer path for Accelerated Approval of RP1, citing positive regulatory indicators including breakthrough therapy designation, no Adcom requirement, completion of late-cycle inspection, and what appears to be "business as usual" at the Center for Biologics Evaluation and Research.
The firm projects RP1 will generate $497 million in adjusted sales by 2030 and $828 million by 2040. Their doctor surveys and calls indicate RP1 could become a preferred treatment option in the second-line setting despite adoption barriers between medical oncologists and interventional radiologists.
Cantor Fitzgerald considers Replimune’s current enterprise value of $381 million an attractive entry point for investors based on the commercial potential of RP1 and its competitive risk/benefit profile compared to available alternatives.
In other recent news, Replimune Group reported its first-quarter earnings for 2025, revealing a significant miss on expected earnings per share (EPS), with a reported EPS of -$3.07 against a forecast of -$0.72. Despite this, the company’s cash and cash equivalents rose to $483.8 million, extending its cash runway into the fourth quarter of 2026. Piper Sandler analysts increased their price target for Replimune stock to $22 from $14, maintaining an Overweight rating, following updates from the company and additional data disclosed at the ASCO conference. JPMorgan analysts also reiterated their Overweight rating for Replimune, highlighting the anticipated approval of RP1 for anti-PD1 failed melanoma and a significant market opportunity in the U.S.
Replimune has been actively preparing for the potential commercialization of RP1, with a PDUFA date set for July 22, 2025, and no expected AdCom meeting. The company has completed late-cycle reviews and manufacturing inspections, anticipating labeling negotiations soon. Replimune aims to have 150 centers ready for RP1 injection on day one of approval, primarily focusing on academic centers. The company’s commercial strategy includes a team of around 60 professionals, indicating a robust infrastructure in place for the launch. Analysts from Piper Sandler expressed confidence in Replimune’s commercial preparedness, noting the favorable risk/reward profile for RP1 despite some investor skepticism.
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