Wedbush Upgrades Replimune Group (REPL) to Outperform

Wedbush analyst Robert Driscoll upgraded Replimune Group (NASDAQ: REPL) from Neutral to Outperform with a price target of $12.00 (from $9.00).

The analyst comments "AdCom panel votes 10-3 in favor of RP1. The FDA convened an Advisory Committee Meeting (AdCom) to discuss the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab for the treatment of PD-1 refractory advanced melanoma based on data from the single-arm IGNYTE study; a BLA is under review with a PDUFA of August 2nd, 2026. The voting panel was composed primarily of melanoma physicians/oncologists practicing at major academic medical centers, as well as biostatisticians and a consumer representative. Overall, while the FDA repeated concerns regarding inadequacies in IGNYTE study design regarding response criteria, unclear contribution of components, and uninterpretable overall survival, we believe the strength of efficacy signal and compelling benefit/ risk profile persuaded the vocal melanoma physician panel members to vote in favor, which we note also included non-melanoma oncologists and one of two biostatisticians. We agree with the decision, and believe that while IGYNTE was not a perfect study, deficiencies in IGNYTE’s design were a result of REPL following standard clinical practice for administration of intratumoral therapies in melanoma that did not align with conventional clinical study guidelines in oncology. Importantly, REPL indicated that the original clinical review team recommended accelerated approval of RP1, and found no conduct or integrity issues, concluding the trial was adequate and well-controlled with substantial evidence of effectiveness – we therefore believe agreement to review the BLA a third time with the addition of an AdCom following the departure of FDA leadership Marty Markary and Vinay Prasad, was strongly indicative of a willingness to approve RP1. We point to the FDA presentation lacking robust conclusions regarding the potential effect size of various trial deficiencies, and an obviously deliberate omission of what the FDA believed to be a clinically meaningful effect size in this patient population. The latter point was highlighted in discussion by melanoma physician Hussein A. Tawbi, MD at MD Anderson Cancer Center. As a reminder, the FDA’s own analysis, and separately the SITC Task Force, found retreatment with anti-PD-1 yields just a 5–7% response rate in advanced melanoma patients. Panel members also highlighted the approval of lifieucel (Amtagvi) with a ~30% ORR, 6% CR in this setting, despite a highly challenging safety profile. Ultimately, we note any deficiencies in IGNYTE appear to be a result of inappropriate or ill-suited FDA guidelines in this proposed indication, and a failure of FDA to address these with REPL during the course of development – we do, however, applaud the FDA for hosting an AdCom to provide an avenue for approval in light of prior rejections apparently driven by prior leadership."

For an analyst ratings summary and ratings history on Replimune Group click here. For more ratings news on Replimune Group click here.

Shares of Replimune Group closed at $5.41 yesterday.

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