Barclays Reiterates Overweight Rating on Replimune Group (REPL), PT $17, 'We see this as a clear positive for Iovance's Amtagvi'

Barclays analyst Peter Lawson reiterated an Overweight rating and $17.00 price target on Replimune Group (NASDAQ: REPL).

The analyst comments "FDA issued a CRL for Replimune's BLA for RP1 in combo with nivo for PD1-refractory melanoma patients. While no safety concerns were raised, FDA cited issues around trial design and evidence of efficacy. This represents a positive read through to Iovance (IOVA, OW) with reduced competitive threat. Our key takeaways from Replimune's announcement this morning on the CRL issued by the FDA for RP1 (see PR here) The FDA issued today a Complete Response Letter (CRL) for RP1 in combo with nivo for anti-PD1 failed melanoma, marking a major setback for Replimune, the oncolytic approach and potentially stricter FDA. While the agency did not raise any safety concerns, the FDA concluded that the IGNYTE trial lacked sufficient control and interpretability due to population heterogeneity, and therefore did not constitute substantial evidence of efficacy. The confirmatory trial design was also found inadequate, including unclear contribution of RP1 within the combo. We were surprised by the FDA’s CRL for RP1, especially given its Breakthrough Therapy Designation and prior alignment on confirmatory trial design. Replimune plans to request a Type A meeting. We see this as a clear positive for Iovance's Amtagvi, which now faces reduced competition in the PD1-refractory melanoma setting. For some investors, the setback adds to a growing list of challenges facing the oncolytic virus field. Amgen’s Imlygic (talimogene laherparepvec)—a genetically engineered HSV-1 encoding GM-CSF—was the first FDA-approved oncolytic virus in 2015. Despite this milestone, Amgen deprioritized further development of Imlygic after limited uptake and no clear survival benefit in visceral disease. Today’s CRL may reflect a stricter FDA stance on efficacy standards for heterogeneous immunotherapy trials and echoes some investor skepticism around OV platform scalability."

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 $12.33 yesterday.

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