Mizuho Desk Comments on Replimune (REPL)

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Barclays Downgrades Replimune Group (REPL) to Equalweight

July 22, 2025 4:31 PM UTC

Barclays analyst Peter Lawson downgraded Replimune Group (NASDAQ: REPL) from Overweight to Equalweight with a price target of $3.00 (from $17.00).

The analyst comments "Downgrade to Equal Weight and lower PT to $3 following the surprising CRL issued by FDA for RP1+PD1 combo, which places... More

Leerink Partners Reiterates Outperform Rating on Replimune Group (REPL), PT $21, 'Estimates Under Review'

July 22, 2025 10:20 AM UTC

Leerink Partners analyst Jonathan Chang reiterated an Outperform rating and $21.00 price target on Replimune Group (NASDAQ: REPL)

The analyst comments "Bottom Line: The FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec; GALV, GM-CSF oncolytic virus) + nivolumab in anti-PD-1-failed melanoma. This update will likely come as a... More

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

July 22, 2025 8:50 AM UTC

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... More

Replimune receives FDA rejection letter for melanoma treatment

July 22, 2025 7:03 AM UTC

Replimune Group, Inc. (NASDAQ: REPL) received a Complete Response Letter from the U.S. Food and Drug Administration rejecting its application for RP1 in combination with nivolumab for treating advanced melanoma.

The FDA stated the IGNYTE trial does not constitute an adequate and well-controlled clinical investigation providing substantial evidence of effectiveness. The agency cited... More