Replimune crashes after FDA meeting

Replimune’s turbulent journey with its oncolytic immunotherapy vusolimogene oderparepvec took another hit, with shares plunging 42% on Thursday after the company revealed no meaningful progress from its recent type A meeting with the FDA. The biotech said it had completed the meeting and was reviewing the regulator’s comments, but noted that an accelerated approval pathway has not been determined. Earlier this year, Replimune was hit with a CRL flagging concerns about the heterogeneity of its phase 1/2 trial population and the difficulty of proving the contribution of individual components in a confirmatory phase 3 trial. More recently the group warned that, without accelerated approval based on its current submission, the future of vuso-vec in advanced melanoma could be in jeopardy. The lack of progress appears to have further eroded investor confidence in both the programme and the company’s ability to secure accelerated approval for the therapy. Replimune’s vuso-vec timeline DateEventNovember 2024Replimune submits BLA under accelerated approval pathwayJanuary 2025FDA accepts the BLAJuly 2025FDA issues a CRL, saying Ignyte trial is not adequate or well controlled; data cannot be interpreted owing to patient heterogeneity; and items related to the confirmatory trial need to be addressed2 September 2025Replimune schedules a type A meeting with the FDA, stating that without accelerated approval under the current application vuso-vec in melanoma would not be viable5 September 2025FDA published the CRL, broadly backing Replimune’s disclosures18 September 2025After type A meeting Relimune says it's evaluating feedback, but accelerated pathway has not been determinedSource: OncologyPipeline.