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
| Date | Event |
|---|---|
| November 2024 | Replimune submits BLA under accelerated approval pathway |
| January 2025 | FDA accepts the BLA |
| July 2025 | FDA 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 addressed |
| 2 September 2025 | Replimune schedules a type A meeting with the FDA, stating that without accelerated approval under the current application vuso-vec in melanoma would not be viable |
| 5 September 2025 | FDA published the CRL, broadly backing Replimune’s disclosures |
| 18 September 2025 | After type A meeting Relimune says it's evaluating feedback, but accelerated pathway has not been determined |
Source: OncologyPipeline.
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