Replimune · RP1 · Aug 2026 –
What remains unresolved after RP1's accelerated approval?
Continued approval may depend on a confirmatory trial; the FDA called the early Phase 3 data insufficient; Phase 3 results are not in this record.
EphemerisX Research · Published · 3 source documents · 1 min read
Short answer
Continued approval may depend on verifying clinical benefit in a confirmatory trial. The FDA's second letter called the early analysis of the Phase 3 trial insufficient, and that trial's results are not in this record.
What the evidence shows
The approval 8-K says Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial(s)
8-K · Aug 7, 2026.
The company's 10-K describes the IGNYTE-3 trial
10-K · Jun 29, 2026 as a randomized Phase 3. The FDA's second letter says the company submitted an early unplanned analysis
FDA · Apr 10, 2026 · p. 2 of the Phase 3 trial it names RP1-104, and that This data is insufficient to support an efficacy claim
FDA · Apr 10, 2026 · p. 4. The FDA letters use only the name RP1-104 and the company's filings only IGNYTE-3; none of these documents uses both.
Not in this record: Phase 3 results, the FDA label, and Replimune's filings after August 7, 2026.
Follow the thread
- What happened to the confirmatory trial Replimune said would not be viable?Continued approval may need a confirmatory trial
- How did RP1 go from a second FDA letter to accelerated approval in four months?Continued approval may need a confirmatory trial
This investigation connects to
- When is one trial enough? How the FDA weighed the evidence in three programsCross-investigation · Comparable evidence · with Aldeyra Therapeutics, Outlook Therapeutics
The documents, by date
The passages quoted
FDA Complete Response Letter, April 10, 2026 · page 2
To support resubmission of the BLA on October 9, 2025, you provided ORR data from an early unplanned analysis from your ongoing, randomized, Phase 3 trial, RP1-104, including 22 patients in the investigational arm of vusolimogene oderparepvec with nivolumab and 18 patients in the control arm (physician’s choice of treatment), representing 10% of the planned enrollment of 400 patients.Open at the source →
FDA Complete Response Letter, April 10, 2026 · page 4
This data is insufficient to support an efficacy claim.Open at the source →
Replimune Form 10-K, filed June 29, 2026
In August 2024, we announced the dosing of the first patient in the IGNYTE-3 trial, or the I-3 trial, a 2-arm randomized Phase 3 clinical trial with physician's choice of treatment as a comparator arm in anti-PD-1 failed melanoma patients.Open at the source →
Replimune Form 8-K, filed August 7, 2026
Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial(s).Open at the source →