Replimune · RP1 · Apr – Aug 2026
How did RP1 go from a second FDA letter to accelerated approval in four months?
Alignment on a path forward in May, a Class 1 resubmission in June, a 10–3 committee vote in July, accelerated approval in August. The FDA's own approval documents are not in this record.
EphemerisX Research · Published · 4 source documents · 1 min read
Short answer
This record holds the company's account of the approval, not the FDA's: accelerated approval based on response rate and duration of response, in the 91 patients with a non-injected lesion, after the advisory committee voted 10 to 3. The FDA's approval letter and review are not in this record.
What the evidence shows
After the second letter, the 10-K says the Company and the FDA aligned on a path forward for resubmission and reconsideration of the BLA
10-K · Jun 29, 2026, and that the FDA accepted the BLA resubmission as a Class 1 resubmission with an action date of August 2, 2026
10-K · Jun 29, 2026. The first resubmission had been on a Class II resubmission timeline
8-K · Oct 20, 2025.
The advisory committee discussed whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population
8-K · Jul 31, 2026, and voted 10 to 3
8-K · Jul 31, 2026 on whether the results are evaluable and clinically meaningful.
The approval 8-K reports accelerated approval based on objective response rate and duration of response
8-K · Aug 7, 2026, in 91 patients with at least one non-injected lesion included in the efficacy-evaluable population
8-K · Aug 7, 2026, and that Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial(s)
8-K · Aug 7, 2026.
The FDA's own reasoning, in its approval letter, review and label, is not in this record.
Follow the thread
- What did Replimune resubmit in October 2025, and what did the FDA make of it?Class II resubmission, then Class 1
- What happened inside Replimune after the second letter?May 29: “aligned on a path forward”
- What remains unresolved after RP1's accelerated approval?Continued approval may need a confirmatory trial
- Why do RP1's reported response rates range from 24.2% to 34%?Committee vote: 10 to 3
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, CorMedix, Outlook Therapeutics, Verrica Pharmaceuticals
- How did two programs move forward after repeat FDA letters without running a new trial?Cross-investigation · Comparable evidence · with Outlook Therapeutics
- What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Cross-investigation · Regulatory pathway · with Aldeyra Therapeutics, CorMedix, Outlook Therapeutics
- 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
Replimune Form 8-K, filed October 20, 2025
The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.Open at the source →
Replimune Form 10-K, filed June 29, 2026
We announced on May 29, 2026, that following collaborative communications with the FDA, the Company and the FDA aligned on a path forward for resubmission and reconsideration of the BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma.Open at the source →
Replimune Form 10-K, filed June 29, 2026
On June 26, 2026 we announced the FDA accepted the BLA resubmission as a Class 1 resubmission with an action date of August 2, 2026. The FDA also stated that they would convene an advisory committee meeting in late July 2026.Open at the source →
Replimune Form 8-K, filed July 31, 2026
The committee discussed two topics: (1) whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population; and (2) the clinical meaningfulness of the response rate and duration of response reported in IGNYTE, and whether the observed responses are indicative of systemic antitumor activity attributable to RP1.Open at the source →
Replimune Form 8-K, filed July 31, 2026
The committee then voted 10 to 3, on the question: "Are the efficacy results from IGNYTE evaluable and clinically meaningful?"Open at the source →
Replimune Form 8-K, filed August 7, 2026
The IGNYTE trial enrolled 140 patients with 91 patients with at least one non-injected lesion included in the efficacy-evaluable population. In this population, TUDRIQEV plus nivolumab achieved an objective response rate (ORR) of 24.2%, with a median duration of response of 14.1 months.Open at the source →
Replimune Form 8-K, filed August 7, 2026
This indication is approved under accelerated approval based on objective response rate and duration of response.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 →