Replimune · RP1 · Sep 2025
What was said at the September 2025 Type A meeting?
Five documents describe the meeting between Replimune and the FDA on September 16, 2025. Each records different points from it.
EphemerisX Research · Published · 6 source documents · 1 min read
Short answer
The meeting's minutes are not in this record. What is: two company 8-Ks from the autumn of 2025, the FDA's April 2026 letter, and the company's April 2026 8-K and June 2026 10-K, each describing what was said.
What the evidence shows
Before the meeting, the company said its briefing book highlighted prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components
8-K · Sep 4, 2025. Two days after it, the company said a path forward under the accelerated approval pathway has not been determined
8-K · Sep 18, 2025.
In November 2025 it reported: In the Type A meeting minutes, the FDA indicated that the IGNYTE-3 trial could potentially support approval
8-K · Nov 6, 2025. The FDA's April 2026 letter says that at the meeting the agency provided recommendations regarding use of data from the ongoing Phase 3 trial to potentially support Accelerated Approval
FDA · Apr 10, 2026 · p. 4, and communicated that the response criteria used in the single-arm trial were not consistent with RECIST v1.1
FDA · Apr 10, 2026 · p. 4.
The company's April 2026 8-K says the agency appears to have contradicted their positions expressed at the September 2025 Type A meeting
8-K · Apr 13, 2026: after the meeting it did not raise further concerns about the heterogeneity of the patient population in IGNYTE
8-K · Apr 13, 2026 and acknowledged that randomizing patients to an anti-PD1 only arm in the confirmatory study was not feasible
8-K · Apr 13, 2026. Its 10-K adds that the minutes named a possible control arm for the Phase 3 trial: may be an acceptable comparator
10-K · Jun 29, 2026.
The letter's account of what followed: Instead, you submitted data from an early unplanned analysis from RP1-104
FDA · Apr 10, 2026 · p. 4.
Follow the thread
- What happened to the confirmatory trial Replimune said would not be viable?The control arm named in the minutes
- What did Replimune resubmit in October 2025, and what did the FDA make of it?“Instead, you submitted” an early Phase 3 analysis
- Was the FDA's advice to Replimune consistent?“Appears to have contradicted” the meeting
The documents, by date
The passages quoted
Replimune Form 8-K, filed September 4, 2025
The Company submitted a briefing book to the FDA addressing the points from the CRL, highlighting prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components. The briefing book also includes an additional analysis of data from the BLA and addresses comments about the phase 3 confirmatory trial design.Open at the source →
Replimune Form 8-K, filed September 18, 2025
The company is evaluating the feedback from the FDA provided during the meeting to determine next steps. At this time, a path forward under the accelerated approval pathway has not been determined.Open at the source →
Replimune Form 8-K, filed November 6, 2025
In the Type A meeting minutes, the FDA indicated that the IGNYTE-3 trial could potentially support approval.Open at the source →
FDA Complete Response Letter, April 10, 2026 · page 4
Instead, you submitted data from an early unplanned analysis from RP1-104, representing 10% of the planned enrollment, as well as additional exploratory analyses of the RPL-001-16 data, to support BLA resubmission. This data is insufficient to support an efficacy claim.Open at the source →
FDA Complete Response Letter, April 10, 2026 · page 4
In the Type A meeting dated September 16, 2025, FDA also communicated that the response criteria used in RPL-001-16 were not consistent with RECIST v1.1 and may not be comparable to response rates reported in the historical literature.Open at the source →
FDA Complete Response Letter, April 10, 2026 · page 4
FDA provided recommendations regarding use of data from the ongoing Phase 3 trial to potentially support Accelerated Approval.Open at the source →
Replimune Form 8-K, filed April 13, 2026
In the CRL, the agency appears to have contradicted their positions expressed at the September 2025 Type A meeting, including on the following points:Open at the source →
Replimune Form 8-K, filed April 13, 2026
After testimony from melanoma experts, the agency did not raise further concerns about the heterogeneity of the patient population in IGNYTE and acknowledged that randomizing patients to an anti-PD1 only arm in the confirmatory study was not feasible.Open at the source →
Replimune Form 10-K, filed June 29, 2026
In the September 2025 type A meeting minutes following the initial CRL, the FDA stated a control arm of nivolumab in combination with relatlimab (Opdualag (R) ) may be an acceptable comparator for the I-3 randomized controlled trial. However, in the second CRL we believe the FDA reverted on its position in the September 2025 type A meeting. Following the recent collaborative communications with the FDA we plan to continue working with the FDA on a path forward for the I-3 trial. We continue to enroll patients in the I-3 trial.Open at the source →