Replimune Eyes FDA Decision on RP1 as Financing Stretches Through 2027

Key development milestones
- PDUFA Date: The FDA is expected to rule on RP1 by April 10, 2026.
- Cash Cushion: Cash and cash equivalents stood at $269.1 million at year-end 2025.
- Credit Update: Immediate access to $35.0 million under a new agreement with Hercules Capital.
- Cash Runway: Operational funding secured through the first quarter of 2027.

FDA approval focus for RP1
Acceptance of the revised regulatory filing by the FDA in October marked a meaningful step forward for Replimune’s oncology portfolio. This came after a prior decision in July 2025, when the agency had requested additional information. With the full submission now in place, a potential market introduction moves into clearer view.

Replimune is actively preparing for commercialization should the April decision be favorable. The therapy is designed for patients with advanced melanoma who have not responded to standard PD-1 inhibitor therapies.

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Financial position and runway
Even as regulatory progress advances, the cost of clinical development remains high. Cash and cash equivalents declined from $483.8 million in the prior year to $269.1 million at year-end 2025. The question remains whether available funds will be sufficient to reach commercial milestones.

To bridge the period until potential market access, management amended the Hercules credit facility. In addition to the immediate $35.0 million cash infusion, the company secured access to up to $120.0 million more, which could be drawn upon reaching milestones after an approval. For the quarter ended December 31, 2025, net loss amounted to $70.9 million.

Clinical research outlook
Alongside the regulatory process, Replimune continues to advance its clinical program. In the global Phase 3 study IGNYTE-3, roughly 400 patients are being evaluated to determine whether RP1 in combination with Nivolumab improves outcomes, with overall survival as the primary endpoint. Progress in the Phase 2 RP2 REVEAL trial for metastatic choroidal melanoma is also anticipated.

April 10, 2026 remains a critical date for investors. An FDA approval would not only open the path to commercialization but would also help stabilize long-term financing by unlocking additional credit tranches after authorization. In the interim, the company is concentrating on building distribution capabilities and completing ongoing patient recruitment.