Replimune Group Stock Price, News & Analysis

Replimune (NASDAQ: REPL) presented late-breaking biomarker and updated clinical data for RP1 plus nivolumab at SITC 2025 on Nov 7, 2025. The IGNYTE trial update (abstract #1327) reported that RP1 appears to reverse multiple mechanisms of resistance to PD-1 blockade and upregulates gene signatures linked to PD-1 responsiveness. With an additional 7 months follow-up, the combination showed an objective response rate (ORR) of 33.6% and a median duration of response of 24.8 months. Consistent durability was observed across PD-L1–positive and PD-L1–negative tumors and in primary and secondary resistance settings. Two additional posters (abstracts 611 and 600) reported comparable efficacy by BRAF status and tolerability with extended RP1 dosing.

Replimune (Nasdaq: REPL) reported fiscal Q2 results for the period ended September 30, 2025 and provided a corporate update. The company said the FDA accepted the BLA resubmission for RP1 with a PDUFA date of April 10, 2026 and indicated the IGNYTE-3 trial could potentially support approval.

Clinical programs continue: IGNYTE-3 (RP1+nivolumab, ~400 patients, primary endpoint overall survival), RP2 REVEAL (metastatic uveal melanoma, ~280 patients), and multiple ongoing Phase 2 trials and presentations through SITC 2025. Financials: $323.6M cash as of Sept 30, 2025 and a Q2 net loss of $83.1M.

Replimune (NASDAQ: REPL) announced that the U.S. Food and Drug Administration has accepted the BLA resubmission for RP1 in combination with nivolumab to treat advanced melanoma in patients who progress on an anti‑PD‑1 containing regimen.

The FDA set a PDUFA target action date of April 10, 2026 under a Class II resubmission timeline. Replimune said the resubmission includes additional information, data and analyses and that the FDA views it as a complete response to the complete response letter issued in July 2025.

Replimune (NASDAQ: REPL) presented an ad hoc analysis from the IGNYTE phase 2 cohort at ESMO Congress 2025 showing activity of RP1 plus nivolumab in acral melanoma (Poster 1644P). The cohort had an objective response rate (ORR) of 44% (8/18) and a median duration of response of 11.9 months (95% CI lower bound 3.9 months, upper bound not reached). Safety was described as favorable with mostly transient grade 1–2 treatment‑related adverse events. The company noted ongoing phase 3 IGNYTE‑3 enrollment in post‑anti‑PD1/CTLA‑4 progressed melanoma and an additional NMSC poster (1661P) at ESMO.

Replimune (NASDAQ: REPL) has completed a Type A meeting with the FDA on September 16th, 2025, to discuss the Complete Response Letter (CRL) received for their RP1 therapy. The meeting focused on their Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment.

The company is currently evaluating the FDA's feedback, noting that a path forward under the accelerated approval pathway remains undetermined. CEO Sushil Patel emphasized strong support from the melanoma community and highlighted the unmet need in advanced melanoma treatment, citing positive risk-benefit profile observed in the IGNYTE trial.

Replimune (NASDAQ:REPL) has scheduled a Type A meeting with the FDA to discuss the Complete Response Letter (CRL) received for their RP1 melanoma treatment BLA. The company has submitted a briefing book addressing CRL points, including prior agreements on patient population, PD-1 resistance criteria, and component contribution analysis.

CEO Sushil Patel emphasized the urgent need for RP1 in advanced melanoma treatment, supported by physicians and patient advocacy groups. However, the company warned that without accelerated approval, continuing the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, would not be viable.

Replimune Group (NASDAQ:REPL) reported fiscal Q1 2026 financial results and provided updates on its oncolytic immunotherapy pipeline. The company received a Complete Response Letter (CRL) from the FDA for RP1 BLA in advanced melanoma on July 22, 2025. Key financial metrics include cash position of $403.3M, increased R&D expenses of $57.8M (vs $43.0M YoY), and a net loss of $86.7M (vs $53.8M YoY).

Multiple clinical trials are progressing, including the Phase 3 IGNYTE-3 trial for RP1 in melanoma, ARTACUS trial showing 34.6% response rate in transplant patients, and the Phase 2/3 REVEAL trial for RP2 in uveal melanoma. The company expects its current cash to fund operations into Q4 2026.

Replimune (NASDAQ:REPL) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment.

The FDA determined that the IGNYTE trial does not provide substantial evidence of effectiveness and cannot be adequately interpreted due to patient population heterogeneity. The agency also raised concerns about the confirmatory trial study design. While no safety issues were identified, the FDA cannot approve the application in its present form.

Replimune plans to request a Type A meeting within 30 days to discuss a path forward for RP1's accelerated approval, noting that without approval, further development for advanced cancer patients may not be viable.

Replimune (NASDAQ: REPL), a clinical stage biotechnology company focused on oncolytic immunotherapies, has granted inducement equity awards to 16 new non-executive employees. The awards include 32,135 non-qualified stock options at an exercise price of $9.65 per share and 64,320 restricted stock units (RSUs).

The stock options have a 10-year term with a 4-year vesting schedule, starting with 25% vesting after one year and the remainder monthly over three years. The RSUs will vest in approximately equal annual installments over four years beginning August 15, 2026. These awards were granted under the company's 2025 Inducement Plan and approved under Nasdaq Listing Rule 5635(c)(4).