Replimune Group Stock Price, News & Analysis

Replimune announced positive results from the IGNYTE clinical trial, showing an overall response rate (ORR) of 33.6% for RP1 plus nivolumab in anti-PD1 failed melanoma patients. The results, independently reviewed, reveal a median duration of response exceeding 35 months, with all responses lasting over 6 months. The company plans to submit a biologics license application (BLA) in the second half of 2024, with first patient enrollment in the IGNYTE-3 trial expected by Q3 2024. The treatment exhibited predominantly mild side effects, with few severe adverse events reported. A conference call to discuss these findings will be held today at 8:00 a.m. ET.

Replimune presented positive data from its RP1 and RP2 clinical programs at the 2024 ASCO Annual Meeting. The IGNYTE trial showed a 32.7% overall response rate (ORR) for RP1 plus nivolumab in anti-PD-1 failed melanoma, with responses lasting over six months and a median duration exceeding 36 months. RP2, both as monotherapy and in combination with nivolumab, achieved an ORR of nearly 30% in uveal melanoma. The company plans a registration-directed trial for RP2 and will submit a Biologics License Application for RP1 in the second half of 2024. These results indicate a promising risk-benefit profile, particularly in hard-to-treat cancers.

Replimune Group, a clinical-stage biotech firm, is set to present at the 2024 ASCO Annual Meeting from May 31-June 4 in Chicago. The company will showcase data from two significant trials: the IGNYTE trial of RP1 combined with nivolumab in anti-PD-1 failed melanoma, and a Phase 1 trial of RP2 combined with nivolumab in advanced uveal melanoma. Additional highlights include three trial-in-progress posters for RP1 and RP2. Oral presentations will feature updated 12-month data and new biomarker results, with key sessions scheduled on June 3.

Replimune has reported its fiscal fourth quarter and year-end 2024 financial results while providing a corporate update. The company highlighted significant progress in its clinical trials, including the IGNYTE trial for RP1 in advanced melanoma. They plan to present 12-month primary analysis results in Q2 2024 and expect to submit a Biologics License Application (BLA) in 2H 2024. Financially, the company reported cash and equivalents of $420.7M, with a net loss of $215.8M for the fiscal year. Operationally, their cash runway extends into 2H 2026.

Key corporate milestones include a successful Type C meeting with the FDA and the expected enrollment of patients in Phase 3 trials in 2H 2024. Replimune also presented new data from various trials at the ASCO Annual Meeting, showing promising outcomes in melanoma and other cancers.