Replimune Group Stock Price, News & Analysis

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).

Replimune Group (NASDAQ: REPL), a clinical stage biotech company focused on oncolytic immunotherapies, has granted inducement equity awards to 10 new non-executive employees. The awards include non-qualified stock options to purchase 36,485 shares at $9.75 per share and restricted stock units for 41,080 shares. The stock options have a 10-year term with 25% vesting after one year and the remainder vesting monthly over three years. The restricted stock units will vest in four annual installments starting May 15, 2026. These awards were granted under the 2025 Inducement Plan and approved by the compensation committee under Nasdaq Listing Rule 5635(c)(4).

Replimune (NASDAQ: REPL) presented new analyses from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma patients at ASCO 2025. The combination therapy showed an objective response rate of 32.9% and complete response rate of 15.0%, with landmark overall survival rates of 75.3%, 63.3%, and 54.8% at 1, 2, and 3 years respectively. Deep/visceral injections demonstrated higher response rates (40.9-42.9%) compared to superficial-only injections (29.8%). The treatment showed effectiveness in both injected (93.6% reduction) and non-injected lesions (79.0% reduction), with robust responses in liver and lung injections. Biosafety analysis confirmed RP1's safety profile, with minimal transmission risk and effectiveness of standard disinfection procedures.

Replimune Group (NASDAQ: REPL), a clinical-stage biotech company focused on developing novel oncolytic immunotherapies, has announced its participation in the 2025 Jefferies Global Healthcare Conference. The company's management team will engage in a fireside chat on June 5, 2025, at 4:20 PM ET. Investors can access the live webcast through Replimune's website investor section, with a replay available for 30 days after the event.

Replimune Group (NASDAQ: REPL), a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, has announced two upcoming investor events. The company will host its fiscal fourth quarter and year-end 2025 earnings call on May 22, 2025, at 8:00 a.m. ET, where it will discuss financial results for the period ending March 31, 2025. Additionally, Replimune will hold an Investor Day on June 24, 2025, starting at 10:00 a.m. ET, targeted at analysts and institutional investors. Both events will be available via webcast, with replays accessible through the company's investor relations website.

Replimune Group (NASDAQ: REPL), a clinical stage biotechnology company focused on oncolytic immunotherapies, has granted inducement equity awards to 18 new non-executive employees. The awards include:

- Non-qualified stock options to purchase 21,960 shares with an exercise price of $10.01 per share - Restricted stock units representing 44,005 shares

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

Replimune Group (NASDAQ: REPL) announced the grant of inducement equity awards to 53 newly hired non-executive employees. The compensation package includes:

• 98,450 non-qualified stock options at $7.49 per share (closing price on April 7, 2025)
• 155,875 restricted stock units (RSUs)

The stock options have a 10-year term with a 4-year vesting schedule: 25% vests after one year, followed by monthly installments over three years. RSUs vest in four annual installments starting May 15, 2026. These inducement awards, approved under Nasdaq Rule 5635(c)(4), align with the company's 2018 Equity Incentive Plan terms despite being granted outside it.