Replimune Group, Inc. reports clinical, regulatory and financial developments for a clinical-stage biotechnology business developing oncolytic immunotherapies for cancer. The company’s proprietary RPx platform uses an engineered HSV-1 backbone intended to promote tumor cell killing, immunogenic cell death and systemic anti-tumor immune responses.
Recurring Replimune news centers on RP1, or vusolimogene oderparepvec, including data from the IGNYTE clinical trial, combination use with nivolumab in advanced melanoma, Biologics License Application activity and FDA complete response letters. Updates also cover RP2 clinical data in advanced solid tumors, scientific presentations at oncology meetings, quarterly financial results, research and development spending, cash runway commentary and management presentations at healthcare conferences.
Replimune Group (REPL) reported a narrower fiscal second-quarter net loss of $57.1 million and outlined its TUDRIQEV commercial launch. Net loss was $83.1 million a year earlier; loss per share narrowed to $0.54 from $0.90. Research and development expenses fell to $34.4 million, while selling, general and administrative expenses fell to $21.9 million.
TUDRIQEV was first delivered to patients on October 6, 2026, and more than 15 institutions have prescribed it. It is available with nivolumab for adults with unresectable advanced cutaneous melanoma after progression on a PD-1-blocking regimen. Continued accelerated approval may depend on confirmatory clinical benefit. The IGNYTE-3 confirmatory trial and RP2 REVEAL trial are enrolling. Cash and cash equivalents were $307.8 million at September 30, following an equity offering and debt draw. Replimune expects its existing cash to fund operations for greater than twelve months from financial-statement issuance.
Replimune Group (REPL) will discuss fiscal second-quarter 2027 financial results and provide a corporate update on October 28, 2026. The conference call begins at 8:00 a.m. ET and covers the quarter ended September 30, 2026. A webcast replay will be available on the company’s investor website approximately two hours after the call concludes.
Replimune (REPL) announced that TUDRIQEV, its first commercially available product, is now available in the United States for advanced melanoma. Providers can order it for next-day delivery. Approved with nivolumab, it treats adults with unresectable advanced cutaneous melanoma that progressed after a PD-1-blocking antibody-based regimen.
FDA accelerated approval in early August was based on tumor response and response duration. Among 91 efficacy-evaluable IGNYTE patients with at least one non-injected lesion, the combination achieved a 24.2% objective response rate and 14.1-month median response duration. Continued approval may depend on confirmation of clinical benefit; the Phase 3 IGNYTE-3 trial is ongoing. Serious adverse reactions occurred in 35% of 140 treated patients. ReplimuneConnect Plus is live to support eligible patients with access, reimbursement and financial assistance.
Replimune (REPL) will participate in a fireside chat at the Cantor Global Healthcare Conference on Thursday, September 10 at 9:10 AM ET.
The presentation will be webcast live in the Investors section of Replimune’s website, with a replay available online for 30 days following the conference.
Replimune (NASDAQ: REPL) granted inducement equity awards to Chief Commercial Officer Michelle DiNapoli under Nasdaq Listing Rule 5635(c)(4). The package includes a non-qualified stock option for 150,000 shares at an exercise price of $15.58 and 100,000 restricted stock units (RSUs).
The option has a 10-year term, vesting 25% after one year and monthly over the following three years. The RSUs vest in roughly four equal annual installments starting August 15, 2027. According to Replimune, these awards were granted outside the 2018 Equity Incentive Plan but follow substantially similar terms.
Replimune (Nasdaq: REPL) reported fiscal Q1 2027 results and a major regulatory milestone. On August 6, 2026, the FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec‑wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma progressing after PD‑1–based therapy. The company expects to launch in the U.S. within 60 days and recently completed a $150 million financing to support commercialization and the IGNYTE‑3 confirmatory Phase 3 trial.
Replimune appointed Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. Q1 R&D expenses were $49.3 million and SG&A $19.0 million, both down year over year, with net loss narrowing to $69.8 million from $86.7 million. Cash, cash equivalents and short-term investments were $195.3 million at June 30, 2026, and, together with $141.0 million of August 2026 equity proceeds, are expected to fund operations for more than 12 months, including the TUDRIQEV commercial scale‑up. The IGNYTE‑3 and RP2 REVEAL trials are actively enrolling, with the REVEAL Phase 2/3 transition expected in Q1 2027.
Replimune (Nasdaq: REPL) priced an underwritten offering of 9,701,490 common shares at $12.06 per share and pre-funded warrants to purchase 2,736,340 shares at $12.0599 per warrant. Expected aggregate gross proceeds are about $150 million, before underwriting discounts, commissions, and expenses.
All securities will be sold by Replimune, with closing expected on August 11, 2026, subject to customary conditions. Leerink Partners, J.P. Morgan, and Cantor are acting as joint bookrunning managers under an effective shelf registration on Form S-3.
Replimune (NASDAQ: REPL) announced that the FDA has granted accelerated approval for TUDRIQEVTM (vusolimogene oderparepvec-wtpg) in combination with nivolumab to treat adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen.
The approval is based on the Phase 1/2 IGNYTE trial, where in 91 efficacy-evaluable patients with at least one non-injected lesion, TUDRIQEV plus nivolumab achieved an objective response rate of 24.2% and a median duration of response of 14.1 months. Treatment was generally well tolerated, with mostly grade 1–2, transient adverse reactions and no grade 4 or 5 common events reported. Continued approval may depend on confirmation of clinical benefit in the ongoing Phase 3 IGNYTE-3 study.
Replimune (Nasdaq: REPL) reported that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee reviewed the resubmitted Biologics License Application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma patients who have progressed on prior anti-PD-1 therapy.
The committee evaluated whether the single-arm IGNYTE study design supports a reliable assessment of response rate and durability, and whether responses indicate systemic antitumor activity attributable to RP1. The committee then voted 10 to 3 that the IGNYTE efficacy results are evaluable and clinically meaningful. According to Replimune, this represents an important step in the BLA review process. The FDA continues its review, with a Class 1 resubmission target action date of August 2, 2026.
Replimune (Nasdaq: REPL) reported fiscal Q4 and full-year 2026 results and updated its clinical pipeline. The FDA accepted the resubmitted BLA for RP1 + nivolumab in advanced melanoma as a class 1 response, with an August 2, 2026 goal date and an advisory committee meeting expected in late July.
RP1 3‑year data in anti‑PD‑1‑failed melanoma showed 47.8% of treated patients alive at 3 years and median overall survival of 32.9 months, with 83.5% 3‑year survival among responders. RP2 Phase 1 yielded a 19% objective response rate as monotherapy and in combination with nivolumab across advanced solid tumors, supporting advancement into the REVEAL Phase 2/3 trial in metastatic uveal melanoma.
Cash, cash equivalents and short-term investments were $268.9 million on March 31, 2026, versus $483.8 million a year earlier. Replimune expects this to fund operations into Q1 2027. Fiscal 2026 R&D expenses were $221.2 million, SG&A $98.7 million, and net loss $313.9 million.