Replimune to Present at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Rhea-AI Summary
Replimune (NASDAQ: REPL) will present multiple clinical updates at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 29–June 2, 2026. The company has two oral abstracts and four poster presentations covering 3‑year overall survival data for RP1 plus nivolumab, final Phase 1 RP2 safety/efficacy/biomarker results, and multiple ongoing RP1/RP2 studies across melanoma, solid tumors, HCC, and biliary tract cancer.
Oral presentations occur May 30 and May 31, 2026; poster sessions are scheduled across May 30–31 in Hall A and other ASCO session locations.
AI-generated analysis. Not financial advice.
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Negative
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News Market Reaction – REPL
On the day this news was published, REPL gained 10.74%, reflecting a significant positive market reaction. Argus tracked a peak move of +7.8% during that session. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $22M to the company's valuation, bringing the market cap to $229.55M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
REPL shows a -15.09% move while close peers in biotechnology are mixed with relatively modest single‑day changes (e.g., BCYC +0.62, RGNX -1.46), and no peers appeared in the momentum scanner. This points to stock‑specific dynamics rather than a broad sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 10 | Regulatory setback | Negative | -64.3% | Second FDA Complete Response Letter for RP1 plus nivolumab in advanced melanoma. |
| Mar 02 | Investor conferences | Neutral | -6.4% | Management presentations at two March 2026 healthcare investor conferences. |
| Feb 03 | Earnings and update | Positive | +5.8% | Fiscal Q3 2026 results with funding update and multiple RP1/RP2 clinical milestones. |
| Dec 18 | Conference appearance | Neutral | +0.3% | Planned presentation at the 44th Annual J.P. Morgan Healthcare Conference. |
| Nov 07 | Clinical data update | Positive | +4.8% | Updated RP1 plus nivolumab IGNYTE data with 33.6% ORR and durable responses. |
Recent major regulatory events, such as the April 10 FDA Complete Response Letter, have coincided with substantial downside moves, while positive clinical/earnings updates have seen more modest positive reactions.
Over the past six months, Replimune has alternated between clinical, regulatory, and corporate milestones. A key event was the FDA Complete Response Letter for RP1 plus nivolumab on Apr 10, 2026, which corresponded with a -64.29% move and plans to scale back U.S. operations. Earlier, fiscal Q3 2026 results on Feb 3, 2026 highlighted a $35M loan draw and $269.1M in cash, with a 5.81% positive reaction. Clinical data at SITC 2025 on Nov 7, 2025 showed an ORR of 33.6% and a 4.81% gain. Against this backdrop, the ASCO presentation news adds further visibility to RP1/RP2 data after a challenging regulatory outcome.
Regulatory & Risk Context
An S-3/A shelf filed on Nov 6, 2025 registers up to $250,000,000 in securities, including an at-the-market program of up to $100,000,000 of common stock under a Sales Agreement with Leerink Partners LLC, all within the same aggregate amount. Shelf usage count is 0, with no recent 424B takedowns reported.
Market Pulse Summary
The stock surged +10.7% in the session following this news. A strong positive reaction aligns with the article’s emphasis on multiple high-profile ASCO presentations for RP1 and RP2, which expand on prior IGNYTE and RP2 data. Historically, clinical and results updates, such as the SITC 2025 presentation with a 33.6% ORR and the Q3 2026 update with a 5.81% move, have supported upside. However, the earlier FDA Complete Response Letter that coincided with a -64.29% move highlights regulatory risk that could temper sustainability.
Key Terms
oncolytic immunotherapies medical
overall survival medical
phase 1 medical
phase 2/3 medical
biomarker medical
immune checkpoint inhibitor medical
hepatocellular carcinoma medical
biliary tract cancer medical
AI-generated analysis. Not financial advice.
WOBURN, Mass., April 27, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 29-June 2, 2026.
The Company has two abstracts selected for oral presentation, including a 3-year landmark overall survival analysis from the IGNYTE clinical trial of RP1 (vusolimogene oderparepvec) plus nivolumab in anti-PD-1 failed melanoma, and an oral presentation on the final safety, efficacy, and biomarker results from the Phase 1 first-in-human study of RP2 alone and combined with nivolumab in advanced solid tumors. Four additional posters for RP1 and RP2 will be presented.
Details for the presentations are as follows:
Oral data presentations
Abstract Title: A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial.
- Session Title: Rapid Oral Abstract Session - Melanoma/Skin Cancers
- Presenter: Michael Wong, MD, PhD
- Date: May 30, 2026, 5:30-5:36 pm CDT
- Location: E451
- Abstract #: 9518
Abstract Title: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study.
- Session Title: Oral Abstract Session - Developmental Therapeutics-Immunotherapy
- Presenter: Joseph Sacco, PhD, MBChB
- Date: May 31, 2026, 9:12-9:24 AM CDT
- Location: Arie Crown Theater
- Abstract #: 2504
Poster presentations
Abstract Title: Safety and feasibility of intratumoral injection of RP1 or RP2 oncolytic immunotherapies in visceral metastases.
- Poster Session Title: Developmental Therapeutics-Immunotherapy
- Presenter: Caroline Robert, MD, PhD
- Date: May 30, 2026, 1:30-4:30 PM CDT
- Location: Hall A, Poster 387
- Abstract #: 2597
Abstract Title: A randomized, phase 2/3 clinical trial investigating RP2 plus nivolumab vs ipilimumab plus nivolumab in immune checkpoint inhibitor-naïve patients with metastatic uveal melanoma.
- Poster Session Title: Melanoma/Skin Cancers
- Presenter: Marlana Orloff, MD
- Date: May 31, 2025, 9:00 AM-12:00 PM CDT
- Location: Hall A, Poster 481a
- Abstract #: TPS9598
Abstract Title: A randomized, controlled, multicenter, phase 3 study of RP1 (vusolimogene oderparepvec) combined with nivolumab vs physician's choice of therapy in patients with advanced melanoma that has progressed on anti-PD-1 and anti-CTLA-4 therapy (IGNYTE-3).
- Poster Session Title: Melanoma/Skin Cancers
- Presenter: Yana Najjar, MD
- Date: May 31, 2026, 9:00 AM-12:00 PM CDT
- Location: Hall A, Poster 480b
- Abstract #: TPS9597
Abstract Title: A multicenter, open-label study of RP2 oncolytic immunotherapy expressing anti-CTLA-4 combined with second-line atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (HCC) or with first-line durvalumab in advanced biliary tract cancer (BTC).
- Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
- Presenter: Richard Kim, MD
- Date: May 30, 2026, 9:00 AM-12:00 PM CDT
- Location: Hall A, Poster 230a
- Abstract #: TPS4255
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About RP2
RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
