Replimune Group Inc

Replimune Group, Inc. is a clinical-stage biotechnology company, which engages in the development of oncolytic immunotherapy product candidates through immulytic platform. Its product candidates include RP1, RP2, and RP3. The firm's Oncolytic immunotherapy is a cancer treatment that exploits the ability of certain viruses to selectively replicate in and directly kill tumors, as well as induce a potent, patient-specific, anti-tumor immune response. The company was founded by Philip Astley-Sparke, Colin A. Love and Robert Coffin in March 2015 and is headquartered in Woburn, MA.

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Replimune Group, Inc. is a clinical-stage biotechnology company. It engages in the business of developing oncolytic immunotherapies for the treatment of cancer. The company was founded by Philip Astley-Sparke, Colin A. Love, and Robert Coffin in March 2015 and is headquartered in Woburn, MA.

REPL stock soars after submitting a BLA to the FDA seeking accelerated approval for its lead candidate, RP1, in combination with Opdivo for advanced melanoma.

Replimune Stock Rallies on BLA Filing for Melanoma Combo Drug

WOBURN, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting.

Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway

Oral presentation highlighting IGNYTE primary analysis data shows anti-tumor activity across all subgroups with injected and non-injected lesions responding with similar frequency, depth, duration, and kinetics

Replimune Presents Late-Breaking Abstract Featuring Data from IGNYTE Clinical Trial of RP1 Combined with Nivolumab in Anti-PD1 Failed Melanoma at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024)

WOBURN, Mass., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the grant of inducement equity awards to newly hired non-executive employees.

Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Late-breaking abstract featuring IGNYTE clinical trial data, including subgroup and initial biomarker analyses, selected for oral presentation

Replimune to Present at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

WOBURN, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the grant of inducement equity awards to newly hired non-executive employees.

Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Data from the IGNYTE primary analysis shows clinically meaningful activity across all subgroups, including those who had received prior anti-PD1 and anti-CTLA-4 or had primary resistance to anti-PD1

Replimune Presents Primary Analysis Data from IGNYTE Clinical Trial of RP1 Combined with Nivolumab in Anti-PD1 Failed Melanoma at European Society for Medical Oncology (ESMO) Congress 2024

Replimune's RP1, an oncolytic immuno-gene therapy, shows promise with a 31.4% ORR in phase 2 trials for post PD-1 melanoma and non-melanoma skin cancers. RP2, adding an anti-CTLA-4 component to RP1, demonstrated a 29.4% ORR in phase 1 trials, with durable responses in difficult-to-treat tumors. Despite competitive challenges and a failed CSCC trial, Replimune's cash runway supports its accelerated approval and phase 3 trials, making it an attractive investment.

Replimune: Strong Data In A Highly Differentiated Space

Confirmatory Phase 3 Trial to assess efficacy and safety of the investigational oncolytic immunotherapy, RP1 (vusolimogene oderparepvec) in combination with nivolumab in patients with advanced melanoma Confirmatory Phase 3 Trial to assess efficacy and safety of the investigational oncolytic immunotherapy, RP1 (vusolimogene oderparepvec) in combination with nivolumab in patients with advanced melanoma

Replimune Announces First Patient Dosed in IGNYTE-3 Clinical Trial in Advanced Melanoma

WOBURN, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that members from the Replimune management team will host investor meetings at the following two conferences:

Replimune to Present at Two Upcoming Investor Conferences

Replimune's (REPL) lead pipeline candidate RP1, in combination with Opdivo, leads to an overall response rate of 33.6% in patients with anti-PD1 failed melanoma. Shares gain.

Replimune (REPL) Gains on Positive Data From Melanoma Study

WOBURN, Mass., June 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that Sushil Patel, Chief Executive Officer of Replimune, will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:00 PM ET.

Replimune to Present at the Goldman Sachs 45th Annual Global Healthcare Conference

Primary endpoint data shows 12-month overall response rate (ORR) of 33.6% Biologics license application (BLA) submission intended for 2H 2024; first patient expected to be enrolled in IGNYTE-3 confirmatory trial in Q3 2024 Company to host conference call and webcast today at 8:00 a.m. ET WOBURN, Mass.

Replimune Announces Positive Topline Primary Analysis Data by Independent Central Review from IGNYTE Clinical Trial of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma

-- Investigator-assessed 12-month results from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD-1 failed melanoma demonstrate an overall response rate of 32.7% and duration of response consistent with the previously reported 6-month data from IGNYTE trial -- -- RP2 as monotherapy and in combination with nivolumab in uveal melanoma demonstrates overall response rate of nearly 30 percent; planning for registration-directed trial underway --

Replimune Presents Positive Data from RP1 and RP2 Clinical Programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

WOBURN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced multiple presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 31-June 4, 2024.

Replimune to Present at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

WOBURN, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2024 and provided a business update.

Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update

RP1 monotherapy showed clear anti-tumor activity with an overall response rate of nearly 35 percent and complete response rate of nearly 22 percent in evaluable patients RP1 monotherapy showed clear anti-tumor activity with an overall response rate of nearly 35 percent and complete response rate of nearly 22 percent in evaluable patients

Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annual Meeting

Philip Astley-Sparke to transition from current role of CEO to Executive Chairman Planned leadership changes position the Company for commercialization Preparations on track to submit RP1 biologics license application (BLA) in 2H 2024 WOBURN, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced changes to its executive leadership team designed to support the Company's preparations for the commercial launch of RP1, pending regulatory submission and approval in anti-PD1 failed melanoma.

Replimune Announces Appointment of Sushil Patel to CEO and Executive Leadership Transitions

The average of price targets set by Wall Street analysts indicates a potential upside of 50.2% in Replimune Group, Inc. (REPL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

How Much Upside is Left in Replimune Group, Inc. (REPL)? Wall Street Analysts Think 50.17%

Replimune Group, Inc. (REPL) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

What Makes Replimune Group, Inc. (REPL) a New Buy Stock

The consensus price target hints at a 70.6% upside potential for Replimune Group, Inc. (REPL). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts See a 70.57% Upside in Replimune Group, Inc. (REPL): Can the Stock Really Move This High?

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update

WOBURN, Mass., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that Philip Astley-Sparke, Chief Executive Officer of Replimune, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 11:15 AM PT at the Westin St. Francis Hotel in San Francisco, CA.

Replimune to Present at the 42nd Annual J.P. Morgan Healthcare Conference

Replimune (NASDAQ: REPL ) stock is falling hard on Tuesday after the clinical-stage biotechnology company shared a primary analysis of its CERPASS trial. This trial is evaluating RP1 alongside cemiplimab in the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma.

Why Is Replimune (REPL) Stock Down 48% Today?

Replimune Group Inc. shares REPL, +5.21% dropped more than 40% premarket on Tuesday after the biotech company said an investigational cancer therapy had failed to meet its primary goals in a clinical trial in skin cancer. The therapy, RP1, was studied in combination with cemiplimab, a Regeneron Pharmaceuticals Inc. REGN, +1.04% monoclonal antibody branded as Libtayo.

News for Replimune Group Inc Stock (REPL)