Replimune Group, Inc. - REPL STOCK NEWS

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Replimune Group, Inc. (NASDAQ: REPL) is a clinical-stage biotechnology company committed to advancing cancer treatment through innovative oncolytic immune-gene therapies. Founded in 2015 and headquartered in Woburn, Massachusetts, Replimune leverages its proprietary Immulytic™ platform to develop product candidates aimed at activating the immune system against solid tumors.

The core of Replimune’s portfolio includes RP1, RP2, and RP3, all based on genetically-engineered strains of herpes simplex virus 1 (HSV-1). These strains are modified to maximize tumor killing and stimulate a systemic anti-tumor immune response. RP1, the company’s lead product, is designed for enhanced tumor killing and has shown promising results in combination with anti-PD1 therapies. It is currently undergoing clinical trials for anti-PD1 failed melanoma and other skin cancers, with plans to submit a Biologics License Application (BLA) in 2H 2024.

Another notable candidate is RP2, which expresses an anti-CTLA-4 antibody-like protein to further enhance immune response. RP2 has demonstrated durable response rates in advanced uveal melanoma patients, a particularly challenging cancer type with limited treatment options. RP3, the third candidate in the pipeline, is engineered to express multiple immune-activating proteins, though its development has currently been paused to focus on higher priority programs.

Replimune's recent achievements include favorable safety profiles and substantial response rates in clinical trials. For instance, RP2 in combination with nivolumab showed a durable overall response rate of nearly 30% in patients with metastatic uveal melanoma. Additionally, RP1 has demonstrated significant anti-tumor activity in organ transplant recipients who typically cannot undergo systemic immunotherapy.

The company has established alliances with major pharmaceutical entities, such as Regeneron Pharmaceuticals, to further its clinical trials and explore combination therapies. Financially, Replimune is robust, with a cash runway extending into early 2026, thanks to strategic reprioritization and successful capital management.

Replimune is dedicated to evolving its portfolio and optimizing its RPx platform. The dual local and systemic mechanism of action of its therapies offers a versatile approach that can be combined with various other cancer treatment modalities, thus holding significant promise for the future of oncology.

04/07/2024 05:00 PM

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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

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Replimune Group, Inc. announced positive interim results from the ARTACUS Phase 1/2 clinical trial evaluating RP1 monotherapy for skin cancers in transplant patients, showing a 34.8% overall response rate with good durability. The treatment was well-tolerated and resulted in immune activation.

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04/04/2024 08:00 AM

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

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Replimune Group, Inc. grants inducement equity awards to Carolyn Trott, the new Senior Vice President, Quality Assurance, comprising a stock option for 75,000 shares and restricted stock units for 50,000 shares.

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03/26/2024 07:30 AM

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

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Replimune Group, Inc. announces leadership changes to support commercialization efforts for RP1 biologics. Sushil Patel to succeed Philip Astley-Sparke as CEO. RP1 BLA submission planned for 2H 2024.

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03/06/2024 08:00 AM

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Replimune to Present at the American Association for Cancer Research Annual Meeting 2024

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Replimune Group, Inc. announces presentations at AACR Annual Meeting 2024 for RP1 and RP2 oncolytic immunotherapies.

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03/05/2024 08:00 AM

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Replimune to Present at Three Upcoming Investor Conferences

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Replimune Group, Inc. announces participation in three upcoming investor conferences to present oncolytic immunotherapies.

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02/08/2024 08:00 AM

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

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Replimune Group, Inc. (Nasdaq: REPL) announced positive data update in December 2023 for all 140 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma, demonstrating durability of response. Centrally reviewed 12-month primary analysis data from IGNYTE trial of RP1 in anti-PD1 failed melanoma and biologics license application (BLA) submission expected in 2H 2024. Phase 3 confirmatory trial of RP1 in anti-PD1 failed melanoma skin cancers expected to initiate 2H 2024. Cash runway extended to fund operations into 2H 2026. CEO Philip Astley-Sparke expressed optimism about the potential of RP1 as a safe and effective treatment option for patients with different skin cancers, planning to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024 and explore potential additional submissions based on evolving data from multiple non-melanoma skin cancer studies.

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01/16/2024 03:59 AM

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DISCO Pharmaceuticals launches as the surfaceome company with EUR 20 Million in Seed Financing

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DISCO Pharmaceuticals, a specialist biotech company, has emerged from stealth with a transformative surfaceome discovery technology to identify new targets and develop first-in-class drugs for cancer treatment. The company has successfully raised seed financing of EUR 20 million and is backed by a world-leading investor syndicate. DISCO has completed the first-ever map of the surfaceome of Small Cell Lung Cancer and is developing proprietary antibody-based treatments for it. The company is also working on Microsatellite-Stable Colorectal Cancer and has a pipeline of further undisclosed programs. The experienced team, led by CEO Roman Thomas, includes leading biopharma executives Dieter Weinand and Carsten Reinhardt. The company's surfaceome mapping platform has the potential to transform oncology treatment options and improve outcomes for patients.

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12/28/2023 08:00 AM

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

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Replimune Group, Inc. (Nasdaq: REPL) announced that CEO Philip Astley-Sparke will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 8, 2024. The company is a clinical stage biotechnology firm focusing on oncolytic immunotherapies.

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12/05/2023 07:00 AM

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Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

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Replimune Group, a clinical stage biotechnology company (NASDAQ: REPL), announced results from the CERPASS trial evaluating RP1 in combination with cemiplimab for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) and provided initial data for all patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. The company also shared a new data snapshot from the IGNYTE cohort of anti-PD1 failed non-melanoma skin cancer (NMSC) patients and data from the ARTACUS trial evaluating RP1 as monotherapy for skin cancer in patients who have had solid organ or hematopoietic cell transplants.

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11/08/2023 09:10 AM

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Replimune Presents Updated Data on RP2 in Uveal Melanoma during Plenary Session at the 20th International Congress of the Society for Melanoma Research

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Replimune Group, Inc. (NASDAQ: REPL) announced updated data from a Phase 1 study of RP2 in metastatic uveal melanoma patients, showing a 29.4% overall response rate and a median duration of response of 11.47 months. The treatment was generally well tolerated with no grade 4 or 5 adverse events. Dr. Joseph Sacco presented the data at the 20th International Congress of the Society for Melanoma Research.

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FAQ

What is the current stock price of Replimune Group (REPL)?

The current stock price of Replimune Group (REPL) is $11.05 as of November 21, 2024.

What is the market cap of Replimune Group (REPL)?

The market cap of Replimune Group (REPL) is approximately 755.7M.

What is Replimune Group, Inc.?

Replimune Group, Inc. is a biotechnology company focused on developing oncolytic immune-gene therapies to treat cancer by activating the immune system against tumors.

What is the Immulytic™ platform?

The Immulytic™ platform is Replimune's proprietary technology for designing and developing therapies that use genetically-engineered strains of herpes simplex virus 1 to maximize tumor killing and stimulate systemic anti-tumor immune responses.

What are Replimune’s main product candidates?

Replimune’s main product candidates are RP1, RP2, and RP3. RP1 focuses on solid tumors, RP2 enhances immune response with an anti-CTLA-4 antibody-like protein, and RP3 expresses multiple immune-activating proteins.

What recent achievements has Replimune made?

Recent achievements include favorable safety profiles and durable response rates for RP2 in combination with nivolumab for metastatic uveal melanoma and significant anti-tumor activity for RP1 in organ transplant recipients.

What are the clinical goals for RP1?

The clinical goals for RP1 include submitting a Biologics License Application (BLA) in the second half of 2024 for the treatment of anti-PD1 failed melanoma and advancing trials for other skin cancers.

How does RP2 differ from RP1?

RP2 differs from RP1 by additionally expressing an anti-CTLA-4 antibody-like protein, enhancing the immune response further. It has shown promising results in treating uveal melanoma.

What is the financial outlook for Replimune?

Replimune has a solid financial outlook with a cash runway extending into early 2026, supported by strategic portfolio reprioritization and effective capital management.

What partnerships does Replimune have?

Replimune has established partnerships with major pharmaceutical companies, including Regeneron Pharmaceuticals, to enhance its clinical trial capabilities and explore combination therapies.

What is the RPx platform?

The RPx platform is Replimune's innovative technology based on HSV-1 strains engineered to induce immunogenic cell death and activate a comprehensive anti-tumor immune response. It supports the development of versatile cancer treatment modalities.

What are Replimune's future plans?

Replimune plans to continue developing its lead candidates, explore new indications, and potentially bring its first oncolytic immunotherapy to market following regulatory submissions and approvals.