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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.
Replimune Group, Inc. (NASDAQ: REPL) announced the dosing of the first patient in a Phase 1 clinical trial for RP3, an oncolytic immuno-gene therapy. This trial will evaluate RP3 both alone and in combination with anti-PD-1 therapy in patients with advanced solid tumors. RP3 aims to enhance anti-tumor immune responses using a unique combination of immune-activating proteins. The trial focuses on safety, tolerability, and determining a recommended Phase 2 dose, with initial results expected later in 2021.
Replimune Group Inc. (Nasdaq: REPL) announced its senior management team's participation in investor meetings at the SVB Leerink Oncology 1x1 Day on November 19, 2020. The biotechnology company, based in Woburn, MA, focuses on developing oncolytic immuno-gene therapies from its Immulytic™ platform. This innovative approach aims to enhance cancer treatment by leveraging virus replication and immune response to tumor antigens. Replimune's goal is to advance these therapies through clinical development, working alongside other immuno-oncology treatments.
Replimune Group Inc. (NASDAQ: REPL) announced the availability of its posters for the Society for Immunotherapy of Cancer (SITC) annual meeting, held virtually from November 9-14, 2020. The company will actively participate in a press conference presenting updated results from its Phase 1/2 clinical trial of RP1, an oncolytic HSV combined with nivolumab. Two notable presentations include data from a Phase 1 trial of RP2 and updated results from skin cancer cohorts. Replimune focuses on developing oncolytic immuno-gene therapies to enhance cancer treatment efficacy.
Replimune Group, Inc. (Nasdaq: REPL) announced its fiscal Q2 2020 financial results, highlighting significant developments in its oncolytic immuno-gene therapies. The company raised approximately $287 million through a public offering, strengthening its balance sheet for further clinical trials and commercial infrastructure. Updated data showed promising responses in patients using RP1 and RP2, validating their Immulytic™ platform. A Phase 1 trial for RP3 is set to commence soon, while the cash runway is extended into H2 2024. The net loss for the quarter was $20.1 million.
Replimune Group, Inc. (Nasdaq: REPL) has announced a public offering of 4,687,500 shares at $40.00 per share, raising approximately $250 million before expenses. Additionally, the company will offer pre-funded warrants for 1,562,500 shares at $39.9999 each. The offering is expected to close on October 26, 2020. J.P. Morgan, SVB Leerink, and Barclays act as joint book-running managers. This follows a previously filed shelf registration statement with the SEC. The funds raised aim to support the company’s oncolytic immuno-gene therapy development.
Replimune Group, Inc. (Nasdaq: REPL) announced a proposed public offering of $125 million in common stock, with a potential 30-day option for underwriters to purchase an additional $18.75 million. The offering is to be managed by J.P. Morgan and SVB Leerink, subject to market conditions. Proceeds are intended to support Replimune's development of its oncolytic immuno-gene therapies derived from the Immulytic™ platform. This press release is not an offer to sell securities and will be filed with the SEC.
Replimune Group, Inc. (NASDAQ: REPL) has filed a Current Report on Form 8-K to update its corporate presentation, now available on their website. The updated presentation includes key information regarding abstracts to be showcased at the 2020 Society for Immunotherapy of Cancer Annual Meeting, featuring clinical trial data updates. Notably, data from these abstracts was accidentally released on October 14, 2020. Replimune's Immulytic™ platform focuses on developing oncolytic immuno-gene therapies aimed at enhancing cancer treatment through immune response activation.
Replimune Group, Inc. (NASDAQ: REPL) announced the appointment of Tanya Lewis to its Board of Directors, effective November 2, 2020. With over 20 years in global drug development, particularly in oncology, her expertise enhances Replimune's regulatory strategies. Previously, she held significant roles at Karyopharm Therapeutics, Tesaro, and Millennium, where she drove successful drug approval processes. This appointment aims to strengthen Replimune's efforts to bring their oncolytic immunotherapies to market amid a growing pipeline.
Replimune Group Inc. (NASDAQ: REPL) announced the initial safety and efficacy data of its oncolytic immuno-gene therapy candidates, RP1 and RP2, during the Society for Immunotherapy of Cancer (SITC) virtual meeting. The Phase 1 trial of RP2 indicated promising results with 50% of patients showing ongoing partial responses. The RP1 trial also demonstrated positive outcomes, including a response rate of 87.5% in non-melanoma skin cancers. Both therapies exhibited manageable safety profiles, supporting further clinical study.
Replimune Group Inc. (Nasdaq: REPL) announces that CEO Philip Astley-Sparke will present at the BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference on June 23, 2020, at 9:30 a.m. ET. Replimune is a biotechnology company based in Woburn, MA, specializing in developing oncolytic immuno-gene therapies through its Immulytic™ platform. This innovative approach aims to enhance the immune response to tumors and improve cancer treatment efficacy, particularly in conjunction with immune checkpoint blockade therapies.
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