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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) reported its financial results for the third fiscal quarter ended December 31, 2021, revealing a net loss of $29.7 million, up from $21.8 million a year ago. Research and development expenses rose to $19.4 million, reflecting heightened clinical activities. The company holds $420.2 million in cash, expected to fund operations until mid-2024. Upcoming milestones include initial data releases from various clinical trials and an investor event in March 2022 to discuss commercial strategies and RP2/3 development plans.
Replimune Group Inc. (NASDAQ: REPL) announced the resignation of Otello Stampacchia, Ph.D., from its Board of Directors effective January 31, 2022. Dr. Stampacchia, a co-leader of Replimune’s seed financing, has decided to focus on his commitments at Omega Funds. CEO Philip Astley-Sparke expressed gratitude for Dr. Stampacchia’s contributions to Replimune's growth from inception to a leader in oncolytic immunotherapies. Replimune aims to innovate cancer treatment through its proprietary RPx platform, enhancing both local and systemic therapeutic effects.
Replimune Group (Nasdaq: REPL) provided a corporate update on January 10, 2022, highlighting the progress of its clinical trials for RP1, RP2, and RP3. The CERPASS trial for RP1 in cutaneous squamous cell carcinoma (CSCC) is on track for enrollment completion mid-year, leading to primary data analysis later. Interim data from the IGNYTE trial, assessing RP1's efficacy in anti-PD1 failed melanoma, is expected by late 2022. Replimune aims to expand RP2 and RP3 trials into diverse cancer types, with detailed development plans to be unveiled in Q1 2022.
Replimune Group, a clinical-stage biotechnology firm, has announced that its CEO, Philip Astley-Sparke, will present on January 10, 2022, at the 40th Annual J.P. Morgan Healthcare Conference. The event will be held virtually at 7:30 AM ET. A webcast will be accessible through Replimune’s website, with a replay available for 30 days. Founded in 2015, Replimune focuses on tumor-directed oncolytic immunotherapies, utilizing its proprietary RPx platform to enhance cancer treatment.
Replimune Group, Inc. (Nasdaq: REPL) has appointed Christy Oliger to its Board of Directors effective December 1, 2021. Oliger brings nearly 30 years of pharmaceutical and biotechnology experience, particularly in oncology, having previously held key roles at Genentech. CEO Philip Astley-Sparke expressed optimism about Oliger's contributions to the company’s leading pipeline of oncolytic immunotherapies. Replimune focuses on advancing its innovative immuno-gene therapy platform aimed at enhancing cancer treatment.
Replimune Group (Nasdaq: REPL) announced updated interim data from its Phase 1 trial of RP2, demonstrating strong responses in difficult-to-treat cancers. The trial includes both RP2 as a monotherapy and in combination with Opdivo. Notable findings include durable responses in patients with esophageal and mucoepidermoid carcinoma lasting 19-22 months. The 30-patient cohort with Opdivo showed a 23.3% partial response rate, with ongoing responses exceeding 425 days. The company plans to enroll an additional 24 patients with liver metastases in response to positive results.
Replimune Group (NASDAQ: REPL) reported a net loss of $29.4 million for Q2 2021, up from $20.1 million in Q2 2020. R&D expenses increased to $19.9 million, driven by expanded clinical programs. The company maintains a strong cash position of approximately $436 million, expected to fund operations into H2 2024. Full patient accrual in the CERPASS trial is anticipated by mid-2022, with primary data trigger expected by late 2022. Initial data from the IGNYTE trial is also set for late 2022, reinforcing Replimune's focus on establishing a robust skin cancer franchise.
Replimune Group, Inc. (NASDAQ: REPL) announced upcoming presentations at two key conferences. The first, BMO Biopharma Spotlight Series, occurs on November 8, 2021, focusing on next-gen oncolytic virus therapies. The second event, Piper Sandler 33rd Virtual Annual Healthcare Conference, runs from November 30 to December 2, 2021, featuring a pre-recorded fireside chat available on-demand starting November 22. Replimune develops innovative oncolytic immuno-gene therapies using its Immulytic® platform to enhance cancer treatment.
Replimune Group, Inc. (Nasdaq: REPL) announced four poster presentations at the Society for Immunotherapy of Cancer’s 36th Annual Meeting, scheduled for November 10-14, 2021. Key presentations include:
- RP2: Phase 1 trial with nivolumab for advanced solid tumors.
- ARTACUS: Phase 1b/2 study on RP1 in transplant recipients.
- CERPASS: Phase 2 study of cemiplimab ± RP1 for advanced squamous cell carcinoma.
- IGNYTE: Phase 1/2 trial of RP1 ± nivolumab in advanced tumors.
Full posters will be available on Replimune's website.
Replimune Group, Inc. (NASDAQ: REPL) announced updates on its ongoing clinical trials and financial results for Q1 2021. The company reported cash reserves of $458 million, sufficient to fund activities into H2 2024. Data for RP1 and RP2 indicate durable responses in advanced skin cancers, supporting ongoing trials, including the CERPASS study for cutaneous squamous cell carcinoma (CSCC). A Phase 2 program focusing on liver metastases is being designed, with plans to disclose details in early 2022. R&D expenses rose to $18.6 million, with a net loss of $27.3 million for the quarter.
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