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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 (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.
Replimune Group (NASDAQ: REPL) announced that its management will present at two upcoming virtual conferences. The BTIG Virtual Biotechnology Conference is scheduled for August 9, 2021, at 11:00 am ET. The second event, the 2021 Wedbush PacGrow Healthcare Virtual Conference, will include a panel discussion on immuno-oncology challenges on August 11, 2021, at 12:35 pm ET. Replimune is focused on developing oncolytic immune-gene therapies to enhance cancer treatment effectiveness through its Immulytic® platform.
Replimune Group, Inc. (NASDAQ: REPL) announced that Dr. Robert Coffin, its President and Chief R&D Officer, will speak at the William Blair Biotech Focus Conference 2021. This virtual event is scheduled for July 14, 2021, at 4:20 PM ET, focusing on addressing PD-(L)1 refractory tumors. A webcast will be available on Replimune's website, with a replay accessible for 90 days. Replimune specializes in oncolytic immuno-gene therapies, leveraging its Immulytic® platform to enhance cancer treatment through improved immune responses and viral-mediated tumor cell killing.
Replimune Group announces encouraging interim results from its Phase 2 clinical trials involving RP1 combined with Opdivo for skin cancer treatments and RP2 for anti-PD1 failed cancers. The results highlight a high rate of complete responses, particularly in cutaneous squamous cell carcinoma, with a current complete response rate of 46%. Replimune plans to initiate a Phase 2 study targeting tumors with liver metastases, a critical unmet need. The virtual investor event is set for today at 8:00 am ET to discuss these findings and future plans.
Replimune Group, Inc. (NASDAQ: REPL) reported fiscal year 2021 financial results, ending with approximately $476 million in cash, projected to fund operations into the second half of 2024. The company announced the addition of a complete response endpoint in the CERPASS clinical trial for non-melanoma skin cancer, aiming to enhance regulatory approval prospects. Additionally, they dosed the first patient in a new NSCLC cohort and strengthened the management team with key hires for commercial preparation.
Replimune Group, Inc. (Nasdaq: REPL) has appointed Tanya Lewis as Chief Development Operations Officer, effective May 10, 2021. Previously a board member, Lewis brings extensive experience from her roles at Karyopharm Therapeutics and other biopharmaceutical firms. She will focus on executing clinical and regulatory strategies for BLA filings and product registrations. CEO Philip Astley-Sparke highlighted her potential to enhance the company’s ambition to broaden its immuno-oncology treatments. Replimune is committed to advancing its oncolytic immuno-gene therapies to address various cancer types.
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