NasdaqGS - Nasdaq Real Time Price • USD Replimune Group, Inc. (REPL) Follow Compare 13.62 -0.45 (-3.20%) At close: 4:00:00 PM EST 13.62 0.00 (0.00%) After hours: 4:20:00 PM EST All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations Replimune price target raised to $21 from $17 at H.C. Wainwright H.C. Wainwright analyst Robert Burns raised the firm’s price target on Replimune (REPL) to $21 from $17 and keeps a Buy rating on the shares. The firm expects a “relatively uneventful” FDA review process for RP1 in combination with Opdivo for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The clinical impact should readily bolster the approval case, the analyst tells investors in a research note. Published first on TheFly – the REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA The FDA accepts and grants priority review to Replimune's BLA for RP1 in combination with Opdivo for advanced melanoma. A decision is due on July 22, 2025. Replimune Stock Soars 16% on FDA Priority Review for Advanced Melanoma Therapy Replimune's RPx platform is designed to support standalone and combination cancer therapies. Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma PDUFA action date of July 22, 2025, with priority reviewWOBURN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The FDA granted the BLA Priority R Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) WOBURN, Mass., Jan. 10, 2025 (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. The Company recently granted equity awards to 30 employees as a material inducement to commencing their employment with the Company. The inducement awards consist of non-qualified stock options to purchase an aggregat Replimune Announces RP2 Development Program Advances with First Patients Enrolled in Metastatic Uveal Melanoma and Hepatocellular Carcinoma Clinical Trials WOBURN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC). “On the heels of our BLA submission for RP1 and designation as breakthrough therapy Replimune to Present at the 43rd Annual J.P. Morgan Healthcare Conference WOBURN, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 2:15 PM PT. A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A replay will be available for 30 Replimune Announces Pricing of Upsized Public Offering BOSTON, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the pricing of its public offering of 6,923,000 shares of its common stock at a public offering price of $13.00 per share. In addition, in lieu of common stock to certain investors, Replimune today announced the pricing of its public offering of pre-funded warrants to purchase 3,846,184 shares of its Replimune Announces Proposed Public Offering WOBURN, Mass., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced a proposed public offering of $125 million of shares of its common stock and pre-funded warrants to purchase shares of common stock. All securities in the offering will be offered by Replimune. In addition, Replimune intends to grant the underwriter a 30-day option to purchase up to an addition S&P 500 Moves Higher; Intuit Shares Fall Following Q1 Results U.S. stocks traded higher toward the end of trading, with the Dow Jones index gaining by more than 350 points on Friday. The Dow traded up 0.82% to 44,228.50 while the NASDAQ rose 0.14% to 18,998.27. The S&P 500 also rose, gaining, 0.31% to ... Replimune Stock Rallies on BLA Filing for Melanoma Combo Drug 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's stock surges 19% after-hours on FDA BLA submission Shares of Replimune Group Inc (NASDAQ:REPL) surged more than 19% in after-hours trading following the company's announcement of significant regulatory progress for its lead product candidate, RP1 (vusolimogene oderparepvec). The clinical-stage biotechnology firm has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration seeking accelerated approval for RP1, an oncolytic immunotherapy, in combination with nivolumab. “We view these updates as encouraging and supportive of regulatory submission of RP1 in combination with nivolumab for anti-PD-1-failed melanoma,” said analysts at Leerink in a note. Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway 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 Acce Replimune Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update Completed Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) and remain on track to submit a BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via the accelerated approval pathway before the end of the year IGNYTE-3 confirmatory trial of RP1(vusolimogene oderparepvec) in advanced melanoma underway with first patient enrolled in August Presented late-breaking abstracts at ESMO and SITC featuring the IGNYTE trial primary analysis showing clinical 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) 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 Initial biomarker data shows increase in tumor CD8+ T cell and PD-L1 expression after dosing along with an increase in gene signatures associated with CD8+ T cells and inflammatory cytokines, highlighting the potential of RP1 plus nivolumab to generate a potent anti-tumor immune response Replimune to Present at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) Late-breaking abstract featuring IGNYTE clinical trial data, including subgroup and initial biomarker analyses, selected for oral presentation Data from ARTACUS clinical trial of RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies selected for encore poster presentation WOBURN, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, toda Morgan Stanley's Strategic Reduction in Replimune Group Inc Holdings On September 30, 2024, Morgan Stanley executed a significant transaction involving the sale of 192,770 shares in Replimune Group Inc (NASDAQ:REPL), a clinical-stage biotechnology company. This move reduced Morgan Stanley's holding by 11.11%, leaving the firm with a total of 1,542,884 shares. Despite the reduction, Morgan Stanley maintains a 2.30% position in REPL, reflecting a strategic adjustment rather than a complete exit. Replimune Group, Inc. (NASDAQ:REPL) Shares Could Be 48% Below Their Intrinsic Value Estimate Key Insights Using the 2 Stage Free Cash Flow to Equity, Replimune Group fair value estimate is US$23.01 Replimune... Replimune to Present at Two Upcoming Investor Conferences WOBURN, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members from the Replimune management team will present and host investor meetings at the following two conferences: BMO 2024 Oncology SummitDate: Tuesday, October 8, 2024 3rd Annual Roth Healthcare Opportunities Conference Date: Wednesday, October 9, 2024 About Replimune Replimune Group, 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 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 Injected and non-injected lesions responded with similar frequency, depth, duration and kinetics WOBURN, Mass., Sept. 15, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announce Performance Overview Trailing total returns as of 1/30/2025, which may include dividends or other distributions. Benchmark is S&P 500 Return REPL S&P 500 YTD +10.46% +2.78% 1-Year +67.94% +23.20% 3-Year -26.81% +36.99%