Institutional Confidence Surges in Replimune as Key Drug Review Looms
Replimune Group Inc. (REPL) shares surged over 13% following reports of significant new investments from institutional funds like Forbion Capital Partners and Readystate Asset Management. This increased confidence comes as the company approaches a critical FDA PDUFA goal date of April 10, 2026, for its lead skin cancer candidate, RP1, which could be a transformative event for the biotech firm. Replimune is well-capitalized with $269.1 million in cash, expected to fund operations into 2027, regardless of the FDA's decision.
Wall Street Analysts Predict a 65.72% Upside in Replimune Group (REPL): Here's What You Should Know
Shares of Replimune Group (REPL) could see a 65.7% upside based on the mean price target of Wall Street analysts, which stands at $12.86. Despite potential biases in analyst price targets, the agreement among analysts predicting better earnings, coupled with a Zacks Rank #2 (Buy), suggests a legitimate reason to expect an upside. Investors are advised to consider price targets with skepticism but note the strong correlation between positive earnings estimate revisions and stock price movements.
Is Replimune Group (NASDAQ:REPL) A Risky Investment?
Replimune Group (NASDAQ:REPL) carries debt but also holds significant net cash, suggesting a seemingly safe balance sheet from a liquidity perspective. However, the company is not yet profitable, burning through cash and incurring losses, which raises concerns about its need to secure additional capital in the near future. While the balance sheet appears liquid, the lack of consistent free cash flow and operating revenue makes it a higher-risk investment, pending the success of new product development.
Replimune burns cash as April 10 RP1 FDA action date approaches
Replimune reported fiscal Q3 2026 results, showing a net loss of $70.9 million and a cash balance decrease to $269.1 million, though the cash runway is extended into late Q1 2027. The company's lead product, RP1, has an FDA PDUFA target action date of April 10, 2026, for its BLA resubmission, with commercial readiness underway. Positive market reaction followed the news, boosting REPL shares by 5.81%, reflecting investor interest in the regulatory timeline and positive clinical updates for RP1 and RP2.
Piper Sandler Maintains 'Overweight' Rating for REPL, Raises PT to $14 | REPL Stock News
Piper Sandler has reaffirmed an 'Overweight' rating for Replimune Group (REPL) and increased its price target from $13.00 to $14.00, indicating a positive outlook. This adjustment follows several other analyst upgrades and price target revisions. Replimune Group is a clinical-stage biotechnology company developing oncolytic immunotherapies for cancer, with an average analyst target price of $12.86.
Replimune Secures Financial Runway Through 2027
Replimune Group Inc. has significantly strengthened its financial position, projecting an operational cash runway through the first quarter of 2027 following an improved fiscal third-quarter performance and an amended credit facility. The company's focus is now firmly on the upcoming FDA regulatory decision for its lead candidate, RP1, with a PDUFA action date set for April 10, 2026. Preparations for commercial launch are underway, alongside continued progress in its broader clinical pipeline.
Analysts Are Neutral on Top Healthcare Stocks: Replimune Group (REPL), ACADIA Pharmaceuticals (ACAD)
Analysts have issued neutral ratings for Replimune Group (REPL) and ACADIA Pharmaceuticals (ACAD), suggesting neither a bullish nor bearish outlook. For Replimune Group, J.P. Morgan maintained a Hold rating with an average price target of $11.50, representing a 63.6% upside. Meanwhile, Morgan Stanley set a Hold rating for ACADIA Pharmaceuticals with a $25.00 price target, and the general Street consensus is a Moderate Buy with a $31.31 average price target.
Analysts Are Neutral on Top Healthcare Stocks: Replimune Group (REPL), ACADIA Pharmaceuticals (ACAD)
Analysts have adopted a neutral stance on healthcare stocks Replimune Group (REPL) and ACADIA Pharmaceuticals (ACAD), issuing "Hold" ratings. J.P. Morgan's Anupam Rama maintained a Hold on Replimune Group with an average price target indicating a 63.6% upside, and Morgan Stanley's Sean Laaman did the same for ACADIA Pharmaceuticals, with an average price target suggesting a 21.9% upside. This indicates that while analysts see potential, they are not strongly bullish on these stocks at present.
Replimune Group, Inc. SEC 10-Q Report
Replimune Group, Inc. has released its Form 10-Q report for Q3 2025, detailing a loss from operations of $(71.9) million and a net loss of $(70.9) million due to increased R&D costs. The report highlights progress in RP1 clinical trials, including the IGNYTE and ARTACUS trials, and the resubmission of a Biologics License Application for RP1 for advanced melanoma with a PDUFA date of April 10, 2026. The company is also developing RP2 and RP3 and expects current cash to fund operations for at least 12 months.
RP1 melanoma setback and SEC probe weigh on Replimune (NASDAQ: REPL)
Replimune (NASDAQ: REPL) reported a widened net loss of $240.7 million for the nine months ended December 31, 2025, primarily due to increased R&D and S&GA expenses for its oncolytic immunotherapy pipeline. The company faces a setback with its lead product candidate, RP1, after the FDA issued a complete response letter in July 2025 for its advanced melanoma BLA, though a resubmission has been accepted with a new PDUFA date of April 10, 2026. Additionally, Replimune is addressing a putative securities class action, shareholder derivative suits, and an SEC investigation related to the RP1 BLA.
Replimune Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update
Replimune Group, Inc. announced its fiscal third quarter 2026 financial results, highlighting the FDA's acceptance of the Biologics License Application resubmission for RP1 in advanced melanoma, with a target action date of April 10, 2026. The company has also amended its loan agreement, extending its cash runway into the first quarter of 2027. Clinical trial updates for RP1 and RP2 showcased promising results in various cancers, while financial figures indicated increased R&D expenses and a net loss for the quarter.
Wedbush Issues Positive Forecast for Replimune Group (NASDAQ:REPL) Stock Price
Wedbush has increased its price target for Replimune Group (NASDAQ:REPL) to $19.00 from $18.00, maintaining an "outperform" rating and implying a potential upside of over 161%. This positive forecast follows Replimune's recent EPS beat of ($0.77) versus the consensus ($0.85). The stock, currently trading at $7.26, has an average "Hold" rating and a consensus target price of $9.88 from ten analysts.
Replimune Group, Inc. Updates on RP1 and RP2 Programs
Replimune Group, Inc. announced new data for its RP1 and RP2 programs at the J.P. Morgan Healthcare Conference, highlighting a near-term PDUFA date for melanoma treatment and commercial launch preparations. The company's trials show promise in expanding treatment beyond skin cancer with successful deep injections, and it reported $269.2M in cash. This update signifies potential advancements in its therapeutic pipeline.
Here's Why Replimune Stock Skyrockets Nearly 131% in 3 Months
Replimune stock has surged by nearly 131% over the past three months, driven by excitement surrounding its lead drug candidate, RP1. Clinical trial results presented at SITC 2023 showed that RP1, used in combination with nivolumab, achieved high response rates in patients with metastatic melanoma, cutaneous squamous cell carcinoma, and CSCC. The company is poised to submit a Biologics License Application (BLA) in the first half of 2024, with potential FDA approval by the end of 2024 or early 2025.
Faruqi & Faruqi Reminds Replimune Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of September 22, 2025 - REPL
Faruqi & Faruqi, LLP is investigating potential claims against Replimune Group, Inc. (NASDAQ: REPL) after the FDA deemed the IGNYTE trial inadequate, leading to a significant stock drop. Investors who suffered losses between November 22, 2024, and July 21, 2025, are encouraged to contact the firm, with a lead plaintiff deadline of September 22, 2025. The lawsuit alleges that Replimune overstated the trial's prospects, resulting in false and misleading statements to investors.
Replimune to Present at the 44th Annual J.P. Morgan Healthcare Conference
Replimune Group, Inc. announced that its management team will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 1:30 PM PT. A webcast will be available on their website, with a replay accessible for 30 days. The company, based in Woburn, MA, specializes in developing novel oncolytic immunotherapies using its proprietary RPx platform.
Replimune to Present at the 44th Annual J.P. Morgan Healthcare Conference
Replimune Group, Inc. (Nasdaq: REPL) announced that its management team will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 1:30 PM PT. A live webcast will be available on their website, with a replay accessible for 30 days. The company focuses on developing novel oncolytic immunotherapies for cancer treatment.
Replimune to Present at the 44th Annual J.P. Morgan Healthcare Conference
Replimune Group, Inc. announced that its management team will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 1:30 PM PT. A webcast of the presentation will be available for 30 days on Replimune’s investor website. The clinical-stage biotechnology company focuses on developing novel oncolytic immunotherapies.
Biotech pioneering oncolytic immunotherapies to speak at J.P. Morgan
Replimune (REPL), a clinical-stage biotechnology company focused on oncolytic immunotherapies, announced it will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2025. This presentation follows recent key milestones, including FDA acceptance of the RP1 BLA resubmission and updated clinical data. Investors will be looking for any new strategic or clinical insights during the webcast.
Replimune Group, Inc. (NASDAQ:REPL) Given Average Rating of "Moderate Buy" by Brokerages
Replimune Group, Inc. (NASDAQ:REPL) has received an average "Moderate Buy" rating from eleven analysts, with an average 12-month price target of $9.75. Several firms recently upgraded their ratings for REPL, though insiders have been selling shares. The company recently missed quarterly EPS estimates and analysts forecast a loss for the current year.
Insiders At Replimune Group Sold US$766k In Stock, Alluding To Potential Weakness
Over the last year, Replimune Group (NASDAQ:REPL) insiders sold US$766k worth of stock, with the Executive Chairman, Philip Astley-Sparke, making the largest individual sale of US$260k at US$8.06 per share. While insider selling doesn't always indicate future weakness, a pattern of multiple insiders selling warrants a closer look by shareholders. Despite this, insiders still hold about 5.1% of the company's shares, totaling US$40 million.
Replimune Shares Face Mounting Headwinds
Replimune Group is experiencing significant stock selling pressure due to insider transactions, technical resistance, and an approaching high-stakes FDA regulatory review for its lead candidate, RP1. The company faces high cash burn and a critical PDUFA target action date of April 10, 2026, for RP1. While analysts have raised ratings, the current market price is in line with the consensus, highlighting the need for regulatory approval to alter the stock's trajectory.
Insiders At Replimune Group Sold US$766k In Stock, Alluding To Potential Weakness
Over the last year, insiders at Replimune Group have sold US$766k worth of shares, with the Executive Chairman making the largest sale of US$260k. This selling activity, particularly at prices below the current market value, suggests potential weakness or that insiders believe the shares are fully valued. Despite insider ownership of 5.1%, the recent sales indicate a cautiously negative outlook on the company's stock.
Replimune Group, Inc. $REPL Shares Sold by Redmile Group LLC
Redmile Group LLC reduced its stake in Replimune Group, Inc. by 4.8%, selling 233,736 shares but still holding 5.98% of the company, valued at approximately $43.3 million. Insider selling has also occurred, with 25,625 shares sold over the last three months, decreasing insider ownership to 5.2%. Despite the selling, analyst sentiment is cautiously positive, with a consensus "Moderate Buy" rating and an average price target of $9.75.
Replimune Group (REPL) Price Target Increased by 10.52% to 12.82
The average one-year price target for Replimune Group (NASDAQ: REPL) has increased by 10.52% to $12.82 per share from its previous estimate of $11.60. This new target represents a 20.86% increase from the latest reported closing price of $10.61. Institutional ownership data shows varied activity, with some firms like Baker Bros. Advisors maintaining their position while others like T Rowe Associates decreased their holdings, and Rtw Investments significantly increased its stake.
Replimune Group Presents Positive Late-Breaking Data on RP1 Plus Nivolumab at SITC 2025 Conference
Replimune Group, Inc. presented positive updated data from the IGNYTE clinical trial of RP1 combined with nivolumab at the SITC 2025 conference. The results indicate that this combination therapy can reprogram the tumor microenvironment, reversing resistance to PD-1 blockade in melanoma patients who previously failed anti-PD-1 treatment, with a 33.6% overall response rate and a median duration of response of 24.8 months. Additional presentations covered RP1's efficacy in different patient subgroups and the safety of extended RP1 treatment.
BMO Capital Upgrades Replimune Group (REPL)
BMO Capital has upgraded Replimune Group (NasdaqGS: REPL) from Underperform to Market Perform following an analysis. The average one-year price target for REPL is set at $10.84/share, indicating an 11.38% upside from its latest closing price. Institutional ownership in Replimune Group shows a slight increase in the number of funds holding positions, despite a marginal decrease in total shares owned by institutions.
PDUFA Apr 10, 2026: Replimune's BLA Resubmission for RP1 Accepted by FDA for Advanced Melanoma
Replimune announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma patients who have progressed on an anti-PD-1 regimen. The FDA has set a PDUFA target action date of April 10, 2026, for this Class II resubmission. This resubmission addresses the complete response letter issued in July 2025 and includes additional data and analyses.
Replimune's stock spikes as FDA accepts melanoma resubmission, sets April decision date
Replimune's stock surged by nearly 100% after the FDA accepted its resubmission for the melanoma drug RP1, setting an April 10, 2026, decision date. The resubmitted biologics license application for RP1, an engineered herpes simplex virus combined with Opdivo, includes additional data and analyses following an earlier rejection due to patient population heterogeneity. CEO Sushil Patel expressed optimism, highlighting the drug's strong risk-benefit profile for advanced melanoma patients with limited treatment options.
Replimune Group, Inc. Shares Promising Data on RP1 and Nivolumab Combination for Acral Melanoma at ESMO Congress 2025 - Quiver Quantitative
Replimune Group, Inc. presented promising data at ESMO Congress 2025 on the combination of RP1 and nivolumab for treating acral melanoma, showing a 44% objective response rate and favorable safety profile. This data from an ad hoc analysis of the IGNYTE phase 2 trial highlights a potential new treatment for this aggressive and rare form of skin cancer, with an ongoing phase 3 trial further exploring its efficacy. The company also provided details on insider trading activity, hedge fund movements, and analyst ratings for its stock, REPL.
Replimune Highlights Acral Melanoma Data for RP1 plus Nivolumab at the ESMO Congress 2025 - The Manila Times
Replimune presented new data at the ESMO Congress 2025 on the efficacy and safety of RP1 in combination with nivolumab for patients with advanced acral melanoma. The data highlighted promising objective response rates and disease control rates in this difficult-to-treat cancer, suggesting RP1 could offer a significant therapeutic advancement. These findings support further investigation into this combination therapy for acral melanoma.
Replimune Highlights Acral Melanoma Data for RP1 plus Nivolumab at the ESMO Congress 2025 - Enidnews.com
Replimune, Inc. is highlighting new data regarding the use of RP1 plus nivolumab for the treatment of acral melanoma at the ESMO Congress 2025. This announcement was made via GlobeNewswire. The article indicates that this is a significant presentation for the company in the medical and pharmaceutical sectors.
44% ORR in acral melanoma — Replimune RP1 + nivolumab; median DOR 11.9 months at ESMO 2025 - Stock Titan
Replimune presented ad hoc Phase 2 data at ESMO 2025, revealing a 44% objective response rate (ORR) and a median duration of response (DOR) of 11.9 months for RP1 plus nivolumab in acral melanoma. The safety profile was favorable, with mostly transient grade 1-2 treatment-related adverse events. The company also noted ongoing enrollment for its Phase 3 IGNYTE-3 trial in progressed melanoma and an additional NMSC poster presentation.
Shareholders that lost money on Replimune Group, Inc.(REPL) should contact Levi & Korsinsky about pending Class Action - REPL
Levi & Korsinsky, LLP is notifying investors of Replimune Group, Inc. (NASDAQ: REPL) about a class action securities lawsuit. The lawsuit seeks to recover losses for investors affected by alleged securities fraud between November 22, 2024, and July 21, 2025, due to alleged misstatements regarding the IGNYTE trial. Investors have until September 22, 2025, to request to be appointed as lead plaintiff.
Replimune Group (REPL) Nosedives 39% as FDA Approval for Melanoma Treatment ‘Uncertain’
Replimune Group's stock (REPL) plummeted 39.40% after the FDA provided an uncertain response regarding its biologics license application for RP1, a melanoma treatment. The company had met with the FDA to discuss its complete response letter for RP1, in combination with nivolumab, for advanced melanoma. Despite the setback, Replimune's CEO emphasized the unmet need for advanced melanoma treatments and the company's commitment to finding an expeditious path forward for RP1.
Melanoma drug developer stock crashes after report from FDA meeting
Shares of Woburn-based Replimune crashed after the company announced it does not anticipate quick approval for its experimental melanoma drug following an FDA meeting. The biotech firm has hundreds of employees and the stock drop was significant. The article mentions Replimune Group Inc. and CRISPR Therapeutics Inc. leasing space in Framingham.
Replimune stock plunges after FDA meeting fails to clear path forward
Replimune Group Inc. (NASDAQ:REPL) stock plunged over 41% after its meeting with the FDA failed to establish a clear accelerated approval pathway for its advanced melanoma treatment, RP1, in combination with nivolumab. The company is now evaluating the FDA's feedback to determine the next steps for RP1. Despite the setback, Replimune's CEO emphasized the unmet need and positive risk-benefit profile observed in trials, reaffirming their commitment to working with the FDA.
Replimune Group, Inc. Investors: Please contact the Portnoy
The Portnoy Law Firm is advising investors of Replimune Group, Inc. (NASDAQ: REPL) about a class action lawsuit. Investors who purchased securities between November 22, 2024, and July 21, 2025, have until September 22, 2025, to file a lead plaintiff motion. The lawsuit alleges that Replimune overstated the prospects of its IGNYTE trial, leading to a significant drop in stock price after the FDA issued a Complete Response Letter for its lead product candidate, RP1.
Replimune Stock Plunged 42% Today – Here’s Why
Replimune Group Inc. (REPL) stock plunged 42% today after the company announced that a path forward for FDA approval of its lead candidate, RP1, for advanced melanoma had not been determined. The FDA previously issued a complete response letter, stating the trial did not provide substantial evidence of effectiveness. While Replimune is evaluating feedback and remains committed to working with the FDA, the continuation of the RP1 program in advanced melanoma is not viable without accelerated approval.
REPLIMUNE GROUP, INC. (NASDAQ: REPL) SHAREHOLDER ALERT
Bernstein Liebhard LLP reminds investors of an upcoming deadline in a securities fraud class action lawsuit against Replimune Group, Inc. The lawsuit alleges misrepresentations concerning the IGNYTE trial’s prospects for Replimune's lead cancer drug candidate, RP1, in combination with nivolumab. Investors who purchased Replimune securities between November 22, 2024, and July 21, 2025, are encouraged to contact the firm to discuss their legal options and the September 22, 2025 lead plaintiff deadline.
INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in Replimune Group, Inc. of Class Action Lawsuit and Upcoming Deadlines – REPL
Pomerantz LLP has filed a class action lawsuit against Replimune Group, Inc. (NASDAQ: REPL) after the FDA issued a Complete Response Letter for its Biologics License Application for RP1, causing Replimune's stock to drop significantly. Investors who suffered losses and purchased Replimune securities during the Class Period have until September 22, 2025, to seek appointment as Lead Plaintiff. The lawsuit alleges securities fraud or other unlawful business practices by Replimune and its officers/directors.
REPL Investors Have the Opportunity to Lead the Replimune Securities Fraud Lawsuit with Faruqi & Faruqi, LLP
Faruqi & Faruqi, LLP is inviting investors who suffered losses exceeding $50,000 in Replimune Group, Inc. (NASDAQ: REPL) between November 22, 2024, and July 21, 2025, to contact them regarding a federal securities class action lawsuit. The lawsuit alleges that Replimune executives made misleading statements about the IGNYTE trial's prospects, leading to the FDA deeming the trial inadequate and a subsequent 73% stock plummet on July 22, 2025. Investors have until September 22, 2025, to seek the role of lead plaintiff.
REPL Stock News: Investors with Large Losses Should Contact Robbins LLP for Information About Leading the Replimune Group, Inc. Class Action Lawsuit
Robbins LLP is investigating a class action lawsuit against Replimune Group, Inc. (REPL) for allegedly misleading investors about the viability of its IGNYTE trial. The lawsuit claims that the FDA deemed the trial inadequate, leading to a significant 77.24% drop in Replimune stock on July 22, 2025. Investors with substantial losses are encouraged to contact Robbins LLP to learn about leading the class action.
Replimune Group Inc divulga resultados do trimestre encerrado em 30 de junho - Resumo de lucros
Replimune Group Inc (REPL) reported an adjusted quarterly loss of 95 cents per share for the quarter ending June 30, which was below analyst expectations of an 81-cent loss. The company's revenue was zero, as anticipated. Following the earnings report, Replimune Group Inc's shares have fallen 40.8% this quarter and 54.6% year-to-date, with the average analyst recommendation being "maintenance" and a median 12-month price target of $4.00.
Replimune’s Turmoil: What Comes Next?
Replimune Group Inc. has experienced significant stock downturns, including a 31.84% drop, due to bearish sentiment, market volatility, and a class-action lawsuit alleging false statements concerning its IGNYTE trial. The FDA's refusal to approve Replimune's RP1 for advanced melanoma further intensified investor concerns, leading to analyst downgrades and a substantial 77% share decline. The company now faces challenges in navigating legal proceedings and rebuilding investor trust amidst its operational struggles and financial adjustments.
REPL Stock Drops: A Closer Look
Replimune Group Inc. (NASDAQ: REPL) saw its stock drop by 33.82% after the FDA rejected its biologics license application for RP1, leading to significant investor concerns. The company faces declining revenue, mounting losses, legal pressures from lawsuits over misleading investor statements, and multiple downgrades from financial institutions. The market questions Replimune’s leadership and its future market position, necessitating groundbreaking structural reforms to rebuild investor confidence.
Replimune stock plunges after FDA cancer drug rejection details emerge
Replimune Group Inc. (NASDAQ: REPL) stock plunged after a report revealed that the FDA's top cancer drug regulator intervened to reject the company's skin cancer therapy, RP1, despite internal support for its approval. This rejection occurred amidst broader internal turmoil at the FDA, including leadership changes and staff upheaval. The revelation highlights internal disagreement within the FDA regarding RP1's approval, providing new context for investors.
REPL LAWSUIT ALERT: The Gross Law Firm Notifies Replimune Group, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline
The Gross Law Firm has issued a notice to investors of Replimune Group, Inc. (NASDAQ: REPL) regarding a class action lawsuit. Investors who purchased shares between November 22, 2024, and July 21, 2025, are encouraged to contact the firm, as the company allegedly made misleading statements about its IGNYTE trial, which the FDA deemed inadequate. The deadline for shareholders to seek lead plaintiff appointment is September 22, 2025.
Replimune Group Inc. Stock (REPL) Opinions on FDA Drug Rejection
Discussion surrounding Replimune Group Inc. (REPL) has intensified following the U.S. FDA's rejection of its drug RP1 for melanoma, leading to a significant stock price drop and sparking debate on the company's future. The article details recent insider sales, institutional investor activity with both additions and reductions in REPL holdings, and a range of analyst ratings and price targets, reflecting ongoing market uncertainty. Legal probes and class-action lawsuits also contribute to the volatile environment surrounding the stock.
Replimune Group: Unexpected Surge Analysis
Replimune Group Inc. (REPL) experienced a significant 65.06% stock surge due to promising clinical trial results for its RP1 treatment in melanoma, leading JPMorgan to initially raise its price target to $19. However, the stock faced a downturn and class-action lawsuit after the FDA rejected RP1, causing JPMorgan to revise its target down to $9. The article provides an overview of Replimune's financial situation, stock price movements, and market implications, advising caution despite speculative optimism.
