Replimune says FDA rejected its lead drug for skin cancer
Replimune announced that the FDA has rejected its lead drug for skin cancer. The rejection impacts the company's primary therapeutic candidate and its development pipeline.
REPL Stock Lost 19% Of Its Value Today – Why Did The FDA Refuse Approval For Its Experimental Melanoma Drug?
Replimune Group Inc. (REPL) saw its stock drop 19% after the FDA refused approval for its experimental melanoma drug, RP1. The FDA deemed the submitted data "insufficient to conclude substantial evidence of effectiveness" and had previously rejected the initial application in July 2025, recommending a fresh trial. Despite a resubmission with additional analyses in October, the agency stood by its original conclusion, noting the objectivity of the review process.
Press Release: Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update
Replimune has released its financial results for the fiscal fourth quarter and year ended March 31, 2026. The report includes key financial figures and a corporate update, offering insights into the company's performance and strategic initiatives for the past year and future outlook.
Replimune's Fiscal Q4 Net Loss Narrows
Replimune (NASDAQ: REPL) reported a narrower net loss for its fiscal fourth quarter, coming in at $0.78 per share compared to $0.85 per share in the prior year. The company's total revenue for the quarter was $7.3 million, primarily driven by product sales. Replimune is an oncology-focused biotechnology company developing oncolytic immunotherapies.
Replimune Group Inc reports results for the quarter ended March 31 - Earnings Summary
Replimune Group Inc has released its earnings summary for the quarter ended March 31. The report contains financial results for the specified period. Further details are available through the provided source, Refinitiv.
Replimune Group FY 2026: Revenue $0 Net loss $(313.9)M — 10-K Summary
Replimune Group, Inc. reported a net loss of $(313.94)M for fiscal year 2026, an increase from the $(247.30)M net loss in fiscal 2025, with no reported product revenue. The company is actively investing in research and development for its lead programs RP1, RP2, and RP3, advancing clinical trials, and building commercial infrastructure for a potential RP1 launch, expecting current cash to fund operations through Q1 2027.
Replimune (REPL) widens FY 2026 loss as FDA accepts RP1 melanoma BLA
Replimune Group, Inc. (REPL) reported a widened net loss of $313.9 million for fiscal year 2026, compared to $247.3 million in the previous year, with operating expenses reaching $319.9 million. Despite the increased losses and a reduced cash position of $268.9 million (expected to fund operations into Q1 2027), the company achieved a significant milestone with the FDA's acceptance of the resubmitted Biologics License Application (BLA) for its lead candidate RP1 in advanced melanoma, setting a goal date of August 2, 2026, and an advisory committee meeting in late July. The company continues to advance other clinical programs, including the IGNYTE-3 trial for RP1 and the REVEAL trial for RP2 in metastatic uveal melanoma.
Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update
Replimune Group, Inc. has announced its financial results for the fiscal fourth quarter and year ended March 31, 2026, alongside a significant corporate update. The FDA has accepted the resubmission of their Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma, with an advisory committee meeting expected in late July 2026. The company also highlighted strong clinical trial progress for RP1 and RP2, demonstrating promising efficacy and durability in advanced melanoma and metastatic uveal melanoma patients.
Replimune’s melanoma drug review moves toward Aug. 2 FDA decision
Replimune reported its fiscal Q4 and full-year 2026 financial results, with a net loss of $313.9 million, and provided a corporate update. The FDA accepted the BLA resubmission for RP1 + nivolumab in advanced melanoma, setting an August 2, 2026 goal date and an advisory committee meeting in late July. The company also highlighted positive 3-year overall survival data for RP1 in anti-PD-1-failed melanoma and promising Phase 1 results for RP2, which is advancing into a Phase 2/3 trial for metastatic uveal melanoma.
Investor Alert: Deadline Approaching to Join Replimune Group, Inc. (REPL) Class Action - Contact Levi & Korsinsky
Levi & Korsinsky LLP has issued an investor alert for Replimune Group, Inc. (REPL) shareholders, reminding them about the approaching deadline to join a class action lawsuit. The lawsuit alleges that Replimune made false statements regarding its IGNYTE trial, which resulted in the FDA deeming it inadequate. Shareholders who suffered losses between November 22, 2024, and July 21, 2025, are encouraged to contact the firm to learn about their rights.
Replimune upgraded by Analyst with a new price target
Replimune Group Inc. (REPL) has been upgraded by an analyst, receiving a new price target. Quantisnow Plus members were alerted to this update shortly after its publication. The article highlights Quantisnow's platform for real-time market data, including analyst ratings, SEC filings, and other market intelligence for retail investors.
Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma
Replimune Group, Inc. announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma. The FDA considers this a complete, class 1 response, with a decision expected by August 2, 2026, and an advisory committee meeting planned for late July. The resubmission seeks accelerated approval based on data from the IGNYTE clinical trial, addressing the significant unmet need for effective treatments in advanced melanoma patients.
Replimune Group Inc. announced that the U.S. Food and Drug Administration (FDA) has officially accepted its resubmitted Biologics License Application (BLA) for the investigational therapy RP1 for the treatment of advanced melanoma.
Replimune Group Inc. has announced that the U.S. FDA has accepted its resubmitted Biologics License Application (BLA) for the investigational therapy RP1, intended for advanced melanoma treatment. This marks a significant step in the marketing process for their oncolytic virus immunotherapy. The FDA has set a PDUFA target review date of December 25, 2024, with the submission largely based on data from the CERPASS clinical trial.
FDA accepts Replimune’s resubmitted application for RP1
The FDA has accepted Replimune Group, Inc.'s resubmitted Biologics License Application for RP1 in combination with nivolumab for advanced melanoma, classifying it as a complete, class 1 response with a goal date of August 2, 2026. An advisory committee meeting is scheduled for late July, prompting a positive response from investors with a 9% stock gain over the past week. This follows a previous rejection and a recent agreement with the FDA to prioritize the review as an urgent matter.
Enterprise value to EBITDA forward of Replimune Group, Inc. – NASDAQ:REPL
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Replimune: FDA Accepts RP1 BLA Resubmission with Aug. 2, 2026 Goal Date
The FDA has accepted Replimune's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) with nivolumab for advanced melanoma. The resubmission is categorized as a complete, class 1 response, and the FDA has set a target action date of August 2, 2026, with an advisory committee meeting expected in late July earlier. Replimune is seeking accelerated approval based on data from its IGNYTE trial involving patients who progressed on anti-PD-1 regimens.
FDA accepts Replimune’s melanoma drug review, decision due Aug. 2
Replimune announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for RP1 combined with nivolumab for advanced melanoma. The FDA classified it as a complete, class 1 response, setting an action date of August 2, 2026, and plans an advisory committee meeting in late July. The resubmission seeks accelerated approval based on data from the IGNYTE clinical trial for patients who have progressed on prior anti-PD-1 therapy.
Price to earnings forward of Replimune Group, Inc. – SWB:7R8
This page from TradingView provides financial information for Replimune Group, Inc. (SWB:7R8), specifically focusing on its price-to-earnings forward metric. The content appears to be a stub or a placeholder, as the actual financial data for the chosen period is missing or not displayed. It indicates that the data is "Made by humans" and sources its financial and reference data from ICE Data Services and FactSet, respectively.
Price to sales forward of Replimune Group, Inc. – SWB:7R8
This article provides financial information for Replimune Group, Inc. (SWB:7R8) on TradingView, specifically focusing on its price-to-sales forward metric. It highlights the company's stock exchange listing and various financial data points available to users. The content primarily serves as a financial data portal, indicating a market closed status and no trades at the time of publication but offering broader financial analysis tools.
Enterprise value to revenue forward of Replimune Group, Inc. – NASDAQ:REPL
This article provides financial information for Replimune Group, Inc. (NASDAQ: REPL), specifically focusing on its enterprise value to revenue forward. The content is presented within the TradingView platform, offering an overview of the company's financials for investors and analysts.
Replimune Group Inc expected to post a loss of 71 cents a share - Earnings Preview
Replimune Group Inc. (REPL) is projected to report a loss of 71 cents per share, according to this earnings preview. The information is provided by Refinitiv and Reuters.
Replimune Group Inc (REPL) Valuation: PE, PB & Fair Value Analysis
This article provides a valuation analysis for Replimune Group Inc (REPL), focusing on its P/E, P/B, and fair value. The company's valuation metrics such as P/E, P/B, P/S, and P/CF ratios are listed as not yet disclosed. The stock closed at $10.00 with a 13.90% increase.
Replimune Group Inc (REPL) Institutional Confidence
This article from TradingKey focuses on the institutional confidence in Replimune Group Inc (REPL). It lists key institutional shareholders and changes in their shareholdings, indicating sustained or increased confidence from major investment firms. The article also provides the stock's current trading data, including its market cap and recent price performance.
REPL Stock On Track To Hit All-Time Lows – Here’s Why This Analyst Slashed Price Target By 85%
Replimune Group, Inc. (REPL) shares plummeted after the FDA rejected its melanoma treatment, RP1, for the second time, citing insufficient evidence of effectiveness. This rejection prompted Jefferies to downgrade the stock to 'Hold' and drastically cut its price target by 85% to $2, while JPMorgan also downgraded the stock, expressing concern about its future and potential job cuts at Replimune. The company warned of scaling back operations, facing significant challenges ahead.
REPL nosedives as FDA chief stands firm against melanoma treatment: ‘I don’t work for Replimune’
This article reports on the significant drop in Replimune's stock price following a strong statement from the FDA chief regarding the company's melanoma treatment. The FDA chief explicitly denied any affiliation with Replimune, underscoring regulatory independence and negatively impacting investor confidence in the company.
Insider Sell: Christopher Sarchi Sells 12,000 Shares of Replimune Group Inc (REPL)
Christopher Sarchi, Chief Commercial Officer at Replimune Group Inc (REPL), sold 12,000 shares of the company on June 1, 2026. This transaction reduces his total holdings to 180,962 shares. Over the past year, Sarchi has sold 27,126 shares with no purchases, and the company's insider transaction history shows 12 insider sells against 0 buys.
Replimune CCO Sarchi sells $110,880 in stock
Christopher Sarchi, Replimune CCO, sold 12,000 shares for $110,880, with the stock seeing a 113% return recently. The company is also making regulatory progress with the FDA for its Biologics License Application for RP1, leading to an analyst upgrade. InvestingPro analysis suggests REPL may be undervalued, holding more cash than debt.
Replimune (REPL) CCO sells 12,000 shares under 10b5-1 plan
Replimune Group Chief Commercial Officer Christopher Sarchi sold 12,000 shares of common stock on June 1, 2026, at a weighted average price of $9.24 per share. This transaction was conducted under a pre-arranged 10b5-1 trading plan adopted on December 15, 2025. Following the sale, Sarchi directly holds 180,962 Replimune shares.
Replimune Group Price Target Raised to $6.00/Share From $2.00 by Wedbush
Wedbush has increased its price target for Replimune Group (NASDAQ: REPL) shares from $2.00 to $6.00. This significant adjustment indicates a more bullish outlook from the firm regarding the company's future stock performance.
Why Is Replimune Stock Gaining Monday?
Replimune Group (NASDAQ: REPL) stock saw gains on Monday due to the presentation of final data from its Phase 1 study of RP2, an oncolytic immunotherapy, at the ASCO annual meeting. The data highlighted RP2's efficacy alone and in combination with Bristol-Myers Squibb's Opdivo, showing positive objective response rates and duration of response in patients with advanced solid tumors, including tumor regression in both injected and non-injected lesions. This positive news comes despite a recent FDA rejection for another of Replimune's therapies and a "weak" momentum score from Benzinga Edge.
Replimune Group (REPL) Is Up 77.0% After FDA Prioritizes RP1 Melanoma BLA Resubmission Path - Has The Bull Case Changed?
Replimune Group's shares surged 77% after the FDA prioritized the resubmission and review path for its RP1 Biologics License Application for advanced melanoma. This regulatory clarity makes RP1 central to the company's investment case, but also concentrates risk around a single binary approval event, especially given Replimune's short cash runway and lack of revenue. Investors are now focused on whether RP1 can secure approval on existing data and how quickly the company can address its balance sheet concerns.
REPL stock soars on plans of BLA resubmission for melanoma combo drug
The article reports that Replimune Group Inc. (REPL) stock increased significantly due to the company's announcement of plans to resubmit its Biologics License Application (BLA) for its lead investigational drug, vusolimogene oderparepvec (vusogeen), combined with nivolumab for advanced melanoma. The resubmission follows positive discussions with the FDA regarding data from its Phase 3 VITAL study, which could lead to an accelerated approval pathway.
REPL Stock Soars on Plans of BLA Resubmission for Melanoma Combo Drug
Shares of Replimune Group (REPL) soared 85.7% following an announcement that the company aligned with the FDA on the resubmission of the biologics license application (BLA) for its lead pipeline asset, RP1, in combination with Bristol Myers' (BMY) Opdivo for advanced melanoma. The FDA plans to prioritize the review of this resubmission, acknowledging the significant unmet medical need. This positive development comes after Replimune previously received two complete response letters for its BLA, which had created significant hurdles for the company.
Replimune Group (REPL) Is Up 77.0% After FDA Prioritizes RP1 Melanoma BLA Resubmission Path - Has The Bull Case Changed?
Replimune Group's stock surged 77.0% after the FDA prioritized the resubmission path for its RP1 (vusolimogene oderparepvec) Biologics License Application for advanced melanoma. This regulatory decision re-centers the investment case around RP1's potential approval but also concentrates risk on this single binary event, especially given the company's limited cash runway and ongoing losses. Investors are now focused on whether RP1 can gain approval with existing data and how Replimune will address its financial standing.
US FDA Consistency Questions Remain As Replimune Eyes Third Shot At RP1 Approval
Replimune is preparing for a third attempt to gain FDA approval for its melanoma therapy, RP1, by resubmitting its Biologics License Application (BLA) in the coming days. This follows previous challenges with the FDA regarding review consistency, despite the company recently receiving an expedited resubmission pathway. The article highlights ongoing questions about the FDA's consistency in its review process.
Cancer therapy RP2 shrank tumors in first-in-human trial
Replimune presented final first-in-human Phase 1 data for its oncolytic immunotherapy RP2, alone and in combination with nivolumab, in 85 heavily pretreated patients with advanced solid tumors. The study showed objective response rates of approximately 19% for both monotherapy and combination treatment, with a pooled objective response rate of 33.3% in uveal melanoma. RP2 demonstrated durable responses, systemic immune activity, and a favorable safety profile, supporting an ongoing randomized Phase 2/3 trial for uveal melanoma.
Replimune Group Says Rp1 Plus Nivolumab Achieves Median Overall Survival Of 32.9 Months In Anti-Pd-1-Failed Melanoma
Replimune Group announced that the combination of RP1 and nivolumab has achieved a median overall survival of 32.9 months in patients with anti-PD-1-failed melanoma. This significant finding demonstrates the potential effectiveness of this treatment in a challenging patient population. The news was reported by Reuters.
Replimune Group Inc. has released the latest data on its candidate therapy Rp1 in combination with nivolumab, showing remarkable long-term survival benefits in patients with advanced melanoma who have developed resistance to PD-1 therapies, with a median overall survival of 32.9 months.
Replimune Group Inc. has announced new data on its candidate therapy Rp1, which, when combined with nivolumab, demonstrates significant long-term survival benefits for patients with advanced melanoma resistant to PD-1 therapies. The study reported a median overall survival of 32.9 months, highlighting the potential of this combination as a new treatment option for this challenging patient population. This finding underscores the clinical value of the therapy.
Nearly half of anti-PD-1-failed melanoma alive 3 years with Replimune combo
Replimune presented 3-year overall survival data from its IGNYTE clinical trial for RP1 plus nivolumab in advanced melanoma patients who failed anti-PD-1 therapy. The data showed promising results with a median overall survival of 32.9 months and a 47.8% 3-year overall survival rate for all treated patients, increasing to 83.5% for responders. The treatment also demonstrated a durable objective response rate of 33.6% with a favorable safety profile.
FDA to prioritize Replimune (NASDAQ: REPL) RP1 advanced melanoma BLA review
Replimune announced its plan to resubmit its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma after collaborative discussions with the FDA. The FDA has indicated it will treat this resubmission as an urgent, prioritized matter due to the significant unmet medical need for patients whose disease has progressed after prior anti-PD-1 therapy. This move is supported by data from the IGNYTE clinical trial and aims to bring the important therapy to the advanced melanoma community swiftly.
Replimune reaches agreement with FDA on melanoma drug resubmission
Replimune Group Inc. has announced an agreement with the FDA for the resubmission of its Biologics License Application (BLA) for RP1 combined with nivolumab to treat advanced melanoma. The FDA plans to prioritize the review of the resubmission, which is supported by data from the IGNYTE clinical trial. This development follows previous regulatory challenges and recent fluctuations in Replimune's stock performance.
Replimune plans third attempt at RP1 approval in coming days
Replimune is making a third attempt to gain FDA approval for its melanoma treatment, RP1, following rejections in June 2025 and April 2026. The company has filed a resubmission, which the FDA will reportedly treat as urgent. This comes after recent layoffs at the company.
Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks
Replimune is filing for a third time for FDA approval of its experimental cancer therapy, RP1, following "productive" discussions with the agency. The company previously faced two rejections despite positive mid-stage trial data, which contributed to a perception of FDA volatility among biotech investors. The recent resignations of top FDA officials suggest a potential shift in the regulatory landscape, which may favor drug developers.
Replimune’s Fortunes Reverse As US FDA Allows Speedy RP1 Resubmission
Replimune's stock has shown volatility due to the FDA's interactions regarding its drug RP1. The company plans to resubmit RP1 for approval after the FDA allowed a speedy resubmission, reversing the negative trend caused by an April Complete Response Letter which led to significant job cuts. This decision marks a potential turnaround for Replimune.
Replimune to resubmit melanoma drug RP1 after FDA shakeup
Replimune plans to resubmit its melanoma drug RP1 for FDA approval. This decision follows recent changes and a shakeup within the FDA, which may offer a more favorable environment for the drug's reconsideration.
Replimune to Resubmit RP1 BLA; FDA to Prioritize Review for Advanced Melanoma
Replimune will resubmit its Biologics License Application (BLA) for RP1 with nivolumab for advanced melanoma after productive discussions with the FDA. The FDA has agreed to prioritize the review of this resubmission, acknowledging the significant unmet need for patients with limited treatment options. This decision is supported by data from the IGNYTE trial, which evaluated the combination therapy in patients who had progressed on anti-PD-1 therapy.
Replimune plans RP1 resubmission to FDA (REPL:NASDAQ)
Replimune shares surged over 60% premarket after the company announced its intention to resubmit a marketing application for its primary drug candidate, RP1, to the FDA. This decision follows a second rejection of RP1 by the FDA in April.
Replimune Gets Third Try at FDA Approval After Makary Departure
Replimune Group announced an agreement with the FDA to resubmit its application for an experimental advanced melanoma treatment, after two previous rejections due to study design concerns. The company did not specify if new clinical data or additional analyses of existing trial results would be included in the resubmission. This provides a third opportunity for approval for their drug.
Replimune gets third chance at US approval for skin cancer drug
Replimune plans to resubmit its experimental skin cancer drug for U.S. approval for the third time after reaching an agreement with the FDA, causing its shares to surge 86%. This decision follows initial rejections due to concerns about study design and reports of White House intervention pushing health officials to re-examine the FDA's stance. The FDA has indicated it will prioritize the urgent review of the resubmitted application for the advanced melanoma treatment.
FDA to prioritize RP1 melanoma review in cancer killing 8,500 a year
Replimune announced its plan to resubmit its Biologics License Application (BLA) for RP1 in advanced melanoma, following productive discussions with the FDA. The FDA agreed to prioritize the urgent review of RP1, which is combined with nivolumab, recognizing the significant unmet need for patients who have progressed on prior anti-PD-1 therapies, a condition that contributes to 8,500 deaths annually in the U.S. The BLA resubmission is supported by data from the IGNYTE clinical trial.
