{"id":997569,"date":"2026-08-24T11:35:09","date_gmt":"2026-08-24T15:35:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/"},"modified":"2026-08-24T11:35:09","modified_gmt":"2026-08-24T15:35:09","slug":"repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/","title":{"rendered":"REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of Securities Class Action Deadline on October 5, 2026"},"content":{"rendered":"<h2>\nInvestors allege Replimune Group, Inc. told the market its RP1 resubmission was a complete response to the FDA&#8217;s prior deficiency letter, while the agency&#8217;s evidentiary standards for an &#8220;adequate and well-controlled&#8221; trial allegedly were never satisfied<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">NEW YORK, Aug.  24, 2026  (GLOBE NEWSWIRE) &#8212; Levi &amp; Korsinsky, LLP notifies investors in Replimune Group, Inc. (NASDAQ: REPL) that a securities class action has been filed on behalf of shareholders who purchased securities between October 20, 2025 and April 10, 2026.\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gLwpY_bKajluR1czk8sZcpRbGu6JjG7N_nh1_y9lmq4n5bgLjdl9tniup0nvVToI_BaKNLbwY5F08Ad3tSA5dUaqbgThZVL90RsdttLCA1aslt0DavnpbO_3ycz6lNrmby4vBMBuTbmy3fEsGsxKb3xYvvXPW6spCKhDtpo51V5jkwPDwbzmjsWM_mOt8QDd\" rel=\"nofollow\" target=\"_blank\"><u>Submit your information now<\/u><\/a>. You may also contact Joseph E. Levi, Esq. at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=c9DmPjoN9T_0U1baIBG5-7kNGEepflSi17SVKsoetRtslBcFULKSFebTdER8XJSM4bBN2n-UpZHEMKufjiTFjiV9KiGKvWKvNQh1oipyd0Y=\" rel=\"nofollow\" target=\"_blank\"><u>jlevi@levikorsinsky.com<\/u><\/a> or (212) 363-7500.<\/p>\n<p align=\"left\">REPL closed at a Class Period high of $10.73 on December 8, 2025. Following the FDA&#8217;s Complete Response Letter, shares fell $1.15 (19.46%) to $4.76 on April 10, 2026, then $3.06 (64.29%) to $1.70 on April 13, 2026, a cumulative decline of roughly $9.03 per share, or approximately 84%. The deadline to apply for lead plaintiff appointment is October 5, 2026.<\/p>\n<p align=\"left\">\n        <strong>The Evidentiary Standard the Company Allegedly Could Not Meet<\/strong>\n      <\/p>\n<p align=\"left\">Approval of a biologic requires substantial evidence of effectiveness from an adequate and well-controlled clinical investigation under Section 505(d) of the Federal Food, Drug, and Cosmetic Act, 21 C.F.R. \u00a7 314.126, and Section 351 of the Public Health Service Act. The April 10, 2026 Complete Response Letter stated that RPL-001-16 &#8220;is not considered to be an adequate and well controlled clinical investigation&#8221; under those provisions. The complaint challenges whether investors were told that the resubmission rested on data the agency would find insufficient.<\/p>\n<p align=\"left\">\n        <strong>Regulatory Gaps Alleged in the Complaint<\/strong>\n      <\/p>\n<ul>\n<li>Study design concerns the FDA states it &#8220;clearly communicated&#8221; in multiple interactions allegedly were not addressed in the resubmission.<\/li>\n<li>The single-arm RPL-001-16 trial allegedly was not designed to isolate RP1&#8217;s contribution from that of nivolumab.<\/li>\n<li>Response criteria used in RPL-001-16 were, per the CRL, &#8220;not consistent with RECIST v1.1&#8221; and may not be comparable to historical literature.<\/li>\n<li>Resubmission support allegedly came from an early unplanned analysis of RP1-104 covering 40 patients, or 10% of the planned 400-patient enrollment.<\/li>\n<li>SEC filings warned generically that without approval the Company &#8220;might not be able to continue the development of RP1,&#8221; while the specific known agency objections allegedly went undisclosed.<\/li>\n<li>Public statements characterized the October 2025 filing as a complete response to the July 2025 deficiency letter, which the lawsuit contends lacked a reasonable basis.\n<\/li>\n<\/ul>\n<p align=\"left\">\n        <strong>Why the Filing Language Matters to Shareholders<\/strong>\n      <\/p>\n<p align=\"left\">\n        <em>&#8220;Generic risk factor language cannot substitute for disclosing specific, known regulatory objections that a company has already received. The complaint raises serious questions about whether Replimune shareholders were told the FDA&#8217;s study design concerns remained unresolved.&#8221;<\/em> &#8212; Joseph E. Levi, Esq.<\/p>\n<p align=\"left\">\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=vnq389ODDsw-KhzBoamqUetKi4FCEoX1xvXqu36_jufgFU4oIivH8EAuyUkKF_K_jES8i47AJKhIOSKAvUPd2Z4IU5V51i57TRCJbfQwBHrnykWh8S1sLN1bEsrjWPmwrBcNUDEtLlhNue1xW4B5CxS4rSCDccNmY9EsIEodhMXxUv6fr8KGM0NoE6UBm9rJ4mT_iManX5hAE3boBB14wcLJktmB8xr1LfCn3YY9umE=\" rel=\"nofollow\" target=\"_blank\"><br \/>\n          <u>Find out if you might qualify to recover losses<\/u><br \/>\n        <\/a> or call (212) 363-7500.<\/p>\n<p align=\"left\">\n        <strong>WHY LEVI &amp; KORSINSKY:<\/strong> Over the past 20 years, Levi &amp; Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi &amp; Korsinsky has ranked in ISS Securities Class Action Services&#8217; Top 50 Report as one of the top securities litigation firms in the United States.<\/p>\n<p align=\"left\">\n        <strong>Frequently Asked Questions About the REPL Lawsuit<\/strong>\n      <\/p>\n<p align=\"left\">\n        <strong>Q: What court was the REPL class action filed in?<\/strong> A: The case was filed in the United States District Court for the District of Massachusetts, governed by the Private Securities Litigation Reform Act of 1995.<\/p>\n<p align=\"left\">\n        <strong>Q: Who are the defendants named in the REPL lawsuit?<\/strong> A: The complaint names Replimune Group, Inc. and individual defendants including senior executives who signed SEC filings, made public statements, or certified financial disclosures under Sarbanes-Oxley.<\/p>\n<p align=\"left\">\n        <strong>Q: What specific misstatements does the REPL lawsuit allege?<\/strong> A: The complaint alleges Replimune made materially false or misleading statements regarding whether previously communicated FDA study design concerns had been addressed and the sufficiency of the data supporting the RP1 BLA resubmission during the Class Period. When the FDA&#8217;s Complete Response Letter rejecting the BLA was disclosed, the stock price declined sharply.<\/p>\n<p align=\"left\">\n        <strong>Q: What is a lead plaintiff and why does it matter?<\/strong> A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.<\/p>\n<p align=\"left\">\n        <strong>Q: What documents do I need to to submit my information?<\/strong> A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.<\/p>\n<p align=\"left\">\n        <strong>Q: What if I already sold my REPL shares &#8212; can I still recover losses?<\/strong> A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.<\/p>\n<p align=\"left\">\n        <strong>Q: What does it cost me to participate?<\/strong> A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, they are generally handled on a contingency basis, with any attorneys&#8217; fees and expenses subject to court approval.<\/p>\n<p align=\"left\">\n        <strong>Q: What if Replimune Group, Inc. goes bankrupt before the case resolves?<\/strong> A: Securities class action claims may survive bankruptcy in many circumstances. D&amp;O insurance policies are frequently a potential source of settlement funds.<\/p>\n<p align=\"left\">CONTACT:<br \/>Levi &amp; Korsinsky, LLP<br \/>Joseph E. Levi, Esq.<br \/>Ed Korsinsky, Esq.<br \/>33 Whitehall Street, 27th Floor<br \/>New York, NY 10004<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=c9DmPjoN9T_0U1baIBG5-7kNGEepflSi17SVKsoetRuNvXpyoUy05Gao_ou24HYigQu-7eyMANMhF5LAHon81b1xJoW3yeHvI6_H5zciRhdVzDfwvqd1GFI2Ji7P1wqf\" rel=\"nofollow\" target=\"_blank\"><u>jlevi@levikorsinsky.com<\/u><\/a><br \/>Tel: (212) 363-7500<br \/>Fax: (212) 363-7171<\/p>\n<p align=\"left\">Attorney Advertising. Prior results do not guarantee similar outcomes.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTgxNDMyNCM3Nzg4MTIyIzIwMjA0MjY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZjhlYzUwOTMtNTRmNS00MWQxLWJjZWItODNlZjIxNjUwZjMzLTEwMzIyOTMtMjAyNi0wOC0yNC1lbg==\/tiny\/Levi-Korsinsky-LLP.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Investors allege Replimune Group, Inc. told the market its RP1 resubmission was a complete response to the FDA&#8217;s prior deficiency letter, while the agency&#8217;s evidentiary standards for an &#8220;adequate and well-controlled&#8221; trial allegedly were never satisfied NEW YORK, Aug. 24, 2026 (GLOBE NEWSWIRE) &#8212; Levi &amp; Korsinsky, LLP notifies investors in Replimune Group, Inc. (NASDAQ: REPL) that a securities class action has been filed on behalf of shareholders who purchased securities between October 20, 2025 and April 10, 2026.\u00a0Submit your information now. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500. REPL closed at a Class Period high of $10.73 on December 8, 2025. Following the FDA&#8217;s Complete Response Letter, shares fell $1.15 (19.46%) to $4.76 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of Securities Class Action Deadline on October 5, 2026&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-997569","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of Securities Class Action Deadline on October 5, 2026 - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of Securities Class Action Deadline on October 5, 2026 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Investors allege Replimune Group, Inc. told the market its RP1 resubmission was a complete response to the FDA&#8217;s prior deficiency letter, while the agency&#8217;s evidentiary standards for an &#8220;adequate and well-controlled&#8221; trial allegedly were never satisfied NEW YORK, Aug. 24, 2026 (GLOBE NEWSWIRE) &#8212; Levi &amp; Korsinsky, LLP notifies investors in Replimune Group, Inc. (NASDAQ: REPL) that a securities class action has been filed on behalf of shareholders who purchased securities between October 20, 2025 and April 10, 2026.\u00a0Submit your information now. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500. REPL closed at a Class Period high of $10.73 on December 8, 2025. Following the FDA&#8217;s Complete Response Letter, shares fell $1.15 (19.46%) to $4.76 &hellip; Continue reading &quot;REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. 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(REPL) Investors of Securities Class Action Deadline on October 5, 2026 - Market Newsdesk","og_description":"Investors allege Replimune Group, Inc. told the market its RP1 resubmission was a complete response to the FDA&#8217;s prior deficiency letter, while the agency&#8217;s evidentiary standards for an &#8220;adequate and well-controlled&#8221; trial allegedly were never satisfied NEW YORK, Aug. 24, 2026 (GLOBE NEWSWIRE) &#8212; Levi &amp; Korsinsky, LLP notifies investors in Replimune Group, Inc. (NASDAQ: REPL) that a securities class action has been filed on behalf of shareholders who purchased securities between October 20, 2025 and April 10, 2026.\u00a0Submit your information now. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500. REPL closed at a Class Period high of $10.73 on December 8, 2025. Following the FDA&#8217;s Complete Response Letter, shares fell $1.15 (19.46%) to $4.76 &hellip; Continue reading \"REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of Securities Class Action Deadline on October 5, 2026\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/","og_site_name":"Market Newsdesk","article_published_time":"2026-08-24T15:35:09+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTgxNDMyNCM3Nzg4MTIyIzIwMjA0MjY=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/repl-deadline-alert-levi-korsinsky-reminds-replimune-group-inc-repl-investors-of-securities-class-action-deadline-on-october-5-2026\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"REPL Deadline Alert: Levi &amp; Korsinsky Reminds Replimune Group, Inc. 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