Allison Bratzel

Anupam Rama

Evan Seigerman

Jiale Song

Jonathan Chang

Peter Lawson

- On **September 18, 2025**, Replimune Group, Inc. (REPL) shares dropped **about 45%** during intraday trading after the company announced that a "path forward under the accelerated approval pathway has not been determined" by the FDA for its lead drug candidate **RP1**.  **[1737953_20250920SF79423:0]** 
- This recent decline follows a **77% stock price crash** on **July 22, 2025**, when the U.S. Food and Drug Administration (FDA) issued a "Complete Response Letter" (CRL) for the Biologics License Application (BLA) for **RP1**, effectively rejecting its approval for advanced melanoma.  **[1737953_20250920SF79423:0]** 
- A securities class action lawsuit has been filed, alleging Replimune misled investors by overstating the likelihood of success for the **IGNYTE trial** for **RP1**, with the **Lead Plaintiff deadline** set for **September 22, 2025**.  **[1737953_20250920SF79423:0]**

Replimune Shares Drop 45% Following FDA Update on RP1, Securities Lawsuit Pending

- On **September 18, 2025**, Replimune Group, Inc. (**REPL**) shares **cratered about 45%** during intraday trading after the company announced that a **"path forward under the accelerated approval pathway has not been determined"** for its lead drug candidate **RP1** following a Type A meeting with the FDA.  **[1737953_20250918SF77445:0]** 
- This recent stock drop follows a **77% stock price crash** on **July 22, 2025**, when the FDA issued a **"Complete Response Letter" (CRL)**, effectively rejecting the approval of **RP1** for advanced melanoma.  **[1737953_20250918SF77445:0]** 
- A securities class action lawsuit has been filed, alleging Replimune misled investors by overstating **RP1**'s success and that the **IGNYTE trial** was fundamentally flawed and inadequate for approval.  **[1737953_20250918SF77445:0]** 
- The **Class Period** for the lawsuit is **November 22, 2024 – July 21, 2025**, with the **Lead Plaintiff deadline set for September 22, 2025**.  **[1737953_20250918SF77445:0]**

Replimune Shares Drop 45% After FDA Update on RP1 Approval Pathway

- Replimune Group, Inc. completed a **Type A meeting with the U.S. Food and Drug Administration (FDA)** on **September 16, 2025**, to discuss the complete response letter (CRL) for its Biologics License Application (BLA) for **RP1** in combination with nivolumab for the treatment of advanced melanoma.  **[1737953_0001104659-25-091066_tm2526397d1_ex99-1.htm:0]** **[1737953_0001104659-25-091066_tm2526397d1_8k.htm:1]** **[1737953_0001104659-25-091066_tm2526397d1_8k.htm:2]** 
- The company is currently **evaluating the feedback** received from the FDA during the meeting to determine its next steps.  **[1737953_0001104659-25-091066_tm2526397d1_ex99-1.htm:0]** **[1737953_0001104659-25-091066_tm2526397d1_8k.htm:1]** 
- At this time, a **path forward under the accelerated approval pathway has not been determined** for RP1.  **[1737953_0001104659-25-091066_tm2526397d1_ex99-1.htm:0]**

Replimune Provides Update on FDA Meeting Regarding RP1 BLA

- A **securities class action lawsuit** has been filed against Replimune Group, Inc. and its executives, alleging they misled investors regarding the success of their lead cancer drug, **RP1**.  **[1737953_761eae6ea38f420c8559b5137eb1180f_0]** 
- On **July 22, 2025**, the U.S. Food and Drug Administration (FDA) issued a **Complete Response Letter (CRL)** for RP1's Biologics License Application (BLA), effectively rejecting its approval for advanced melanoma.  **[1737953_761eae6ea38f420c8559b5137eb1180f_0]** 
- The FDA deemed the IGNYTE trial, the foundation of Replimune's application, as **not "sufficiently well-designed or controlled"**, citing issues such as patient heterogeneity and flawed design.  **[1737953_761eae6ea38f420c8559b5137eb1180f_0]** **[1737953_761eae6ea38f420c8559b5137eb1180f_1]** 
- This FDA rejection triggered a **77% stock price crash** for Replimune, wiping out billions in market value.  **[1737953_761eae6ea38f420c8559b5137eb1180f_0]** 
- The lawsuit covers investors who purchased Replimune securities between **November 22, 2024, and July 21, 2025**, with a Lead Plaintiff Deadline of **September 22, 2025**.  **[1737953_761eae6ea38f420c8559b5137eb1180f_0]**

Replimune Faces Lawsuit Following FDA Rejection of RP1

- A new securities class action lawsuit has been filed against **Replimune Group, Inc. (REPL)** and its executives, alleging the company misled investors by overstating the success of its lead cancer drug, **RP1**.  **[1737953_fda7bc992c474fc3813f63b9407477b7_0]** 
- The lawsuit follows the U.S. Food and Drug Administration (FDA) issuing a "Complete Response Letter" (CRL) for RP1's Biologics License Application (BLA) on **July 22, 2025**, effectively rejecting the drug's approval for advanced melanoma.  **[1737953_fda7bc992c474fc3813f63b9407477b7_0]** 
- This rejection caused Replimune's stock to **plummet by 77%** in a single day.  **[1737953_fda7bc992c474fc3813f63b9407477b7_0]** 
- The complaint alleges that Replimune failed to disclose that the company had **overstated the likelihood of success** for the IGNYTE trial and that the FDA was likely to find the trial's design and data inadequate for approval due to fundamental flaws like a heterogeneous patient population.  **[1737953_fda7bc992c474fc3813f63b9407477b7_0]** 
- The class period for investors who bought Replimune securities is between **November 22, 2024, and July 21, 2025**, with a lead plaintiff deadline of **September 22, 2025**.  **[1737953_fda7bc992c474fc3813f63b9407477b7_0]**

Replimune Faces Securities Class Action Lawsuit After FDA Rejects RP1

- A securities class action lawsuit has been filed against **Replimune Group Inc. (REPL)** and its leadership, alleging they concealed critical risks and overstated clinical trial data for their cancer therapy, **RP1**.  **[1737953_20250911SF71730:0]** 
- The lawsuit, on behalf of investors who acquired stock between **November 22, 2024, and July 21, 2025**, stems from the FDA's issuance of a Complete Response Letter (CRL) for RP1's Biologics License Application on **July 22, 2025**.  **[1737953_20250911SF71730:0]** 
- The FDA's CRL halted RP1's approval, citing concerns about the adequacy of supporting clinical data, specifically regarding **patient diversity** and **combination therapy ambiguity** in the IGNYTE trial.  **[1737953_20250911SF71730:0]** 
- Following the FDA's decision, Replimune's shares plunged **77%** in a single trading session.  **[1737953_20250911SF71730:0]** 
- The lead plaintiff deadline for investors to submit losses is **September 22, 2025**.  **[1737953_20250911SF71730:0]**

Replimune Faces Investor Lawsuit After FDA Rejects Cancer Drug

- Replimune Group's (REPL) stock **plummeted by 77%** on **July 22, 2025**, after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for its leading cancer drug, **RP1**, effectively halting its approval process.  **[1737953_a0ba5a0b7d4d4b23ba5cb7e137e38681_0]** 
- A securities class action lawsuit, _Jboor v. Replimune Group, Inc., et al._, has been filed against Replimune and its executives, alleging they misled investors by overstating the **IGNYTE trial** data and failing to disclose critical regulatory risks.  **[1737953_a0ba5a0b7d4d4b23ba5cb7e137e38681_0]** 
- The lawsuit covers investors who bought Replimune securities between **November 22, 2024, and July 21, 2025**, with a lead plaintiff deadline of **September 22, 2025**.  **[1737953_a0ba5a0b7d4d4b23ba5cb7e137e38681_0]** 
- The FDA's rejection of RP1 was rooted in specific issues with the **IGNYTE trial's methodology**, including patient heterogeneity and flaws in the design of the planned confirmatory trial.  **[1737953_a0ba5a0b7d4d4b23ba5cb7e137e38681_0]**

Replimune Faces Lawsuit Following FDA Drug Rejection and Stock Crash

- Replimune Group, Inc. **(NASDAQ: REPL)** is facing a securities class action lawsuit after its stock plummeted **77%** on July 22, 2025, following the FDA's issuance of a Complete Response Letter (CRL) for its leading cancer drug, RP1.  **[1737953_e1f2ec559e524a519906c5592f01be54_0]** 
- The lawsuit, _Jboor v. Replimune Group, Inc., et al._, is on behalf of investors who bought Replimune securities between **November 22, 2024, and July 21, 2025**, with a lead plaintiff deadline of **September 22, 2025**.  **[1737953_e1f2ec559e524a519906c5592f01be54_0]** 
- The complaint alleges that Replimune misled investors by overstating the likelihood of success for its IGNYTE trial and failing to disclose that the FDA was likely to find the trial's design and data inadequate for approval.  **[1737953_e1f2ec559e524a519906c5592f01be54_0]** 
- The FDA's rejection was due to specific issues with the IGNYTE trial's methodology, including **patient heterogeneity** and flaws in the **confirmatory trial design**.  **[1737953_e1f2ec559e524a519906c5592f01be54_0]**

Replimune Group (REPL)