Allison Bratzel

Anupam Rama

Evan Seigerman

Jiale Song

Jonathan Chang

Peter Lawson

- **Replimune Group, Inc.** announced that the **U.S. Food and Drug Administration (FDA) accepted the resubmission of its Biologics License Application (BLA) for RP1**.  **[1737953_0001104659-25-100605_tm2529069d1_ex99-1.htm:0]** **[1737953_0001104659-25-100605_tm2529069d1_8k.htm:1]** 
- The BLA is for **RP1 in combination with nivolumab** for the treatment of **advanced melanoma** in patients who have progressed on an anti-PD-1 containing regimen.  **[1737953_0001104659-25-100605_tm2529069d1_ex99-1.htm:0]** **[1737953_0001104659-25-100605_tm2529069d1_8k.htm:1]** 
- The FDA has set a **Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026**, based on a Class II resubmission timeline.  **[1737953_0001104659-25-100605_tm2529069d1_ex99-1.htm:0]** **[1737953_0001104659-25-100605_tm2529069d1_8k.htm:1]** 
- This resubmission is considered a **complete response** to the complete response letter received in July 2025.  **[1737953_0001104659-25-100605_tm2529069d1_ex99-1.htm:0]**

Replimune Announces FDA Acceptance of BLA Resubmission for RP1

- Replimune Group announced that the **U.S. Food and Drug Administration (FDA) has accepted the resubmission of its Biologics License Application (BLA) for RP1**.  **[1737953_6713156325724ce9b3f80a698e3ce389_0]** 
- The BLA is for **RP1 in combination with nivolumab** for the treatment of advanced melanoma in patients who have progressed on an anti-PD-1 containing regimen.  **[1737953_6713156325724ce9b3f80a698e3ce389_0]** 
- The FDA has set a **PDUFA date of April 10, 2026**, for the review, based on a Class II resubmission timeline.  **[1737953_6713156325724ce9b3f80a698e3ce389_0]** 
- This resubmission is considered a complete response to the complete response letter received in July 2025, with additional information, data, and analyses included.  **[1737953_6713156325724ce9b3f80a698e3ce389_0]**

Replimune Announces FDA Acceptance of RP1 BLA Resubmission

- Replimune Group, Inc. announced **new data** from an ad hoc analysis of the **IGNYTE phase 2 cohort** of **RP1 plus nivolumab** for acral melanoma patients.  **[1737953_291c996d4f1546e0a680ff180456a081_0]** 
- Presented at the **European Society for Medical Oncology (ESMO) Congress 2025**, the analysis showed an objective response rate of **44% (8/18)** with a median duration of response of **11.9 months** in acral melanoma patients.  **[1737953_291c996d4f1546e0a680ff180456a081_0]** 
- Acral melanoma is a **rare and aggressive** type of cutaneous melanoma that typically does not respond well to available therapies, and the safety profile of RP1 plus nivolumab was **favorable**.  **[1737953_291c996d4f1546e0a680ff180456a081_0]** 
- The **IGNYTE-3 randomized controlled phase 3 trial** evaluating RP1 plus nivolumab in melanoma that has progressed on anti-PD1 and anti-CTLA-4 therapy is currently recruiting.  **[1737953_291c996d4f1546e0a680ff180456a081_0]**

Replimune Group Highlights RP1 plus Nivolumab Acral Melanoma Data at ESMO Congress 2025

- 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 Group (REPL)