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Shareholders who lost money on Replimune Group, Inc. (NASDAQ: REPL) Should Contact Wolf Haldenstein Immediately as Lead Plaintiff Deadline is September 22nd
GlobeNewswire News Room· 2025-07-29 20:57
Group 1 - A securities class action lawsuit has been filed against Replimune Group, Inc. alleging possible securities fraud or other unlawful business practices [5] - The lawsuit covers a class period from November 22, 2024, to July 21, 2025, with a lead plaintiff deadline of September 22, 2025 [5] - The trigger event for the lawsuit was the FDA's Complete Response Letter rejecting Replimune's Biologics License Application for RP1, citing inadequate clinical evidence from the IGNYTE trial [5] Group 2 - Following the FDA's announcement, Replimune's stock experienced a significant decline of 77.24%, closing at $2.81 per share after a drop of $9.52 [5]
REPL LAWSUIT: Replimune Group, Inc. Sued for Fraud after FDA Response Letter – Contact BFA Law by September 22 Court Deadline (NASDAQ:REPL)
GlobeNewswire News Room· 2025-07-28 12:36
Core Viewpoint - A lawsuit has been filed against Replimune Group, Inc. and its senior executives for potential violations of federal securities laws, following a significant decline in stock price after the FDA's response regarding the company's lead product candidate RP1 [1][2][5]. Group 1: Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with its lead product candidate being RP1 for melanoma [3]. - The company announced positive results from its IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab on June 6, 2024, and subsequently submitted a biologics license application (BLA) to the FDA based on these results [3]. Group 2: Legal Issues - The lawsuit claims violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, representing investors who purchased Replimune securities [2]. - The complaint alleges that the IGNYTE Phase 1/2 trial design was inadequate to produce reliable results, despite the company promoting its outcomes [4]. Group 3: Stock Performance - Following the FDA's Complete Response Letter on July 22, 2025, which indicated that the IGNYTE trial was not considered adequate for substantial evidence of effectiveness, Replimune's stock price fell by more than 75% [5].
REPL STOCK NEWS: Replimune Group, Inc. (NASDAQ:REPL) is Facing a Securities Fraud Investigation – Investors with Losses are Notified to Contact BFA Law
GlobeNewswire News Room· 2025-07-24 12:07
Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in stock price after the FDA's response regarding its lead product candidate RP1 [1][4]. Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with RP1 as its lead product candidate aimed at melanoma [2]. Clinical Trial Results - On June 6, 2024, Replimune announced positive top-line results from the IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab [2]. - The company repeatedly promoted the results of the IGNYTE trial, but the trial design was criticized for not being adequate to produce reliable results [3]. Regulatory Response - On July 22, 2025, Replimune received a Complete Response Letter from the FDA, indicating that the IGNYTE trial was not considered adequate and well-controlled, leading to a significant stock price drop of over 75% [4]. - The FDA specifically noted that the trial's results could not be adequately interpreted due to the heterogeneity of the patient population [4].
Rosen Law Firm Encourages Replimune Group, Inc. Investors to Inquire About Securities Class Action Investigation - REPL
Prnewswire· 2025-07-24 00:33
Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Replimune Group, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Replimune Group, Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1, indicating that the application cannot be approved in its current form [3]. - The FDA stated that the IGNYTE trial does not provide substantial evidence of effectiveness, which contributed to a significant drop in Replimune's stock price [3]. - Following the announcement of the CRL, Replimune's common stock fell by $9.52 per share, representing a decline of over 77%, closing at $2.80 on July 22, 2025 [3]. Group 2: Legal Action and Investor Rights - Investors who purchased Replimune securities may be entitled to compensation through a class action lawsuit, with no out-of-pocket fees due to a contingency fee arrangement [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. - The firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4].
REPLIMUNE ALERT: Bragar Eagel & Squire, P.C. is Investigating Replimune Group, Inc. on Behalf of Replimune Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-23 22:52
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Replimune Group, Inc. following a significant stock price drop after the FDA issued a Complete Response Letter regarding its Biologics License Application for RP1 [1][3]. Company Summary - Replimune Group, Inc. (NASDAQ: REPL) faced a major setback when the FDA issued a Complete Response Letter on July 22, 2025, indicating that the application for RP1 in combination with nivolumab for advanced melanoma could not be approved in its current form [3]. - The FDA's letter highlighted that the IGNYTE trial was not considered adequate and well-controlled, lacking substantial evidence of effectiveness due to the heterogeneity of the patient population [3]. - Following the announcement, Replimune's stock price plummeted by $9.52, or 77.24%, closing at $2.81 per share [3]. Legal Investigation - Bragar Eagel & Squire, P.C. is encouraging investors who suffered losses from Replimune's stock decline to contact them to discuss potential legal rights and claims [1][4]. - The law firm is specifically looking into whether Replimune violated federal securities laws or engaged in unlawful business practices [1].
Kirby McInerney LLP Announces Investigation Against Replimune Group, Inc. (REPL) on Behalf of Investors
GlobeNewswire News Room· 2025-07-23 21:10
Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in its stock price after receiving a Complete Response Letter from the FDA regarding its lead product RP1 [1][3]. Company Summary - Replimune received a Complete Response Letter from the FDA on July 22, 2025, indicating that its IGNYTE trial was not considered adequate for demonstrating the effectiveness of RP1 in combination with nivolumab for advanced melanoma [3]. - Following the FDA's announcement, Replimune's stock price fell by $9.52, or approximately 77.24%, closing at $2.81 per share [3]. Legal Investigation Summary - Kirby McInerney LLP is investigating potential claims against Replimune and its officers for possible violations of federal securities laws and other unlawful business practices [1][4].
INVESTOR ALERT: Investigation of Replimune Group, Inc. (REPL) Announced by Holzer & Holzer, LLC
GlobeNewswire News Room· 2025-07-22 17:17
Core Points - Holzer & Holzer, LLC is investigating Replimune Group, Inc. for potential compliance issues with federal securities laws following the receipt of a Complete Response Letter from the FDA regarding its Biologics License Application for RP1 [1] - The FDA's Complete Response Letter indicated that the IGNYTE trial was not considered adequate to provide substantial evidence of effectiveness for the treatment of advanced melanoma [1] - Following the announcement of the CRL, Replimune's stock price experienced a decline [1] Company Information - Replimune Group, Inc. is focused on developing treatments for advanced melanoma, specifically through the use of RP1 in combination with nivolumab [1] - The company is publicly traded on NASDAQ under the ticker REPL [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation, representing shareholders and investors in class action and derivative litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]
I-Mab Strengthens Givastomig Intellectual Property Portfolio through Acquisition of Bridge Health
GlobeNewswire News Room· 2025-07-17 11:00
Core Viewpoint - I-Mab has announced a definitive agreement to acquire 100% ownership of Bridge Health Biotech Co., Ltd., enhancing its capabilities in developing the bispecific antibody givastomig for cancer treatment [1][2][4] Acquisition Details - The acquisition involves an upfront payment of $1.8 million and non-contingent payments of $1.2 million through 2027, with potential future milestone payments of up to $3.875 million [4] - The transaction is expected to close in Q3 of 2025 [4] Givastomig Development - Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells, currently in development for first-line metastatic gastric cancers, with potential expansion into other solid tumors [5][10] - Recent Phase 1b data showed an 83% objective response rate (ORR) in selected doses for dose expansion cohorts, indicating promising anti-tumor activity [3][6][8] Strategic Importance - The acquisition strengthens I-Mab's intellectual property rights related to givastomig, reduces future milestone payments, and eliminates royalty obligations [2][7] - The CLDN18.2 parental antibody used in givastomig exhibits higher affinity to human CLDN18.2 compared to other antibodies, which may differentiate it as a best-in-class therapy [2][5] Clinical Trial Progress - Enrollment in the first dose expansion cohort has been completed ahead of schedule, with topline results expected in Q1 of 2026 [3][8]
I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswire· 2025-07-02 15:15
Core Insights - I-Mab announced positive Phase 1b combination data for givastomig, showing a confirmed objective response rate (ORR) of 83% at selected doses for ongoing expansion studies [1][2][3] - The study demonstrated favorable tolerability and safety profile, with no Grade 3 or greater events for nausea and vomiting [2][21] - Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB, being developed for first-line treatment of Claudin 18.2-positive gastric cancers [15][18] Study Results - The Phase 1b study showed an overall ORR of 71% across all doses and 83% at doses selected for expansion (8 mg/kg and 12 mg/kg) [2][10] - Responses were observed in tumors with low PD-L1 and/or Claudin 18.2 expression, indicating broad potential for the therapy [2][3] - The disease control rate (DCR) was 100% across all dose levels, with a median follow-up of 9.0 months [12][13] Safety Profile - Treatment-related adverse events (TRAEs) leading to discontinuation were 12%, with common TRAEs being Grade 1 or 2 [21] - No dose-limiting toxicities (DLT) were observed, and a maximum tolerated dose (MTD) was not reached [21] - Grade 3 TRAEs were rare, with only isolated cases reported [21] Future Plans - I-Mab plans to host a virtual investor event on July 8 to discuss the Phase 1b data further [1][4] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [16][18]
I-Mab Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research
Globenewswire· 2025-06-30 20:01
Core Insights - I-Mab announced the publication of first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, showing an objective response rate (ORR) of 16% in heavily pretreated Claudin 18.2-positive gastric cancer patients [1][2][4] Summary of Monotherapy Results - The Phase 1 monotherapy study evaluated 75 patients, with 43 being efficacy-evaluable for advanced or metastatic gastroesophageal carcinoma (GEC) [2][5] - The ORR increased to 18% after the enrollment of two additional patients, resulting in 8 out of 45 patients achieving a confirmed partial response (PR) [2][6] - The study demonstrated a disease control rate (DCR) of 49% among the efficacy-evaluable patients [7] Safety and Tolerability - Givastomig was well tolerated, with no dose-limiting toxicity reported up to 15 mg/kg dosed every two weeks and 18 mg/kg dosed every three weeks [15] - The most common treatment-related adverse events were mainly Grade 1 or 2 [15] Development Strategy - The findings support the development of givastomig in combination with standard immunochemotherapy (nivolumab plus mFOLFOX6) as a first-line treatment for gastric cancers [3][4] - An ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [10] Unique Mechanism - Givastomig's bispecific design allows for high binding affinity to Claudin 18.2-positive cancer cells, enabling localized T cell stimulation while minimizing gastrointestinal toxicity [4][9]