BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the second quarter ended June 30, 2025. "Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better tha ...

Core Insights - Capricor Therapeutics, Inc. is under investigation for potential claims related to its common stock following a significant stock price drop after receiving a Complete Response Letter from the FDA regarding its lead product candidate, Deramiocel [1][2]. Company Developments - Capricor is a clinical-stage drug company focused on developing Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy [1]. - The company completed its Phase 2 HOPE-2 clinical trial in 2021 [1]. - On September 24, 2024, Capricor filed a Biologics License Application (BLA) with the FDA for Deramiocel, which led to a stock price increase from $5.97 to $9.10 per share [2]. - On May 13, 2025, Capricor reported no significant deficiencies following a mid-cycle review meeting with the FDA [2]. - On July 11, 2025, Capricor announced it received a Complete Response Letter from the FDA, stating that the BLA did not meet the requirements for substantial evidence of effectiveness and required additional clinical data, resulting in a stock price drop of 33% to $7.64 per share [2]. Investor Information - Investors who experienced losses in Capricor's common stock are encouraged to contact Wolf Popper LLP for discussions regarding the investigation [3].

Core Viewpoint - Genmab A/S plans to submit a supplemental Biologics License Application (sBLA) for subcutaneous epcoritamab in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma in the first half of 2025 [1][3] Company Announcement - The sBLA submission is based on positive topline results from the Phase 3 EPCORE FL-1 trial, which showed that epcoritamab plus rituximab (R) met one of its dual primary endpoints of overall response rate (ORR) with a p-value of less than 0.0001 [2][7] - The safety profile of the combination therapy was consistent with known safety profiles of the individual components, and no new safety signals were observed [2][3] About Follicular Lymphoma (FL) - Follicular lymphoma is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all cases, with approximately 15,000 new cases diagnosed annually in the U.S. [4] - It is considered incurable with current standard therapies, and patients often experience shorter remission periods with each relapse [4] About the EPCORE FL-1 Trial - The EPCORE FL-1 trial is a Phase 3 open-label interventional study evaluating the safety and efficacy of epcoritamab plus rituximab and lenalidomide versus rituximab alone in patients with relapsed/refractory follicular lymphoma [5] About Epcoritamab - Epcoritamab is an IgG1-bispecific antibody developed using Genmab's DuoBody technology, designed to target CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [6][7] - It is currently approved by the FDA as a monotherapy for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy [3][7] Collaboration and Future Plans - Genmab is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, and both companies are pursuing additional international regulatory approvals for the investigational indication [8][9] - Genmab and AbbVie are also evaluating epcoritamab in various hematologic malignancies across multiple ongoing Phase 3 trials [9]