--- title: "Cabaletta Bio Inc. Unveils Corporate Presentation on Pioneering Cellular Therapies for Autoimmune Diseases" description: "Cabaletta Bio Inc. has unveiled a corporate presentation detailing its plans for the development and submission of a biologics license application (BLA) for resecabtagene autoleucel (rese-cel) in 2027" type: "news" locale: "en" url: "https://longbridge.com/en/news/240357757.md" published_at: "2025-05-15T11:09:52.000Z" --- # Cabaletta Bio Inc. Unveils Corporate Presentation on Pioneering Cellular Therapies for Autoimmune Diseases > Cabaletta Bio Inc. has unveiled a corporate presentation detailing its plans for the development and submission of a biologics license application (BLA) for resecabtagene autoleucel (rese-cel) in 2027, following FDA alignment. The company aims to accelerate enrollment across 62 clinical sites, initially targeting myositis, with future expansions to lupus and systemic sclerosis. The presentation emphasizes an innovative clinical strategy and highlights FDA Fast Track and RMAT designations. New data will be presented at the EULAR 2025 congress. Cabaletta Bio Inc. has announced plans for the development and submission of their biologics license application (BLA) for resecabtagene autoleucel (rese-cel) in 2027, following recent alignment with the FDA. The company is focusing on rapidly accelerating enrollment across a broad portfolio of indications at 62 active clinical sites. The initial BLA submission will target myositis, with plans to expand to systemic lupus erythematosus/lupus nephritis and systemic sclerosis. The presentation highlights the innovative clinical strategy that supports an accelerated regulatory path, emphasizing the efficacy and safety data from the RESET clinical program. Cabaletta Bio has received FDA Fast Track Designation for several conditions, including dermatomyositis and multiple sclerosis, and RMAT designation for myositis. New clinical safety and efficacy data for rese-cel will be presented at the EULAR 2025 congress. You can access the full presentation through the link below. ### Related Stocks - [CABA.US - Cabaletta Bio](https://longbridge.com/en/quote/CABA.US.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | 美股夜盘异动:Cabaletta Bio 高管集体增持,夜盘股价飙升 7.48% 引市场关注 | Cabaletta Bio 夜盘涨 7.48%;Moderna 夜盘跌 3.03%,成交额达到 5.18 百万美元;Recursion Pharmaceuticals 夜盘涨 1.41%,成交额达到 98.66 万美元;ImmunityBi | [Link](https://longbridge.com/en/news/273466369.md) | | Cabaletta Bio 公布了首个针对自身免疫疾病的治愈性 CAR T 疗法计划 | Cabaletta Bio Inc. 宣布其在自身免疫疾病临床项目方面取得了进展,使用其主要候选药物 rese-cel,这是一种 CD19-CAR T 细胞疗法。该公司在肌炎和狼疮等疾病的关键研究中取得了进展,预计到 2026 年中期将获得 | [Link](https://longbridge.com/en/news/272279076.md) | | FDA 批准了 Cabaletta Bio 公司 Rese-cel 临床生产的 IND 修正案 | Cabaletta Bio Inc. 已获得 FDA 对 IND 修正案的批准,以利用 Cellares 的自动化 Cell Shuttle™ 和 Cell Q™ 平台进行其 CAR T 细胞疗法 rese-cel 的生产和质量控制。该批准 | [Link](https://longbridge.com/en/news/272268539.md) | --- > **Disclaimer**: This article is for reference only and does not constitute any investment advice.