Welcome to our dedicated page for Cabaletta Bio news (Ticker: CABA), a resource for investors and traders seeking the latest updates and insights on Cabaletta Bio stock.
Cabaletta Bio, Inc. develops engineered T cell therapies for autoimmune diseases as a late-stage clinical biotechnology company. Its CABA platform includes the CARTA strategy, and its lead investigational therapy, rese-cel (resecabtagene autoleucel), is a fully human CD19-CAR T cell therapy evaluated through the RESET clinical development program across rheumatology, neurology and dermatology.
Recurring company updates cover rese-cel clinical and translational data, trial-program presentations, manufacturing scale-up, and supply arrangements using automated cell-therapy production platforms. News also includes financial results, business updates, conference participation, shareholder voting matters, capital-structure disclosures, and regulatory disclosures tied to Cabaletta Bio’s autoimmune cell-therapy pipeline.
Cabaletta Bio (NASDAQ: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, announced its participation in the upcoming Jefferies Global Healthcare Conference. The company will engage in a fireside chat on June 4, 2025, at 11:05 a.m. ET in New York. Investors and interested parties can access a live webcast of the presentation through Cabaletta's website, with replays available for 30 days following the event.
Cabaletta Bio (NASDAQ: CABA) has reported its Q4 and full year 2024 financial results. The company is enrolling approximately one patient per week across its RESET™ clinical program, with 33 patients enrolled across 56 active clinical sites in the U.S. and Europe as of March 14, 2025.
Key highlights include:
- FDA meeting planned for 1H25 to align on myositis registrational trial designs
- Cash position of $164.0 million as of December 31, 2024, providing runway into 1H26
- Three oral presentations on rese-cel planned for EULAR 2025 Congress in June
In clinical developments, the company reported positive responses across multiple indications: three out of four SLE patients achieved DORIS remission, the first lupus nephritis patient achieved complete renal response, and dermatomyositis patients showed improvement. However, one systemic sclerosis patient experienced a grade 3 ICANS toxicity event, which resolved following treatment.
Cellares and Cabaletta Bio have successfully completed their Technology Adoption Program (TAP) for manufacturing rese-cel using the Cell Shuttle™ platform. The collaboration demonstrates the capability of Cellares' IDMO Smart Factory to automate and scale manufacturing for Cabaletta's clinical-stage CAR T program targeting autoimmune diseases.
The TAP successfully achieved automated, concurrent production of multiple rese-cel batches on a single Cell Shuttle. The platform performed all unit operations automatically, including cell isolation, enrichment, gene editing, activation, and expansion, meeting predefined quality requirements.
This partnership could enable Cabaletta Bio to meet global patient demand across multiple autoimmune conditions, including:
- Myositis (~70,000 US patients)
- Scleroderma (~90,000 US patients)
- Lupus nephritis (~100,000 US patients)
Through Cellares' network of planned global IDMO Smart Factories in the US, Europe, and Japan, the collaboration aims to reduce costs and enable rapid technology transfer for global expansion of rese-cel manufacturing.
Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotechnology company specializing in curative targeted cell therapies for autoimmune diseases, has announced its participation in the TD Cowen 45th Annual Health Care Conference. The company will engage in a fireside chat on March 3, 2025, at 11:50 a.m. ET in Boston, MA.
Interested parties can access a live webcast of the presentation through the News and Events section on www.cabalettabio.com. The presentation recording will remain available for replay on the company's website for 30 days following the event.
Cabaletta Bio (NASDAQ: CABA) reported updated clinical data for resecabtagene autoleucel (rese-cel) across multiple autoimmune diseases. Key highlights from the first 10 patients include:
- Three SLE patients achieved DORIS remission
- First lupus nephritis patient reached complete renal response
- First dermatomyositis patient maintained major TIS improvement
- 90% of patients experienced either no CRS or Grade 1 CRS
- Deep B cell depletion observed in all patients
The RESET clinical development program has expanded to 50 clinical sites across the U.S. and Europe, with 26 patients enrolled as of February 13, 2025. The company plans to meet with FDA in the first half of 2025 to discuss registrational trial designs. Patient enrollment has accelerated to approximately one patient per week since November.
Cabaletta Bio (NASDAQ: CABA) has reported updated clinical data for resecabtagene autoleucel (rese-cel) across multiple autoimmune indications. The data covers 10 patients treated through the RESET clinical development program, showing significant clinical responses:
Key highlights include three SLE patients achieving DORIS remission, the first lupus nephritis patient reaching complete renal response, and the first dermatomyositis patient maintaining major TIS improvement. Notably, all these patients discontinued immunosuppressants and steroids. The safety profile remains favorable, with 90% of patients experiencing either no or Grade 1 CRS, and 90% showing no ICANS.
The company's clinical trial network has expanded to 50 sites across the U.S. and Europe, with 26 patients enrolled in the RESET program as of February 13, 2025. Deep B cell depletion was observed in all patients post-treatment, with B cell repopulation typically starting around 2 months post-infusion.
Cabaletta Bio (NASDAQ: CABA) announced upcoming presentations featuring updated clinical data on resecabtagene autoleucel (rese-cel) at two scientific meetings in February 2025. The presentations will cover safety, translational data, and clinical outcomes from the first 10 patients dosed with rese-cel across multiple ongoing RESET™ clinical trials.
The data will be presented at the 2025 American Association for the Advancement of Science Annual Meeting in Boston (February 13-15) and the 5th International Conference on Lymphocyte Engineering in Munich (February 20-22). The presentations will focus on rese-cel's application in treating autoimmune diseases, including Myositis, SLE, and Systemic Sclerosis.