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. (Nasdaq: CABA) is a clinical-stage biotechnology company pioneering engineered T cell therapies for autoimmune diseases. This page serves as the definitive source for official updates on clinical trials, research advancements, and corporate developments related to their innovative CAART and CARTA platforms.
Investors and researchers will find curated press releases detailing progress across multiple Phase 1/2 trials targeting conditions including lupus, myositis, and pemphigus vulgaris. Our collection features updates on therapeutic mechanisms that selectively eliminate pathogenic B cells while preserving healthy immune function.
The resource covers essential developments including trial design innovations, manufacturing process improvements, and strategic collaborations. All content is rigorously verified to ensure accuracy in reporting on this cutting-edge approach to autoimmune treatment.
Bookmark this page for streamlined access to Cabaletta Bio's latest milestones in developing potentially curative therapies. Check regularly for updates on clinical programs demonstrating the company's commitment to transforming autoimmune disease management.
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.
Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotechnology company specializing in curative targeted cell therapies for autoimmune diseases, has announced its upcoming participation in Guggenheim's SMID Cap Biotech Conference. The company will engage in a fireside chat scheduled for Wednesday, February 5, 2025, at 10:30 a.m. ET in New York, NY.
Interested parties can access a live webcast of the presentation through the News and Events section of Cabaletta Bio's website. The presentation recording will remain available for replay on the company's website for 30 days following the event.
Cabaletta Bio has outlined its strategic priorities and key milestones for 2025, focusing on the development of rese-cel (formerly CABA-201). The company aims to align with the FDA on registrational trial designs in the first half of 2025, leveraging data from its expanding clinical trials.
As of December 31, 2024, 21 patients have been enrolled across 44 clinical sites in the U.S. and Europe. In the first 10 patients dosed with rese-cel, 90% experienced either no CRS or grade 1 CRS, and 90% experienced no ICANS. Additional data will be presented in February 2025.
Key developments include:
- First patient enrolled in the RESET-PV trial evaluating rese-cel without preconditioning
- First site opened in the juvenile myositis cohort of the RESET-Myositis trial
- IND application for rese-cel cleared for the RESET-MS trial with Fast Track Designation
The company has expanded its CDMO agreement with Lonza to support increased enrollment and prepare for registrational trials. Cabaletta's cash position of $164 million as of December 31, 2024, is expected to fund operations into the first half of 2026.
Cabaletta Bio (Nasdaq: CABA) has announced its participation in two major investor conferences this December. The company will present a fireside chat at the 7th Annual Evercore HealthCONx Conference on December 4, 2024, at 7:55 a.m. ET in Coral Gables, FL. On the same day, management will be available for one-on-one meetings at Citi's 2024 Global Healthcare Conference in Miami, FL.
The fireside chat will be webcast live and accessible through Cabaletta's website, with replays available for 30 days. The company specializes in developing curative targeted cell therapies for autoimmune diseases.
Cabaletta Bio presented clinical data for CABA-201 at ACR Convergence 2024, showing promising results in treating autoimmune diseases. Eight patients across multiple trials received a single infusion of CABA-201, with follow-up periods up to six months. The therapy demonstrated a favorable safety profile with only three patients experiencing low-grade CRS. Key findings include complete B cell depletion in all patients, early signs of immune system reset, and compelling clinical responses in lupus, myositis, and systemic sclerosis patients. All patients discontinued immunosuppressants prior to treatment. The company has expanded to 40 U.S. clinical sites with 16 patients enrolled and 10 dosed as of November 2024.
