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 developing targeted cell therapies for autoimmune diseases, with news flow closely tied to its lead investigational CAR T cell therapy, rese-cel (resecabtagene autoleucel). The company regularly issues updates on clinical data, regulatory interactions, manufacturing progress and corporate developments that are relevant to investors and followers of autoimmune-focused biotechnology.
News about Cabaletta Bio often highlights clinical milestones within its RESET™ (REstoring SElf-Tolerance) development program. These updates include Phase 1/2 data readouts and trial expansions in indications such as myositis, systemic sclerosis, systemic lupus erythematosus, lupus nephritis, generalized myasthenia gravis and pemphigus vulgaris. Press releases have described outcomes from disease-specific cohorts, registrational cohort designs aligned with the U.S. Food and Drug Administration, and emerging data from cohorts evaluating rese-cel without preconditioning regimens.
Regulatory and manufacturing news is another key theme. Cabaletta Bio has reported on FDA designations for rese-cel, including Regenerative Medicine Advanced Therapy and Fast Track designations, as well as PRIME access from the European Medicines Agency. The company also issues announcements regarding chemistry, manufacturing and controls activities and its collaboration with Cellares to use fully automated platforms, such as the Cell Shuttle™ and Cell Q™, for clinical manufacturing and quality control testing of rese-cel.
Corporate and financial updates, including quarterly financial results, public offerings and participation in healthcare and investor conferences, are frequent components of Cabaletta Bio’s news flow. These communications provide context on the company’s cash position, operating plans and engagement with the investment community. For readers tracking CABA, the news stream offers insight into the progress of rese-cel across multiple autoimmune indications, evolving registrational strategies and the company’s preparations for potential future commercialization. Bookmarking the news feed can help users follow ongoing clinical, regulatory and corporate developments related to Cabaletta Bio and its RESET program.
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.
Cabaletta Bio (NASDAQ: CABA) reported Q3 2024 financial results and business updates. The company has 40 U.S. clinical sites actively recruiting patients across its RESET clinical trials, with 16 patients enrolled and 10 dosed as of November 12. Clinical data from RESET-Myositis, RESET-SLE, and initial data from RESET-SSc trials will be presented at ACR Convergence 2024. The company received EMA CTA authorization for CABA-201 in lupus, expanding into Europe. Cash position stands at $183.0 million as of September 30, 2024, expected to fund operations into first half of 2026.
Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotechnology company developing curative targeted cell therapies for autoimmune diseases, announced its participation in Guggenheim's Inaugural Healthcare Innovation Conference. The company will engage in a fireside chat on Monday, November 11, 2024, at 10:00 a.m. ET in Boston, MA.
The presentation will be accessible through a live webcast on the News and Events section of Cabaletta's website, with replays available for 30 days following the event.
Cabaletta Bio (Nasdaq: CABA) announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, featuring new and updated clinical data on CABA-201, their 4-1BB-containing fully human CD19-CAR T cell investigational therapy. The presentations will cover:
1. An oral presentation on the safety and efficacy of CABA-201 in patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical Trials.
2. A poster presentation on correlative studies of CABA-201 in the same patient groups.
The ACR Convergence 2024 will be held from November 14-19, 2024, in Washington, D.C. Presentation materials will be available on Cabaletta Bio's website following the event.