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. (symbol: CABA) is a clinical-stage biotechnology company dedicated to the discovery and development of engineered T cell therapies for patients suffering from B cell-mediated autoimmune diseases. Utilizing its proprietary Chimeric AutoAntibody Receptor (CAAR) and Chimeric Antigen Receptor T cells for autoimmunity (CARTA) technologies, Cabaletta aims to provide targeted, effective, and potentially curative treatments.
The company's flagship product candidate, DSG3-CAART, is in Phase I clinical trials for treating mucosal pemphigus vulgaris, an autoimmune blistering skin disease. Other promising candidates include MuSK-CAART for myasthenia gravis and FVIII-CAART for a subset of patients with hemophilia A. Cabaletta is also actively developing DSG3/1-CAART for mucocutaneous pemphigus vulgaris, with several products in various stages of preclinical and discovery phases.
In recent developments, Cabaletta Bio received approval from the U.S. FDA for its Investigational New Drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy for generalized myasthenia gravis (gMG). This expands their portfolio into neurology, complementing prior clearances for lupus, myositis, and systemic sclerosis. The upcoming Phase 1/2 clinical trial for CABA-201 aims to test its efficacy in treating gMG patients, potentially offering a groundbreaking one-time dose treatment.
Furthermore, Cabaletta has secured multiple Fast Track Designations from the FDA for CABA-201 in conditions like dermatomyositis and systemic sclerosis, facilitating expedited development and review. These designations highlight the critical unmet needs in these patient populations and amplify Cabaletta’s commitment to pioneering advanced therapies.
Based in Philadelphia, PA, Cabaletta Bio continues to advance its innovative pipeline, guided by robust scientific research and strategic collaborations. The company is well-positioned financially, with adequate resources to fund its operations into the first half of 2026. Cabaletta's mission is to harness the power of engineered T cells to unlock transformative therapies, offering patients durable, drug-free remissions and improved quality of life.
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.
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