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) priced an underwritten public offering of 51,725,000 shares of common stock at $2.90 per share, producing approximately $150 million in gross proceeds. The offering is expected to close on or about May 5, 2026 and included participation from Bain Capital Life Sciences, Adage Capital Management, Cormorant Asset Management and Eli Lilly.
The shares are being sold by Cabaletta under an effective Form S-3-ASR registration and are subject to customary closing conditions.
Cellares and Cabaletta Bio (NASDAQ: CABA) signed a 10-year commercial supply agreement for automated manufacture of rese-cel (resecabtagene autoleucel). The deal secures long-term capacity to support thousands of batches per year using Cellares’ Cell Shuttle™ and Cell Q™ platforms, following successful dosing of initial patients with product that met release specifications and an FDA-cleared IND amendment for Cell Shuttle clinical manufacturing.
Cabaletta Bio (Nasdaq: CABA) and Cellares signed a 10-year commercial supply agreement to manufacture rese-cel using Cellares’ automated Cell Shuttle and planned Cell Q platforms. The deal secures the ability to supply thousands of batches per year with minimal capital investment and aims for among the lowest per-batch costs in autologous cell therapy.
Initial translational data from the first two patients dosed with Cellares-manufactured rese-cel will be presented at ASGCT in May 2026; longer-term data expected in 2H26, and commercial supply is pending FDA approval.
Cabaletta Bio (Nasdaq: CABA) will present multiple manufacturing, translational and clinical updates on resecabtagene autoleucel (rese-cel) at the ASGCT 2026 Annual Meeting in Boston, May 11–15, 2026. Sessions include data on rese-cel without preconditioning, automated Cellares Cell Shuttle manufacturing, donor vs patient product comparability, and single-cell profiling across RESET Phase 1/2 cohorts.
Selected poster dates: May 12 and May 14; presentation materials and accepted abstracts will be posted after presentation.
Cabaletta Bio (Nasdaq: CABA) and Cellares announced that the first two GMP doses of rese-cel manufactured on Cellares' automated Cell Shuttle platform met all release specifications, were delivered on time, and have been infused into patients in Cabaletta’s RESET clinical trial.
The FDA cleared an Investigational New Drug amendment to use the Cell Shuttle after three years of process adaptation and comparability testing; collaboration began in 2023 to benchmark the automated process against Cabaletta’s established method.
Cabaletta Bio (NASDAQ: CABA) reported Q4 and full‑year 2025 results and a program update. Key items: a projected BLA submission in 2027 for rese‑cel in myositis based on a 17‑patient registrational cohort, no‑preconditioning data due in 1H26, and automated Cellares manufacturing expected in 1H26.
Financials: R&D was $142.7M for 2025, cash and short‑term investments were $133.6M at year‑end, and $30M was raised post‑year end, supporting operations into Q4 2026.
Cabaletta Bio (Nasdaq: CABA) will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 11:10 a.m. ET in Boston. A live webcast will be available on the company website and replays will be available for 30 days.
Cabaletta Bio (Nasdaq: CABA) will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026 at 9:30 a.m. ET in New York. A live webcast will be available on the company website and replays will be posted for 30 days.
Cabaletta Bio (Nasdaq: CABA) outlined 2026 priorities to advance rese-cel development, regulatory alignment, and scalable automated manufacturing.
Key plans: an FDA-aligned 17-patient myositis registrational cohort supporting a planned 2027 BLA submission; RMAT designation for systemic sclerosis; registrational cohort designs in SLE and LN (~25 patients each); IND amendment cleared to manufacture rese-cel using the Cellares automated platform with clinical manufacturing data expected in 1H26; and multiple Phase 1/2 data readouts across RESET trials expected in 1H26, including durability and no-preconditioning dose-ranging results.
Cabaletta Bio (Nasdaq: CABA) received FDA clearance of an IND Amendment to manufacture its investigational CAR T therapy rese-cel using Cellares' automated Cell Shuttle™ and Cell Q™ platforms. The clearance enables clinical manufacturing and QC release on Cellares' end-to-end automated systems, marking the platforms' first use supporting an active clinical program. First patient dosing is anticipated in the first half of 2026. Cabaletta and Cellares presented split apheresis comparability data and completed multi-batch engineering runs to support the transition to automated GMP production.