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) 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.
Cabaletta Bio (Nasdaq: CABA) reported Q3 2025 results and a business update on Nov 10, 2025. Key operational points: rese-cel clinical data from 32 patients across four autoimmune trials showed drug-free responses and a favorable safety profile supporting outpatient use. All myositis Phase 1/2 patients with sufficient follow-up who met registrational criteria achieved the 16-week primary endpoint. A 14-patient DM/ASyS registrational cohort will begin enrolling this quarter, supporting a planned BLA submission in 2027. Regulatory progress includes EMA PRIME and FDA RMAT and Fast Track designations. Financials: R&D expense rose to $39.8M in Q3; cash and investments were $159.9M, funding operations into H2 2026.
Cabaletta Bio (Nasdaq: CABA) announced participation in five investor conferences in November–December 2025 with scheduled webcasted fireside chats and investor meetings.
Key dates and times: Guggenheim fireside chat on Nov 11, 2025 at 10:30 a.m. ET; TD Cowen on Nov 13, 2025 at 11:00 a.m. ET; Jefferies (London) on Nov 17, 2025 at 1:30 p.m. GMT (meetings Nov 17–18); Evercore on Dec 2, 2025 at 8:20 a.m. ET; and Citi on Dec 3, 2025 at 1:45 p.m. ET.
All webcasted fireside chats will be available on the company's News and Events website page and replays will be posted for 30 days. The company will be available for in-person and virtual investor meetings as noted per event.
Cabaletta Bio (Nasdaq: CABA) reported positive clinical and development updates for rese-cel across RESET-Myositis, RESET-SSc and RESET-SLE at ACR Convergence 2025 (data cut-off Sept 11, 2025).
Key points: all 4 DM/ASyS patients meeting registrational criteria achieved moderate/major TIS at week 16; Cabaletta plans a 14-patient DM/ASyS registrational cohort with a 16-week primary endpoint; 76 patients enrolled at 77 sites as of Oct 24, 2025; SSc and SLE cohorts showed clinical responses off immunomodulators; a no-preconditioning dose-escalation cohort for SLE is being added with initial data expected in 2026.
Cabaletta Bio (Nasdaq: CABA) appointed Steve Gavel as Chief Commercial Officer effective Oct 14, 2025, to lead global commercial strategy and execution for rese-cel (resecabtagene autoleucel) and future pipeline opportunities. The company anticipates a first BLA submission in myositis in 2027. Gavel previously led CAR T launch and commercialization at Legend Biotech (2018–2025) including CARVYKTI, and has prior roles at Celgene, Takeda and Johnson & Johnson.
On Oct 13, 2025 Cabaletta granted an inducement award of 275,000 non-qualified stock options at an exercise price of $2.49 (Nasdaq close Oct 13), 10-year term, vesting over four years under the 2025 Inducement Plan.
Cabaletta Bio (NASDAQ: CABA) presented initial data from the RESET-PV trial showing rese-cel administered at 1x10^6 cells/kg without preconditioning in three evaluable pemphigus vulgaris patients (data cut-off Sept 11, 2025).
Key findings: complete peripheral B cell depletion in 2 of 3 patients, CAR T expansion comparable to preconditioned trials, rapid reductions in desmoglein autoantibodies, meaningful PDAI score improvements (examples: 83→3 and 22→2), and no reported ICANS. All three patients remained off immunomodulators at cut-off.
Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, has announced its participation in four major investor conferences in September 2025.
The company will present at the Cantor Global Healthcare Conference (Sept 3), Wells Fargo Healthcare Conference (Sept 4), Morgan Stanley Global Healthcare Conference (Sept 10), and H.C. Wainwright Global Investment Conference (Sept 10). Webcasted fireside chats will be available on the company's website for 30 days.
Cabaletta Bio (Nasdaq: CABA) reported significant progress in Q2 2025, highlighting advancements in their rese-cel (resecabtagene autoleucel) development program. The company is on track to initiate registrational cohort enrollment for myositis treatment in 2H 2025, targeting a BLA submission in 2027.
Key developments include successful enrollment across five disease-specific cohorts from over 70 clinical sites, promising clinical data presented at EULAR 2025 Congress, and completion of a $100 million public offering extending cash runway into 2H 2026. The company reported Q2 2025 R&D expenses of $37.6 million and ended the quarter with $194.7 million in cash and equivalents.