Cabaletta Bio, Inc. CABA
Cabaletta Bio, Inc. (Nasdaq: CABA) is an immunology/inflammation drug developer. Its lead program, rese-cel (resecabtagene autoleucel, CABA-201), is in Phase 2 for Autoimmune disease; lead registrational cohort in dermatomyositis / anti-synthetase syndrome (myositis). Its next catalyst on record is rese-cel (DM/ASyS): BLA-enabling topline data from registrational cohort (June 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: rese-cel (DM/ASyS) — BLA-enabling topline data from registrational cohort (June 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| rese-cel RESET-Myositis (DM/ASyS registrational cohort) | Dermatomyositis / anti-synthetase syndrome | cell therapy | Phase 2 |
| rese-cel RESET-Myositis (IMNM, juvenile cohorts) | Immune-mediated necrotizing myopathy; juvenile idiopathic inflammatory myopathy | cell therapy | Phase 1 |
| rese-cel RESET-SSc | Systemic sclerosis (incl. SSc-ILD) | cell therapy | Phase 1 |
| rese-cel RESET-SLE (incl. PC-free dose exploration) | Systemic lupus erythematosus / lupus nephritis | cell therapy | Phase 1 |
| rese-cel RESET-MG (incl. PC-free dose exploration) | Generalized myasthenia gravis | cell therapy | Phase 1 |
| rese-cel RESET-PV (preconditioning-free) | Pemphigus vulgaris | cell therapy | Phase 1 |
Recent results and decisions
- Aug 13, 2026n/a FDA granted Regenerative Medicine Advanced Therapy designation to rese-cel for generalized myasthenia gravis.
In addition, rese-cel was granted Regenerative Medicine Advanced Therapy designation by the FDA for the treatment of generalized myasthenia gravis, building on this designation already granted to rese-cel as a potential treatment for myositis, systemic sclerosis, and lupus.
Filing - Jun 3, 2026positive Phase 1/2 data: 80% (8/10) of DM and ASyS patients would have met the registrational primary endpoint; 83% (5/6) of DM patients had IM-free moderate-to-major TIS response at 16 weeks, durable up to 1.5 years.
RESET-Myositis®: Phase 1/2 cohort data demonstrate 80% (8/10) of dermatomyositis (DM) and antisynthetase syndrome (ASyS) patients would have met the primary endpoint of the registrational cohort.
Filing - May 14, 2026positive Preconditioning-free lowest-dose rese-cel produced drug-free clinical responses in half of the 4 evaluable pemphigus vulgaris patients through 6 months of follow-up (ASGCT 2026).
today we are presenting data at ASGCT demonstrating that without preconditioning, even the lowest dose of rese-cel demonstrated compelling drug-free clinical responses in half of the pemphigus vulgaris patients through 6-months of follow-up
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.