Cabaletta Bio, Inc. CABA
Cabaletta Bio, Inc. (Nasdaq: CABA) is an immunology/inflammation drug developer. Its lead program, Resecabtagene autoleucel (rese-cel), is in Phase 3 for Myositis (dermatomyositis and antisynthetase syndrome). Its next catalyst on record is Rese-cel PC-free approach in SLE/LN: Go-forward clinical development plan update (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Rese-cel PC-free approach in SLE/LN — Go-forward clinical development plan update (H1 2027). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Rese-cel | Dermatomyositis/Antisynthetase syndrome (myositis) | cell therapy | Phase 3 |
| Rese-cel | Systemic sclerosis with interstitial lung disease | cell therapy | Phase 3 |
| Rese-cel | Systemic lupus erythematosus | cell therapy | Phase 2 |
| Rese-cel | Lupus nephritis | cell therapy | Phase 2 |
| Rese-cel | Generalized myasthenia gravis | cell therapy | Phase 2 |
| Rese-cel | Pemphigus vulgaris | cell therapy | Phase 2 |
Recent results and decisions
- Nov 5, 2026started Cabaletta initiated the registrational approximately 25-patient cohort in systemic sclerosis patients with interstitial lung disease.
Cabaletta initiated the registrational, approximately 25-patient cohort in systemic sclerosis patients with a focus on interstitial lung disease and an outpatient dosing option.
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 3 immunology/inflammation companies
- Sanofi SNY
- Argenx SE ARGX
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Celldex Therapeutics, Inc. CLDX
- Biohaven Ltd. BHVN
- BioCryst Pharmaceuticals, Inc. BCRX
- Zenas BioPharma ZBIO
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.