FDA Events for Cabaletta Bio (CABA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cabaletta Bio (CABA).
Over the past two years, Cabaletta Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CABA-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CABA-201 - FDA Regulatory Timeline and Events
CABA-201 is a drug developed by Cabaletta Bio for the following indication: For Treatment of Generalized Myasthenia Gravis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CABA-201
- Announced Date:
- June 11, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced new clinical and translational data from the ongoing RESET-Myositis™, RESET-SLE™ and RESET-SSc™ trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201).
AI Summary
Cabaletta Bio, Inc. announced promising new clinical and translational data from its ongoing RESET-Myositis™, RESET-SLE™, and RESET-SSc™ trials evaluating rese-cel (resecabtagene autoleucel, formerly CABA-201). In the RESET-Myositis trial, 7 of 8 patients achieved clinically meaningful total improvement score responses after stopping immunomodulators and tapering steroids. Similarly, in the RESET-SLE trial, all evaluable patients, including those without renal involvement, reached remission criteria while off immunomodulators and steroids. In the RESET-SSc trial, both patients experienced significant improvements in modified Rodnan Skin Scores following treatment. The safety profile was favorable, with most patients experiencing little to no cytokine release syndrome and scarce neurotoxicity. Enrollment in the RESET program is accelerating, with plans to initiate registrational myositis cohorts this year and discussions with the FDA on further registrational program designs for SLE, scleroderma, and other indications in the near future.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- May 15, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced that SLE and LN registrational discussions with FDA anticipated in 3Q25;
AI Summary
Cabaletta Bio, Inc. announced that it plans to have registrational discussions with the FDA concerning its studies in systemic lupus erythematosus (SLE) and lupus nephritis (LN) in the third quarter of 2025. These discussions are part of the company’s ongoing efforts to build a strong clinical program for autoimmune diseases using its investigational rese-cel therapy.
The upcoming FDA meetings are expected to help set the stage for future registration studies by confirming the trial design and necessary data requirements for the SLE and LN cohorts. Each proposed cohort will include about 15 patients, with the study evaluating a single, weight-based dose of rese-cel and monitoring patient improvement over a 26‐week period. This milestone represents a significant step forward for Cabaletta Bio in advancing treatment options for patients suffering from autoimmune conditions like SLE and LN.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- May 15, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration (FDA) meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel (resecabtagene autoleucel, formerly known as CABA-201).
AI Summary
Cabaletta Bio, a biotechnology company developing targeted cell therapies for autoimmune diseases, announced plans to file a Biologics License Application (BLA) for its rese-cel product by 2027. This decision follows a recent FDA meeting that reviewed the proposed registrational cohort design for the RESET-Myositis trial. According to the meeting, the trial will use two independent cohorts of about 15 patients each, evaluating a single, weight-based dose of rese-cel. Patient outcomes will be measured within 26 weeks using a validated clinical improvement score originally used for IVIg approval in dermatomyositis. The FDA also supported the use of pooled safety data from Cabaletta’s broader RESET program to strengthen the application. With rese-cel having received RMAT designation, the company aims to offer a transformative treatment option for myositis, a severe and disabling autoimmune disease affecting roughly 80,000 U.S. patients.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- May 15, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced that Multiple Phase 1/2 disease cohorts fully enrolled across the RESET™ clinical development program; 44 patients enrolled and 23 patients dosed as of May 9, 2025 –
AI Summary
Cabaletta Bio, Inc. recently announced a significant milestone in its RESET™ clinical development program. The company revealed that multiple Phase 1/2 disease cohorts have been fully enrolled, with 44 patients participating and 23 already dosed as of May 9, 2025. This progress marks an important step in evaluating rese-cel, a promising cell therapy designed to treat severe autoimmune diseases. The RESET program focuses on assessing the safety and efficacy of a single, weight-based infusion of rese-cel for patients who have stopped their previous immunosuppressant therapies. This achievement highlights the strength of Cabaletta Bio’s clinical trial network and reinforces its commitment to developing targeted cell therapies that may provide meaningful improvements over current treatment options. The enrollment milestone supports ongoing future discussions with the FDA, helping pave the way for further advancement of rese-cel in clinical research.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- May 15, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 - 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced that New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June –FDA anticipated in 3Q25;
AI Summary
Cabaletta Bio, Inc. announced that new clinical data on its investigational therapy rese-cel will be featured in three oral sessions at the EULAR 2025 Congress in June. The data will focus on rese-cel’s performance in treating myositis, systemic lupus erythematosus/lupus nephritis (SLE/LN), and systemic sclerosis—serious autoimmune diseases that currently have limited treatment options.
Further, the company expects registrational discussions with the FDA for SLE/LN to begin in the third quarter of 2025, with discussions for systemic sclerosis anticipated in the fourth quarter of 2025. This upcoming presentation at EULAR highlights key clinical insights and reinforces rese-cel’s potential as a targeted cell therapy aimed at offering new hope for patients suffering from these challenging conditions.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- February 18, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced new and updated clinical data from the first 10 patients dosed with resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) across the RESET clinical development program.
AI Summary
Cabaletta Bio, Inc. has shared promising new clinical data from the first 10 patients dosed with its investigational therapy resecabtagene autoleucel (rese-cel) in the RESET clinical development program. The updated results show deep and lasting clinical responses in patients with autoimmune diseases such as SLE, lupus nephritis, dermatomyositis, and systemic sclerosis. Notably, three SLE patients reached DORIS remission, the first LN patient achieved complete renal response, and a dermatomyositis patient maintained major improvement, all while being off immunosuppressants and steroids. The therapy demonstrated a favorable safety profile, with 90% of patients experiencing no or only minor cytokine release syndrome and minimal neurotoxicity. Additionally, rese-cel consistently achieved profound B cell depletion, with repopulation showing a transitional naïve B cell phenotype, supporting its potential to reset the immune system in autoimmune disorders.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- February 11, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced that updated clinical data on resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) will be featured in presentations at the 2025 American Association for the Advancement of Science Annual Meeting, which is being held at the Hynes Convention Center in Boston, MA from February 13-15, 2025, and the 5th International Conference on Lymphocyte Engineering, which is being held at the Holiday Inn Munich – City Center in Munich, Germany from February 20-22, 2025.
AI Summary
Cabaletta Bio, Inc. announced that updated clinical data on its investigational therapy, resecabtagene autoleucel (rese-cel, formerly CABA-201), will be showcased at two upcoming international conferences. The data will be presented at the 2025 American Association for the Advancement of Science Annual Meeting at the Hynes Convention Center in Boston, MA (February 13-15, 2025) and at the 5th International Conference on Lymphocyte Engineering at the Holiday Inn Munich – City Center in Munich, Germany (February 20-22, 2025).
These presentations will highlight safety results, translational insights, and clinical outcomes from the first 10 patients dosed with rese-cel in the RESET™ clinical development program. The Boston session, titled “Unleashing Immune Cells on Autoimmune Disease,” and the Munich session on clinical and translational studies will provide important updates on the therapy’s performance in treating autoimmune conditions.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- January 13, 2025
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
- Cabaletta Bio, Inc. today announced recent pipeline and operational progress and outlined its strategic priorities and anticipated key milestones for 2025.
AI Summary
Cabaletta Bio, Inc. has outlined new pipeline progress and strategic priorities for 2025. The company is focused on advancing its investigational therapy, rese-cel, to treat autoimmune diseases. Riding on encouraging safety profiles—where 90% of the first 10 dosed patients experienced no or only mild side effects—the firm is accelerating its clinical programs across multiple trials in the U.S. and Europe. Notably, Cabaletta plans to meet with the FDA in the first half of 2025 to align on registrational trial designs based on emerging clinical and translational data. This meeting is part of the company’s drive to speed up development and prepare for potential registration of rese-cel as a curative cell therapy. The company is also expanding its clinical site network and increasing patient enrollment across its RESET program, setting a robust foundation for future regulatory discussions and trial success.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- November 18, 2024
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced new and updated clinical data on CABA-201 demonstrating the potential to achieve drug-free, compelling clinical responses based on eight patients dosed across the ongoing Phase 1/2 RESET-Myositis™, RESET-SLE™ and RESET-SSc™ clinical trials.
AI Summary
Cabaletta Bio, Inc. has announced promising updated clinical data on its investigational therapy, CABA-201, from ongoing Phase 1/2 RESET-Myositis™, RESET-SLE™, and RESET-SSc™ trials. In a study involving eight patients with refractory autoimmune diseases, the therapy showed potential for drug-free, compelling clinical responses. Notably, patients with lupus and myositis experienced significant improvements, while the first patient with systemic sclerosis (SSc) demonstrated an emerging clinical response without the use of immunosuppressants. All patients received a single dose of CABA-201 after discontinuing their existing immunosuppressant therapies. The treatment led to complete B cell depletion within the first month and early signs of new, naïve B cell repopulation were observed as early as eight weeks. These results, presented at the American College of Rheumatology Convergence 2024 meeting, support further development of CABA-201 as a potentially transformative therapy for autoimmune conditions.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- September 25, 2024
- Indication:
- For Treatment of Generalized Myasthenia Gravis
Announcement
Cabaletta Bio, Inc. announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington Convention Center in Washington, D.C.
AI Summary
Cabaletta Bio, Inc. announced it will present two sessions at the upcoming American College of Rheumatology (ACR) Convergence 2024, which takes place at the Walter E. Washington Convention Center in Washington, D.C. from November 14-19, 2024. The company’s oral presentation, scheduled for November 17, 2024 at 3:30 p.m. ET, will focus on the safety and efficacy of CABA-201—a fully human, autologous 4-1BB anti-CD19 CAR T cell therapy—in patients with immune-mediated necrotizing myopathy and systemic lupus erythematosus. Additionally, a poster presentation on November 16, 2024 from 10:30 a.m. to 12:30 p.m. ET will review correlative studies related to the same therapy. These presentations will display new clinical data that highlight the potential of CABA-201 to achieve an “immune system reset” and offer durable remission for autoimmune disease patients.
Read Announcement- Drug:
- CABA-201
- Announced Date:
- June 14, 2024
- Estimated Event Date Range:
- June 14, 2024 - June 14, 2024
- Target Action Date:
- June 14, 2024
- Indication:
- CD19 chimeric antigen receptor
Announcement
Cabaletta Bio, Inc. today reported positive initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials. These data will be presented today at 8:15 a.m. CEST (2:15 a.m. ET) at a EULAR European Congress of Rheumatology 2024 Industry Symposia session titled "Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease" in Vienna, Austria.
AI Summary
Cabaletta Bio, Inc. announced promising initial clinical data from the first two patients treated with its investigational therapy, CABA-201, in the Phase 1/2 RESET-Myositis and RESET-SLE trials. The company reported that both patients tolerated the single-dose infusion well, with no signs of serious adverse events, cytokine release syndrome (CRS), or neurotoxicity. Early results showed that CABA-201 led to complete B cell depletion by day 15 post-infusion and demonstrated the expected pattern of CAR T cell expansion and contraction. Additionally, improvements in disease-specific measures were noted in both patients, with one showing evidence of an immune system reset indicated by immature, naïve B cell repopulation at week 8. These initial positive outcomes will be presented at the EULAR European Congress of Rheumatology 2024 during the Industry Symposia titled “Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease.”
Read Announcement- Drug:
- CABA-201
- Announced Date:
- June 14, 2024
- Indication:
- CD19 chimeric antigen receptor
Announcement
Cabaletta Bio, Inc today reported positive initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials.
AI Summary
Cabaletta Bio, Inc. announced positive early results from the first two patients treated with CABA-201 in its Phase 1/2 RESET-Myositis and RESET-SLE trials. In both cases, no serious adverse events, cytokine release syndrome (CRS), ICANS, or infections have been observed through the follow-up cut-off. The therapy showed the expected CAR T cell expansion and contraction, resulting in complete B cell depletion by day 15 after the single infusion. Early clinical improvements in disease-specific measures were also noted, matching experiences seen with similar CAR T constructs. In the myositis patient, signs of an immune system reset emerged with immature, naïve B cell repopulation observed by week 8. These promising initial findings support the continued development of CABA-201 as a potential curative therapy for patients with autoimmune diseases.
Read Announcement
Cabaletta Bio FDA Events - Frequently Asked Questions
As of now, Cabaletta Bio (CABA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cabaletta Bio (CABA) has reported FDA regulatory activity for CABA-201.
The most recent FDA-related event for Cabaletta Bio occurred on June 11, 2025, involving CABA-201. The update was categorized as "New Data," with the company reporting: "Cabaletta Bio, Inc. announced new clinical and translational data from the ongoing RESET-Myositis™, RESET-SLE™ and RESET-SSc™ trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201)."
Currently, Cabaletta Bio has one therapy (CABA-201) targeting the following condition: For Treatment of Generalized Myasthenia Gravis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:CABA) was last updated on 7/10/2025 by MarketBeat.com Staff
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