Earnings summaries and quarterly performance for Cabaletta Bio.
Executive leadership at Cabaletta Bio.
Steven Nichtberger
Detailed
Chief Executive Officer and President
CEO
AM
Anup Marda
Detailed
Chief Financial Officer
AD
Arun Das
Detailed
Chief Business Officer
DC
David Chang
Detailed
Chief Medical Officer
GB
Gwendolyn Binder
Detailed
President, Science and Technology
HH
Heather Harte-Hall
Detailed
Chief Compliance Officer
MG
Michael Gerard
Detailed
General Counsel and Secretary
NS
Nicolette Sherman
Detailed
Chief HR Officer
SB
Samik Basu
Detailed
Chief Scientific Officer
SY
Sarah Yuan
Detailed
Chief Technology Officer
SG
Steve Gavel
Detailed
Chief Commercial Officer
Board of directors at Cabaletta Bio.
Research analysts covering Cabaletta Bio.
Recent press releases and 8-K filings for CABA.
Cabaletta Bio Announces 2026 Strategic Priorities
CABA
Product Launch
New Projects/Investments
Guidance Update
- Cabaletta Bio announced its 2026 strategic priorities, focusing on the development and launch of rese-cel, including advancements in automated manufacturing and expanding patient access.
- The company is actively enrolling its pivotal myositis trial with a planned 17-patient cohort, targeting a Biologics License Application (BLA) submission for rese-cel in myositis in 2027.
- An Investigational New Drug (IND) amendment was cleared for automated manufacturing of rese-cel using the Cellares platform, with clinical manufacturing data expected in 1H26 to confirm GMP readiness.
- Key clinical data readouts are anticipated in 1H26, including complete Phase 1/2 data for RESET-SLE, RESET-SSc, and RESET-MG, as well as new durability and higher dose initial clinical data from RESET-PV.
- The FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to rese-cel for systemic sclerosis, with registrational alignment updates for RESET-SSc and RESET-MG expected in 1H26 and mid-2026, respectively.
Jan 12, 2026, 1:02 PM
Cabaletta Bio Announces 2026 Strategic Priorities and Rese-cel Development Updates
CABA
New Projects/Investments
Product Launch
Guidance Update
- Cabaletta Bio announced its 2026 strategic priorities focused on the development and launch of rese-cel (resecabtagene autoleucel) for autoimmune diseases.
- The company is actively enrolling a registrational myositis trial with a planned 17-patient cohort, targeting a Biologics License Application (BLA) submission in 2027 for rese-cel in myositis.
- An Investigational New Drug (IND) amendment was cleared for automated manufacturing of rese-cel using the Cellares platform, with clinical manufacturing data expected in 1H26 to confirm GMP readiness.
- Key clinical data readouts are anticipated in 1H26 and 2026 for various trials, including durability data from RESET-PV and dose-ranging data from RESET-SLE without preconditioning, along with complete Phase 1/2 data for lupus, scleroderma, and myasthenia gravis.
- FDA alignment has been achieved for registrational study designs in systemic lupus erythematosus (SLE) and lupus nephritis (LN), and rese-cel received a Regenerative Medicine Advanced Therapy (RMAT) designation for systemic sclerosis.
Jan 12, 2026, 1:00 PM
Cabaletta Bio Receives IND Amendment Clearance for Rese-Cel Clinical Manufacturing
CABA
Product Launch
New Projects/Investments
- Cabaletta Bio has obtained FDA clearance of an IND Amendment to utilize Cellares’ automated Cell Shuttle™ and Cell Q™ platforms for the clinical manufacturing and quality control release testing of its investigational CAR T cell therapy, rese-cel.
- This milestone marks the first use of Cellares’ platforms to support an active clinical program, with first patient dosing anticipated in the first half of 2026.
- The collaboration aims to provide scalable, reliable, and operationally efficient manufacturing for rese-cel, which is being developed for autoimmune indications with large patient populations.
- Initial clinical data is expected in the first half of 2026 to inform GMP readiness, including supply chain logistics.
Jan 12, 2026, 12:30 PM
Cabaletta Therapeutics Provides Update on CABA-201 Development and Commercial Strategy
CABA
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- CABA-201 has demonstrated positive clinical data across multiple autoimmune diseases, including myositis, scleroderma, lupus, and pemphigus vulgaris, with the pivotal myositis program on track to initiate enrollment imminently.
- The therapy exhibits a favorable safety profile, with approximately one-third of patients developing Grade 1 CRS and a median onset of about seven days, which is anticipated to facilitate outpatient administration.
- Cabaletta plans to file its Biologics License Application (BLA) for CABA-201 in 2027, with a projected launch in either 2027 or 2028.
- The company is prioritizing manufacturing scalability through partnerships with Lonza and Cellares (for fully automated manufacturing) to ensure sufficient supply at launch and support a broad commercial footprint.
- CABA-201 is positioned as a compelling value proposition, offering durable efficacy after a single infusion compared to expensive annual therapies, and is expected to achieve healthy profit margins through outpatient reimbursement.
Dec 3, 2025, 6:45 PM
Cabaletta Bio Highlights CABA-201 Clinical Progress, Outpatient Potential, and Scalable Manufacturing Strategy
CABA
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Cabaletta Bio's CABA-201 has shown promising Phase 1/2 results in autoimmune diseases, with four out of four myositis patients reaching the primary endpoint at 16 weeks post-dosing, and a pivotal myositis program on track to initiate enrollment imminently. Early data also indicates positive outcomes in scleroderma and lupus.
- CABA-201 demonstrates a favorable safety profile with approximately one-third of patients developing Grade 1 Cytokine Release Syndrome (CRS), significantly lower than other CAR-T therapies, which supports the company's belief that its pivotal program is the only one where outpatient therapy is possible.
- To ensure supply at launch, Cabaletta is partnering with Lonza as a CDMO and has a strategic collaboration with Cellares for a fully automated, closed manufacturing system. Cabaletta will be the first company to file an IND using Cellares' system, aiming for scalability to "many, many thousands of patients independently".
- Key milestones for 2026 include the initiation of the myositis pivotal trial, FDA alignment on scleroderma and lupus by the end of 2025, and data from pemphigus and lupus programs without preconditioning.
Dec 3, 2025, 6:45 PM
Cabaletta Provides Update on Regulatory Alignment, Clinical Data, and Commercial Strategy for Autoimmune CAR-T
CABA
Product Launch
New Projects/Investments
Hiring
- Cabaletta confirmed FDA alignment in August for its 14-patient, single-arm pivotal trial in myositis, with minimal comments and no changes to the trial design or patient number.
- The company reported positive clinical data from its RESET program, with four out of four myositis patients meeting the primary endpoint at 16 weeks, and also presented data in scleroderma, lupus, and pemphigus.
- Chief Commercial Officer Steve Gavel detailed the attractive commercial model for autoimmune CAR-T, citing lower manufacturing out-of-spec rates and the potential for outpatient administration due to a favorable safety profile, which is expected to improve hospital reimbursement and patient access compared to oncology CAR-T.
- Cabaletta recently appointed Steve Gavel as Chief Commercial Officer, leveraging his 10-12 years of CAR-T experience, including the launch of CARVYKTI.
Dec 2, 2025, 1:20 PM
Cabaletta Provides Clinical and Commercial Strategy Update
CABA
New Projects/Investments
Hiring
Product Launch
- Cabaletta presented positive Phase 1-2 data from its RESET clinical trial program in myositis, with 4 out of 4 patients meeting the primary endpoint at 16 weeks, and confirmed FDA alignment in August for a 14-patient single-arm pivotal trial. The company also reported groundbreaking data in scleroderma and frequent remissions in lupus.
- The company highlighted an attractive commercial business model for autoimmune CAR-T, citing healthier patients, lower manufacturing out-of-spec rates, and a low CRS rate for its product, which facilitates outpatient treatment and a favorable ASP + 6% reimbursement for hospitals.
- Cabaletta recently appointed Steve Gabel as Chief Commercial Officer, who brings extensive CAR-T commercialization experience, including the launch of Carvykti.
Dec 2, 2025, 1:20 PM
Cabaletta Highlights Positive Clinical Data and Commercial Strategy for Autoimmune CAR-T
CABA
Product Launch
New Projects/Investments
Management Change
- Cabaletta presented positive data from its Phase 1-2 RESET clinical trial program at ACR, demonstrating safety, efficacy, and durability of autologous CAR-T in myositis, scleroderma, lupus, and pemphigus.
- The company has confirmed regulatory alignment with the FDA for a 14-patient, single-arm pivotal trial for myositis, with expectations for similar designs in lupus and scleroderma, reflecting a broader industry trend for autologous CAR-T in autoimmunity.
- Cabaletta recently appointed Steve Gabel as Chief Commercial Officer, who brings extensive CAR-T launch experience and highlights the attractive commercial model for autoimmune CAR-T due to healthier patients, lower manufacturing out-of-spec rates, and the potential for outpatient administration.
- The company's CAR-T therapy, rese-cel, exhibits a low CRS rate, enabling outpatient treatment which offers a financially viable reimbursement model (ASP + 6%) for hospitals and targets a younger patient demographic with private insurance.
Dec 2, 2025, 1:20 PM
Cabaletta Bio Outlines Regulatory Pathway and Commercial Strategy for Autoimmune CAR-T Program
CABA
Product Launch
New Projects/Investments
Guidance Update
- Cabaletta Bio expects to file its first Biologics License Application (BLA) in 2027 for myositis, based on an aligned registrational protocol involving 14 patients. The company also anticipates announcing FDA alignment for scleroderma and lupus/lupus nephritis by the end of 2025.
- The company positions its lead program, rese-cel, as a potential first-to-market, one-time curable therapy for myositis and scleroderma, targeting large patient populations of 80,000-90,000 each.
- Cabaletta Bio aims to establish a financially viable outpatient CAR-T model for autoimmune diseases, leveraging a "CAR-T light" toxicity profile and a more favorable reimbursement structure (ASP plus 6%) compared to inpatient oncology CAR-T treatments.
Nov 17, 2025, 1:30 PM
Cabaletta Bio Outlines 2027 BLA Filing for Myositis and Outpatient CAR-T Strategy
CABA
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Cabaletta Bio expects to file its first Biologics License Application (BLA) in 2027 for myositis, based on an FDA-aligned registrational protocol involving 14 patients. The company also anticipates announcing FDA alignment for scleroderma and lupus/lupus nephritis by the end of 2025.
- The company positions itself as a leader in the myositis and scleroderma markets, targeting an estimated 80,000-90,000 myositis patients with a potential one-time, functionally curable therapy.
- Cabaletta highlights its favorable safety profile and the ability to administer its autologous CAR-T product, rese-cel, in an outpatient setting, which is expected to offer a more viable reimbursement model for hospitals (ASP + 6%) and improve market adoption compared to traditional inpatient CAR-T therapies.
Nov 17, 2025, 1:30 PM
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