FDA meeting to align on myositis registrational trial designs for rese-cel in 1H25 on track Enrolling approximately one patient per week across the RESET™ clinical development program since ACR Convergence presentation in November 2024 with 33 patients enrolled across 56 active clinical trial sites in the U.S. & Europe as of March 14, 2025 Clinical and translational data on rese-cel to be presented in three oral... Read More

Technology Adoption Program (TAP) program success demonstrates the ability of Cellares’ IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio’s clinical-stage CAR T program to treat patients with autoimmune diseases. SOUTH SAN FRANCISCO, Calif. / Mar 19, 2025 / Business Wire / Cellares , the first Integrated Development and Manufacturing Organization (IDMO), has concluded the Technology... Read More

PHILADELPHIA, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:50 a.m. ET in... Read More

Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off or tapering steroids as of the latest follow-up Safety profile continues to suggest favorable risk-benefit in the first 10 patients... Read More

Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off steroids as of the latest follow-up Safety profile continues to suggest favorable risk-benefit in the first 10 patients dosed; 90% of... Read More

PHILADELPHIA, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that updated clinical data on resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) will be featured in presentations at the 2025... Read More

PHILADELPHIA, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at Guggenheim’s SMID Cap Biotech Conference on Wednesday, February 5, 2025, at 10:30 a.m. ET in... Read More

Company plans to meet with the FDA to align on registrational trial designs in 1H25 based on emerging clinical profile of resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) and increased pace of enrollment with 44 active clinical trial sites Favorable safety profile observed across the first 10 patients dosed with rese-cel: 90% experienced either no CRS or grade 1 (fever) CRS and 90% experienced no ICANS;... Read More

PHILADELPHIA, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following investor conferences in December: 7th Annual Evercore HealthCONx Conference: Fireside chat on... Read More

CABA-201 safety profile suggests favorable risk-benefit with no CRS or ICANS in the majority of patients; low-grade CRS in three of eight patients and one previously reported ICANS event Compelling clinical responses observed in lupus and myositis patients with up to six months of follow-up; first SSc patient demonstrated an emerging, drug-free clinical response All eight patients with active, refractory autoimmune disease... Read More

Clinical data from the RESET-Myositis™ and RESET-SLE™ trials, along with initial clinical data from the RESET-SSc™ trial, to be presented this weekend in oral and poster presentations at ACR Convergence 2024 16 patients enrolled with 10 patients dosed as of November 12 across the RESET™ clinical development program; 40 U.S. clinical sites actively recruiting patients Data permitting, anticipate meeting with the FDA in 2025... Read More

PHILADELPHIA, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at Guggenheim's Inaugural Healthcare Innovation Conference on Monday, November 11, 2024, at... Read More

PHILADELPHIA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington... Read More

PHILADELPHIA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare Conference:... Read More

Nine patients enrolled as of August 5, 2024 across the RESET™ clinical development program, including four since EULAR in June, with 22 U.S. clinical sites now enrolling Additional clinical data from the RESET-Myositis™ and RESET-SLE™ trials as well as initial clinical data from the RESET-SSc™ and RESET-MG™ trials anticipated in 2H24 Initial clinical and translational data from each of the first patients in the... Read More

PHILADELPHIA, July 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Stifel 2024 Virtual Cell Therapy Forum on Tuesday,... Read More

No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 CABA-201 exhibited anticipated profile of CAR T cell expansion and contraction with complete B cell depletion observed in both patients by day 15 post-infusion Improvements in both patients’ specific disease measures, consistent with academic experience of a similar 4-1BB CD19-CAR T, suggest... Read More

PHILADELPHIA, May 29, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on... Read More

No CRS or ICANS of any grade observed during the 28-day DLT observation window for either of the first patients dosed with CABA-201 in the RESET-Myositis™ and RESET-SLE™ trials Initial clinical data from each of the first patients in the RESET-Myositis and RESET-SLE trials to be presented at a satellite symposium at the EULAR 2024 Congress in June Evaluating CABA-201 without preconditioning by initiation of the RESET-PV™... Read More

PHILADELPHIA, May 13, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ on Monday, May 20,... Read More

First patient dosed with CABA-201 in the RESET™ (REstoring SElf-Tolerance) clinical trial program Initial clinical data from each of the first patients in the RESET-Myositis™ and RESET-SLE™ trials anticipated in 1H24; longer term follow-up on these and additional patients to be reported in 2H24 RESET-SSc™ (systemic sclerosis) and RESET-MG™ trials initial clinical data anticipated to be reported in 2H24 Rare Pediatric Disease... Read More

PHILADELPHIA, March 20, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational... Read More

PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in two upcoming investor conferences in March: TD Cowen 44 th Annual Health Care Conference: Steven Nichtberger, M.D., Chief Executive... Read More

PHILADELPHIA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational... Read More

PHILADELPHIA, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 6 th Annual Biotechnology Conference on... Read More

Second and third FDA Fast Track Designations for CABA-201, following the systemic lupus erythematosus (SLE) and lupus nephritis (LN) designation, providing the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune diseases PHILADELPHIA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching... Read More

PHILADELPHIA, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 5:15 p.m. PT... Read More

PHILADELPHIA, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Wednesday, November 29,... Read More

Initial clinical data from CABA-201 treated patients in Phase 1/2 trials for lupus and/or myositis expected in the first half of 2024, with the first lupus clinical site actively recruiting patients Expanded CABA-201 clinical development program within rheumatology and into neurology with additional IND clearances in systemic sclerosis and generalized myasthenia gravis CABA-201 now being evaluated in four concurrent Phase... Read More

Collaboration with intent to validate Cellares’ Cell Shuttle platform for manufacturing of CABA-201, Cabaletta Bio’s fully human CD19-CAR T product candidate, which is being evaluated in parallel phase 1/2 trials across multiple autoimmune diseases SOUTH SAN FRANCISCO, Calif. / Nov 06, 2023 / Business Wire / Cellares , the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and... Read More

First cleared CD19-CAR T IND application for generalized myasthenia gravis announced in the U.S. and fourth IND clearance for CABA-201 across a broad range of autoimmune diseases Clearance expands the clinical development of CABA-201 beyond rheumatology into neurology Phase 1/2 clinical trial evaluating CABA-201 in generalized myasthenia gravis features parallel cohort design and a starting dose consistent with the... Read More

PHILADELPHIA, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in three upcoming investor conferences in November: Guggenheim 5th Annual Inflammation, Neurology, & Immunology Conference: Steven... Read More

Third IND application clearance for CABA-201 within the past 6 months across a broad range of autoimmune diseases Phase 1/2 clinical trial evaluating CABA-201 in systemic sclerosis features parallel cohort design and the same starting dose as the CABA-201 INDs for lupus and myositis Three-month clinical data in initial patients treated with CABA-201 from Phase 1/2 trials in lupus and/or myositis remain on track to be... Read More

PHILADELPHIA, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in two upcoming investor conferences in September: Jefferies Cell & Genetic Medicine Summit: Steven Nichtberger, M.D., Chief Executive... Read More

PHILADELPHIA, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in four upcoming investor conferences in September: 2023 Wells Fargo Healthcare Conference: Members of management will be available for... Read More

Agreement expansion facilitates preparation for commercial readiness for CABA-201, enabling treatment of patients in multiple planned clinical trials with separate parallel cohorts Partnership for CABA-201 builds on existing manufacturing agreement for clinical trial supply of MuSK-CAART for MusCAARTes™ trial PHILADELPHIA, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology... Read More

Received second IND application clearance for CABA-201 in myositis as well as Fast Track Designation in SLE and LN Strengthened balance sheet by closing $100M public offering extending cash runway into the fourth quarter of 2025 PHILADELPHIA, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell... Read More

Ms. Tomasello created and led global commercial and medical affairs functions at Kite Pharma from pre-launch through its acquisition by Gilead Sciences PHILADELPHIA, July 24, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced the appointment of... Read More

PHILADELPHIA, May 31, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present a company presentation at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 10:30 a.m.... Read More

PHILADELPHIA, May 22, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, announced today the closing of an underwritten public offering of 8,337,500 shares of its common stock, including the exercise in full by the underwriters of... Read More

PHILADELPHIA, May 17, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced the pricing of an underwritten public offering of 7,250,000 shares of its common stock at a public offering price of $12.00 per share.... Read More

PHILADELPHIA, May 17, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, announced today that it has commenced an underwritten public offering of its common stock. All of the shares are being offered by Cabaletta. In addition,... Read More

Phase 1/2 trial for CABA-201 planned to initiate in patients with myositis at an initial dose that is equivalent to the dose used in a patient with myositis as reported in the recent Lancet Rheumatology publication Second IND clearance for CABA-201, obtained within two months of first IND clearance in systemic lupus erythematosus (SLE) PHILADELPHIA, May 16, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a... Read More

IND application cleared within 30 days for clinical trial of CABA-201 in patients with LN and SLE and Fast Track Designation granted by the FDA for CABA-201 to deplete CD19-positive B cells and improve disease activity in patients with LN and SLE Phase 1/2 trial planned to evaluate CABA-201 in six patients with active LN and six patients with SLE without renal involvement in parallel cohorts at an initial dose of 1.0 x 10 6... Read More

PHILADELPHIA, May 02, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Samik Basu, M.D., Chief Scientific Officer at Cabaletta Bio, will deliver an invited, oral presentation titled “CD 19 CAR T-cells for SLE” as part of the session... Read More

PHILADELPHIA, May 01, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy,... Read More

PHILADELPHIA, April 25, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference at NASDAQ on Tuesday,... Read More

PHILADELPHIA, April 13, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present a company presentation at the 22nd Annual Needham Virtual Healthcare Conference on Thursday, April... Read More

IND application cleared within 6 months of in-licensing CABA-201 binder CABA-201 data package and experience from prior autoimmune cell therapy INDs informed Phase 1/2 clinical trial design, including the initial dose to be evaluated and the patient dosing intervals PHILADELPHIA, March 31, 2023 (GLOBE NEWSWIRE) - - Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching... Read More

Company expecting Investigational New Drug (IND) clearance in the first half of 2023 for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell therapy, with potential to generate initial clinical data by the first half of 2024 PHILADELPHIA, March 16, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell... Read More

PHILADELPHIA, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023 at... Read More

PHILADELPHIA, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present at the 41 st Annual J.P. Morgan Conference being held in San Francisco, CA on Thursday, January 12 th... Read More

PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that it has agreed to sell, by way of an underwritten public offering, pre-funded warrants, in lieu of common stock, to purchase 6,213,776... Read More