CABALETTA BIO DL -,00001

PHILADELPHIA, May 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 the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 11:05 a.m. ET in New York, NY.» Mehr auf globenewswire.com

– Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – – RMAT designation granted for rese-cel in myositis, which is a disabling, multi-system autoimmune disease affecting approximately 80,000 U.S. patients with no approved treatments other than monthly IVIg – – 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 – – SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 – – 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 – PHILADELPHIA, May 15, 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 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). “Myositis is a severe, disabling, and potentially life-threatening multi-system disease that affects approximately 80,000 patients in the U.S. with a three-fold increased mortality risk primarily due to interstitial lung disease, cardiovascular disease and an increased risk of cancer.» Mehr auf globenewswire.com

– 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 presentations at the EULAR 2025 Congress in June – – Operational runway into 1H26 with cash and cash equivalents of $164.0 million as of December 31, 2024 – PHILADELPHIA, March 31, 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 reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “We are looking forward to meeting with the FDA to align on registrational trial designs in myositis, which affects approximately 70,000 patients in the U.S., by leveraging our emerging clinical data and our efficient development strategy.» Mehr auf globenewswire.com