Cabaletta Bio, Inc. Stock Price, News & Analysis

Cabaletta Bio (Nasdaq: CABA) appointed Steve Gavel as Chief Commercial Officer effective Oct 14, 2025, to lead global commercial strategy and execution for rese-cel (resecabtagene autoleucel) and future pipeline opportunities. The company anticipates a first BLA submission in myositis in 2027. Gavel previously led CAR T launch and commercialization at Legend Biotech (2018–2025) including CARVYKTI, and has prior roles at Celgene, Takeda and Johnson & Johnson.

On Oct 13, 2025 Cabaletta granted an inducement award of 275,000 non-qualified stock options at an exercise price of $2.49 (Nasdaq close Oct 13), 10-year term, vesting over four years under the 2025 Inducement Plan.

Cabaletta Bio (NASDAQ: CABA) presented initial data from the RESET-PV trial showing rese-cel administered at 1x10^6 cells/kg without preconditioning in three evaluable pemphigus vulgaris patients (data cut-off Sept 11, 2025).

Key findings: complete peripheral B cell depletion in 2 of 3 patients, CAR T expansion comparable to preconditioned trials, rapid reductions in desmoglein autoantibodies, meaningful PDAI score improvements (examples: 83→3 and 22→2), and no reported ICANS. All three patients remained off immunomodulators at cut-off.

Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, has announced its participation in four major investor conferences in September 2025.

The company will present at the Cantor Global Healthcare Conference (Sept 3), Wells Fargo Healthcare Conference (Sept 4), Morgan Stanley Global Healthcare Conference (Sept 10), and H.C. Wainwright Global Investment Conference (Sept 10). Webcasted fireside chats will be available on the company's website for 30 days.

Cabaletta Bio (Nasdaq: CABA) reported significant progress in Q2 2025, highlighting advancements in their rese-cel (resecabtagene autoleucel) development program. The company is on track to initiate registrational cohort enrollment for myositis treatment in 2H 2025, targeting a BLA submission in 2027.

Key developments include successful enrollment across five disease-specific cohorts from over 70 clinical sites, promising clinical data presented at EULAR 2025 Congress, and completion of a $100 million public offering extending cash runway into 2H 2026. The company reported Q2 2025 R&D expenses of $37.6 million and ended the quarter with $194.7 million in cash and equivalents.

Cabaletta Bio (NASDAQ: CABA), a clinical-stage biotech company focused on autoimmune disease cell therapies, has announced the pricing of a public offering. The offering consists of 39.2M shares of common stock and warrants, plus pre-funded warrants for 10.8M additional shares, with accompanying warrants for each. The common stock and warrant combination is priced at $2.00, while pre-funded warrants and accompanying warrants are priced at $1.99999. The warrants have a $2.50 exercise price and a 15-month expiration. Underwriters have a 30-day option to purchase up to 15M additional shares/warrants. The offering, expected to close around June 12, 2025, aims to raise approximately $100M in gross proceeds. Jefferies, TD Cowen, and Cantor are serving as joint book-running managers.

Cabaletta Bio (NASDAQ: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, has announced a public offering of common stock and warrants. The offering includes common stock shares, pre-funded warrants, and accompanying warrants to purchase common stock. The company will grant underwriters a 30-day option to purchase up to 15% additional shares and warrants. Jefferies, TD Cowen, and Cantor are serving as joint book-running managers. The offering is expected to close around June 12, 2025, subject to market conditions and customary closing requirements. The securities will be offered through a shelf registration statement on Form S-3 that was declared effective on March 31, 2025.

Cabaletta Bio (CABA) presented promising new clinical data for rese-cel (resecabtagene autoleucel) at EULAR 2025 Congress. The data showed strong efficacy across multiple autoimmune conditions: 7/8 myositis patients achieved meaningful responses, all SLE patients without nephropathy reached remission, and both scleroderma patients demonstrated significant skin improvements. Notably, these responses were achieved while patients discontinued immunomodulators and steroids. Safety data from 18 patients showed 94% had either no or Grade 1 CRS, and 89% had no ICANS. The company is advancing its RESET clinical program with 51 patients enrolled and 24 dosed across their network. Cabaletta plans registrational discussions with FDA for SLE/LN in Q3 2025, scleroderma in Q4 2025, and myasthenia gravis in 1H 2026.

Cabaletta Bio (NASDAQ: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, announced its participation in the upcoming Jefferies Global Healthcare Conference. The company will engage in a fireside chat on June 4, 2025, at 11:05 a.m. ET in New York. Investors and interested parties can access a live webcast of the presentation through Cabaletta's website, with replays available for 30 days following the event.

Cabaletta Bio (NASDAQ: CABA) has announced plans for a 2027 BLA submission for rese-cel in myositis following FDA alignment. The company received RMAT designation for rese-cel in treating myositis, a severe autoimmune disease affecting 80,000 U.S. patients. The RESET-Myositis trial will include two registrational cohorts of ~15 patients each: one for dermatomyositis/antisynthetase syndrome and another for immune-mediated necrotizing myopathy. The primary endpoint will use the total improvement score (TIS) within 26 weeks of rese-cel infusion. Currently, 44 patients are enrolled and 23 dosed across the RESET program. The company has $131.8M cash as of March 2025, funding operations into H1 2026. New clinical data will be presented at EULAR 2025 Congress in June.