Cabaletta Bio's Promising Clinical Data and Positive Trajectory Supports Buy Rating

Morgan Stanley analyst Michael Ulz maintained a Buy rating for Cabaletta Bio with a $22.00 price target. The positive rating is based on promising clinical data and ongoing progress in the company's rese-cel program for conditions such as myositis, lupus, and scleroderma. Ulz believes the company's safety profile and long-term growth potential support the Buy rating.

Cabaletta Bio (CABA) has presented encouraging clinical data for its investigational therapy, rese-cel (resecabtagene autoleucel), at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress. The data showcase strong efficacy across multiple autoimmune diseases, including myositis, systemic lupus erythematosus (SLE), and scleroderma. The company's progress in its RESET clinical program is notable, with 51 patients actively enrolled and 24 already dosed across various clinical sites.

In the clinical trials, 7 out of 8 myositis patients achieved clinically meaningful responses, and all non-nephropathy SLE patients reached remission while off immunomodulators and steroids. Both scleroderma patients demonstrated significant skin condition improvements. Safety data from 18 patients showed that 94% experienced either no or Grade 1 cytokine release syndrome (CRS), and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS).

The company is making strides towards registrational discussions with the FDA. These discussions are scheduled for SLE/LN in Q3 2025, scleroderma in Q4 2025, and myasthenia gravis in the first half of 2026. Morgan Stanley analyst Michael Ulz maintained a Buy rating for Cabaletta Bio with a $22.00 price target, citing the promising clinical data and ongoing progress in the company's rese-cel program.

The consistent efficacy across multiple autoimmune conditions indicates the potential for a platform therapy approach rather than a single-indication treatment, significantly expanding the drug's potential market and impact. However, the company faces significant regulatory risks, as successful interactions with the FDA and eventual clearance for registrational pathways are uncertain and dependent on future trial results.

References:
[1] https://www.stocktitan.net/news/CABA/cabaletta-bio-announces-new-rese-cel-safety-and-efficacy-data-in-p67eeqw1f6ta.html
[2] https://www.gurufocus.com/news/2920320/cabaletta-bio-announces-new-resecel-safety-and-efficacy-data-in-patients-with-myositis-lupus-and-scleroderma-to-be-presented-at-the-eular-2025-congress-caba-stock-news
[3] https://www.gurufocus.com/news/2920351/cabaletta-bio-caba-showcases-promising-resecel-data-at-eular-2025-caba-stock-news
[4] https://www.nasdaq.com/articles/cabaletta-bio-reports-promising-clinical-results-reset-trials-autoimmune-diseases-eular