Cabaletta Bio (CABA) surges 14.06% on clinical trial success, regulatory momentum

Cabaletta Bio (CABA) surged to its highest level since September 2025, with shares rising 9.17% intraday and climbing 14.06% over two days amid renewed investor optimism.

The stock’s rally follows encouraging clinical data from Cabaletta’s RESET trials for rese-cel, a CD19-CAR T cell therapy targeting autoimmune diseases. The trials showed 7 of 8 myositis patients achieved meaningful improvement off immunosuppressants, while all 7 systemic lupus erythematosus patients met remission criteria. Safety data also highlighted manageable side effects, with 94% of patients experiencing no or mild cytokine release syndrome. These results reinforce rese-cel’s potential as a first-in-class curative therapy.

Regulatory momentum has also fueled interest. The company plans to initiate pivotal trials for myositis in 2025 and has scheduled FDA discussions for lupus nephritis, scleroderma, and myasthenia gravis by early 2026. Enrollment in the RESET program has accelerated, with 51 patients enrolled across 65+ sites as of May 2025, underscoring strong clinical demand.

Analyst upgrades and institutional activity further support the stock’s trajectory. Multiple firms raised price targets in September 2025, and Cantor Fitzgerald significantly increased its stake in Q1 2025. Reduced short interest and upcoming investor conferences have also bolstered confidence, though risks remain tied to long-term safety monitoring and regulatory outcomes.

With rese-cel advancing through key trials and strategic partnerships strengthening its commercial potential, Cabaletta Bio’s near-term focus on regulatory milestones and trial data will likely remain a critical driver for its stock.