Cabaletta Bio's Rese-Cel Shows 80% Pivotal Response in Myositis, Plans SSc Registrational Study
CABA has more than doubled off its 52-week low of $1.26.
Summary
Cabaletta Bio announced strong clinical data for its rese-cel therapy across multiple autoimmune indications. The RESET-Myositis trial showed an 80% pivotal response signal in dermatomyositis patients, with 83% achieving IM-free moderate-to-major TIS. Encouraging early preconditioning-free data was also reported for lupus, and a registrational study for systemic sclerosis (SSc) is planned for Q4 2026. This follows recent positive clinical data announcements for rese-cel in other indications and a highly dilutive $141 million financing that extended its cash runway to mid-2027. The 80% pivotal response signal in myositis is highly significant, suggesting a strong path towards regulatory approval for a severe autoimmune disease, which is critical for a company that recently issued a 'going concern' warning. Topline data for the DM/ASyS registrational cohort is expected mid-2027, and the SSc registrational study is planned to start in Q4 2026.
At the time of this announcement, CABA was trading at $3.83 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $600M. The 52-week trading range was $1.26 to $4.23. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Wiseek News.