Cabaletta Bio, Inc. announced its strategic priorities for 2026, focusing on enrolling the pivotal myositis trial and advancing innovations in cell therapies for autoimmune diseases.
The company aims to submit a BLA for rese-cel in 2027, including an outpatient dosing option with a single weight-based dose.
Key initiatives include initiating the myositis registrational cohort and aligning with the FDA on new cohort designs for SLE and LN.
Enrollment Focus
Prioritizing enrollment in the myositis trial to support the planned BLA submission for rese-cel next year.
FDA Alignment
Aligned with the FDA on new registrational cohort designs for SLE and LN, evaluating the current dose of 1 million cells/kg in a single infusion.
RMAT Designation
Received RMAT designation for rese-cel in systemic sclerosis, with further cohort alignments and initiations expected in 2026.
- The strategic priorities outlined by Cabaletta Bio aim to drive advancements in cell therapies for autoimmune diseases, potentially offering more accessible and effective treatment options for patients in need.
- The company's focus on enrollment and FDA alignment indicates a commitment to regulatory compliance and continued progress in their clinical development programs.
Cabaletta Bio's emphasis on innovative treatments and strategic enrollment efforts signifies a commitment to advancing cell therapies for autoimmune diseases. Their proactive engagement with regulatory bodies and focus on scalability through automated manufacturing are key aspects driving their growth and impact in the industry.