Cabaletta Bio (CABA) shares extended gains in recent premarket activity Friday after the company said it anticipates a 2027 biologics license application submission on a proposed registrational cohort design for a trial of resecabtagene autoleucel to treat myositis.
"Based on the minutes from our recent [Food and Drug Administration] meeting, we are proceeding with a registrational study design that includes two independent, subtype specific cohorts, each with approximately 15 patients and a primary endpoint within 26 weeks of rese-cel infusion," Chief Medical Officer David Chang said.
The company said the FDA granted regenerative medicine advanced therapy designation to rese-cel to treat myositis, a disabling, multi-system autoimmune disease.
Cabaletta also said it had cash and cash equivalents of $131.8 million as of March 31, expected to fund operating plan into H1 2026.
The company's shares closed 39% higher Thursday and were up 18% pre-bell Friday.
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