05:59 AM EDT, 05/16/2025 (MT Newswires) -- 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.