Cabaletta Bio reports Q2 EPS (73c), consensus (61c)

“We achieved significant progress advancing rese-cel in the first half of 2025, including aligning with the FDA on a registrational pathway for rese-cel in myositis to support an anticipated 2027 first BLA submission. We also presented new data that reinforce the therapeutic potential of rese-cel across several autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “As our early clinical data are emerging, enrollment in dermatomyositis, scleroderma and myasthenia gravis has been particularly robust. We look forward to building on this momentum by initiating the myositis registrational program, obtaining regulatory alignment on registrational pathways for two additional indications this year and presenting new clinical data at multiple scientific meetings in the second half of 2025, including complete Phase 1/2 data from RESET-Myositis as well as initial clinical data from RESET-PV evaluating rese-cel without pre-conditioning.”