Cabaletta Bio reports Q4 EPS (65c), consensus (63c)

“We are looking forward to meeting with the FDA to align on registrational trial designs in myositis, which affects approximately 70,000 patients in the U.S., by leveraging our emerging clinical data and our efficient development strategy. Since presenting clinical and translational data from the RESET program demonstrating that a single weight-based dose of rese-cel was able to provide potentially transformative clinical responses after discontinuation of all immunosuppressants and while off or tapering off steroids, we have seen robust physician and patient interest in the RESET clinical program,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “In addition, we are advancing innovations that have the potential to enhance the patient and physician experience, including an apheresis-free approach and evaluation of a RESET-PV(TM) cohort with no preconditioning.”