Designation recognizes ISP-002, an engineered B cell therapy designed for sustained enzyme delivery SAN FRANCISCO, Jan. 26, 2026 /PRNewswire/ — Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ISP-002, the company’s investigational therapy for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The FDA grants RPD designation for serious or life-threatening diseases that primarily affect children 18 years old or younger and affect fewer than 200,000 people nationwide. RPD designation allows recipient companies, upon approval of their designated treatment, to be eligible for a Priority Review Voucher (PRV1), which may be used for priority review
AN2 aims to advance oral treatment option for patients currently reliant on complex, off-label IV therapies Led by nontuberculous mycobacteria (NTM) expert Dr. Kevin Winthrop , trial will focus on early-stage, treatment-naive patients, a key difference from AN2's previous studies in mycobacterium