Tanruprubart (ANX005) - (FORWARD)

August 6, 2026: Annexon, Inc. (NASDAQ: ANNX) reported early data from the ongoing open-label FORWARD study of tanruprubart in Guillain-Barré syndrome (GBS). In the first 10 U.S. and European adult and pediatric patients, all showed rapid, clinically meaningful improvement in muscle strength within four days after a single 30 mg/kg infusion. Four patients who were bedbound walked with or without assistance between days 2 and 8; one patient requiring ventilation came off the ventilator within four days; and five others showed marked functional gains within 48 hours.

The company said tanruprubart was generally well tolerated, with the most common adverse events related to GBS or disease complications and consistent with Phase 3 results. The initial FORWARD cohort included patients ages 12 to 78 with moderate to severe disease. Annexon said these findings were consistent with prior Phase 3 results, in which about 90% of patients showed rapid, clinically meaningful improvement by day 8.

Catalysts: Annexon said FORWARD data will be presented at upcoming medical conferences and are intended to support a planned BLA submission in Q4 2026. Tanruprubart’s MAA is currently under review by the EMA.