Md Saiful Islam Khan/iStock via Getty Images Annexon ( NASDAQ: ANNX ) shares climbed ~26% premarket Tuesday after the company said its lead candidate ANX005 reached the primary endpoint in a Phase 3 trial for Guillain-Barré syndrome (GBS), a neurological disorder. Based on topline data from a trial conducted in Bangladesh and the Philippines, the Brisbane, California-based biotech said ANX005 at a 30 mg/kg dose led to a statistically significant 2.4-fold improvement in the GBS-disability scale over placebo, the study's primary goal.
While the 75 mg/kg dose tested in the study also outperformed placebo, its results were not statistically significant on the GBS-disability scale. Annexon ( ANNX ) said the experimental drug was well tolerated, and the study did not reveal any new safety signals. The company added that the high prevalence of the disease and poor access to standard of care prompted it to conduct the study in Bangladesh and the Philippines, even as GBS causes more than 22,000 annual hospitalizations in the U.
S. and Europe. Following the FDA feedback, the company has started a 2,000-patient real-world study for ANX005.
Its results and Annexon's ( ANNX ) planned BLA submission for the drug are expected in H2 2025. More on Annexon Biosciences Annexon: Unforced Error Sullies Prospects Biggest stock movers today: GME, HQY, and more Seeking Alpha’s Quant Rating on Annexon Biosciences Historical earnings data for Annexon Biosciences Financial information for Annexon Bi.
