FDA Grants Breakthrough Therapy Designation to…

SAN CARLOS, Calif.--September 23, 2026--Glycomine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to GLM101 for the treatment of phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), a serious, multisystem disorder with no approved treatments. GLM101 is an investigational liposomal mannose-1-phosphate substrate replacement therapy designed to address the underlying deficiency in mannose-1-phosphate and resulting disruption of glycosylation in PMM2-CDG. The designation is based on clinical evidence from Glycomine’s open-label Phase 2a study, including improvements in ataxia and other clinical measures after 24 weeks of GLM101 treatment.