FDA grants Breakthrough Therapy designation to Glycomine’s GLM101 for PMM2-CDG treatment
Bitget2026/09/23 21:10- Glycomine won FDA Breakthrough Therapy designation for GLM101 in PMM2-CDG, a rare multisystem disorder with no approved treatments.
- Decision followed Phase 2a data showing improvements in ataxia and other clinical measures after 24 weeks of treatment.
- GLM101 is an investigational liposomal mannose-1-phosphate substrate replacement therapy targeting the underlying glycosylation defect.
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