FDA grants Breakthrough Therapy designation to Glycomine’s GLM101 for PMM2-CDG treatment

Bitget2026/09/23 21:10

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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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FDA grants Breakthrough Therapy designation to Glycomine’s GLM101 for PMM2-CDG treatment

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