Xeris Biopharma Holdings Inc

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Products, Regulatory

Xeris Pharmaceuticals Inc Says European Medicines Agency's CHMP Has Adopted Positive Opinion For Ogluo

Published: 12/11/2020 09:20 GMT
Xeris Biopharma Holdings Inc (XERS) - European Medicines Agency's Committee for Medicinal Products for Human Use Has Adopted Positive Opinion for Ogluo.
Final Decision on Marketing Authorization Application for Ogluo in European Union is Expected in Q1 of 2021.
If Ogluo is Approved, Company Could Launch Ogluo in Certain European Countries in Second Half of 2021.
Positive Chmp Opinion Based on Data From a Multi-center, Randomized Phase 3 Trial.
Xeris - Chmp Recommends Ogluo for Treatment of Severe Hypoglycaemia in Adults, Adolescents, Children Aged 2 Years and Over With Diabetes Mellitus.