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Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes
Globenewswire· 2025-05-15 16:10
Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).Positive opinion paves the way for potential marketing authorization in the EU and EEA.Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).In vivo data in murine models confirm pre ...