Brief: PledPharma: FDA Grants Rare Pediatric Disease Designation To Emcitate

Egetis Therapeutics AB (publ)

18/11/2020 14:04

Nov 18 (Reuters) - PledPharma AB (publ)  PLED.ST :
    * FDA GRANTS RARE PEDIATRIC DISEASE DESIGNATION TO EMCITATE®
    * US FOOD AND DRUG ADMINISTRATION HAS GRANTED COMPANY'S
APPLICATION FOR RARE PEDIATRIC DISEASE DESIGNATION FOR ITS LEAD
CANDIDATE EMCITATE® IN TREATMENT OF MCT8 DEFICIENCY
    * A SUCCESSFUL PHASE IIB TRIAL HAS BEEN COMPLETED AND A
PIVOTAL
STUDY IS EXPECTED TO START IN Q4 2020
    * EMCITATE HOLDS ORPHAN DRUG DESIGNATION (ODD) IN BOTH EU
AND US

Source: https://bit.ly/35H1Pep
Further company coverage:  PLED.ST 

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