Brief: Theranexus And BBDF Obtain ODD And RPDD From FDA For BBDF-101 For Batten Disease
11/08/2020 17:27
Aug 11 (Reuters) - Theranexus SA ALTHX.PA :
* THERANEXUS AND BBDF OBTAIN ORPHAN DRUG DESIGNATION (ODD)
AND
RARE PEDIATRIC DISEASE DESIGNATION (RPDD) FROM THE FOOD AND DRUG
ADMINISTRATION (FDA) FOR BBDF-101 FOR BATTEN DISEASE
* PREPARING TO LAUNCH BBDF-101 PRECLINICAL TRIAL TO CONFIRM
PRECLINICAL SAFETY OF BBDF-101 OVER LONG EXPOSURE TIME, WITH AIM
OF SUPPLEMENTING DATA ALREADY AVAILABLE SO CLINICAL PROGRAM CAN
BE LAUNCHED IN 2021
Source text for Eikon: ID:nACT64699
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