Brief: Theranexus And BBDF Win FDA Approval On Endpoints For Phase III Trial To Evaluate Batten-1 In CLN3 Batten Disease
09/05/2023 07:55
May 9 (Reuters) - Theranexus SA ALTHX.PA :
* THERANEXUS AND BEYOND BATTEN DISEASE FOUNDATION (BBDF),
HAVE
TODAY ANNOUNCED RECEIPT OF APPROVAL FROM FOOD AND DRUG
ADMINISTRATION (FDA)
* FDA CONFIRMS THAT A SOLE PHASE III TRIAL AS DEFINED ABOVE
WOULD
SECURE APPROVAL OF BATTEN-1 CANDIDATE IN BATTEN DISEASE
* COMPANY'S GOAL IS TO USE RESULTS OF THIS TRIAL TO WIN
PRODUCT
APPROVAL IN BOTH UNITED STATES AND EUROPE.
Source text for Eikon: urn:newsml:reuters.com:*:nACT79873
Further company coverage: ALTHX.PA
(Gdansk Newsroom)
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