Brief: Relief Therapeutics Announces Acer Therapeutics Says It Has Not Yet Received A Decision From U.S. FDA For New Drug Application For Acer-001

MindMaze Therapeutics Holding SA

08/06/2022 06:05

June 8 (Reuters) - RELIEF THERAPEUTICS HOLDING SA  RLFB.S :
    * RELIEF REPORTS THAT ITS COLLABORATION PARTNER, ACER
THERAPEUTICS, ISSUED A STATEMENT REGARDING THE PDUFA TARGET
ACTION DATE FOR ACER-001
    * ACER THERAPEUTICS, INC. ("ACER"), ANNOUNCED THAT IT HAS
NOT YET
RECEIVED A DECISION FROM U.S. FOOD AND DRUG ADMINISTRATION
("FDA") ON ITS 505(B)(2) NEW DRUG APPLICATION ("NDA") FOR
ACER-001 (SODIUM PHENYLBUTYRATE), FOR TREATMENT OF UREA CYCLE
DISORDERS ("UCDS")
    * NDA FOR ACER-001 FOR UCDS WAS ACCEPTED FOR REVIEW BY FDA
ON
OCTOBER 5, 2021, AT WHICH TIME FDA ASSIGNED A PDUFA TARGET
ACTION DATE OF SUNDAY, JUNE 5, 2022

Source text for Eikon:  ID:nEQ9wll0Ja 
Further company coverage:  RLFB.S 

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