Brief: Akebia Therapeutics Completed Type A Meeting With The FDA
18/07/2023 12:55
July 18 (Reuters) - Akebia Therapeutics Inc AKBA.O :
* AKEBIA THERAPEUTICS COMPLETED TYPE A MEETING WITH THE FDA
AND
EXPECTS TO RESUBMIT VADADUSTAT NDA IN THIRD QUARTER 2023
* AKEBIA THERAPEUTICS INC - UPON ACCEPTANCE OF NDA, AKEBIA
EXPECTS
FDA TO SET A PDUFA DATE OF SIX MONTHS FROM DATE OF SUBMISSION
* AKEBIA THERAPEUTICS INC - EXPECTS TO RECEIVE FDA'S MEETING
MINUTES BY MID-AUGUST AND PLANS TO RESUBMIT ITS NDA FOR
VADADUSTAT BY END OF Q3 OF 2023
Source text for Eikon: ID:nPn769bVxa
Further company coverage: AKBA.O
((Reuters.Briefs@thomsonreuters.com;))
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