Akebia Therapeutics up after FDA outlines plan to resubmit NDA for anemia treatment

Akebia Therapeutics

30/05/2023 13:58

**  Shares of drug developer Akebia Therapeutics Inc
 AKBA.O  surge 3.5% to $1.17 premarket
    ** Co says it received a letter from FDA outlining plan to
resubmit new drug application (NDA) without generating
additional clinical data for its anemia treatment vadadustat 
    ** Says it plans to request a Type A meeting as soon as
possible and then resubmit NDA for vadadustat in H2 
    ** FDA letter is in response to co's Formal Dispute
Resolution Request (FDRR) regarding the Complete Response Letter
(CRL) received in March 2022 for vadadustat
    ** Says FDA letter addressed issues outlined in the CRL and
highlighted information to be included in an NDA resubmission
    ** AKBA up about 95.8% YTD

 (Reporting by Vaibhav Sadhamta)
 ((Vaibhav.Sadhamta@thomsonreuters.com;))