Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Akebia's New Drug Application (NDA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under review for the treatment of anemia due to chronic kidney disease (CKD). The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.
Conference Call
Akebia will host a conference call Wednesday, March 30 at 6:00 p.m. Eastern Time to discuss the CRL and next steps.
To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 7961118. The call will also be webcast LIVE and can be accessed via the Investors section of Akebia's website at http://ir.akebia.com.
An online archive of the conference call can be accessed via the Investors section of Akebia's website at http://ir.akebia.com. A replay of the conference call will be available two hours after the completion of the call through April 6, 2022. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 7961118.
https://finance.yahoo.com/news/akebia-therapeutics-receives-complete-response-173300745.html
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