- Akebia Therapeutics ( NASDAQ: AKBA ) on Thursday said it had got a response from the U.S. Food and Drug Administration (FDA) to its appeal to the regulator's rejection of its treatment for anemia due to kidney disease.
- The micro-cap biopharma's shares hit a historic low earlier this year when the FDA sent it a so-called complete response letter for its marketing application for vadadustat.
- "Akebia met with the FDA in November to discuss its appeal and subsequently received a request for additional clarifying information from the Office of New Drugs, Center for Drug Evaluation and Research, which is deciding the appeal," the company said in a statement .
- AKBA expects to submit the requested additional information to the FDA in Jan. 2023.
- AKBA stock +1% to $0.42 in premarket trading.
For further details see:
Akebia Therapeutics to submit more information on kidney disease therapy to FDA