What happened
Shares of Akebia Therapeutics (AKBA) were up more than 10% Tuesday after rising to as high as 13.1% in early trading. The biopharmaceutical company, which specializes in therapies to fight kidney disease, has seen its shares climb more than 168% so far this year.
So what
On Monday, the company announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) had granted marketing approval for Vafseo (vadadustat) to treat anemia connected with chronic kidney disease in adults on maintenance dialysis. The drug was already approved in April by the European Commission and in Japan in 2020.
That wasn't the only bit of good news for Akebia: The stock's rise has meant that it is no longer in danger of being delisted on the Nasdaq.
On Monday afternoon after the markets closed, the company said it had received a notice from the exchange saying it had regained compliance with the $1 minimum bid price. That decision came after the company appealed a May 9 notification from the Nasdaq, saying that the company wasn't in compliance. A hearing was scheduled before the Nasdaq Hearings Panel, but because the stock rose, allowing Akebia to become compliant, the hearing was canceled.
Now what
Akebia is hoping it can still get Vafseo approved in the U.S., and the approval in the U.K. may help the company's case. In March, the Food and Drug Administration (FDA) issued a complete response letter for the company's New Drug Application (NDA) for Vafseo, citing safety concerns. On May 8, Akebia said that it expects a response to formal dispute resolution regarding the NDA within 30 days.
In the first quarter, the company reported revenue of $40.1 million, down 35% year over year. It also reported a net loss of $26.2 million, a 58% improvement over the same period last year. Akebia said it had cash of $57 million, enough to finance operations for another 12 months.
