Akebia Therapeutics Stock Slumps After FDA Meeting Ends Without Path Forward for Vafseo Label Expansion

• Vafseo is currently indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.
• The company said on Tuesday that it met with the U.S. Food and Drug Administration (FDA) but did not come to an agreement on a path forward for the design of a clinical trial in patients with late-stage chronic kidney disease not on dialysis. 
• Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed.
   

Shares of Akebia Therapeutics (AKBA) slumped 24% on Wednesday morning after the company said that it does not expect to pursue a broad label for Vafseo for the treatment of anemia in patients with late-stage chronic kidney disease not on dialysis.

The company said on Tuesday that it met with the U.S. Food and Drug Administration (FDA) but did not come to an agreement on a path forward for the design of a clinical trial for the use of the drug in the said patient population.

While the company is yet to receive the final minutes of the meeting with the FDA, Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed. This, in turn, would require “meaningfully more” time and cost to complete, and the company does not plan to initiate the trial, the company said.

What Did The CEO Say?

CEO John P. Butler said that the company is “disappointed” in the meeting outcome.

“We believe our decision not to pursue a broad NDD-CKD label, based on our discussion with the FDA, is in the best interests of our shareholders. We were encouraged by the discussion with FDA on smaller subgroups of CKD patients where we may be able to align on a potential clinical trial design and path forward,” he added.

Vafseo is currently indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. In the second quarter ended June, the company reported Vafseo net product revenue of $13.3 million after nephrologists began prescribing it in January.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around AKBA stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.

A Stocktwits user expressed optimism for the stock, saying the FDA did not shut the door on the trial in its entirety.

Another highlighted that the company’s product is already on the market, and it has good financials.

AKBA stock is up by 23% this year and by 37% over the past 12 months. 

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