Markets

Why Akebia Therapeutics' Shares Are Soaring 53% Today

Akebia Therapeutics President & CEO John Butler presenting at the American Kidney Fund

What: After reporting positive phase 2 trial results for its anemia drug, shares in Akebia Therapeutics jumped by 53% earlier today.

Akebia Therapeutics is developing vadadustat for the treatment of anemia in patients with chronic kidney disease receiving dialysis.

So what:

Anemia is common in these patients, and it's frequently treated with Epogen, an erythropoiesis-stimulating agent manufactured by Amgen .

In a 16-week phase 2 trial, Akebia Therapeutics patients that were converted from Epogen to vadadustat didn't see any drop-off in hemoglobin levels. Hemoglobin levels were similar across all three dosing options, including 300 mg daily, 450 mg daily, and 450 mg three times weekly. Importantly, there were no serious safety concerns associated with taking vadadustat.

Now what: Akebia Therapeutics plans to design and launch a phase 3 study soon, and if that study confirms earlier stage findings, then it could result in a needle-moving FDA approval.

That's because Epogen was a multibillion dollar blockbuster drug for Amgen prior to losing patent protection, and even though Epogen faces off against biosimilars overseas, it's still selling at an annualized $2 billion clip.

Vadadustat's oral dosing could give it an important advantage over Epogen, which is injected, but safety is actually the biggest reason why vadadustat could win away market share from Epogen. Epogen has been associated with increasing the risk of cardiac events and with shortening overall survival in certain cancer patients -- risks that haven't been seen in vadadustat's trials to date.

For that reason, I think that if Akebia Therapeutics skates through its final stage of trials, eases its way through regulators, and nets a favorable prescribing label, then investors could be smart for buying shares of the company now.

The next billion-dollar iSecret

The world's biggest tech company forgot to show you something at its recent event, but a few Wall Street analysts and the Fool didn't miss a beat: There's a small company that's powering their brand-new gadgets and the coming revolution in technology. And we think its stock price has nearly unlimited room to run for early in-the-know investors! To be one of them, just click here .

The article Why Akebia Therapeutics' Shares Are Soaring 53% Today originally appeared on Fool.com.

Todd Campbell has no position in any stocks mentioned. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .

Copyright © 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy .

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story

AKBA

Other Topics

Stocks

Latest Markets Videos

The Motley Fool

Founded in 1993 in Alexandria, VA., by brothers David and Tom Gardner, The Motley Fool is a multimedia financial-services company dedicated to building the world's greatest investment community. Reaching millions of people each month through its website, books, newspaper column, radio show, television appearances, and subscription newsletter services, The Motley Fool champions shareholder values and advocates tirelessly for the individual investor. The company's name was taken from Shakespeare, whose wise fools both instructed and amused, and could speak the truth to the king -- without getting their heads lopped off.

Learn More