Ardelyx IBS-C Candidate Succeeds in Pivotal Study, Stock Up

Ardelyx, Inc.ARDX announced meeting the primary endpoint in a second phase III study - T3MPO-2 - evaluating tenapanor in patients with irritable bowel syndrome with constipation (IBS-C). Based on the positive top-line data from this study as well as previously completed T3MPO-1 study, the company is planning to file a new drug application ("NDA") in the second half of 2018.

Ardelyx's stock surged more than 36% in after-market trading on Wednesday, following the announcement. However, shares of the company are down 62% so far this year, significantly underperforming the industry 's gain of 0.7% in the period.

Data from the T3MPO-2 study showed that the candidate achieved the primary endpoint and all secondary endpoint with statistical significance. The candidate reduced abdominal pain by 30% in greater number of patients compared to placebo (36.5% vs. 23.7%) and increased one or more complete spontaneous bowel movements (CSBM) in the same week for at least six weeks in the 12-week treatment period. The improvements were consistent over the 26 weeks of study.

In May, the company had announced positive data from the first phase III study (T3MPO-1) on tenapanor for the same indication. Meanwhile, another phase III study, T3MPO-3, is evaluating the candidate in this indication where patients are treated for up to one year. The study is expected to be complete by 2017. Data from this study will also be included in the NDA.

Ardelyx is currently focusing on finding a collaboration partner to expand its reach through successful commercialization.

The candidate is also being evaluated in a phase III study in hyperphosphatemia in patients who are suffering from end-stage renal disease and are on dialysis.

IBS-C is a gastrointestinal disorder in which patients suffer from significant abdominal pain and constipation. Ardelyx estimates 11 million patients with IBS-C in the United States.

However, there are other companies marketing or developing drugs for the treatment of IBS-C in the United States. Ironwood Pharmaceuticals, Inc. IRWD along with its partner Allergan plc AGN markets Linzess for IBS-C. Synergy Pharmaceuticals Inc.'s SGYP is developing its chronic idiopathic constipation drug Trulance for the treatment of IBS-C with an application for label expansion under review. A decision for Trulance is expected in January next year.

Ardelyx, Inc. Price and Consensus

Ardelyx, Inc. Price and Consensus | Ardelyx, Inc. Quote

Ardelyx carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Wall Street's Next Amazon

Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It's a once-in-a-generation opportunity to invest in pure genius.

Click for details >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Allergan PLC. (AGN): Free Stock Analysis Report

Ironwood Pharmaceuticals, Inc. (IRWD): Free Stock Analysis Report

Synergy Pharmaceuticals, Inc. (SGYP): Free Stock Analysis Report

Ardelyx, Inc. (ARDX): Free Stock Analysis Report

To read this article on click here.

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


Other Topics


Latest Markets Videos


Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

Learn More