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Ardelyx

Ardelyx Inc is a biotechnology company focused on the discovery, development, and commercialization of innovative, first-in-class medicines that meet significant unmet medical needs. The company has a proprietary drug discovery and design platform. Its lead product candidate is tenapanor, which aims to reduce the absorption of dietary sodium and phosphorus for the treatment of kidney disease, irritable bowel syndrome with constipation, and hyperphosphatemia in patients with dialysis.

Ardelyx Inc

ArdCoin

Ardelyx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) reported its third-quarter results after Thursday's closing bell. Here's a look at the details <a href="https://www.benzinga.com/pressreleases/24/10/g41663791/ardelyx-reports-third-quarter-2024-financial-results-and-provides-business-update">from the report.&nbsp;&nbsp;</a>
The Details: Ardelyx reported quarterly sales of $98.24 million, which beat the analyst consensus estimate of $86.64 million.&nbsp;
The company reported IBSRELA generated $40.6 million in net product sales revenue and the company expects full-year 2024 IBSRELA net sales revenue to be between $145 million and $150 million.&nbsp;
XPHOZAH generates $51.5 million in net product sales revenue and Ardelyx ended the quarter with approximately $190 million in cash, cash equivalents and investments. 
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&#8220;The continued strong performance of Ardelyx reported during the third quarter demonstrates our ability to execute and deliver on our goals, to focus on serving the patient and to build towards the future,&#8221; said Mike Raab, president and CEO of Ardelyx.
ARDX Price Action: According to <a href="https://pro.benzinga.com/?gspk=YWRhbWVja2VydDUzMzY&amp;gsxid=zBMR4PKmcgBw">Benzinga Pro</a>, Ardelyx shares are up 3.07% after-hours at $6.05 at the time of publication Thursday.
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Photo: HeungSoon from Pixabay

Earnings

News

Health Care

Movers

ARDX

Ardelyx Beats Q3 Sales Estimates, Shares Climb

<h3>Gainers</h3>
<ul>
<li>Athira Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATHA#NASDAQ">ATHA</a>) stock rose 28.5% to $0.55 during Thursday's after-market session. The market value of their outstanding shares is at $21.0 million. </li>
<li>Theriva Biologics (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/TOVX#AMEX">TOVX</a>) shares increased by 28.08% to $1.87. The company's market cap stands at $2.5 million. </li>
<li>Pro-Dex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PDEX#NASDAQ">PDEX</a>) shares increased by 19.69% to $37.13. The market value of their outstanding shares is at $124.6 million. </li>
<li>ChromaDex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDXC#NASDAQ">CDXC</a>) stock increased by 18.62% to $4.14. The market value of their outstanding shares is at $314.3 million. As per the news, the Q3 earnings report came out today. </li>
<li>Halozyme Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HALO#NASDAQ">HALO</a>) stock moved upwards by 7.7% to $54.49. The company's market cap stands at $6.9 billion. The company's, Q3 earnings came out today. </li>
<li>Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) shares rose 7.49% to $6.31. The company's market cap stands at $1.4 billion. The company's, Q3 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Biofrontera (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BFRI#NASDAQ">BFRI</a>) stock decreased by 10.6% to $1.1 during Thursday's after-market session. The company's market cap stands at $6.0 million. </li>
<li>BioRestorative Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BRTX#NASDAQ">BRTX</a>) stock decreased by 5.74% to $1.47. The market value of their outstanding shares is at $10.1 million. </li>
<li>Palisade Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PALI#NASDAQ">PALI</a>) stock decreased by 5.52% to $2.57. The company's market cap stands at $3.0 million. </li>
<li>Innovative Eyewear (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LUCY#NASDAQ">LUCY</a>) shares fell 5.49% to $7.75. The company's market cap stands at $18.6 million. </li>
<li>Ocean Biomedical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCEA#NASDAQ">OCEA</a>) shares fell 5.23% to $0.83. The company's market cap stands at $28.8 million. </li>
<li>Trinity Biotech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRIB#NASDAQ">TRIB</a>) stock decreased by 5.12% to $1.67. The market value of their outstanding shares is at $15.8 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

ATHA

BFRI

BRTX

CDXC

HALO

LUCY

OCEA

PALI

PDEX

TOVX

TRIB

12 Health Care Stocks Moving In Thursday's After-Market Session

Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) reported quarterly sales of $98.24 million which beat the analyst consensus estimate of $86.64 million by 13.39 percent. This is a 74.21 percent increase over sales of $56.39 million the same period last year.

Earnings Beats

Ardelyx Q3 Sales $98.24M Beat $86.64M Estimate

Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) is preparing to release its quarterly earnings on Thursday, 2024-10-31. Here's a brief overview of what investors should keep in mind before the announcement.
Analysts expect Ardelyx to report an earnings per share (EPS) of $-0.05.
Anticipation surrounds Ardelyx's announcement, with investors hoping to hear about both surpassing estimates and receiving positive guidance for the next quarter.
New investors should understand that while earnings performance is important, market reactions are often driven by guidance.
<h3>Performance in Previous Earnings</h3>
The company's EPS beat by $0.04 in the last quarter, leading to a 10.0% increase in the share price on the following day.
Here's a look at Ardelyx's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.11</td>
<td>-0.15</td>
<td>-0.09</td>
<td>-0.11</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.07</td>
<td>-0.11</td>
<td>-0.12</td>
<td>0.03</td>
</tr>
<tr>
<td>Price Change %</td>
<td>10.0%</td>
<td>28.000000000000004%</td>
<td>-2.0%</td>
<td>-0.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1730311460_0.png" alt="eps graph" />
<h3>Analyst Opinions on Ardelyx</h3>
For investors, staying informed about market sentiments and expectations in the industry is paramount. This analysis provides an exploration of the latest insights on Ardelyx.
With 3 analyst ratings, Ardelyx has a consensus rating of Buy. The average one-year price target is $11.33, indicating a potential 88.52% upside.
<h3>Comparing Ratings with Peers</h3>
This comparison focuses on the analyst ratings and average 1-year price targets of Travere Therapeutics and Dynavax Technologies, three major players in the industry, shedding light on their relative performance expectations and market positioning.
<ul>
<li>The consensus among analysts is an Buy trajectory for Travere Therapeutics, with an average 1-year price target of $22.17, indicating a potential 268.89% upside.</li>
<li>The consensus among analysts is an Buy trajectory for Dynavax Technologies, with an average 1-year price target of $24.33, indicating a potential 304.83% upside.</li>
</ul>
<h3>Insights: Peer Analysis</h3>
The peer analysis summary offers a detailed examination of key metrics for Travere Therapeutics and Dynavax Technologies, providing valuable insights into their respective standings within the industry and their market positions and comparative performance.

<table>
<thead>
<tr>
<th>Company</th>
<th>Consensus</th>
<th>Revenue Growth</th>
<th>Gross Profit</th>
<th>Return on Equity</th>
</tr>
</thead>
<tbody>
<tr>
<td>Ardelyx</td>
<td>Buy</td>
<td>227.86%</td>
<td>$63.79M</td>
<td>-11.05%</td>
</tr>
<tr>
<td>Travere Therapeutics</td>
<td>Buy</td>
<td>68.08%</td>
<td>$52.05M</td>
<td>-157.84%</td>
</tr>
<tr>
<td>Dynavax Technologies</td>
<td>Buy</td>
<td>22.48%</td>
<td>$61.81M</td>
<td>1.81%</td>
</tr>
</tbody>
</table>

Key Takeaway:
Ardelyx ranks highest in Revenue Growth among its peers. It has the lowest Gross Profit margin. Ardelyx has the lowest Return on Equity compared to its peers.
<h3>About Ardelyx</h3>
Ardelyx Inc is a biotechnology company focused on the discovery, development, and commercialization of innovative, first-in-class medicines that meet significant unmet medical needs. The company has a proprietary drug discovery and design platform. Its lead product candidate is tenapanor, which aims to reduce the absorption of dietary sodium and phosphorus for the treatment of kidney disease, irritable bowel syndrome with constipation, and hyperphosphatemia in patients with dialysis.
<h3>Unraveling the Financial Story of Ardelyx</h3>
Market Capitalization Analysis: The company's market capitalization is below the industry average, suggesting that it is relatively smaller compared to peers. This could be due to various factors, including perceived growth potential or operational scale.
Revenue Growth: Ardelyx's revenue growth over a period of 3 months has been noteworthy. As of 30 June, 2024, the company achieved a revenue growth rate of approximately 227.86%. This indicates a substantial increase in the company's top-line earnings. As compared to its peers, the revenue growth lags behind its industry peers. The company achieved a growth rate lower than the average among peers in Health Care sector.
Net Margin: The company's net margin is a standout performer, exceeding industry averages. With an impressive net margin of -22.47%, the company showcases strong profitability and effective cost control.
Return on Equity (ROE): Ardelyx's ROE excels beyond industry benchmarks, reaching -11.05%. This signifies robust financial management and efficient use of shareholder equity capital.
Return on Assets (ROA): Ardelyx's ROA excels beyond industry benchmarks, reaching -4.8%. This signifies efficient management of assets and strong financial health.
Debt Management: With a below-average debt-to-equity ratio of 0.71, Ardelyx adopts a prudent financial strategy, indicating a balanced approach to debt management.
<a href="https://www.benzinga.com/quote/ARDX/earnings">To track all earnings releases for Ardelyx visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Ardelyx's Earnings Outlook

Ardelyx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that data supporting additional positive clinical observations of XPHOZAH&#xAE; (tenapanor) was presented in a series of poster presentations at the American Society of Nephrology's (ASN) Kidney Week, currently taking place in San Diego. Ardelyx is also hosting an Exhibitor Spotlight discussing hyperphosphatemia management.
XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.

Biotech

General

Ardelyx Shares Additional Data Supporting First-In-Class XPHOZAH At The American Society Of Nephrology's Kidney Week

Ardelyx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that additional data supporting XPHOZAH&#xAE; (tenapanor) will be presented at the American Society of Nephrology's (ASN) Kidney Week, to be held October 24-27, 2024, in San Diego. &nbsp;
XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.

Ardelyx To Present Additional Data Supporting First-In-Class XPHOZAH For Adults With Chronic Kidney Disease On Dialysis At The American Society Of Nephrology's Kidney Week

Ardelyx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the recent publication of a review article, titled "Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome With Constipation in the United States" in Clinical and Experimental Gastroenterology, an international, peer reviewed, open access journal focusing on all aspects of gastroenterology research, as well as clinical results in human, animal and in vitro studies that shed light on disease processes and potential new therapies. &nbsp;
The article provides an overview of treatment options and disease management for irritable bowel syndrome with constipation (IBS-C) from a U.S. perspective and discusses the importance of the relationship between patient and health care provider in diagnosis and treatment. It recommends a positive diagnostic strategy for IBS-C, based on clinical history, physical examination, and minimal laboratory tests.

Ardelyx Announces Publication Of A Review Article Exploring 'The Patient Burden And Therapeutic Landscape Of IBS-C In The U.S.' In Clinical And Experimental Gastroenterology

HC Wainwright &amp; Co. analyst Ed Arce maintains Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) with a Buy and raises the price target from $10 to $11.

Price Target

Analyst Ratings

HC Wainwright & Co. Maintains Buy on Ardelyx, Raises Price Target to $11

Citigroup analyst Yigal Nochomovitz maintains Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) with a Buy and raises the price target from $10 to $12.

Citigroup Maintains Buy on Ardelyx, Raises Price Target to $12

In the latest quarter, 6 analysts provided ratings for Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>), showcasing a mix of bullish and bearish perspectives.
The following table provides a quick overview of their recent ratings, highlighting the changing sentiments over the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th style="text-align: right;">Bullish</th>
<th style="text-align: right;">Somewhat Bullish</th>
<th style="text-align: right;">Indifferent</th>
<th style="text-align: right;">Somewhat Bearish</th>
<th style="text-align: right;">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">4</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
</tbody>
</table>
Providing deeper insights, analysts have established 12-month price targets, indicating an average target of $12.0, along with a high estimate of $15.00 and a low estimate of $10.00. Experiencing a 9.09% decline, the current average is now lower than the previous average price target of $13.20. 
<img src="https://www.benzinga.com/files/images/story/2024/1722610886_0.png" alt="price target chart" />
<h2>Understanding Analyst Ratings: A Comprehensive Breakdown</h2>
A clear picture of Ardelyx's perception among financial experts is painted with a thorough analysis of recent analyst actions. The summary below outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Laura Chico</td>
<td>Wedbush</td>
<td>Maintains</td>
<td>Outperform</td>
<td>$11.00</td>
<td>$11.00</td>
</tr>
<tr>
<td>Ed Arce</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$10.00</td>
<td>-</td>
</tr>
<tr>
<td>Laura Chico</td>
<td>Wedbush</td>
<td>Maintains</td>
<td>Outperform</td>
<td>$11.00</td>
<td>$11.00</td>
</tr>
<tr>
<td>Yigal Nochomovitz</td>
<td>Citigroup</td>
<td>Lowers</td>
<td>Buy</td>
<td>$10.00</td>
<td>$14.00</td>
</tr>
<tr>
<td>Laura Chico</td>
<td>Wedbush</td>
<td>Maintains</td>
<td>Outperform</td>
<td>$15.00</td>
<td>$15.00</td>
</tr>
<tr>
<td>Christopher Raymond</td>
<td>Piper Sandler</td>
<td>Maintains</td>
<td>Overweight</td>
<td>$15.00</td>
<td>$15.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts respond to changes in market conditions and company performance, frequently updating their recommendations. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to Ardelyx. This information offers a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Analysts assign qualitative assessments to stocks, ranging from 'Outperform' to 'Underperform'. These ratings convey the analysts' expectations for the relative performance of Ardelyx compared to the broader market.</li>
<li>Price Targets: Analysts gauge the dynamics of price targets, providing estimates for the future value of Ardelyx's stock. This comparison reveals trends in analysts' expectations over time.</li>
</ul>
For valuable insights into Ardelyx's market performance, consider these analyst evaluations alongside crucial financial indicators. Stay well-informed and make prudent decisions using our Ratings Table.
<a href="https://www.benzinga.com/quote/ARDX/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Ardelyx analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>Get to Know Ardelyx Better</h2>
Ardelyx Inc is a biotechnology company focused on the discovery, development, and commercialization of innovative, first-in-class medicines that meet significant unmet medical needs. The company has a proprietary drug discovery and design platform. Its lead product candidate is tenapanor, which aims to reduce the absorption of dietary sodium and phosphorus for the treatment of kidney disease, irritable bowel syndrome with constipation, and hyperphosphatemia in patients with dialysis.
<h3>A Deep Dive into Ardelyx's Financials</h3>
Market Capitalization: Indicating a reduced size compared to industry averages, the company's market capitalization poses unique challenges.
Revenue Growth: Ardelyx displayed positive results in 3 months. As of 31 March, 2024, the company achieved a solid revenue growth rate of approximately 304.81%. This indicates a notable increase in the company's top-line earnings. As compared to its peers, the company achieved a growth rate higher than the average among peers in Health Care sector.
Net Margin: Ardelyx's net margin surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive -57.62% net margin, the company effectively manages costs and achieves strong profitability.
Return on Equity (ROE): The company's ROE is below industry benchmarks, signaling potential difficulties in efficiently using equity capital. With an ROE of -16.69%, the company may need to address challenges in generating satisfactory returns for shareholders.
Return on Assets (ROA): The company's ROA is below industry benchmarks, signaling potential difficulties in efficiently utilizing assets. With an ROA of -8.29%, the company may need to address challenges in generating satisfactory returns from its assets.
Debt Management: With a high debt-to-equity ratio of 0.7, Ardelyx faces challenges in effectively managing its debt levels, indicating potential financial strain.
<h2>The Significance of Analyst Ratings Explained</h2>
Within the domain of banking and financial systems, analysts specialize in reporting for specific stocks or defined sectors. Their work involves attending company conference calls and meetings, researching company financial statements, and communicating with insiders to publish "analyst ratings" for stocks. Analysts typically assess and rate each stock once per quarter.
Analysts may enhance their evaluations by incorporating forecasts for metrics like growth estimates, earnings, and revenue, delivering additional guidance to investors. It is vital to acknowledge that, although experts in stocks and sectors, analysts are human and express their opinions when providing insights.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

What 6 Analyst Ratings Have To Say About Ardelyx

Wedbush analyst Laura Chico reiterates Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) with a Outperform and maintains $11 price target.

Reiteration

Wedbush Reiterates Outperform on Ardelyx, Maintains $11 Price Target

WIIM

Ardelyx shares are trading higher after the company reported better-than-expected Q2 financial results.

Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) reported quarterly losses of $(0.07) per share which beat the analyst consensus estimate of $(0.10) by 30 percent. This is a 12.5 percent increase over losses of $(0.08) per share from the same period last year. The company reported quarterly sales of $73.222 million which beat the analyst consensus estimate of $55.019 million by 33.09 percent. This is a 227.86 percent increase over sales of $22.333 million the same period last year.

Ardelyx Q2 2024 GAAP EPS $(0.07) Beats $(0.10) Estimate, Sales $73.222M Beat $55.019M Estimate

Ardelyx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the publication of plain language summaries of results from two clinical trials on XPHOZAH&#xAE; (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult patients with chronic kidney disease receiving dialysis, and their family members and caregivers, better understand some of the safety and efficacy data related to XPHOZAH. &nbsp;
XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action, blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.

Ardelyx Announces Publication Of Two Plain Language Summaries From XPHOZAH Clinical Trials In Current Medical Research And Opinion

HC Wainwright &amp; Co. analyst Ed Arce reiterates Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) with a Buy and maintains $10 price target.

HC Wainwright & Co. Reiterates Buy on Ardelyx, Maintains $10 Price Target

Drugmaker Ardelyx Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) has reportedly taken legal action against the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) regarding their decision to incorporate its kidney disease treatment drug, Xphozah, into the <a target="_blank" href="https://www.benzinga.com/news/24/07/39600079/why-ardelyx-stock-is-dropping" rel="noreferrer noopener">Medicare payment bundle system</a>.
The lawsuit contends that including Xphozah and other oral-only phosphate-lowering therapies in the End-Stage Renal Disease Prospective Payment System (ESRD PPS) will severely limit patient access and choice of crucial medications.
Ardelyx argues that such medications, including Xphozah, are not administered during dialysis sessions and cannot feasibly be provided by dialysis facilities.
The ESRD PPS is designed to reimburse facilities offering renal dialysis services, a critical component in managing end-stage renal disease.
In October 2023, the FDA approved Xphozah (tenapanor). It&#8217;s the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have inadequate response to phosphate binders or who are intolerant of any dose of <a href="https://www.benzinga.com/general/biotech/23/10/35304129/after-initial-rejection-fda-approves-ardelyxs-kidney-disease-related-drug" target="_blank" rel="noreferrer noopener">phosphate binder therapy</a>. 
Xphozah is a single tablet taken twice daily that blocks phosphate absorption through its primary pathway.
In 2021, the FDA <a href="https://www.benzinga.com/general/biotech/21/07/22243047/ardelyxs-tenapanor-application-for-chronic-kidney-disease-receives-fda-response-letter" target="_blank" rel="noreferrer noopener">declined approval</a> for Xphozah (tenapanor). It noted the magnitude of the treatment effect as &#8220;small and of unclear clinical significance.&#8221; 
However, the CMS&#8217;s recent regulatory update aims to include oral-only ESRD drugs and therapies in the bundled payment system starting January 1, 2025.
Reuters highlights that the move threatens timely access to essential medications for patients who rely on these therapies outside the dialysis setting.
Ardelyx&#8217;s lawsuit underscores broader concerns within the pharmaceutical industry regarding regulatory decisions that impact drug accessibility and patient care standards.
Price Action: ARDX stock is down 2% at $5.64 at last check Thursday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Government

Regulations

Legal

Ardelyx Files Lawsuit Over Medicare Drug Payment Rules, Claims It Will Limit Patient Access To Kidney Disease Treatment

Citigroup analyst Yigal Nochomovitz maintains Ardelyx (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) with a Buy and lowers the price target from $14 to $10.

Citigroup Maintains Buy on Ardelyx, Lowers Price Target to $10

Ardelyx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARDX#NASDAQ">ARDX</a>) shares are trading lower Tuesday after the company announced it has chosen not to apply to include XPHOZAH in the Centers for Medicare &amp; Medicaid Services End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)<a href="https://www.benzinga.com/pressreleases/24/07/g39591851/to-preserve-patient-access-to-xphozah-ardelyx-chooses-not-to-file-for-tdapa"> Transitional Drug Add-on Payment Adjustment.</a>
The Details:
Ardelyx said its analysis of the CMS policy to include oral-only medicines in the PPS and the calendar year 2025 ESRD PPS Proposed Rule released on June 27, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients.
Read Next: <a href="https://www.benzinga.com/news/24/07/39585976/lawsuit-against-keith-gill-voluntarily-dismissed-whats-going-on-with-gamestop-stock">Lawsuit Against Keith Gill Voluntarily Dismissed: What&#8217;s Going On With GameStop Stock?</a>
"We have carefully and thoughtfully considered the potential impact of CMS&#8217;s decision to add XPHOZAH into the Medicare PPS and have determined that even during the TDAPA period, the restrictions placed on XPHOZAH would be such that patient access to this novel therapy would be effectively eliminated for all patients. We believe that the proposed bipartisan legislation extending the exclusion of oral-only medications from the Medicare ESRD PPS is the best option to ensure continued patient access, and we call on Congress to pass the bill," commented Mike Raab, president and CEO of Ardelyx.
Last week, Ardelyx <a href="https://www.benzinga.com/pressreleases/24/06/g39546659/ardelyx-presents-additional-data-detailing-educational-needs-related-to-ibs-c-management-across-he">presented data</a> detailing educational needs related to irritable bowel syndrome with constipation (IBS-C) across healthcare disciplines. The data revealed differences between nurse practitioners (NPs)/physician assistants (PAs) and physicians, in their choice of IBS-C diagnostic criteria and testing methodologies, tendency to refer patients to specialists and approach to assessing pain levels.&nbsp;
<h2 class="wp-block-heading">Will ARDX Stock Go Up?</h2>
When trying to assess whether or not Ardelyx will trade higher from current levels, it's a good idea to take a look at analyst forecasts. 
Wall Street analysts have an average 12-month price target of $14.50 on Ardelyx. The Street high target is currently at $15 and the Street low target is $14. Of all the analysts covering Ardelyx, 6 have positive ratings, no one has neutral ratings and no one has negative ratings.
In the last month, one analyst has adjusted price targets. Here's a look at recent price target changes <a href="https://www.benzinga.com/quote/ARDX/analyst-ratings">[Analyst Ratings]</a>. Benzinga also tracks Wall Street's most accurate analysts. Check out how analysts covering Ardelyx have performed in recent history. 
Stocks don't move in a straight line. The average stock market return is approximately 10% per year. Ardelyx is 82.97% up year-to-date. The average analyst price target suggests the stock could have further upside ahead.
For a broad overview of everything you need to know about Ardelyx, visit <a href="https://www.benzinga.com/quote/ARDX">here</a>. If you want to go above and beyond, there's no better tool to help you do just that than <a href="https://pro.benzinga.com/">Benzinga Pro</a>. Start your free trial today.
ARDX Price Action: According to <a href="https://pro.benzinga.com/?gspk=YWRhbWVja2VydDUzMzY&amp;gsxid=zBMR4PKmcgBw">Benzinga Pro</a>, Ardelyx shares are down 20.9% at $5.99 at the time of publication Tuesday.
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Image: Phoenix Locklear from Pixabay

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Press Releases

ARDX LAWSUIT ALERT: Levi & Korsinsky Notifies Ardelyx, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline

Ardelyx to Present Additional Data Supporting First-In-Class XPHOZAH® (tenapanor) for Adults with Chronic Kidney Disease on Dialysis at the American Society of Nephrology's Kidney Week

FINAL DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Ardelyx

Ardelyx to Report Third Quarter 2024 Financial Results on October 31, 2024

Ardelyx Announces the Derek Forfang Patient Advocate Award to Recognize Advocates for the Chronic Kidney Disease Community

Ardelyx Announces Launch of Gut Matters: Discoveries and Innovations, a New Podcast for the IBS-C Patient Community

ARDELYX ALERT: Bragar Eagel & Squire, P.C. is Investigating Ardelyx, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

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