Ardelyx showcases IBSRELA data at Digestive Disease Week

WALTHAM, Mass. - Biopharmaceutical company Ardelyx, Inc. (NASDAQ: ARDX) presented new data on its FDA-approved drug IBSRELA (tenapanor) at the Digestive Disease Week Conference in San Diego, highlighting the medication’s potential benefits for patients with irritable bowel syndrome with constipation (IBS-C). The company, which has seen its stock decline over 31% in the past week and is currently trading near its 52-week low of $3.62, maintains strong liquidity with a current ratio of 4.12, according to InvestingPro data.

The company shared findings from a supplemental survey, "IBS in America 2024," which linked greater IBS-C symptom severity to increased financial burden on patients. Utilizing tools like the Functional Assessment of Chronic Illness Therapy Measure of Financial Toxicity (FACIT-COST) and Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales, the survey aimed to quantify the financial toxicity and symptom burden experienced by patients.

In addition to the survey results, Ardelyx presented interim safety data from the Phase 3 R-ALLY study of tenapanor in pediatric patients aged 12 to less than 18 years with IBS-C. The open-label extension study reported no serious adverse events or unexpected safety signals, with diarrhea being the only adverse event related to the drug, consistent with its known mechanism of action.

Further bolstering the safety profile of IBSRELA, data from a Phase 1 study in healthy lactating females indicated that neither tenapanor nor its major metabolite were detectable in breast milk after four days of dosing, suggesting a low risk for exposure in breastfeeding infants.

IBSRELA works by inhibiting the sodium/hydrogen exchanger 3 (NHE3) on the surface of the small intestine and colon, reducing sodium absorption, and consequently increasing luminal water content which aids in softening stool consistency and reducing abdominal pain.

Ardelyx’s commitment to understanding the IBS patient experience and the impact of their drug on different patient groups was emphasized by Laura Williams, Chief Patient Officer of Ardelyx, who expressed satisfaction in partnering with the "IBS in America" survey to gain insights into the quality of life of patients with IBS.

The company, which has a mission to develop first-in-class medicines for significant unmet medical needs, has two commercial products approved in the United States: IBSRELA for IBS-C and XPHOZAH for hyperphosphatemia. Despite challenging market conditions, Ardelyx has demonstrated impressive revenue growth of 127% in the last twelve months, reaching $361.7 million, though analysts anticipate continued challenges ahead. InvestingPro analysis suggests the stock may be undervalued at current levels, with additional insights available in the comprehensive Pro Research Report, which provides detailed analysis of the company’s financial health and growth prospects. The data presented at the conference are publicly accessible on demand.

This news report is based on a press release statement from Ardelyx and does not include any additional analysis or opinions. For deeper insights into Ardelyx’s financial health, growth prospects, and market position, investors can access over 30 key financial metrics and exclusive analysis through InvestingPro, including 10 additional ProTips that provide valuable context for investment decisions.

In other recent news, Ardelyx Inc. reported its first-quarter 2025 earnings, revealing a net loss of $0.17 per share, which missed the forecasted loss of $0.11 per share. The company’s revenue for the quarter was $74.1 million, falling short of the expected $78.09 million. Despite a year-over-year revenue growth of 61%, these results have raised concerns among investors. Ardelyx’s key products, Ibsrela and Xphozah, experienced strong sales growth, yet both fell short of consensus estimates for net sales. Analyst Ryan Deschner from Raymond James downgraded Ardelyx’s stock from "Strong Buy" to "Outperform" and lowered the price target from $13.00 to $11.00. This decision was influenced by weaker-than-expected sales and increased spending in sales, general, and administrative expenses. Ardelyx’s management remains optimistic, maintaining their 2025 guidance for Ibsrela and Xphozah, with projected peak sales of $750 million for Xphozah. The company continues to explore corporate development and licensing opportunities to enhance its market position.

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