Welcome to our dedicated page for Ardelyx news (Ticker: ARDX), a resource for investors and traders seeking the latest updates and insights on Ardelyx stock.
Ardelyx, Inc. (Nasdaq: ARDX) is a biotechnology company focused on the discovery, development, and commercialization of innovative, first-in-class medicines that address significant unmet medical needs. The company's mission is to enhance the treatment of renal and gastrointestinal diseases through its proprietary drug discovery and design platform.
One of Ardelyx's lead products is tenapanor, which has been developed to reduce the absorption of dietary sodium and phosphorus. It is being investigated for multiple conditions, including hyperphosphatemia in patients with end-stage renal disease on dialysis and irritable bowel syndrome with constipation (IBS-C). The company has made significant strides in these areas, recently gaining FDA approval for tenapanor under the brand names IBSRELA® and XPHOZAH®. IBSRELA is targeted at treating IBS-C, while XPHOZAH is aimed at controlling serum phosphorus levels in patients with chronic kidney disease on dialysis.
Ardelyx has also forged strategic partnerships to extend the reach of its therapies globally. This includes collaborations with Kyowa Kirin in Japan, Fosun Pharma in China, and Knight Therapeutics in Canada. Notably, Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan, while a New Drug Application for the same indication is under review in China.
In its latest financial update, Ardelyx reported strong revenue growth for IBSRELA, achieving approximately $80 million in net product sales revenue for its first full year of commercialization. The company anticipates even higher sales in 2024, projecting revenues between $140 million and $150 million. Additionally, XPHOZAH, which launched in November 2023, recorded $2.5 million in net product sales revenue in its first quarter. To support these products, Ardelyx is investing in expanding its sales team and digital capabilities, as well as enhancing its patient services through the ArdelyxAssist™ program.
As of December 31, 2023, Ardelyx maintained a strong cash position with approximately $184 million in cash, cash equivalents, and short-term investments. The company’s financial stability and continuous investment in its robust R&D pipeline underscore its commitment to advancing the standard of care for patients with renal and gastrointestinal diseases.
Ardelyx continues to engage with the medical community and investors through various platforms, including regular webcasts and conferences. The company remains focused on executing its commercial strategy, expanding market penetration, and exploring new avenues for growth through internal development and external partnerships.
Ardelyx (ARDX) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's Chief Financial and Operations Officer, Justin Renz, and Chief Commercial Officer, Eric Foster, will engage in a fireside chat on Wednesday, December 4, 2024, at 12:30pm EST in New York City.
The presentation will be accessible via live webcast on the Events and Presentations page of Ardelyx's website, with a replay available for 30 days following the event.
Ardelyx (ARDX) faces a setback as the U.S. District Court dismisses their lawsuit against CMS's decision to include oral-only phosphate-lowering therapies in the ESRD PPS starting January 1, 2025. This decision affects XPHOZAH, Ardelyx's FDA-approved therapy for reducing serum phosphorus in adults with chronic kidney disease on dialysis. The company argues this inclusion in the bundled payment system will restrict patient access to essential medications. CEO Mike Raab expressed disappointment, stating the decision could harm dialysis patients' access to optimal care. Ardelyx is reviewing the court's decision and considering all legal options while urging Congress to pass the Kidney PATIENT Act.
Ardelyx (ARDX) has announced its participation in the 2024 Jefferies London Healthcare Conference. The company's leadership team, including President and CEO Michael Raab, CFO Justin Renz, and CCO Eric Foster, will engage in a fireside chat on Tuesday, November 19, 2024, at 12:30pm GMT / 7:30am EST in London.
The presentation will be accessible via live webcast on the Events and Presentations page of Ardelyx's website, with a replay available for 30 days following the event.
Ardelyx (ARDX) reported strong Q3 2024 financial results, with IBSRELA generating $40.6 million in net product sales (15% quarter-over-quarter growth) and XPHOZAH achieving $51.5 million (39% quarter-over-quarter growth). Total revenue reached $98.2 million, compared to $56.4 million in Q3 2023. The company ended Q3 with $190.4 million in cash and investments. Ardelyx expects full-year 2024 IBSRELA net sales to be between $145-150 million. The company secured additional financing through an amended loan agreement with SLR Capital Partners, drawing $50 million with the option for an additional $50 million.
Ardelyx (ARDX) presented results from its IBS in America 2024 supplemental survey at the American College of Gastroenterology's Annual Meeting. The nationwide online survey of over 280 IBS-C patients revealed significant impacts on quality of life, with 90% reporting negative effects on mental, emotional, and sexual health, relationships, and independence.
Key findings show that 85% of patients experienced rectal pain during bowel movements, 86% reported bloating, and 85% suffered from abdominal cramps. Over 45% of patients considered IBS-C a financial hardship. Among perimenopausal or menstruating respondents, over 80% reported menstruation worsened abdominal pain and bloating symptoms.
Ardelyx (ARDX) presented additional clinical data for XPHOZAH (tenapanor) at ASN Kidney Week. XPHOZAH, the first phosphate absorption inhibitor, is FDA-approved to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy. Two key poster presentations highlighted: (1) A post-hoc analysis showing greater reductions in iFGF23 with better phosphate control, and (2) Data demonstrating XPHOZAH's efficacy when combined with various phosphate binders. The company also hosted an Exhibitor Spotlight on hyperphosphatemia management.
Ardelyx, Inc. (Nasdaq: ARDX) has launched a new podcast called 'Gut Matters: Discoveries and Innovations' for the irritable bowel syndrome with constipation (IBS-C) patient community. The podcast is co-hosted by Johannah Ruddy, M.Ed., Ardelyx's director of patient advocacy, and Dr. Andrea Shin, a practicing gastroenterologist.
The monthly podcast will feature discussions with patients, caregivers, advocacy leaders, healthcare providers, and gastroenterology experts about the impact of IBS-C. It aims to provide education, hope, and valuable insights for those affected by the condition. The hosts hope to create a safe space where people with IBS-C can find fact-based information and hear relatable stories, empowering patients and their support networks.
The first episode is already available, and interested individuals can subscribe to the podcast on various platforms.
Ardelyx (Nasdaq: ARDX) has launched the Derek Forfang Patient Advocate Award to honor passionate supporters of chronic kidney disease (CKD) patients. The award, named after the late Derek Forfang, aims to recognize individuals who raise awareness of CKD challenges and advocate for the community.
Nominations are open until January 31, 2025, and can be submitted by anyone in the community. Recipients will receive a $1,000 honorarium and a $4,000 donation to a non-profit supporting the CKD community. Eligible nominees must demonstrate achievements in advocating for CKD patients, such as raising awareness, educating others, and advancing research.
The Derek Forfang Patient Advisory Council (DFPAC) will consider candidates for the award. Ardelyx emphasizes the importance of supporting and celebrating voices in the CKD community through this initiative.
Ardelyx (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative, first-in-class medicines for significant unmet medical needs, has announced its plans to report third quarter 2024 financial results on October 31, 2024. The company will host a conference call at 4:30 p.m. Eastern Time to discuss the financial results and provide a business update.
Interested parties can participate in the conference call by dialing (877) 346-6112 (domestic) or (848) 280-6350 (international) and asking to join the Ardelyx call. A live audio webcast will be available on the company's website under the Investors section at www.ardelyx.com. The webcast will be archived and available for replay for 30 days following the call.
Ardelyx (Nasdaq: ARDX) announced that additional data supporting XPHOZAH® (tenapanor) will be presented at the American Society of Nephrology's (ASN) Kidney Week, October 24-27, 2024, in San Diego. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is FDA-approved to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy.
Two poster presentations will be featured:
- Sustained Phosphate Reduction Assessed by P AUC With Tenapanor Is Associated With Reduced Fibroblast Growth Factor 23 in Patients With CKD and Hyperphosphatemia on Dialysis
- Tenapanor Reduces Serum Phosphate With Similar Efficacy and Tolerability Profiles When Added to Various Phosphate Binders
Additionally, Ardelyx is sponsoring an Exhibitor Spotlight on October 25, 2024, discussing XPHOZAH's mechanism of action, efficacy, and safety data from Phase 3 clinical trials.
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