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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, Inc. (Nasdaq: ARDX) announced plans to launch IBSRELA, a treatment for irritable bowel syndrome with constipation (IBS-C), in Q2 2022. The IBS-C market, driven by high-writing physicians, is substantial, with the potential for IBSRELA to generate over $500 million in peak annual revenue. The approval of IBSRELA was based on successful Phase 3 trials involving over 1,200 patients, demonstrating significant improvements in bowel movements and abdominal pain. Ardelyx is also pursuing FDA approval for another product, tenapanor, targeting hyperphosphatemia.
Ardelyx, Inc. (Nasdaq: ARDX) reported its third-quarter financial results for the period ending September 30, 2021. The company generated $1.2 million in revenue, attributed mainly to a collaborative agreement with Kyowa Kirin. Operating expenses rose significantly, with R&D expenses up by 94% to $23.7 million and G&A expenses increasing by 158% to $19.7 million. The company faced a net loss of $43.6 million, compared to $18.1 million in the same quarter of 2020. Ardelyx will appeal the FDA's Complete Response Letter regarding its NDA for tenapanor.
Ardelyx, Inc. (Nasdaq: ARDX) announced participation in a fireside chat at the Jefferies London Healthcare Conference from November 16-19, 2021. CEO Mike Raab will engage in discussions about the company's innovative medicines for kidney and cardiorenal diseases. The chat will be available on-demand for registered participants from 3:00 a.m. ET on November 18 to 12:00 p.m. ET on November 19, 2021. Ardelyx's product candidate tenapanor has completed three Phase 3 trials and is FDA-approved for IBS-C. The company has international agreements for tenapanor's development.
On November 5, 2021, Ardelyx, Inc. (Nasdaq: ARDX) reported positive clinical data for tenapanor at the ASN Kidney Week 2021. The drug, developed for managing serum phosphorus in chronic kidney disease (CKD) patients on dialysis, has completed three Phase 3 trials. Presentations highlighted tenapanor's effectiveness in lowering serum phosphorus, parathyroid hormone (PTH), and fibroblast growth factor 23 (FGF23). The OPTIMIZE trial results indicated improved patient experiences with phosphorus management. Tenapanor represents a first-in-class innovation, aiming to enhance treatment outcomes for CKD patients.
Ardelyx, Inc. (Nasdaq: ARDX) plans to file a Formal Dispute Resolution Request (FDRR) to appeal a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for tenapanor, aimed at controlling serum phosphorus in chronic kidney disease patients on dialysis. The company emphasizes the lack of resolution during prior discussions and seeks to challenge the FDA's decision. The FDRR submission is expected in Q4 2021, with the FDA aiming for a decision within 30 days. Tenapanor has shown promising clinical benefits, with patients experiencing reduced phosphorus levels.
Ardelyx, Inc. (Nasdaq: ARDX) announced that four abstracts featuring tenapanor have been accepted for presentation at the ASN Kidney Week 2021, occurring virtually from November 4-7, 2021. Tenapanor, a first-in-class phosphate absorption inhibitor, has successfully completed three Phase 3 clinical trials aimed at managing serum phosphorus levels in adults with chronic kidney disease (CKD) on dialysis. The abstracts will cover various aspects of tenapanor's efficacy and patient experience during clinical trials.
Ardelyx, Inc. (Nasdaq: ARDX) announced a Type A meeting with the FDA regarding its New Drug Application (NDA) for tenapanor, aimed at controlling serum phosphorus in chronic kidney disease (CKD) patients on dialysis. The FDA did not provide clear guidance on the clinical relevance of treatment effects, prompting Ardelyx to implement a restructuring plan to extend cash resources, including significant workforce reductions. The restructuring is projected to incur approximately $2.3 million in charges while saving around $18.1 million annually. As of September 30, 2021, Ardelyx held $141.7 million in cash.
Ardelyx, Inc. (Nasdaq: ARDX) announced the publication of its long-term 52-week Phase 3 PHREEDOM trial results in the journal Kidney360. The trial evaluated tenapanor monotherapy for controlling serum phosphorus in chronic kidney disease patients on dialysis. Results showed a significant reduction in phosphorus levels, with decrease from 7.7 mg/dL to 5.1 mg/dL. The trial supports tenapanor's safety and efficacy, presenting it as a promising treatment option for managing hyperphosphatemia. The study's findings highlight the potential of tenapanor to improve patient outcomes in a challenging treatment area.
Ardelyx, Inc. (Nasdaq: ARDX) reported its second quarter 2021 financial results, revealing a net loss of $45.2 million, up from $25.0 million a year prior. Revenue for the quarter was $1.3 million, primarily from a collaboration with Kyowa Kirin. The company faces challenges as the FDA issued a Complete Response Letter for its tenapanor NDA, prompting a restructuring plan expected to incur $3.4 million in charges but reduce annual cash compensation costs by $17 million. As of June 30, 2021, Ardelyx held $171.8 million in cash and equivalents.
Ardelyx, Inc. (Nasdaq: ARDX) announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for tenapanor aimed at controlling serum phosphorus in CKD patients on dialysis. The FDA acknowledged substantial evidence of tenapanor's effectiveness but deemed the treatment effect as small and unclear in clinical significance. Ardelyx must conduct further trials for approval. The company plans to request a Type A meeting with the FDA to discuss the CRL. Ardelyx reported $171.8 million in cash at the end of Q2 2021.
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