Ardelyx Stock Price, News & Analysis

Ardelyx, Inc. (Nasdaq: ARDX) announced a $27.5 million debt financing agreement with SLR Capital Partners, aimed at supporting the upcoming launch of IBSRELA for irritable bowel syndrome with constipation (IBS-C) in adults. The agreement includes a senior secured term loan facility maturing on March 1, 2027, with an interest-only period through March 2024. The funds will repay an existing term loan. Ardelyx may borrow an additional $22.5 million, contingent on FDA approval for a New Drug Application by December 31, 2022. This financing aims to strengthen Ardelyx's balance sheet and extend its cash runway.

Ardelyx, Inc. (Nasdaq: ARDX) announced a conference call scheduled for February 28, 2022, at 4:30 pm ET, to discuss its fourth-quarter and year-end 2021 financial results. The call will also include a corporate update. Ardelyx recently received approval for IBSRELA (tenapanor), with plans for its launch in Q2 2022. The company is advancing tenapanor for managing serum phosphorus in adult CKD patients on dialysis and developing RDX013 for hyperkalemia treatment. Global partnerships have been established for tenapanor's commercialization in Japan, China, and Canada.

On February 4, 2022, Ardelyx, Inc. (Nasdaq: ARDX) announced the grant of options to purchase 35,547 shares and 25,750 Restricted Stock Units (RSUs) to new non-executive employees. The options, granted as inducements for employment, have an exercise price of $0.84 per share, equal to the closing price on the grant date. Each option vests over four years, with 25% vesting on the first anniversary, and RSUs vest similarly. Ardelyx focuses on innovative medicines, including IBSRELA^® and candidates targeting kidney-related conditions.

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.