Ardelyx

Ardelyx, Inc. is a biopharmaceutical company. engages in the research, development and commercialization of medicine for the treatment of cardiorenal diseases. Its product portfolio includes tenapanor, which is an experimental medication that works exclusively in the gut and is in late-stage clinical development. The company was founded by Dominique Charmot, Peter G. Schultz, and Jean M. Frechet on October 17, 2007 and is headquartered in Fremont, CA.

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Ardelyx reports strong Q4 earnings, poised for product expansion

Ardelyx's Q4 performance reflects revenue growth, improved financial efficiency, and progress towards expanding its product portfolio.
While facing challenges such as regulatory processes and market competition, Ardelyx's strengths lie in successful product launches and a proactive commercial strategy.
Opportunities for Ardelyx include leveraging positive feedback for XPHOZAH, raising additional funds for growth, and diversifying revenue through new product launches.

Ardelyx reports sales growth, readies XPHOZAH launch amid challenges

Ardelyx showed strong sales growth for IBSRELA and is poised for the XPHOZAH launch
Financially, the company raised significant funds and maintains a healthy cash position
Challenges include managing expenses and improving profitability amidst losses
Opportunities lie in upcoming product launches and optimizing financial operations

Ardelyx reports strong Q2 performance amidst legislative challenges and growth opportunities

Ardelyx's Q2 performance reflects growth in IBSRELA sales and overall revenue, despite incurring a net loss.
The company faces challenges from pending legislation and financial burdens related to XPHOZAH launch preparation.
Opportunities lie in the potential of XPHOZAH launch, market reception of IBSRELA, and addressing legislative impacts.

Ardelyx reports strong Q3 earnings, poised for successful XPHOZAH launch

Ardelyx's Q3 performance reflects financial strength and positive market reception for IBSRELA.
Challenges in pricing strategy and market competition require strategic planning for XPHOZAH's launch.
Opportunities lie in leveraging financial stability, physician interest, and promotional activities for XPHOZAH success.
The company's commitment to patient access and learnings from IBSRELA will drive future growth and market penetration.

Ardelyx reports strong revenue growth driven by IBSRELA success

Ardelyx is strategically investing in growth, focusing on sustaining momentum for its products. The company is well-resourced and optimistic about the future performance of IBSRELA and XPHOZAH. Despite challenges in operating expenses, Ardelyx remains committed to its commercialization efforts.

Ardelyx reports robust Q1 performance driven by XPHOZAH success

Ardelyx's Q1 2024 earnings call showcased strong revenue growth, particularly driven by XPHOZAH and IBSRELA. The company's cash position remains healthy, and there is a clear focus on expanding market reach and driving adoption of key therapies.

Ardelyx reports robust Q2 earnings, focuses on patient access advocacy

Ardelyx's Q2 2024 performance reflects strong revenue growth driven by IBSRELA and XPHOZAH, with a focus on shareholder value and patient access advocacy. While facing challenges in legal battles and expense management, the company is poised to capitalize on opportunities through sales force expansion and market differentiation strategies.

Ardelyx (ARDX) reports robust Q3 earnings, navigates Medicare coverage challenges

Ardelyx's Q3 earnings call highlighted strong financial performance, success of key medications, and strategies to address Medicare coverage challenges. The company's focus on patient access, commitment to therapy availability, and positive market impact showcase its growth potential and resilience in the market.

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Ardelyx, Inc. is a biopharmaceutical company, which engages in the business of developing and commercializing biopharmaceutical products. The firm is also involved in developing a unique and innovative platform that enables the discovery of new biological mechanisms and pathways to develop potent and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines. The company was founded by Dominique Charmot, Peter G. Schultz, and Jean M. Frechet in October 2007 and is headquartered in Waltham, MA.

WALTHAM, Mass., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), 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 Ardelyx management will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023, at 2:30 p.m. E.T. in New York City.

Ardelyx to Participate at the Piper Sandler 35th Annual Healthcare Conference

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Ardelyx (ARDX) announces that the FDA has granted orphan drug designation to Xphozah for the treatment of pediatric hyperphosphatemia. The stock rises 4%.

Ardelyx (ARDX) Up on Xphozah's Orphan Tag for Hyperphosphatemia

WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), 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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia

WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), 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 Geoffrey Block, MD, is stepping down from the Board of Directors after nearly five years of service. Dr. Block currently serves as the Associate Chief Medical Director and Senior Vice President of Clinical Research and Medical Affairs at U.S. Renal Care.

Ardelyx Announces Departure of Board Member

WALTHAM, Mass., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), 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 Ardelyx management will participate in a fireside chat at the Jefferies London Healthcare Conference on Thursday, November 16, 2023, at 8:30 a.m. GMT in London, UK.

Ardelyx to Participate at the Jefferies London Healthcare Conference

WALTHAM, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today shared positive data on the use of XPHOZAH® (tenapanor) in poster presentations at the American Society of Nephrology (ASN) Kidney Week 2023 meeting, currently being held in Philadelphia, Pennsylvania, and will showcase XPHOZAH in an Exhibitor Spotlight event. Ardelyx's presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.

Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023

Ardelyx delivered a surprise profit thanks to strong sales of Ibsrela, its first FDA-approved product. The company has also commenced the launch of Xphozah, which only just received FDA approval two weeks ago, with product expected in channel early next month.

Why Ardelyx Stock Soared Today

Ardelyx, Inc. (NASDAQ:ARDX ) Q3 2023 Earnings Conference Call October 31, 2023 8:00 AM ET Company Participants Caitlin Lowie - Vice President of Corporate Communications & Investor Relations Mike Raab - President & Chief Executive Officer Susan Rodriguez - Chief Commercial Officer Justin Renz - Chief Financial Officer & Chief Operations Officer Conference Call Participants Louise Chen - Cantor Yigal Nochomovitz - Citi Research Joseph Thome - TD Cowen Matt Kaplan - Ladenburg Thalmann Operator Good day and welcome to the Ardelyx Third Quarter 2023 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded.

Ardelyx, Inc. (ARDX) Q3 2023 Earnings Call Transcript

Ardelyx (ARDX) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of a loss of $0.11 per share. This compares to loss of $0.14 per share a year ago.

Ardelyx (ARDX) Q3 Earnings and Revenues Top Estimates

Continued successful launch of IBSRELA, with Q3 net sales revenue of $22.3 million; Company currently expects 2023 full year IBSRELA U.S. net sales revenue to be $76 to $78 million

Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA® Net Sales Revenue Guidance

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WALTHAM, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, announced that they will share positive data on IBSRELA® (tenapanor) via an oral presentation and two posters at the American College of Gastroenterology (ACG) annual meeting, being held October 20 to 25 in Vancouver, Canada. IBSRELA, discovered and developed by Ardelyx, is a first-in-class treatment that is currently approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults.

Ardelyx Shares Positive Data on Symptom Response During Treatment With IBSRELA® (tenapanor) for IBS-C and hosts IBS-C Product Theater at ACG 2023

Ardelyx (ARDX) gets FDA approval for Xphozah to reduce serum phosphorus in adult patients with kidney disease on dialysis as an add-on therapy. The stock of the company climbs 13%.

Ardelyx (ARDX) Up on FDA Nod to Xphozah for Hyperphosphatemia

Late yesterday, Ardelyx announced that the FDA has approved its first-in-class chronic kidney disease drug Xphozah. The drug adds an important new treatment option for patients on dialysis with hyperphosphatemia, or high phosphorus.

Why Ardelyx Stock Popped Today

WALTHAM, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), 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 it will hold a conference call on Tuesday, October 31, 2023, at 8:00 a.m.

Ardelyx to Report Third Quarter 2023 Financial Results on October 31, 2023

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Ardelyx (NASDAQ: ARDX ) stock is climbing today after the U.S. Food and Drug Administration (FDA) approved the firm's treatment for excessive phosphate levels in kidney disease patients. Shares of ARDX are up more than 14% as of this writing.

FDA Sends ARDX Stock Soaring After Approving Ardelyx's Kidney Disease Drug

Ardelyx will almost certainly gain FDA approval for XPHOZAH. The XPHOZAH launch will likely be smoother than Ardelyx's IBSRELA, which is the same drug and gaining traction in IBS. Ozempic won't slow the CKD market at all.

Ardelyx: XPHOZAH Is No Niche Product

Ardelyx Inc. ARDX, -0.58% on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.

Ardelyx wins long battle for FDA approval of kidney-disease treatment

Additional non-dilutive capital extends runway to support the launch of XPHOZAH® (tenapanor) and continued commercial investment into IBSRELA® (tenapanor) in the U.S. Additional non-dilutive capital extends runway to support the launch of XPHOZAH® (tenapanor) and continued commercial investment into IBSRELA® (tenapanor) in the U.S.

Ardelyx Announces Amendment of Debt Financing Agreement with SLR Capital Partners to Provide $50 Million of Additional Committed Capital

The U.S. Food and Drug Administration (FDA) has approved Ardelyx's drug to treat high phosphate levels in patients with chronic kidney disease (CKD), the company said on Tuesday, more than two years after it was initially rejected.

US FDA approves Ardelyx's kidney disease-related drug

XPHOZAH has been approved 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

FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor

WALTHAM, Mass., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), 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 upcoming data presentations for tenapanor for hyperphosphatemia at the American Society of Nephrology (ASN) Kidney Week 2023 meeting to be held in Philadelphia, PA, November 1-5, 2023. XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor.

Ardelyx to Present Data Updates for XPHOZAH (tenapanor) for Hyperphosphatemia at Kidney Week 2023 November 1-5 in Philadelphia, PA

Ardelyx has only one approved therapy, IBS drug Isbrela. The company saw improved second-quarter financials but is not yet profitable.

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