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.

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Shares of biopharmaceutical concern Ardelyx, Inc. have fallen over 60% since the FDA initially rejected its hyperphosphatemia therapy XPHOZOA (tenapanor) in mid-2021. The rejection, which was very surprising given its three Phase 3 trial successes, compelled Ardelyx to lay off ~60% of its workforce and significantly dilute shareholders.

Ardelyx: The Journey Continues

Ardelyx Inc. ARDX, +5.02% stock is up 5.2% in premarket trades on Thursday after the Waltham, Mass., biopharmaceutical company said the U.S. Food and Drug Administration granted an appeal for its Xphozah medicine.

Ardelyx stock rises as FDA grants appeal for new drug application for Xphozah

Office of New Drugs directs the Division of Cardiology and Nephrology to work with Ardelyx to develop a label to support the commercialization of XPHOZAH; Ardelyx to resubmit NDA in the first half of 2023 Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism Conference call to be held Dec. 29, 2022, at 8:00 AM ET WALTHAM, Mass. , Dec. 29, 2022 /PRNewswire/ -- 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 Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH.

FDA Grants Appeal for Ardelyx's XPHOZAH® (tenapanor)

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WALTHAM, Mass. , Dec. 16, 2022 /PRNewswire/ -- 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, provided an update regarding the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH (tenapanor).

Ardelyx Provides Update on FDA Appeal for XPHOZAH® (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

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WALTHAM, Mass. , Nov. 22, 2022 /PRNewswire/ -- 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 management will participate in a fireside discussion at the 34th Annual Piper Sandler Healthcare Conference on Thursday, December 1, 2022, at 10:00 a.m.

Ardelyx to Present at the 34th Annual Piper Sandler Healthcare Conference

Ardelyx is relatively new to the market and was doing well until a small drug approval issue last year. Strong earnings and smart partnerships could save them

Is Ardelyx is A Buy After Slip in Early 2022

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The FDA's CRDAC recommends granting marketing approval to Ardelyx's (ARDX) oral pill to control serum phosphorus in adult patients with chronic kidney disease on dialysis.

Ardelyx (ARDX) Up 41% After FDA Committee Endorses CKD Drug

Ardelyx Inc saw its value soar today after the US Food and Drug Administration's (FDA) advisory panel recommended the approval of the group's drug for chronic kidney disease patients on dialysis, more than a year after it was initially rejected. The panel voted 9-4 in favor of the drug, Xphozah (tenapanor), to be administered as a single therapy for treating high phosphate levels in the blood of patients on dialysis.

Ardelyx shares jump 43% as US FDA advisory panel backs Xphozah

Ardelyx (NASDAQ: ARDX ) stock is taking off on Thursday after an advisory committee to the U.S. Food and Drug Administration (FDA) voted in favor of its kidney disease drug. This saw the FDA's Cardiovascular and Renal Drugs Advisory Committee vote that the benefits of XPHOZAH outweigh the risks.

Why Is Ardelyx (ARDX) Stock Up 38% Today?

In a surprise move, a committee of the agency's outside advisors voted in favor of the proposition that the drug's benefits outweigh its risks.

Ardelyx Skyrockets. Its Kidney Disease Drug Is a Step Closer to FDA Approval.

Shares of Ardelyx Inc. ARDX, -3.17% rocketed 75.4% on heavy volume toward a 16-month high in premarket trading Thursday, after an advisory panel of the U.S. Food and Drug Administration voted that benefits of the biopharmaceutical company's treatment for chronic kidney disease (CKD) on dialysis, XPHOZAH, outweigh the risks. Trading volume was 11.7 million shares ahead of the open, compared with the full-day average of 4.3 million shares.

Ardelyx stock rockets on heavy volume after positive FDA panel vote on kidney disease treatment

The Advisory Committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in combination with phosphate binders The Office of New Drugs is expected to provide a response to Ardelyx's appeal within thirty (30) days If approved, XPHOZAH will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily Conference call to be held tomorrow, November 17, 2022, at 8:00 AM ET WALTHAM, Mass. , Nov. 16, 2022 /PRNewswire/ -- 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 the vote of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

A panel of advisers to the U.S. health regulator on Wednesday recommended the approval of Ardelyx Inc's drug for chronic kidney disease patients on dialysis, more than a year after it was initially rejected.

U.S. FDA advisers back Ardelyx's kidney disease drug

WALTHAM, Mass. , Nov. 16, 2022 /PRNewswire/ -- 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 Nasdaq has halted trading of the Company's common stock.

Ardelyx Stock Trading Halted Today; FDA Advisory Committee to Discuss XPHOZAH® (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

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Ardelyx, Inc. (NASDAQ:ARDX ) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Kimia Keshtbod - Investor Relations Justin Renz - Chief Financial Officer Susan Rodriguez - Chief Commercial Officer Laura Williams - Chief Medical Officer David Rosenbaum - Chief Development Officer Rob Blanks - Chief Regulatory Affairs and Quality Assurance Officer Conference Call Participants Yigal Nochomovitz - Citigroup Laura Chico - Wedbush Securities Joseph Thome - Cowen and Company Matt Kaplan - Ladenburg Thalmann Chris Howerton - Jefferies Operator Welcome to the Ardelyx Third Quarter 2022 Earnings Conference Call. My name is Sean.

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