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.

The FDA notes deficiencies in the NDA seeking approval for Ardelyx's (ARDX) lead pipeline candidate, tenapanor, as a potential treatment for hyperphosphatemia.

Ardelyx (ARDX) Tumbles Following Deficiencies in Tenapanor NDA

MILWAUKEE, July 21, 2021 /PRNewswire/ -- Ademi LLP is investigating possible securities fraud claims against Ardelyx (Nasdaq: ARDX). The investigation results from inaccurate statements Ardelyx may have made regarding its business operations and prospects.

Ademi LLP Investigates Claims of Securities Fraud against Ardelyx, Inc.

NEW YORK--(BUSINESS WIRE)-- #ARDX--Scott+Scott Attorneys at Law LLP Announces Investigation into Ardelyx Inc. (ARDX)

Scott+Scott Attorneys at Law LLP Announces Investigation into Ardelyx Inc. (ARDX)

Ardelyx (NASDAQ: ARDX) shares are trading lower after the company received an FDA letter regarding its NDA for tenapanor indicating deficiencies that preclude discussion of labeling and post-marketing requirements/comments at this time.  Ardelyx Inc. is a biopharmaceutical company that develops and sells medicines for the treatment of kidney and cardiorenal diseases in the United States and internationally.

Why Ardelyx Shares Tanked Today

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With the trading day more than halfway over, the broad markets were rallying after the carnage on Monday.

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Boston, Massachusetts--(Newsfile Corp. - July 20, 2021) - Block & Leviton LLP announces that the firm is investigating whether Ardelyx, Inc. (NASDAQ: ARDX) committed securities fraud. Investors who have lost money should contact the firm to learn more about how they might recover those losses. For more details, please visit https://www.blockleviton.com/cases/ardx.What is this all about?On July 19, 2021, Ardelyx announced that it had received a letter from the U.S. Food and Drug Administration on July...

Investors Who Have Lost Money in Their Ardelyx, Inc. (ARDX) Investment Should Contact Block & Leviton, Who Is Investigating Potential Securities Fraud Claims Against Ardelyx

News from the FDA is not good for ARDX stock. Investor reaction has been swift and harsh, as is often the case with risky biotech stocks.

ARDX Stock: Disastrous FDA News Sends Ardelyx Shares Plummeting

SAN DIEGO, July 20, 2021 /PRNewswire/ -- Shareholder rights law firm Johnson Fistel, LLP is investigating potential violations of the federal securities laws by Ardelyx, Inc. ("Ardelyx" or the "Company") (NASDAQ: ARDX). On July 19, 2021, Ardelyx announced that it had received a letter from the FDA on July 13, 2021, regarding its New Drug Application for Tenapanor.

(ARDX) Alert: Johnson Fistel, Investigates Ardelyx Following FDA Notification. Did You Lose Money on Your Ardelyx Investment?

The FDA doesn't appear to be impressed by the biotech's experimental kidney disease drug.

Why Ardelyx Stock Is Getting Crushed Today

The stock price of Ardelyx Inc (NASDAQ: ARDX) fell by over 70% pre-market. This is why it happened.

ARDX Fell Over 70% Pre-Market: Why It Happened

Three months after revealing that the FDA had asked for more information to support tenapanor application for a chronic kidney disease drug, the FDA issued a letter to Ardelyx Inc (NASDAQ: ARDX) identifying deficiencies in its application ahead of its PDUFA date next week (July 29). The Company, which got word from the FDA on July 13, said they asked for a meeting with the agency to discuss the rejection and fix any shortcomings but were turned down.

Ardelyx Stock Collapses After FDA Rejects Its Kidney Disease Candidate Pitch

Atlanta, Georgia--(Newsfile Corp. - July 19, 2021) -  Holzer & Holzer, LLC is investigating whether Ardelyx, Inc. ("Ardelyx" or the "Company") (NASDAQ: ARDX) complied with federal securities laws. On July 19, 2021, the Company announced that "it received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the Company's New Drug Application ("NDA") for the control of serum phosphorus in...

SHAREHOLDER ALERT: Investigation of Ardelyx, Inc. Announced by Holzer & Holzer, LLC

Shares in Ardelyx Inc. plummeted more than 70% in after-hours trading Monday, following the biopharmaceutical company's announcement that the Food and Drug Administration appears unlikely to approve a drug for dialysis patients. Ardelyx revealed that it received a letter from the FDA stating that deficiencies in the information provided had been found that would preclude discussion of approvals Ardelyx has sought.

Pharma company's stock plunges 70% after bad news from FDA

Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

FREMONT, Calif. and WALTHAM, June 7, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced two presentations highlighting new tenapanor data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021, taking place June 5-8, 2021.

Ardelyx Announces Presentations at ERA-EDTA Virtual Congress 2021

Ardelyx to Present at the Jefferies 2021 Virtual Healthcare Conference

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ARDX had a PDUFA on April 29, which got delayed by three months because the FDA wants to review new analyses it requested. This has brought the stock down.

Ardelyx: Second Opportunity

Ardelyx Reports First Quarter 2021 Financial Results and Recent Business Highlights

The stock price of Ardelyx Inc (NASDAQ: ARDX) fell from $8.43 to $7.31 yesterday (down 13.29%). This is why it happened.

ARDX Stock: From $8.43 To $7.31 Explanation

The FDA pushed back its approval decision for the company's lead candidate.

Why Ardelyx Stock Is Sinking Today

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for Ardelyx Inc's (NASDAQ: ARDX) tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The agency asked the company to submit additional analyses to help the FDA better understand the clinical data in light of tenapanor's novel mechanism of action as compared to approved therapies.

Ardelyx Stock Plummets As Review Period For Tenapanor US Application Pushed By 3 Months

Ardelyx (ARDX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

News for Ardelyx Stock (ARDX)