IBS-C

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 22, 2024
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WALTHAM, Mass., Feb. 22, 2024 (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 reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Ardelyx Provides Update on Growing Commercial Momentum and 2024 Strategic Priorities

Retrieved on: 
Monday, January 8, 2024
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WALTHAM, Mass., Jan. 08, 2024 (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 provided an update on the company’s progress in 2023 and initial expectations for 2024.

Key Points: 
  • “2023 was a landmark year for Ardelyx, marking our first full year as a commercial entity and the approval and launch of our second first-in-class product.
  • XPHOZAH® joins IBSRELA in our portfolio of important treatment options for patients with unmet needs,” said Mike Raab, president and chief executive officer.
  • We are poised to continue with a growth trend in 2024.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.

Ardelyx to Provide Company Update on IBSRELA® and Host a KOL Discussion on the IBS-C Landscape on Monday, January 8

Retrieved on: 
Wednesday, January 3, 2024
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The event is being held at Convene, located at 100 Stockton Street, San Francisco, Calif. and will be webcast live.

Key Points: 
  • The event is being held at Convene, located at 100 Stockton Street, San Francisco, Calif. and will be webcast live.
  • A link to the webcast can be accessed on the Investors section of the company's website at www.ardelyx.com .
  • The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age.
  • IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

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

Retrieved on: 
Tuesday, October 31, 2023
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WALTHAM, Mass., Oct. 31, 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 reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue.
  • We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients.
  • Driven by increased demand for IBSRELA, the company reported net sales revenue of $22.3 million in the third quarter, 22 percent quarter-over-quarter growth compared to the second quarter of 2023.
  • Ardelyx currently expects full-year 2023 U.S. net product revenue for IBSRELA to be between $76.0 and $78.0 million.

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

Retrieved on: 
Monday, October 23, 2023
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“Physicians and other professionals attending ACG 2023 work with IBS-C patients every day and know all too well how challenging this condition can be.

Key Points: 
  • “Physicians and other professionals attending ACG 2023 work with IBS-C patients every day and know all too well how challenging this condition can be.
  • “While a significant proportion of patients will have an early positive response to IBSRELA treatment, patient response rates increase with continued therapy.
  • The researchers concluded that these patients experience a relatively quick onset of symptom relief under tenapanor treatment and that weekly response rates continued to increase with treatment duration.
  • IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Ironwood Releases New IBS-C and CIC Data at the American College of Gastroenterology 2023 Annual Scientific Meeting

Retrieved on: 
Monday, October 23, 2023
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Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global GI-focused healthcare company, presented new data from four scientific abstracts during the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting and Postgraduate Course.

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global GI-focused healthcare company, presented new data from four scientific abstracts during the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting and Postgraduate Course.
  • “The data presented at ACG peel back the many layers of these disorders’ impact.
  • While pain is usually associated with IBS-C, it also can be experienced by those with CIC and both patient groups can be affected by anal/rectal-related adverse consequences.
  • Non-D-IBS and CIC cases had higher costs versus controls on both a per-patient and a per-utilization basis.

Ardelyx Shares Preliminary Data on Use of IBSRELA® (tenapanor) in Pediatric IBS-C Patients at NASPGHAN 2023

Retrieved on: 
Wednesday, October 4, 2023
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The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age and IBSRELA is contraindicated in patients less than 6 years of age.

Key Points: 
  • The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age and IBSRELA is contraindicated in patients less than 6 years of age.
  • Patients enrolled in the study will be administered either tenapanor (25mg or 50mg) or placebo for 12 consecutive weeks.
  • The study expects to enroll approximately 180 pediatric patients with IBS-C who meet the entry criteria during a two-week screening period at up to 60 US sites.
  • The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established.

Ardelyx Announces Publication of Positive Results from T3MPO-3 Long-Term Open-Label Safety Trial of Tenapanor for IBS-C in the Journal of Neurogastroenterology and Motility

Retrieved on: 
Thursday, September 28, 2023
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In this long-term open-label safety study, tenapanor showed acceptable tolerability with a safety profile consistent with that reported in the prior studies.

Key Points: 
  • In this long-term open-label safety study, tenapanor showed acceptable tolerability with a safety profile consistent with that reported in the prior studies.
  • “The T3MPO-3 results provide important data on IBSRELA’s safety profile in a longer-term setting,” said David Rosenbaum, Ph.D., chief development officer of Ardelyx.
  • Adults with IBS-C frequently suffer from constipation, abdominal pain, bloating and other symptoms, which has a significant impact on their quality of life.
  • Patients received open-label tenapanor 50 mg twice a day for up to an additional 39 (T3MPO-1) or 26 (T3MPO-2) weeks.

Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C at GHAPP 2023

Retrieved on: 
Monday, September 11, 2023
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There is a growing body of data that continues to expand our understanding of IBSRELA and how it works to provide symptomatic relief.

Key Points: 
  • There is a growing body of data that continues to expand our understanding of IBSRELA and how it works to provide symptomatic relief.
  • These data provide additional evidence of IBSRELA’s safety and efficacy, bringing much needed relief to those living with IBS-C,” said Laura Williams, MD, MPH, chief medical officer of Ardelyx.
  • The Phase 3 T3MPO-2 trial randomized patients to tenapanor 50 mg twice a day or matched placebo for 26 weeks of treatment.
  • This post hoc analysis found that IBSRELA-treated patients with IBS-C reported a reduction in abdominal symptom scores compared to placebo.

Ardelyx Reports Second Quarter 2023 Financial Results and Provides 2023 IBSRELA Net Sales Revenue Guidance

Retrieved on: 
Wednesday, August 2, 2023
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WALTHAM, Mass., Aug. 02, 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 reported financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • The May 2023 LaunchDynamix report published in Q2 by Spherix reports significant increases in awareness and experience with IBSRELA, while continuing to rate the product highly, 12-months post-launch.
  • R&D Expenses: Research and development expenses were $8.3 million for the quarter ended June 30, 2023, compared to $9.7 million for the quarter ended June 30, 2022.
  • Net Loss: Net loss for the quarter ended June 30, 2023 was $17.1 million, or $(0.08) per share, compared to net loss of $26.9 million, or $(0.19) per share, for the quarter ended June 30, 2022.
  • Ardelyx currently expects full-year 2023 net product revenue for IBSRELA to be between $72.0 and $77.0 million.