IBS-C

Ardelyx Presents Additional Data at the 2024 Digestive Disease Week Conference on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults

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火曜日, 5月 21, 2024
DDW, Irritable bowel syndrome, Food, Safety, Constipation, Conference, MD, IBS-C, D.C, Post hoc analysis, Pharmaceutical industry

“We are thrilled to share new data on the safety and efficacy of IBSRELA in adults with IBS-C at this year’s DDW Conference as we seek to continually elucidate its potential benefit in this patient population.

Key Points: 
  • “We are thrilled to share new data on the safety and efficacy of IBSRELA in adults with IBS-C at this year’s DDW Conference as we seek to continually elucidate its potential benefit in this patient population.
  • These data provide additional information for both patients and prescribers as they consider IBSRELA as a potential new treatment option when symptoms of IBS-C persist despite current therapies,” said Laura Williams, MD MPH, chief medical officer of Ardelyx.
  • A clinically meaningful response to tenapanor – defined as a complete spontaneous bowel movement response and an abdominal pain response in the same week for ≥6 of the first 12 treatment weeks – was observed among adults with IBS-C regardless of prior IBS-C prescription medication use.
  • Per the analysis, efficacy of tenapanor was comparable, or more pronounced, in Hispanic patients than in non-Hispanic patients.

Ardelyx to Present Additional Data Supporting First-In-Class IBSRELA® (tenapanor) for Adults with Irritable Bowel Syndrome with Constipation at the 2024 Digestive Disease Week Conference

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火曜日, 5月 7, 2024
Patient, D.C, Safety, Food, MD, Conference, Irritable bowel syndrome, Constipation, IBS-C, DDW, Pharmaceutical industry

WALTHAM, Mass., May 07, 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 announced that additional data supporting IBSRELA® (tenapanor) will be presented at the 2024 Digestive Disease Week Conference (DDW), to be held May 18-21, 2024, in Washington, D.C. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults.

Key Points: 
  • WALTHAM, Mass., May 07, 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 announced that additional data supporting IBSRELA® (tenapanor) will be presented at the 2024 Digestive Disease Week Conference (DDW), to be held May 18-21, 2024, in Washington, D.C. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults.
  • Title: Comparing the Efficacy of Tenapanor in Irritable Bowel Syndrome with Constipation in Hispanic vs Non-Hispanic Patients: A Posthoc Analysis of Patients in the Phase 3 T3MPO-1 and T3MPO-2 Studies
    In addition to the poster presentations during DDW, Ardelyx is sponsoring a Product Theater titled: “Discover IBSRELA: a Different Mechanism of Action to Treat Adults With IBS-C: A Case-Based Discussion,” on May 19, 2024, from 2:30-3:15 PM EDT, where Brooks Cash, MD, will lead an engaging discussion about important clinical considerations for managing IBS-C in adult patients.
  • The presentation will include interactive patient case studies, along with IBSRELA efficacy and safety data from the Phase 3 clinical trial program.

Ironwood Pharmaceuticals to Present New Data on Once-Weekly Apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF) at Digestive Disease Week® 2024

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水曜日, 5月 1, 2024
Biotechnology, Health, Science, Other Science, Pharmaceutical, PS, FDA, Irritable bowel syndrome, Safety, Functional constipation, Gastrointestinal disease, Diagnosis, NDA, Food, SBS, Ironwood Pharmaceuticals, Short bowel syndrome, Effect, Research, IBS-C, Ironwood, Constipation, DDW, STARS, FC, Drug development, Medication, IBS, Pharmaceutical industry

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present new data from studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which patients are dependent on parenteral support (PS), during the 2024 Digestive Disease Week® (DDW) meeting.

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present new data from studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which patients are dependent on parenteral support (PS), during the 2024 Digestive Disease Week® (DDW) meeting.
  • Apraglutide data from the STARS Phase III trial, which evaluated the safety and efficacy of once-weekly apraglutide in reducing PS dependency in adult patients with SBS-IF, will be presented at DDW 2024 as a late-breaker oral presentation.
  • Ironwood announced topline data from the STARS Phase III trial in February 2024.
  • The late-breaker presentation includes new apraglutide data from the STARS Phase III trial.

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

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木曜日, 2月 22, 2024
Fosun Pharma, Kyowa Kirin, Research, New Drug Application, Investment, Dialysis, Growth, Sale, Death, Diarrhea, Webcast, Abdominal distension, Orphan, XBR, Chronic kidney disease, Incidence, Peritoneal dialysis, Rat, Record, Calendar, ESG, CKD, Hyperphosphatemia, Safety, Human, Nephrology, IBS-C, Master of Science, Gastroenterology, FDA, Food, Social, Emeritus, Dehydration, Risk, Constipation, Society, Patient, Pharmaceutical industry

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

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月曜日, 1月 8, 2024
Hyperphosphatemia, Food, Nephrology, Constipation, Risk, Death, Diarrhea, FDA, Master of Science, Incidence, Prescription, Bank statement, Rat, IBS-C, Calendar, Abdominal distension, Emeritus, Growth, Investment, Webcast, Patient, Human, Gastroenterology, Dehydration, Safety, Pharmaceutical industry

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

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水曜日, 1月 3, 2024
Constipation, Risk, Death, Learning Technology Partners, Diarrhea, FDA, Master of Science, Incidence, Rat, IBS-C, Abdominal distension, Emeritus, Webcast, Patient, Human, Gastroenterology, Dehydration, Safety, Birth control

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

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火曜日, 10月 31, 2023
Rat, Research, Constipation, American College, Food, Northside Hospital, Prescription, Dehydration, Risk, New Drug Application, CKD, Human, Sale, MPH, Diarrhea, Jefferies Group, Journal, Chronic kidney disease, Irritable bowel syndrome, NDA, Safety, App, Investment, Patient, D, Fosun Pharma, IBS-C, Hyperphosphatemia, ACG, Growth, Clinical trial, SLR, Kyowa Kirin, FDA, Incidence, Conversation, Regulation of tobacco by the U.S. Food and Drug Administration, American College of Gastroenterology, Society, Death, Abdominal distension, Dialysis, Pharmaceutical industry, Fine chemical, Beauty salon, Video game, Nursing, Birth control, Health, Motility, RD

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

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月曜日, 10月 23, 2023
IBS-C, Rat, Bloating, Patient, Abdominal pain, Constipation, American College, Incidence, Food, MPH, Diarrhea, RD, ACG, Post hoc analysis, Duration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American College of Gastroenterology, AS3, Death, Abdominal distension, Dehydration, Risk, Safety, Pain, Mayo Clinic, Human, Pharmaceutical industry, Birth control, CSBM, MD

“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

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月曜日, 10月 23, 2023
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Ironwood Pharmaceuticals, IBS-C, Abdominal pain, Constipation, American College, Ageing, Menopause, Medication, ACG, Post hoc analysis, American College of Gastroenterology, David Geffen School of Medicine at UCLA, Drug development, IBS, UCLA, Irritable bowel syndrome, Pain, Patient, CIC, Pharmaceutical industry, Woman, Medicine

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

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水曜日, 10月 4, 2023
Rat, Diarrhea, Dehydration, IBS-C, Quality of life, Constipation, Abdominal pain, Death, Incidence, Patient, IBS, Risk, Randomness, Poster, MPH, Society, Human, Food, Safety, Abdominal distension, Pharmaceutical industry, Birth control, Nutrition, MD

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.