1. Scrip
  2. >>Business
  3. >>Financing

Ardelyx Plans Mid-2020 NDA Filing For Tenapanor In Hyperphosphatemia

 
• By Jessica Merrill

The company reported positive Phase III data from a second trial testing the first-in-class therapy as monotherapy for managing hyperphosphatemia in patients on dialysis.

SC1912_Success_325170179_1200.jpg
Aredlyx's tenapanor was successful in a second Phase III trial • Source: Shutterstock

Ardelyx Inc. expects to file a new drug application with the US Food and Drug Administration for tenapanor for the treatment of hyperphosphatemia in patients on dialysis in mid-2020 after data from a second Phase III trial read out positively. The company announced the positive results of the Phase III PHREEDOM trial testing the first-in-class NH3E inhibitor as a monotherapy on 3 December.

The company is ramping up to launch tenapanor in 2021 independently for hyperphosphatemia, even though it is still seeking a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Financing

Stock Watch: When The Biotech Bandwagon Music Stops

 
• By Andy Smith

The number of viable biotech companies exploiting a particular technology should be limited by intellectual property but the number of biotech IPOs exploiting that same technology always seems greater than those with freedom to operate.

China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 
• By Mandy Jackson, Joseph Haas, and Sarah Karlin-Smith

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.

More from Business

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By Joseph Haas

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

Positive Fabry Data Should Smooth Way For Sangamo’s Partnering Efforts

 
• By Alaric DeArment

The biotech announced results from the pivotal trial of isaralgagene civoparvovec and plans to file for approval in 2026 as it looks for a commercialization partner.

Industry’s Vaccines Pipeline In A Changing Regulatory Landscape

 
• By Jessica Merrill

More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.