(ARDX) Market Cap $164 M-- Cash $186 M--Shares Out 62 M--2 MEGA drugs in Pipeline one is close to FDA decision expected in September and another one close to Phase 3 readout expected by mid year / Very strong institutional and Insider Ownership /Low float stock = Next potential 10 Bagger Gem here .
The company's most promising late-stage product candidate is called Tenapanor. Thanks to a unique mechanism of action, this molecule demonstrates potential to treat two separate conditions: irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia in end-stage renal disease (ESRD).
IBS-C: An estimated one million Americans currently are taking or seeking prescription medication for IBS-C, while millions more suffer from IBS-C but go undiagnosed. Unfortunately, just 40% of patients in need of medication are sufficiently treated today because existing treatment options work only in a minority of patients. Tenapanor offers a novel mechanism of treatment for IBS-C in patients who do not respond to available drugs. Additionally, clinical trials have shown that Tenapanor's efficacy and safety profile is comparable to and in some respects better than that of the leading IBS-C drug, which is called Linzess and which generates $1 billion in sales annually.
Hyperphosphatemia: Tenapanor's potential in hyperphosphatemia is even greater than that in IBS-C. Every year, 90,000 ESRD patients die in the United States alone, and elevated phosphate levels are a major cause of ESRD-related deaths. Despite a mortality rate of greater than 20%, almost one-half of all ESRD patients are not compliant with their prescribed pill regimen. To a large extent, this noncompliance is a result of the overwhelming pill burden: ESRD patients, many of whom are limited to just 32 ounces of water intake per day, swallow roughly 20 pills daily with almost one-half of these pills being hyperphosphatemia drugs. Tenapanor could resolve this problem by providing the same level of efficacy and tolerability with only two pills per day.
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