Ardelyx Inc. (NASDAQ: ARDX) opened Wednesday’s trading session at $7.25 and achieved its intraday high of $8.17. Ardelyx stock closed the trading session at $7.84, rising 8.89%. The Ardelyx stock remained very active on Wednesday, recording a greater than 128.72% trading volume compared to the average daily trading volume. The ARDX stock traded 2.58 million shares on Wednesday, more than the daily average volume of 1.10 million.
News of the start of four phase 3 trials by its partner sent the ARDX stock soaring.
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What actually happened?
Ardelyx aims to enhance the lives of patients with kidney and cardiorenal diseases by discovering, developing, and commercializing first-in-class medicines. ARDX is developing tenapanor for control of serum phosphorus in adults with chronic kidney disease on dialysis. Its NDA is currently being reviewed by the FDA, and a PDUFA date of April 29, 2021, is scheduled.
ARDX is also developing RDX013, a potassium secretagogue, for the treatment of elevated serum potassium levels that occur in patients with a number of kidney and/or heart diseases, and is working on metabolic acidosis in patients with congestive heart failure.
Ardelyx announced yesterday that its collaboration partner in Japan, Kyowa Kirin Co. has initiated four Phase 3 clinical studies in Japan assessing the efficacy and safety of tenapanor in the treatment of hyperphosphatemia.
ARDX will be remunerated with a $5 million payment if this development milestone is achieved.
Phase 3 clinical trials consist of the following:
- A randomized, double-blind, control-group comparative study on randomized, double-blind, controlled, and placebo-controlled subjects;
- A parallel group comparison of phosphate binder combinations;
- A single-arm open-label study evaluating patients taking dialysis for hyperphosphatemia;
- Long term study in Japan, looking at serum phosphorus in patients switching from one or more phosphate binders to tenapanor for hyperphosphatemia.
Based on Ardelyx (ARDX) analysis, tenapanor, alone or combined with sevelamer carbonate, is capable of significantly lowering phosphorus levels. Despite treatment with low doses of sevelamer or tenapanor, patients exhibited a mean serum phosphorus reduction after nearly one year. The current clinical trials will be assessing the ability of ARDX to demonstrate that reduction as well.