Ardelyx, Inc. (ARDX - Free Report) announced that it has received FDA approval for Ibsrela (tenapanor) as a treatment for irritable bowel syndrome with constipation (IBS-C) in adults. This marks the first FDA approval for the company for any of its pipeline candidates.
Ibsrela, an NHE3 sodium transport inhibitor, received approval in the United States based on encouraging data from two phase III studies, which evaluated twice-daily, 50 mg dose of the drug in IBS-C patients. Data from the studies demonstrated that Ibsrela achieved a statistically significant reduction in constipation and abdominal pain.
Ardelyx is in discussions to ink a collaboration deal to support the launch of Ibsrela. With no deal, the company’s cash resources may prove to be inadequate for successful commercialization of the drug. Please note that the drug is likely to face stiff competition from Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) /Allergan’s (AGN - Free Report) , Linzess, which holds a strong position in the IBS-C segment. Bausch Health (BHC - Free Report) also has an IBS-C drug, Trulance, in its portfolio.
Shares of Ardelyx however declined 10.5% in pre-market trading on Sep 13, presumably due to the absence of a collaboration partner. However, the company’s shares have surged 250.9% so far this year compared with industry’s increase of 6.7%. The significant year-to-date increase in shares is driven by encouraging progress of Ibsrela in other indications.
Apart from IBS-C, Ardelyx is developing tenapanor for treating hyperphosphatemia as monotherapy or in combination with phosphate binders.
Earlier this month, the company announced that the drug met primary and all key secondary endpoints in the pivotal phase III study – AMPLIFY – evaluating its combination regimen for treating hyperphosphatemia. The tenapanor combination regimen achieved a statistically significant reduction in serum phosphorus from baseline after four weeks of treatment. Top-line data from the phase III study – PHREEDOM – evaluating tenapanor monotherapy is expected in the fourth quarter of 2019. The company expects to file regulatory applications following the PHREEDOM data, seeking approval for tenapanor monotherapy and combination therapy.
The company is also developing another pipeline candidate, RDX013, as a treatment for hyperkalemia — a condition of elevated level of potassium in the blood.
Ardelyx currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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