H.C. Wainwright Starts Ardelyx, Inc (ARDX) at Buy 'Ahead of the potential approval of XPHOZAH next quarter'

H.C. Wainwright analyst Ed Arce initiates coverage on Ardelyx, Inc (NASDAQ: ARDX) with a Buy rating and a price target of $9.00.

The analyst comments "

Disrupting two therapeutic markets with a unique and highly differentiated mechanism of action. Founded in 2007, Ardelyx is a biopharmaceutical company engaged in discovering, developing and commercializing innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx's proprietary drug discovery and design platform, coupled with a deep understanding of the primary mechanism of sodium transport in the intestine, led to the discovery and development of its first compound, tenapanor. A targeted, oral, small molecule therapy, tenapanor is a sodium hydrogen exchange 3 (NHE3) inhibitor that acts locally in the gut and is minimally absorbed, thereby minimizing the side effects and drug-drug interactions (DDIs) frequently encountered with traditional, systemically absorbed medicines. Our positive thesis on the name is based on the following expectations: (1) IBSRELA (tenapanor) net sales for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) meets or exceeds 2023 guidance of $72-$75M, and continues to gain momentum and take market share, reaching peak net sales of over $700M; (2) XPHOZAH (tenapanor) is approved by the FDA on its October 17 PDUFA date, for the control of serum phosphorus in adult CKD patients on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy. We anticipate the commercial launch of XPHOZAH in 4Q23, as guided, to be differentiated from currently available therapies that rely on the binder mechanism of action (MoA) and require frequent dosing with multiple large pills; (3) Continued international expansion of both IBSRELA and XPHOZAH via commercialization partners similar to agreements established with Fosun Pharma (Shanghai: 600196; not rated) for greater China, Knight Therapeutics (TSX: GUD; not rated) for Canada, and Kyowa Kirin (TSE: 4151; not rated) for Japan; and (4) in the medium-to-long term, advance discovery and early developmental assets, such as RDX013 and RDX020, for additional GI and cardiorenal indications. Ahead of the potential approval of XPHOZAH next quarter, we initiate coverage of Ardelyx with a Buy rating and $9.00 price target."

For an analyst ratings summary and ratings history on Ardelyx, Inc click here. For more ratings news on Ardelyx, Inc click here.

Shares of Ardelyx, Inc closed at $4.73 yesterday.

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