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Relypsa Up on CRL for AstraZeneca Hyperkalemia Drug

Shares of Relypsa, Inc. RLYP gained 8.8% after AstraZeneca plc AZN received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for ZS-9 for the treatment of hyperkalemia (high potassium level in blood serum).

The CRL cited observations from a pre-approval manufacturing inspection. The agency is also yet to review the recently submitted data on ZS-9. AstraZeneca stated that it is currently evaluating the contents of the CRL and intends to work closely with the FDA to determine the next step for getting the filing back on track. ZS-9 was added to AstraZeneca’s pipeline following its acquisition of ZS Pharma in Dec 2015.

A delay on the approval of ZS-9 comes as great news for Relypsa, which would otherwise have faced tough competition for its recently approved drug, Veltassa, in the hyperkalemia space. We note that Veltassa’s approval, in the U.S. in Oct 2015 marked the first new drug approved in more than 50 years for the treatment of hyperkalemia. However, the approval was accompanied with a black box label warning patients against the use of other oral medications within 6 hours of taking Veltassa.

The market for the treatment of hyperkalemia is huge given the addressable patient population of about 3 million in the U.S. In the first quarter of 2016, Relypsa generated Veltassa sales of 0.6 million.

Meanwhile, last week, Relypsa submitted a supplemental New Drug Application (sNDA) to the FDA requesting label changes for the drug for oral suspension based on data from a phase I drug-drug interaction studies in healthy volunteers.

We expect investors to focus on further updates on the regulatory approval of ZS-9 as well as a label change for Veltassa.

Currently, both Relypsa and AstraZeneca carry a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE, both sporting a Zacks Rank #1 (Strong Buy).

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ASTRAZENECA PLC (AZN): Free Stock Analysis Report
 
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RELYPSA INC (RLYP): Free Stock Analysis Report
 
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