AstraZeneca plc AZN announced that the FDA has accepted for review its complete re-submission of the new drug application (NDA) for ZS-9 (sodium zirconium cyclosilicate).
The company is looking to get ZS-9 approved for the treatment of hyperkalemia (high potassium level in the blood serum).
The regulatory agency has classified the re-submission as a complete class 2 response. This means that it may include a presentation to an advisory committee and require a re-inspection of its manufacturing facility. A review of the class 2 resubmissions usually takes six months from the receipt date.
We remind investors that AstraZeneca had received a complete response letter from the FDA for ZS-9 in May 2016. The CRL had cited observations from a pre-approval manufacturing inspection and the receipt of new data, which was yet to be reviewed.
An approval would be a major boost for the company. Hyperkalemia represents a huge market given the addressable patient population of approximately 3 million in the U.S. We note that the approval of Relypsa, Inc.’s Veltassa in the U.S. in Oct 2015 marked the first drug in more than 50 years to be indicated for the treatment of hyperkalemia.
Meanwhile, ZS-9 is currently under review in the EU and Australia, with responses expected in the first half of 2017.
ZS-9 became part of AstraZeneca’s pipeline following the Dec 2015 acquisition of ZS Pharma.
Zacks Rank & Key Picks
AstraZeneca currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. BMRN, Exelixis, Inc. EXEL and Amarin Corporation plc AMRN. While BioMarin and Exelixis sport a Zacks Rank #1 (Strong Buy), Amarin carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 100.9% year to date.
Amarin’s loss estimates have narrowed from 46 cents to 40 cents for 2016 and from 34 cents to 27 cents for 2017 over the last 60 days. The company’s share price has soared 58.7% year to date.
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