We are a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic diseases. Our proprietary zirconium silicate technology allows us to create highly selective ion traps that can reduce toxic levels of specific electrolytes without disturbing the balance of other electrolytes. Our initial focus is on the development of sodium zirconium cyclosilicate (ZS-9), our product candidate for which we recently completed two Phase III clinical trials for the treatment of hyperkalemia, a life-threatening condition in which elevated levels of potassium in the blood (greater than 5.0 mEq/L) increase the risk of muscle dysfunction including cardiac arrhythmias and sudden cardiac death. We have designed our development program based on input from the United States Food and Drug Administration, or FDA including a recent pre-NDA meeting, and European Medicines Agency, or EMA, and plan to submit our New Drug Application, or NDA, in the United States in the second quarter of 2015 and our Marketing Authorization Application, or MAA, in Europe in the second half of 2015 with the goal of obtaining approval for the treatment of acute and chronic hyperkalemia, regardless of the underlying disease state. If we receive regulatory approval, we intend to commercialize ZS-9 for the treatment of hyperkalemia in the United States with our own specialty sales force targeting nephrologists and cardiologists and intend to seek one or more partners for commercialization in markets outside of the United States. As of March 1, 2015, we have enrolled over 1,474 patients in our clinical studies. In our ongoing long-term studies, patients have safely received once-daily ZS-9 for over 10 months. We have completed three, double-blind, randomized placebo controlled clinical studies with ZS-9 that together enrolled 1,101 patients with hyperkalemia including patients with chronic kidney disease (CKD), heart failure (HF), type 2 diabetes and those on renin-angiotensin aldosterone system (RAAS) inhibitor therapy. Our first in-man study, ZS002, was completed in May 2012 and our first Phase III study, ZS003, was completed in November 2013. Our second Phase III study, ZS004, was completed in September 2014. All three trials met their pre-specified primary efficacy endpoints with clinically meaningful and statistically significant results. We announced the top-line results for ZS004 in September 2014, and presented detailed primary and secondary endpoint results for ZS004 at the American Heart Association Scientific Sessions on November 17, 2014. The ZS004 study results were simultaneously published in theJournal of the American Medical Association, and we announced the publication of detailed results from the ZS003 study in theNew England Journal of Medicine on November 21, 2014. We initiated an extension to the ZS004 study, or ZS004e, and a long-term safety study, ZS005, in the second quarter of 2014. We expect to file our NDA with the FDA in the second quarter of 2015 and our MAA with the EMA in the second half of 2015.
Company profile
Ticker
ZSPH
Exchange
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
SEC CIK
Corporate docs
Latest filings (excl ownership)
15-12B
Securities registration termination
28 Dec 15
SC TO-T/A
Third party tender offer statement (amended)
21 Dec 15
SC 14D9/A
Tender offer solicitation (amended)
18 Dec 15
25-NSE
Exchange delisting
17 Dec 15
8-K
AstraZeneca COMPLETES ACQUISITION OF ZS PHARMA
17 Dec 15
S-8 POS
Registration of securities for employees (post-effective amendment)
17 Dec 15
S-8 POS
Registration of securities for employees (post-effective amendment)
17 Dec 15
SC 14D9/A
Tender offer solicitation (amended)
17 Dec 15
SC TO-T/A
Third party tender offer statement (amended)
17 Dec 15
SC TO-T/A
Third party tender offer statement (amended)
25 Nov 15
Latest ownership filings
Institutional ownership, Q3 2019
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Total holders | 0 |
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Total value | 0.00 |
Total shares | 0.00 |
Total puts | 0.00 |
Total calls | 0.00 |
Total put/call ratio | – |
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