| Clinical and Regulatory | |
|---|---|
| Event Type: | PDUFA |
| Timing: | 05/26/2016 |
| Designation(s): | None |
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This event is set for a specific date and makes planning easier. However, specific dates may change.
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| Disease and Treatment | |
|---|---|
| Disease: | Other |
| Indication: | Hyperkalemia |
| Lead Indication?: | Yes |
| Treatment Name: | ZS-9 (sodium zirconium cyclosilicate) |
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Likelihood of event success varies depending on disease, treatment and lead indication classification.
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| Company Information | |
|---|---|
| Co. Name: | ZS Pharma |
| Stock Symbol: | ZSPH |
| Shares Traded: | NASDAQ |
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The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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| Event Status | |
|---|---|
| Event Outcome: | Negative |
| Event Discussion: | Forums |
| Event Announcement(s): | http://www.sec.gov/Archives/edgar/data/1459266/000119312515268241/d66049dex991.htm |
| Partnership: | No |
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Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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Detailed Event Description from Company Announcement
Redwood City, Calif. – July 29, 2015 – ZS Pharma, Inc. (Nasdaq: ZSPH), today announced that its New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia, has been accepted for filing by the United States Food and Drug Administration (FDA).
We have been informed that the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is May 26, 2016.