| Clinical and Regulatory | |
|---|---|
| Event Type: | PDUFA |
| Timing: | 10/22/2016 |
| 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: | Endocrine |
| Indication: | Secondary Hyperparathyroidism |
| Lead Indication?: | No |
| Treatment Name: | RAYALDEE® (calcifediol) |
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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: | OPKO |
| Stock Symbol: | OPK |
| Shares Traded: | NYSE |
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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: | Positive |
| Event Discussion: | Forums |
| Event Announcement(s): | http://investor.opko.com/releasedetail.cfm?ReleaseID=976439 |
| 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
MIAMI --(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved RAYALDEE®(calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3).