| Clinical and Regulatory | |
|---|---|
| Event Type: | PDUFA |
| Timing: | 07/19/2016 |
| 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: | Opioid-Induced Constipation |
| Lead Indication?: | No |
| Treatment Name: | RELISTOR (methylnaltrexone bromide) |
|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
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| Company Information | |
|---|---|
| Co. Name: | Valeant Pharmaceuticals |
| Stock Symbol: | VRX |
| 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://ir.progenics.com/releasedetail.cfm?ReleaseID=963260 |
| Partnership: | Yes |
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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
QuoteLAVAL, Quebec and TARRYTOWN, N.Y. , April 4, 2016 /CNW/ -- Valeant Pharmaceuticals International, Inc. ( NYSE : VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Oral RELISTOR (methylnaltrexone bromide) new drug application (NDA) by three months to July 19, 2016 . The FDA extended the action date to allow for a full review of Valeant's responses to recent information requests from the FDA .