Jazz Pharma [NASDAQ:JAZZ] drug may face a review panel |
Companies - Biotechnology Companies | |||
Written by Hugh McManus | |||
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It's very possible that the fibromyalgia drug, JZP-6, from Jazz Pharmaceuticals may face an FDA review panel. The drug has a PDUFA date of October 11, so it could face a review between mid-July to mid-August at the latest. Jazz Pharmaceuticals is an emerging company in the Bay Area of California. It recently announced a public offering of 7 million shares of common stock to be priced at $8.35 a share. The stock has preformed well over the last twelve months, rising from below a dollar (about eighty cents) to a recent high of almost $14. The company closed on Wednesday at $8.65. The company has two marketed products and four active clinical programs. JZP-6 for fibromyalgia is furthest along. On February 28, 2010, the company reported that the FDA had accepted its NDA which was reported as submitted on December 15, 2009 and that it had a PDUFA date of October 11. It echoed previous reports that two successful phase III trials were completed on JZP-6. Looking at the schedule of upcoming meetings, I think it's likely that the drug could face a review panel in mid-July. A positive outcome could give the drug a boost; if the committee concurs that both phase III trials gave meaningful results and there are no safety or potential abuse issues with the drug, it could likely be approved in October. The stock could move to between $12 and $16 a share.
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