Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of NPS Pharmaceuticals (NASDAQ:NPSP), a biopharmaceutical company focused on developing drugs aimed at a wide array of therapeutic areas, surged higher by as much as 22% after the Food and Drug Administration posted the briefing materials (link opens PDF) on its website regarding NPS Pharma's experimental hypoparathyroidism drug, Natpara, which is scheduled to be reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee this Friday. Hypoparathyroidism is a condition where a hormone that controls calcium and phosphorous levels isn't properly produced.
So what: Briefing documents are released by the FDA two days prior to an FDA panel's vote on whether or not to recommend approval of a drug, and they can give investors insight into the thoughts of the FDA panel prior to their vote. The FDA will weigh the vote of its panel during the PDUFA decision meeting to approve or deny a drug, but it's not obligated to follow the recommendation of its panel.
According to the briefing documents released today, the FDA's panel appears to be impressed with Natpara's efficacy, calling the REPLACE study "conservative" when assessing the primary endpoint, and referring to Natpara as "superior to placebo" and "effective" in maintaining serum calcium levels with a reduction in oral calcium and vitamin D dosing. The panel also appeared to have no qualms with the safety of Natpara, either.
As a refresher, in the REPLACE study the primary endpoint was a combination of at least a 50% reduction in oral calcium dose, at least a 50% reduction in active vitamin D dose, and calcium serum concentrations steady in a range of 7.5 mg/dL to 10.6 mg/dL. Per the results, just one out of 40 placebo patients met the primary endpoint, while 46 out of 84 patients in the Natpara arm met the primary endpoint.
Now what: On the surface this looks like a positive sign that NPS will be staring down a recommendation for approval from the FDA's panel this Friday. Of course, the FDA has also been known to throw more curveballs investors' way than award-winning pitchers in the major leagues, so make sure you don't count your chickens before they're hatched. It's rare that the FDA's panel doesn't find something to harp on, and I wouldn't be surprised if we see this on Friday, either.
Overall, though, NPS and Natpara would appear to be on track for a positive PDUFA review on or before Oct. 24, 2014. I, for one, am leaning toward the drug being approved (but keep in mind my aforementioned statements about curveballs).
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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