NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) is up huge in regular trading on Wednesday, due to positive preliminary results of a clinical trial. The FDA has posted the briefing materials prior to the meeting for approval. The trial has not yet been approved by the FDA, but the way the stock has been trading it would suggest otherwise.

The company designed the drug, Natpara, for hormone replacement therapy. Specifically the drug treats hypoparathyroidism which causes the parathryroid gland not to secrete enough hormones that in turn work with vitamin D to regulate body calcium.

Upon a preliminary review by the FDA, Natpara reduced the need for calcium and vitamin D supplements in clinical trials. One significant note from the trial was that data from one of the trial sites was excluded due to manufacturing violations. Another fact worth noting from the study was that serious adverse effects were seen in both the treatment group and the placebo group.

The news of this comes days before a formal FDA review on September 12, of NPS’s BLA for Natpara by the Endocrinologic and Metabolic Drugs Advisory Committee. Natpara has a PDUFA date set for October 24, 2014.

Coming down the pipeline, NPS has two more drug candidates in its pipleline — Teduglutide (Gattex, approved for pediatric Short Bowel Syndrome) and NPSP795 (conducting an ongoing Phase 2a study of NPSP795 in adults with ADH). Teduglutide is currently finished with Phase 2 clinical trials and treats Pediatric Short Bowel Syndrome. NPSP795 is currently finished with Phase 1 clinical trials and treats Autosomal Dominant Hypocalcemia.

On the day, the stock has been as high as $31.88 up 25.8% from a low of $25.34 from the previous day. The favorable news from the trial has been the driving force behind NPS throughout the day. What stands out equally as much as the percentage gain is the exponential volume spike associated with the move — over 8.9 million shares as of 3:00 p.m. Easter versus 1.6 million shares on average.

In mid-August, FBR Capital initiated coverage with a rating of Outperform, with a $34 price target. That call is looking rather solid now, although the formal outcome is still in the ‘pending’ category.

NPS Pharmaceuticals shares were last seen trading at $31.71, for a gain of 23.05% on the day. The consensus price target is $37.46 and it has a 52-week trading range of $21.60 to $39.68.

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