NPS Pharmaceuticals (NPSP) announced that the tentative review date of the biologics license application (BLA) for Natpara, by an advisory panel of the FDA, has been pushed back by the U.S. regulatory body to Sep 12, 2014. The Advisory Committee was originally scheduled to meet tentatively on Jul 24 to review Natpara’s BLA.
NPS Pharma stated in its press release that the FDA should publish a definitive date for the panel meeting in the Federal Register at least 15 days before the meeting. The company is looking to get Natpara approved for treating patients suffering from hypoparathyroidism.
NPS Pharma had submitted the BLA to the FDA in Oct 2013. The BLA was accepted for standard review by the FDA in Jan 2014. Though the tentative meeting date of the FDA’s advisory panel meeting has been pushed back, the target date of Oct 24, 2014 remains the same.
Currently, Gattex is NPS Pharma’s sole marketed product. Gattex was launched in the U.S. in Feb 2013 as a subcutaneous injection for treating adults with short bowel syndrome, dependent on parenteral support.
We note that NPS Pharma trimmed its net sales outlook for 2014 while releasing its first quarter 2014 results last month. The company now expects sales in the range of $100–$110 million (old guidance: $110–$120 million). The guidance was slashed following the slowdown in Gattex sales in January and February.
We expect investor focus to remain on updates regarding Natpara. Approval of Natpara would reduce the company’s dependence on Gattex.
NPS Pharma carries a Zacks Rank #5 (Strong Sell). Better-ranked stocks in the healthcare sector include Regeneron Pharmaceuticals (REGN), Gilead Sciences (GILD) and Alexion Pharmaceuticals (ALXN). While Gilead and Regeneron sport a Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2 (Buy).
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