Paratek Pharmaceuticals Inc (NASDAQ:PRTK) shares have surged over 30% in after-hours after the company reported positive results from a phase 3 study of Omadacycline in community-acquired bacterial pneumonia. Specifically, Omadacycline met all FDA primary and secondary endpoints and EMA co-primary endpoints, and the drug candidate was generally safe and well tolerated. Due to the data, a U.S. NDA is planned as early as the first quarter of 2018.
CEO and Chairman Michael Bigham said:
This successful study demonstrates the potential of omadacycline to treat community-acquired bacterial pneumonia, a significant and serious health issue. This Phase 3 study in pneumonia along with our previously announced successful Phase 3 study in skin infections satisfy the regulatory filing requirements of our special protocol assessment with the FDA. We look forward to sharing these data with the FDA and EMA. Our plan is to submit our NDA in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.
Community acquired bacterial pneumonia is a major problem, resulting in 3.3 million hospitalizations in the U.S. alone each year, with a mortality risk of over 5% in observational studies.
What Does The Smart Money Sentiment Say?
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According to our data, the smart money was relatively bullish in the fourth quarter. Of the 742 elite funds we track, 19 funds owned $78.45 million of Paratek Pharmaceuticals Inc (NASDAQ:PRTK) and accounted for 22.50% of the float on December 31, an increase from 17 funds and $63.71 million respectively on September 30. Seth Klarman‘s Baupost Group was one of the bulls, having reported a stake of 2.04 million shares at the end of 2016.
The Bottom Line
Given the need to successfully treat community-acquired bacterial pneumonia, traders have bid up Paratek Pharmaceuticals Inc (NASDAQ:PRTK) after results from a phase 3 study showed that the company’s lead drug candidate, Omadacycline, had met its primary and secondary endpoints and was generally safe as well. For another interesting read, check out the 10 least addictive drugs.