BioCentury
ARTICLE | Clinical News

Nabriva rises on Phase III CABP success

September 18, 2017 8:24 PM UTC

Nabriva Therapeutics plc (NASDAQ:NBRV) jumped $2.01 (29%) to $8.87 on Monday after reporting that IV-to-oral lefamulin (BC-3781) met the FDA- and EMA-defined primary endpoints in the Phase III LEAP 1 trial to treat moderate to severe community-acquired bacterial pneumonia. Top-line data from the Phase III LEAP 2 trial evaluating oral lefamulin to treat CABP are expected next spring, with an NDA submission to FDA to follow in 2H18. The company plans to submit an MAA to EMA “within a few months” after its NDA submission.

After market close, Nabriva proposed to raise $80 million in a follow-on underwritten by Morgan Stanley, BofA Merrill Lynch, SunTrust Robinson Humphrey, Needham and Wedbush...

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