Our lead product, lefamulin, is the first pleuromutilin antibiotic for intravenous and oral administration in humans. We have completed two pivotal Phase 3 trials evaluating the safety and efficacy for the treatment of community-acquired bacterial pneumonia (CABP), the leading cause of infection death and the second most common cause of hospitalization in the United States. Lefamulin met all FDA and EMA primary endpoints in both LEAP 1 and LEAP 2 and was shown to be generally well tolerated. We expect to apply for US marketing approval of lefamulin for the treatment of CABP in the fourth quarter of 2018 and an MAA with the European Medicines Agency a few months later.
|Bank Name||Nabriva Therapeutics plc|
|CEO||Dr. Colin Broom|