The FDA has accepted Melinta Therapeutics’ (NASDAQ:MLNT) supplemental New Drug Software (sNDA) for BAXDELA (delafloxacin) for precedence evaluate.
The sNDA submitting seeks to develop the present indication for BAXDELA to incorporate grownup sufferers with community-acquired bacterial pneumonia (CABP).
The FDA has assigned a PDUFA motion date of October 24.
Precedence Evaluation shortens the evaluate clock to 6 months from the usual 10 months.
Shares are up 64% premarket.