Rate this post


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.