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Biotech Stocks Facing FDA Decision In October 2019

Melinta Therapeutics
Melinta Therapeutics

Melinta Therapeutics Inc.’s (MLNT) supplemental New Drug Application for Baxdela seeking approval in the indication of community-acquired bacterial pneumonia is under priority review by the FDA, with a decision expected on October 24, 2019.

Baxdela received its initial approval in the U.S. in July 2017 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive and gram-negative bacteria.

Available as a 450mg tablet and 300mg single-dose vial for oral and intravenous administration, Baxdela is developed by Melinta Therapeutics in partnership with Ligand Pharmaceuticals.

Baxdela is also under review by the European Commission for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive and gram-negative bacteria. If approved, the drug will be marketed in the EU under the brand name Quofenix.

MLNT closed Friday’s (Sep.27, 2019) trading at $3.57, down 1.92%.