Melinta Therapeutics Inc. (fka MLNTQ)

[boston127]

FDA approval. Very few OS shares.

Melinta Therapeutics Inc. (MLNT) shares were higher premarket after the company said the U.S. Food and Drug Administration accepted a supplemental New Drug Application for Baxdela for priority review.

Shares rose 45% to $2.87 premarket.

The sNDA filing seeks to expand the current indication for Baxdela to include adult patients with community-acquired bacterial pneumonia.

The FDA granted priority review status based on the previous Qualified Infectious Disease Product designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections. The FDA assigned a proposed review deadline of Oct. 24.

Baxdela was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.