Melinta Therapeutics Inc. (NASDAQ: MLNT) has announced that the U.S. Food and Drug Administration (FDA) has approved Baxdela (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.
The FDA approval of Baxdela for the treatment of CABP is based on positive results from a Phase 3 study that compared the efficacy and safety of Baxdela to moxifloxacin. The study results demonstrated that Baxdela met all key primary and secondary endpoints in the trial.
The approval represents a label expansion for Baxdela, which was originally approved in 2017 for acute bacterial skin and skin structure infections.
However, the company flagged liquidity concerns and said it is delaying the commercial launch of Baxdela for CABP until it gains some insight into its ability to secure additional sources of liquidity.
This supplemental approval follows FDA priority review 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.
Jennifer Sanfilippo, interim CEO of Melinta, commented:
We are pleased to announce the approval of Baxdela for the treatment of CABP in adults. As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives. As such, while we believe that Baxdela will play a significant role in the treatment of this potentially life-threatening illness, we are delaying the commercial launch of CABP until we have greater insight into our ability to secure additional sources of liquidity.
Shares of Melinta traded down 20% on Friday to $3.50, in a 52-week range of $1.62 to $15.35. The consensus price target is $12.33.