Health and Healthcare
It's Not the FDA Holding Back This New Pneumonia Treatment
Published:
Last Updated:
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.
Credit card companies are at war, handing out free rewards and benefits to win the best customers. A good cash back card can be worth thousands of dollars a year in free money, not to mention other perks like travel, insurance, and access to fancy lounges. See our top picks for the best credit cards today. You won’t want to miss some of these offers.
Flywheel Publishing has partnered with CardRatings for our coverage of credit card products. Flywheel Publishing and CardRatings may receive a commission from card issuers.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.