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Melinta delays antibiotic after US FDA approval, sending shares tumbling

Melinta Therapeutics Inc.'s antibiotic Baxdela has been approved by the U.S. Food and Drug Administration to treat community-acquired bacterial pneumonia in adults, but the launch will be delayed as the company reviews its finances.

Shares of the Morristown, N.J.-based company closed down about 7.8% to $4.37 on Oct. 24, but continued to plummet 22% in after-hours trading to $3.45.

Baxdela was previously granted a qualified infectious disease product designation and a priority review, which allows for certain incentives to accelerate the development of therapies for life-threatening conditions.

"As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives," interim CEO Jennifer Sanfilippo said in an Oct. 24 press release. "We are delaying the commercial launch of [community-acquired bacterial pneumonia] until we have greater insight into our ability to secure additional sources of liquidity."

The FDA's decision is based on a phase 3 clinical trial of Baxdela that found the antibiotic to be equal to moxifloxacin, a common medicine for bacterial infections. The agency accepted the application for approval in community-acquired bacterial pneumonia, one of the most common infectious diseases, in June, causing Melinta's stock to jump 146%.