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Melinta Therapeutics Nearing D-Day...

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Melinta Therapeutics Inc. (MLNT), which has gained 59 percent over the last two months, awaits a regulatory catalyst next week.

Melinta is a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections. The Company has four marketed antibiotics - Baxdela, Vabomere, Orbactiv, and Minocin.

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. The Company has sought to expand the indication of Baxdela in the treatment of community-acquired bacterial pneumonia (CABP). The FDA decision on the additional indication of Baxdela is expected on October 24, 2019.

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.

Jefferies analyst David Hoang expects Baxdela to achieve peak U.S. sales of $133 million in 2028 - with ABSSSI indication contributing $122 million, and the CABP indication, if approved, accounting for $11 million.

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.

A phase I study evaluating the pharmacokinetics and safety of a new formulation of Orbactiv versus the approved formulation in subjects with ABSSSI is underway. The new formulation aims to reduce infusion time from three hours to one hour.

In the six months ended June 30, 2019, the Company had net product sales of $25.6 million compared to $20.9 million in the year-ago period.

Following the resignation of John Johnson as the Company CEO in August, Jennifer Sanfilippo was appointed interim CEO and director, effective August 28, 2019.

Melinta is scheduled to report its third-quarter financial results in the second week of November. But before that, as previously mentioned, there is an important regulatory catalyst to watch out for.

Will Melinta get the FDA nod for the expanded indication of Baxdela? Stay tuned…

A one-for-five reverse stock split of the Company's common stock was implemented on February 22, 2019. MLNT has traded in a range of $1.62 to $20.00 in the last 1 year.

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