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www.fdanews.com/articles/176691-melintas-baxdela-soars-in-pivotal-study

Melinta’s Baxdela Soars in Pivotal Study

May 18, 2016

Melinta Therapeutics’ anionic quinolone candidate Baxdela shined in a Phase 3 trial, meeting its primary endpoints for treating acute bacterial skin and skin structure infections.

In the trial, conducted under the FDA’s Special Protocol Assessment, the candidate reached both the EMA’s and FDA’s primary endpoints of statistical non-inferiority compared to IV vancomycin combination therapy plus aztreonam.

 

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