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Paratek Eyes FDA Approval of Antibiotic After Advisory Panel Nod

Xconomy Boston — 

An FDA advisory committee voted to recommend U.S. approval of Paratek Pharmaceuticals’ experimental antibiotic, omadacycline, both for the treatment of certain types of bacterial skin infections and hospital-acquired pneumonia.

The independent advisory panel’s endorsement isn’t binding, but the FDA often follows the guidance of such committees. The FDA’s decision is expected in early October, Boston-based Paratek (NASDAQ: PRTK) said in a press release announcing the positive vote. Pending approval, Paratek plans to start selling the drug next year.

Trading of Paratek shares was halted much of Wednesday, but ticked up 1 percent, to $11 apiece, when trading resumed in the afternoon. Paratek’s stock closed at $10.55 on Wednesday, down from Tuesday’s close of $10.90.

Paratek ran two successful Phase 3 clinical trials of omadacycline, a “broad spectrum” antibiotic that can handle multiple types of infections. It is also developing the antibiotic for complicated urinary tract infections, with Phase 2 data expected in 2019. Here’s more on Paratek, omadacycline, and the commercial challenges antibiotic developers face.