Nabriva Shares Rip Higher Following FDA Nod For Novel Antibiotic

Nabriva Therapeutics PLC – ADR NBRV shares are trading sharply higher, riding on the back of a positive FDA verdict on one of its pipeline assets.

What Happened

Nabriava, a thinly-traded micro-cap biotech, announced late Monday the FDA approved its NDA for the oral and intravenous formulations of Xenleta, or lefamulin, for the treatment of community-acquired bacterial pneumonia, or CABP, in adults.

"Today's approval of XENLETA is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP," said CEO Ted Schroeder.

Why It's Important

Xenleta is the first IV and oral antibiotic with a novel mechanism of action, approved by the FDA in nearly two decades, the company said.

Due to Xenleta novel mechanism of action, the likelihood of developing resistance as well as cross resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes is low.

It's available as 600mg oral dosage every 12 hours and 150mg intravenous dosage every 12 hours, and is to be administered with a short five- to seven-day course of therapy.

Both the formulations have Fast Track as well as Qualified Infectious Disease Product designation.

What's Next

The product is likely to be made available through major specialty distributors in the U.S. in mid-September at a wholesale acquisition price of $205 per intravenous patient treatment day and $275 per oral patient treatment day.

The stock was rallying 24.89% to $2.76 per share Tuesday morning.

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