Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
Nabriva Therapeutics PLC – ADR (NASDAQ:NBRV) shares are trading sharply higher, riding on the back of a positive FDA verdict on one of its pipeline assets.
What Happened
ENTER TO WIN $500 IN STOCK OR CRYPTO
Enter your email and you'll also get Benzinga's ultimate morning update AND a free $30 gift card and more!
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.
Want Private Access to Benzinga Analyst?
Check out the latest strategies our team of experts are using every week so that you can always adapt to the market like the pros!—Get FULL Access to This Week's Webinar Here.
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.
Related Links:
FDA Issues Complete Response For Vanda's Hetlioz In Jet Lag Disorder
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.