1.9900 +0.01 (0.51%)
After hours: 7:55PM EDT
|Bid||1.9900 x 3100|
|Ask||1.9800 x 3200|
|Day's Range||1.9500 - 2.0701|
|52 Week Range||1.1200 - 3.2700|
|Beta (3Y Monthly)||2.67|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
This most-searched list is a feature included in Benzinga Pro's Newsfeed tool. It highlights stocks frequently searched by Benzinga Pro users on the platform. iBio (NYSE: IBIO ) shares were down 14% to ...
The FDA approves Nabriva's (NBRV) new drug application for both intravenous and oral formulations of Xenleta to treat adult patients with community-acquired bacterial pneumonia.
The FDA approved Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV )'s lead antibiotic asset, Xenleta, on Monday for the treatment of community-acquired bacterial infections. The Analysts Bank of America ...
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. 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.
Shares of Nabriva Therapeutics PLC shot up 27% to pace the premarket gainers in active trading Tuesday, after the biotechnology company said its new drug application (NDA) for the oral and intravenous formulations of Xenleta, a treatment for community-acquired bacteria pneumonia, was approved by the Food and Drug Administration. Trading volume of over 1.3 million shares was already more than the full-day average of about 922,000 shares. "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 Chief Executive Ted Schroeder. The company expects Xenleta to be available in mid-September through U.S. specialty distributors, and will have a wholesale acquisition price of $205 per IV patient treatment day and $275 per oral patient treatment day. The stock has slumped 7.5% over the past three months through Monday, while the S&P 500 has gained 2.9%.
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The company is also planning to resubmit an application for a second new drug candidate that the FDA rejected earlier this year.
Nabriva (NBRV) intends to resubmit the NDA for Contepo in Q4. The intravenous candidate is being studied for treating patients with complicated urinary tract infection including acute pyelonephritis.
Nabriva Therapeutics Plc on Monday priced an oral and injectable version of its antibiotic Xenleta, which treats community-acquired pneumonia, at more than $200 per day after it received approval from the U.S. Food and Drug Administration. It's the first drug by the company to be approved by the FDA and is expected to launch in mid-September.
Biotech stocks succumbed to the broader market weakness, as trade tensions and recession fears shook the broader markets. Earnings and stray clinical readouts triggered some activity in the space. Here ...
Following the receipt of the final minutes of a Type A meeting Nabriva had with the FDA, the company said it expects to resubmit the NDA for injectable Contepo — which is being evaluated for complicated urinary tract infections, including acute pyelonephritis — early in the fourth quarter of 2019. Nabriva's original NDA was accepted by the FDA for priority review Jan. 4, with a PDUFA action date of June 30. The FDA, however, handed down a complete response letter to the NDA April 30, urging the company to address issues related to facility inspections and deficiencies at one of the company's manufacturers.
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We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. The...
Melinta (MLNT) announces preliminary sales for the second quarter. However, sales number suggests estimates miss for the quarter. Shares fall.
The EMA endorses Nabriva Therapeutics' (NBRV) marketing application for both the intravenous and oral formulations of lefamulin to treat adult patients with community-acquired pneumonia.
The first quarter was a breeze as Powell pivoted, and China seemed eager to reach a deal with Trump. Both the S&P 500 and Russell 2000 delivered very strong gains as a result, with the Russell 2000, which is composed of smaller companies, outperforming the large-cap stocks slightly during the first quarter. Unfortunately sentiment shifted […]
ADR (NASDAQ: NBRV) shares traded higher last week after the micro-cap biotech said it requested a Type A meeting with the FDA regarding the complete response letter for the new drug application for its investigational compound Contepo to treat complicated urinary tract infections, including acute kidney infections. The FDA shot down the regulatory application in early May, citing issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers. The FDA and the applicants of regulatory filings interact with each other during the review period regarding advice relating to the development and review of investigational new drugs and biologics.
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Nabriva is seeking European approval for both intravenous and oral formulations of Lefamulin as a treatment of community-acquired pneumonia in adults.
Microcap biotech Nabriva announced Tuesday after the close that it received a complete response letter for its New Drug Application for Contepo injection, chemically fosfomycin, for treating complicated urinary tract infections, or cUTIs, including acute pyelonephritis. Nabriva said the letter pertains to issues related to facility inspections and manufacturing deficiencies at one of its contract manufacturers. Nabriva said it will seek a Type A meeting with the FDA to discuss the findings.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on April 30) VolitionRX Ltd (NYSE: VNRX ) ZEALAND PHARMA/S ADR ...
The federal agency wants the King of Prussia company to adress facility inspection issues and manufacturing deficiencies at one if its contract manufacturers.