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Nabriva (NBRV) Posts Positive Data From Cystic Fibrosis Study
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Nabriva Therapeutics plc announced positive top-line data from the phase I study evaluating its marketed drug, Xenleta (lefamulin), for a new indication.
The phase I study is evaluating the safety and pharmacokinetics (PK) of oral and intravenous (IV) Xenleta for the treatment of adult patients with cystic fibrosis (CF).
Per the company, the data demonstrates PK of Xenleta in CF patients is similar to that seen in previous studies, which evaluated the approved oral and IV dosing of Xenleta for treating adults with community-acquired bacterial pneumonia (CABP).
Additionally, treatment with Xenleta was generally well-tolerated and the adverse side effects in CF patient population were consistent with that seen across the clinical program. The data from the above phase I study underlines the potential utility of lefamulin in patients with CF.
NBRV plans to announce complete data from the study in the first half of 2023.
Despite the positive update, shares of Nabriva were down 4.2% on Monday following the announcement of the news. The stock has plunged 86.1% so far this year compared with the industry’s decline of 19.5%.
Image Source: Zacks Investment Research
In August 2022, Nabriva completed enrollment in a phase I study on Xenleta as a potential treatment of resistant bacterial infections in patients with CF.
We remind investors that the FDA approved both IV and oral formulations of Xenleta (lefamulin) to treat adult patients with CABP in August 2019.
In July 2020, the European Commission issued a legally binding decision for the approval of the marketing authorization application for Xenleta for the treatment of community-acquired pneumonia in adults, following a review by the European Medicines Agency.
Nabvira has another candidate in its portfolio called Contepo (fosfomycin), which is a potentially first-in-class epoxide intravenous antibiotic developed for treating adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.
A potential label expansion for Xenleta and approval for other candidates are likely to boost Nabriva’s growth prospects in the days ahead.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Immunocore have narrowed 39.7% for 2022 and 39.4% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
Loss per share estimates for Angion Biomedica have narrowed 6.1% for 2022 and 3.9% for 2023 in the past 60 days.
Earnings of Angion Biomedica surpassed estimates in three of the trailing four quarters and missed the mark on the other occasion. ANGN witnessed an earnings surprise of 66.42% on average.
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Nabriva (NBRV) Posts Positive Data From Cystic Fibrosis Study
Nabriva Therapeutics plc announced positive top-line data from the phase I study evaluating its marketed drug, Xenleta (lefamulin), for a new indication.
The phase I study is evaluating the safety and pharmacokinetics (PK) of oral and intravenous (IV) Xenleta for the treatment of adult patients with cystic fibrosis (CF).
Per the company, the data demonstrates PK of Xenleta in CF patients is similar to that seen in previous studies, which evaluated the approved oral and IV dosing of Xenleta for treating adults with community-acquired bacterial pneumonia (CABP).
Additionally, treatment with Xenleta was generally well-tolerated and the adverse side effects in CF patient population were consistent with that seen across the clinical program. The data from the above phase I study underlines the potential utility of lefamulin in patients with CF.
NBRV plans to announce complete data from the study in the first half of 2023.
Despite the positive update, shares of Nabriva were down 4.2% on Monday following the announcement of the news. The stock has plunged 86.1% so far this year compared with the industry’s decline of 19.5%.
Image Source: Zacks Investment Research
In August 2022, Nabriva completed enrollment in a phase I study on Xenleta as a potential treatment of resistant bacterial infections in patients with CF.
We remind investors that the FDA approved both IV and oral formulations of Xenleta (lefamulin) to treat adult patients with CABP in August 2019.
In July 2020, the European Commission issued a legally binding decision for the approval of the marketing authorization application for Xenleta for the treatment of community-acquired pneumonia in adults, following a review by the European Medicines Agency.
Nabvira has another candidate in its portfolio called Contepo (fosfomycin), which is a potentially first-in-class epoxide intravenous antibiotic developed for treating adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.
A potential label expansion for Xenleta and approval for other candidates are likely to boost Nabriva’s growth prospects in the days ahead.
Zacks Rank & Stocks to Consider
Nabriva currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited (ASLN - Free Report) , Immunocore Holdings plc (IMCR - Free Report) and Angion Biomedica Corp. , all carrying a Zacks Rank #2 (Buy) at present.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Immunocore have narrowed 39.7% for 2022 and 39.4% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
Loss per share estimates for Angion Biomedica have narrowed 6.1% for 2022 and 3.9% for 2023 in the past 60 days.
Earnings of Angion Biomedica surpassed estimates in three of the trailing four quarters and missed the mark on the other occasion. ANGN witnessed an earnings surprise of 66.42% on average.