Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) is off to an incredibly strong start in the early hours of today’s trading session and for good reason. The company released clinical data with regard to a key trial that proved to be overwhelmingly positive. Of course, this led to excitement among investors who are pushing the stock toward the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:06), NBRV is trading at $12.40 per share after a gain of $5.54 per share or 80.83% thus far today.
NBRV Gains On Strong Clinical Data
As mentioned above, NBRV is having an overwhelmingly strong start to the trading session this morning after the company announced positive top-line data from a key clinical trial. The trial, known as LEAP 1 was designed to evaluate the safety and efficacy of intravenous to oral lefamulin in patients with community acquired bacterial pneumonia. This is a key treatment as CABP is the leading cause of infectious death in the United States.
The data comes from the first of 2 pivotal Phase 3 clinical trials surrounding lefamulin. According to the press release offered by Nabriva Therapeutics, the trial met the United States Food and Drug Administration primary endpoint of non-inferiority when compared to moxifloxacin with or without adjunctive liezolid for early clinical response assesed 72 to 120 hours following initiation of therapy in the intent to treat population. The company announced that ECR rates were 87.3% for lefamulin and 90.2% for moxifloxacin with or without linezolid. In a statement, Dr. Colin Broom, CEO at NBRV, had the following to offer:
“These Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen… Due to lefamulin’s flexible dose and targeted spectrum of activity against the pathogens most commonly associated with CABP, including multidrug-resistant strains, we believe that lefamulin is well suited to be a first-line empiric monotherapy. I am extremely proud and appreciative of the Nabriva Therapeutics team that has advanced lefamulin, which has the potential to be the first in a new class of antibiotics for CABP in more than 15 years, from initial discovery in our labs to this important milestone. We continue to execute on our second pivotal trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in the fourth quarter of 2017 and topline results anticipated in the spring of 2018.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on NAVB. In particular, we’re interested in following the continued development of lefamulin as the treatment seems to be an overwhelmingly promising new option for treating CABP. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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