Nabriva Therapeutics plc NBRV announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA), seeking approval for both intravenous (IV) and oral formulations of lefamulin for the treatment of community-acquired pneumonia (CAP) in adult patients. This quick validation from the EMA confirms that the MAA submission is ready for the formal review process by the regulatory agency.
Nabvira expects a decision from the Committee on Human Medicinal Products in the next 12-15 months. Last month, the company submitted the MAA for both the IV and oral formulations of lefamulin for treating patients with CAP aged 18 years and above.
The company plans to enter into a commercial partnership to commercialize lefamulin across Europe for adult patients with CAP. If approved, lefamulin will be available across all the 28 member states of EU along with Norway, Liechtenstein and Iceland.
Shares of Nabvira have surged 44.5% so far this year, outperforming the industry's increase of 4.2%.
Lefamulin is a potentially first-in-class, semi-synthetic pleuromutilin antibiotic available for oral as well as IV administration in humans to address community-acquired bacterial pneumonia (CABP).
Notably, last December, Nabvira submitted two new drug applications to the FDA for both the IV and oral formulations of lefamulin to treat CABP in the United States. The regulatory body has set an action date of Aug 19, 2019.
Apart from lefamulin, Nabvira has another candidate in its portfolio - Contepo - a potentially first-in-class epoxide intravenous antibiotic developed for treating adult patients with complicated urinary tract infection (cUTI).
Zacks Rank & Stocks to Consider
Nabvira currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. ACOR , Repligen Corporation RGEN and Merus N.V. MRUS , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
Acorda's loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
Repligen's earnings estimates have been revised 9.4% upward for 2019 and 9.8% upward for 2020 over the past 60 days. The stock has soared 52.6% year to date.
Merus' loss per share estimates have been narrowed 22.2% for 2019 and 17.2% for 2020 over the past 60 days.
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