Nabriva Therapeutics plc NBRV announced that it plans to resubmit a new drug application (NDA) for Contepo (Fosfomycin) injection to the FDA early in the fourth quarter of 2019. A potentially first-in-class epoxide intravenous antibiotic Contepo is being developed for treating patients with complicated urinary tract infection (cUTI) including acute pyelonephritis.
The decision came following the receipt of the final Type A Meeting minutes from the regulatory body.
In April this year, Nabriva received a Complete Response Letter (CRL) from the FDA in connection with the NDA for Contepo regarding facility inspections and manufacturing deficiencies at one of its contract manufacturers. The company had filed the NDA for Contepo last October for treating the given patient population.
The FDA has neither requested any new clinical or non-clinical data nor raised any concerns about the safety and efficacy of Contepo post the meeting. The regulatory agency will review the resubmission within six months of the receipt date, which will now be designated as “Class 2.”
The company is looking forward to bring this important treatment option to patients as quickly as possible.
Shares of Nabvira have soared 56.2% so far this year against the industry’s decline of 2%.
We would like to remind investors that apart from Contepo, the company has another candidate in its portfolio called lefamulin, which is a potentially first-in-class, semi-synthetic pleuromutilin antibiotic available for oral as well as intravenous (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. A decision is expected shortly.
In June this year, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA), seeking approval for both IV and oral formulations of lefamulin for the treatment of community-acquired pneumonia (CAP) in adult patients.
If approved, lefamulin will be available across all the 28 member states of the EU along with Norway, Liechtenstein and Iceland.
Zacks Rank & Other Stocks to Consider
Nabvira currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the healthcare sector include FibroGen, Inc FGEN, Celcuity, Inc. CELC and Eton Pharmaceuticals, Inc. ETON, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
FibroGen’s loss per share estimates have been narrowed 57.5% for 2019 and 64.2% for 2020 over the past 60 days.
Celcuity’s loss per share estimates have been narrowed 13.6% for 2019 and 26% for 2020 over the past 60 days.
Eton Pharmaceuticals’ loss per share estimates have been narrowed 26.2% for 2019 and 51.5% for 2020 over the past 60 days.
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