Paratek Pharmaceuticals (NASDAQ:PRTK) is up 5.5% postmarket after it announced it’s withdrawn its application to the European Medicines Agency for marketing authorization for Nuzyra (omadacycline).
The EMA is recommending approval of Nuzyra for
treating acute bacterial skin and skin structure infections, but not for
community-acquired bacterial pneumonia — saying a second study is
required for that indication.
The company wants an approval of both indications
concurrently, since a 10-year market exclusivity would begin with the
first approval.
It plans to resubmit the application after completion of a CABP study already agreed to with the FDA.
https://seekingalpha.com/news/3506762-paratek-plus-5_5-percent-withdrawing-europe-application-nuzyra
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