Organogenesis (ORGO) said late Monday that it plans to file a Biologics Licenses Application for ReNu, its amniotic suspension allograft developed to manage symptomatic knee osteoarthritis, by the end of the year.
The company said the move followed "the successful" completion of a planned Type-B meeting with the US Food and Drug Administration.
Shares of the company were up 9% in recent Tuesday premarket activity.