Priority Review for Symbiomix's Solosec

Symbiomix Therapeutics LLC (Newark, N.J.) said FDA accepted and granted Priority Review to an NDA for Solosec secnidazole to treat bacterial vaginosis. Its PDUFA date is Sept. 17.

Solosec has met the primary endpoints in a Phase III trial and a pivotal Phase II study. If it is approved, Symbiomix said the candidate would be the only single-dose oral therapy for the indication. ...