Oragenics Inc (NYSEMKT:OGEN) shares were up 28% pre-market on Monday after the company announced that US Food and Drug Administration (FDA) granted Fast Track designation to AG013, its lead therapeutic candidate for the treatment of OM.
Oragenics expects to file an Investigational New Drug (IND) update and initiate a Phase 2 study with AG013 in the United States and Europe in early 2017.
Oragenics is a leader in the development of novel antibiotics against infectious disease and developing effective treatments for oral mucositis (OM), today
Fast Track is a process designed to facilitate the development and review of drugs to treat serious conditions and address key unmet medical needs by allowing for more frequent meetings and communications with the FDA. It also provides eligibility submission of a New Drug Application on a rolling basis as well as Accelerated Approval and Priority Review.
Oragenics shares were up 27.9% at $0.55 pre-market on Monday.
Story by ProactiveInvestors