AGRX - Agile Therapeutics: Preparing For The AdCom And PDUFA Run-Up
Back in May, Agile Therapeutics (AGRX), publicized that they resubmitted Twirla’s NDA to FDA. Twirla is Agile’s lead product candidate that is a low-dose combination hormonal contraceptive patch. Subsequently, Agile stated that the FDA accepted the NDA resubmission with the PDUFA date set for November 16th but without an advisory committee "AdCom." About a month later, the FDA informed Agile that they scheduled AdCom on October 30th. Recently, the company closed a public offering that expects to clear $12.6M in net proceeds. Altogether, these catalysts and events have set Agile and