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AGRX > SEC Filings for AGRX > Form 8-K on 13-Jul-2016All Recent SEC Filings

Show all filings for AGILE THERAPEUTICS INC



Other Events, Financial Statements and Exhibits

Item 8.01. Other Events.

On July 12, 2016, Agile Therapeutics, Inc. ("Agile") issued a press release announcing that preparations are underway for an initial Phase 2 clinical trial of a novel contraceptive regimen, which will begin the development of its pipeline beyond its current lead product candidate, Twirlaź, a once weekly contraceptive patch currently in Phase 3 development. The planned Phase 2 clinical trial will examine the use of Twirla in an innovative regimen designed to allow women to experience shorter, lighter periods, using a smaller lower dose combination ethinyl estradiol/levonorgestrel patch ("SmP"). Agile has started preparations for the trial and expects to initiate dosing in the first quarter of 2017. Agile also announced that it has plans to develop an extended cycle regimen for Twirla (AG200-ER) that may also utilize the SmP with the goal of allowing women to have fewer periods each year.

On July 12, 2016, Agile also updated its corporate presentation that it intends to use in connection with presentations at conferences and meetings with investors. The updates include the information on its pipeline announced in the press release referenced above and the appointment of a new chief commercial officer, which was previously announced.

Copies of Agile's press release and presentation are attached hereto as Exhibits 99.1 and 99.2, respectively, and are hereby incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d)                 Exhibits.

Number                            Description

99.1 Agile Therapeutics, Inc. Press Release dated July 12, 2016.
99.2 Agile Therapeutics, Inc. Presentation.

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