Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events

ME Staff 8-k
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Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events
Item 8.01. Other Events.

On December22, 2017, Agile Therapeutics,Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) dated December21, 2017 in response to the New Drug Application (NDA) resubmission for the Company’s investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15).

The Company also hosted a conference call on December22, 2017, at 8:00 a.m.Eastern Time to discuss the regulatory update.

A copy of the Company’s press release is attached hereto as Exhibit99.1 and a copy of the Company’s script to the conference call is attached hereto as Exhibit99.2, and each is hereby incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.


AGILE THERAPEUTICS INC Exhibit
EX-99.1 2 a17-28884_1ex99d1.htm EX-99.1 Exhibit 99.1   Agile Therapeutics,…
To view the full exhibit click here

About Agile Therapeutics,Inc. (NASDAQ:AGRX)

Agile Therapeutics, Inc. is a women’s health specialty pharmaceutical company. The Company is focused in the development and commercialization of prescription contraceptive products. The Company has developed a transdermal patch technology, called Skinfusion. The Company’s lead product candidate is Twirla, also known as AG200-15, is a combined hormonal contraceptive (CHC) patch. In addition to Twirla, the Company is developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen. Each of its product candidates utilizes its Skinfusion technology designed to deliver contraceptive-levels of hormones to the blood stream through the skin over a seven-day period.