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 July27, 2017, Agile Therapeutics,Inc. (“Agile”) announced that it had received a letter from the U.S. Food and Drug Administration (“FDA”) acknowledging that the resubmission of the the New Drug Application (“NDA”) for its lead product candidate, Twirla®, an investigational low-dose combined hormonal contraceptive patch (AG200-15), was a complete response to a February2013 Complete Response Letter (“CRL”) from the FDA. The FDA established December26, 2017 as the target Prescription Drug User Fee Act (“PDUFA”) goal date.

A copy of Agile’s press release is attached hereto as Exhibit99.1 and is hereby incorporated by reference herein.

Item 8.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number

Description

99.1

Press release issued by Agile Therapeutics,Inc. dated July27, 2017.


AGILE THERAPEUTICS INC Exhibit
EX-99.1 2 a17-18496_2ex99d1.htm EX-99.1 Exhibit 99.1   Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla®   FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of December 26,…
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.