Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events
Item8.01.Other Events.
On March16, 2017, Agile Therapeutics,Inc. (Agile) a womens
healthcare company, announced a poster presentation of data from
the SECURE Phase 3 clinical trial for its lead product candidate,
Twirla, (ethinyl estradiol and levonorgestrel transdermal
system), also known as AG200-15. The poster, titled The
SECURE Study, a Real-World Trial of a Low-Dose Contraceptive
Patch: Addressing the Changing U.S. Population, will be
presented at the Contraceptive Technology Conferences on
March16-18, 2017 in San Francisco, CA and March19 April1, in
Boston, MA. The first author is Anita Nelson, MD, one of the
Co-Primary Investigators for the SECURE trial.
The SECURE clinical trial was designed to evaluate the efficacy,
safety, and tolerability of Twirla in a representative U.S.
population of women seeking birth control. SECURE was a 1-year,
multicenter, single-arm, open-label trial in 2032 healthy women
aged 18 and over, at 102 experienced investigative sites across
the United States.
The Company plans to resubmit its new drug application (NDA) for
Twirla in the first half of 2017.
Copies of Agiles press release and poster presentation are
attached hereto as Exhibit99.1 and 99.2, respectively, and are
hereby incorporated by reference herein.
Item 9.01.Financial Statements and
Exhibits.
(d) Exhibits.
|
Exhibit Number |
|
Description |
|
99.1 |
Agile Therapeutics,Inc. Press Release dated March16, 2017. |
|
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99.2 |
Agile Therapeutics,Inc. Poster Presentation dated March16, |
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. Agile Therapeutics, Inc. (NASDAQ:AGRX) Recent Trading Information
Agile Therapeutics, Inc. (NASDAQ:AGRX) closed its last trading session up +0.33 at 2.69 with 330,796 shares trading hands.