Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Regulation FD Disclosure
Item 7.01.Regulation FD Disclosure.
On December13, 2018, Agile Therapeutics,Inc. (the “Company”) issued a press release announcing that, on December11, 2018, it had met with the Division of Bone, Reproductive and Urological Products, or DBRUP, to discuss the design and success criteria of the comparative wear study between Twirla® and Xulane® suggested by the FDA’s Office of New Drugs, or OND in its decision on the Company’s formal dispute resolution request, which was announced in October2018. The Company expects to conduct a crossover wear study in healthy women with a Body Mass Index (BMI) less than 35 kg/m2who will be randomized to either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week. The Company plans to discuss the results of the meeting and the design of the study in more detail after it receives the final meeting minutes from the FDA in January. The Company announced that its current plan is to complete the study in the first quarter of 2019, and to resubmit the Twirla new drug application in the first half of 2019, which, if the Company is successful, provides it the opportunity to receive approval by the end of 2019.
A copy of the Company’s press release is attached hereto as Exhibit99.1.
In accordance with General Instructions B.2 and B.6 of Form8-K, the information included in this Current Report on Form8-K (including Exhibit99.1 hereto), shall not be deemed “filed” for the purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Xulane®is a registered trademark of Mylan N.V.
Item 7.01. Financial Statements and Exhibits.
(d) Exhibits.
AGILE THERAPEUTICS INC Exhibit
EX-99.1 2 a18-41518_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.