Agile Therapeutics, Inc.

Robbins Arroyo LLP: Agile Therapeutics, Inc. (AGRX) Misled Shareholders According to a Recently Filed Class Action

Robbins Arroyo LLP announces that a class action complaint was filed against Agile Therapeutics, Inc. (NASDAQGM: AGRX) in the U.S. District Court for the District of New Jersey. The complaint is brought on behalf of all purchasers of Agile securities between March 9, 2016 and January 3, 2017, for alleged violations of the Securities Exchange Act of 1934 by Agile’s officers and directors. Agile, a specialty pharmaceutical company, focuses on the development and commercialization of prescription contraceptive products for women. The company’s lead product is the Twirla contraceptive patch.

Agile Accused of Lying About the Efficacy of Its Product

According to the complaint, Agile conducted a clinical trial, known as SECURE, to evaluate the safety, efficacy, and tolerability of Twirla in 2,032 women. Agile touted the SECURE trial in its public filings, stating that it believed the clinical trial data from the SECURE trial would support its future marketing of Twirla. Agile continued to report on the progression of the trial, stating that it had “made significant progress on the execution of our business strategy to build a commercially competitive women’s health franchise.” Agile further stated that it believed making Twirla commercially available would fill a strong need for innovative products in women’s health.

However, the complaint alleges that Agile officials failed to disclose that: (1) the Twirla contraceptive patch had an efficacy rating below peer group standards; (2) over half of patients in its SECURE trial discontinued the study early; and (3) therefore, the U.S. Food and Drug Administration (“FDA”) would likely not approve the Twirla patch marketing application. On January 3, 2017, Agile revealed that the Twirla patch’s efficacy measure, which was 4.80, failed to meet the industry standard for FDA approved contraceptives, which is 3.19. The company further announced that 51.4% of patients failed to continue the study to completion. On this news, Agile’s stock fell $2.37 per share, or nearly 50%, to close at $2.63 per share on January 4, 2017.

Agile Shareholders Have Legal Options

Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.


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