Agile Therapeutics, Inc.
Period: Mar 9, 2016 to Jan 3, 2017
Lead Plaintiff Deadline: Mar 7, 2017 + Deadline passed
Summary of Case:
A securities class action has been filed against Agile Therapeutics, Inc., ("Agile") behalf of persons and entities that acquired Agile securities between March 9, 2016 through January 3, 2016. This case has been filed in the USDC - New Jersey.
The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose: (1) that the Twirla contraceptive patch had an efficacy rating that fell below peer group standards; (2) that over half of patients in its "Secure" Phase 3 Study discontinued the study early; (3) that the Twirla patch therefore allegedly had a slight chance of U.S. Food and Drug Administration ("FDA") approval; and (4) that, as a result of the foregoing, Defendants' statements about Agile's business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.
On January 3, 2017, Agile disclosed statistical information pertaining to its Phase 3 SECURE study analyzing the Company's combined hormonal contraceptive patch Twirla. The study, which was initiated at the request of the FDA, comes after the FDA rejected Agile's initial marketing application back in 2013. The Company cited "positive top-line results" in the study, yet reported an efficacy measure that failed to meet the standard set by other approved contraceptive patches. Additionally, 51.4% of subjects opted to discontinue the study.
On this news, Agile stock fell nearly 64% during intraday trading on January 4, 2017.
If you purchased this company's shares during the Class Period and suffered a loss or for further information about the case, please review the links below.