Agile develops women’s healthcare products. The Company’s lead product is the Twirla contraceptive patch containing the active ingredients levonorgestrel and ethinyl estradiol.
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 made false and/or misleading statements and/or failed to disclose that: (i) the Twirla contraceptive patch had an efficacy rating below peer group standards; (ii) over half of the patients in its “Secure” Phase 3 Study discontinued the study early; (iii) therefore the FDA would likely not approve the Twirla patch marketing application; and (iv) 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, the Company published a press release announcing top line results from its Phase 3 “Secure” clinical study. According to the Company, the Twirla patch’s efficacy measure, known as its “Pearl Index” failed to meet the industry standard for FDA approved contraceptives, as the highest Pearl Index for a hormonal contraceptive product approved by the FDA is 3.19. In addition, the Company announced that 51.4% of patients failed to continue the study to completion.
On this news, Agile’s share price fell $2.37, or nearly 50%, to close at $2.63 on January 4, 2017, on unusually heavy trading volume.
The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
Source: www.euroinvestor.com
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