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Agile Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results

AGILE THERAPEUTICS (AGRX)  More Company Research Source: GlobeNewswire
Last agile therapeutics earnings: 8/3 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.agiletherapeutics.com/investor-relations
PDF PRINCETON, N.J., March 12, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare company, today reported financial results for the three months and year ended December 31, 2017 and provided a corporate update. Fourth quarter 2017 and other recent corporate developments include: Twirla® Update – On December 22, 2017, the Company announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in response to the New Drug Application (NDA) resubmission for the Company’s investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15).  The CRL stated that the FDA has determined that it could not approve the NDA in its present form due to deficiencies related to the manufacturing process for Twirla, and questions on the in vivo adhesion properties of Twirla and their potential relationship to the phase 3 clinical trial results.  Under the FDA’s regulations, the Company is entitled to reque [Read more]

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