Agile Therapeutics Reports Second Quarter 2019 Financial Results
Agile Therapeutics, Inc. (AGRX)
Last agile therapeutics, inc. earnings: 5/2 04:15 pm
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US:NASDAQ Investor Relations:
ir.agiletherapeutics.com/investor-relations
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Source: GlobeNewswire
FDA Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 Cash Expected to Enable Company to Fund Operations through the End of 2019 PRINCETON, N.J., Aug. 01, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three and six months ended June 30, 2019 and provided a corporate update. Second quarter 2019 and other recent corporate developments: Twirla® Update Acceptance of New Drug Application (NDA) Resubmission of Twirla: The Company resubmitted its Twirla NDA on May 16, 2019. The NDA resubmission was intended to be a complete response to the complete response letter the Company received from the U.S. Food and Drug Administration (FDA) in December 2017 (2017 CRL) and included the results from a comparative wear study, which was recommended by the FDA, additional information on the Company’s manufacturing process, and other analyses responding to the 2017 CRL. The
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