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Agile Therapeutics Inc (AGRX.OQ)

AGRX.OQ on NASDAQ Stock Exchange Global Market

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21 May 2018
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Latest Key Developments (Source: Significant Developments)

Perceptive Advisors Reports 9.9 Pct Passive Stake In Agile Therapeutics
Tuesday, 9 Jan 2018 

Jan 9 (Reuters) - Perceptive Advisors LLC::Perceptive Advisors LLC Reports A 9.9 Pct Passive Stake In Agile Therapeutics Inc <<>> As Of Dec 22, 2017 - SEC Filing.  Full Article

Agile Therapeutics Gets Response Letter From FDA For Pregnancy Prevention Drug Twirla
Friday, 22 Dec 2017 

Dec 22 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS, INC. RECEIVES A COMPLETE RESPONSE LETTER FROM THE FDA FOR TWIRLA® (AG200-15) FOR THE PREVENTION OF PREGNANCY.AGILE THERAPEUTICS - CRL STATES THAT FDA HAS DETERMINED THAT IT CANNOT APPROVE NDA FOR TWIRLA ITS PRESENT FORM.AGILE THERAPEUTICS INC - CRL IDENTIFIES DEFICIENCIES RELATING TO QUALITY ADHESION TEST METHODS.AGILE THERAPEUTICS-FDA INDICATED APPLICABLE SECTIONS OF AMENDED NDA SUBMITTED BY CO COULD BE INCORPORATED WHEN RESPONDING TO DEFICIENCIES NOTED IN CRL.AGILE THERAPEUTICS - CRL ALSO NOTED THAT OBSERVATIONS IDENTIFIED DURING INSPECTION OF A FACILITY OF CORIUM INTERNATIONAL FOR TWIRLA NDA MUST BE RESOLVED.AGILE THERAPEUTICS INC - CRL DOES NOT IDENTIFY ANY SPECIFIC ISSUES RELATING TO SAFETY OF TWIRLA.AGILE THERAPEUTICS SAYS CRL RECOMMENDS THAT CO ASSESS IN VIVO ADHESION PROPERTIES DEMONSTRATED IN SECURE CLINICAL TRIAL.AGILE THERAPEUTICS - CRL "QUESTIONS" THE IN VIVO ADHESION PROPERTIES OF TWIRLA & THEIR POTENTIAL RELATIONSHIP TO SECURE PHASE 3 CLINICAL TRIAL RESULTS.AGILE THERAPEUTICS INC - "WE ARE EVALUATING THE FDA'S RESPONSE".  Full Article

Agile Therapeutics Q3 loss per share $0.22
Monday, 6 Nov 2017 

Nov 6 (Reuters) - Agile Therapeutics Inc :Agile therapeutics reports third quarter 2017 financial results.Q3 loss per share $0.22.Q3 earnings per share view $-0.24 -- Thomson Reuters I/B/E/S.Agile Therapeutics Inc - PDUFA goal date for Twirla is December 26, 2017​.Agile Therapeutics - ‍believes cash, cash equivalents as of sept. 30, will be sufficient to meet its operating requirements into Q2 of 2018​.  Full Article

‍Caxton Corp reports 5.3 pct passive stake in Agile Therapeutics Inc
Friday, 18 Aug 2017 

Aug 18 (Reuters) - Agile Therapeutics Inc ::‍Caxton Corp reports 5.3 percent passive stake in Agile Therapeutics Inc as on August 9, 2017 - SEC filing​.  Full Article

Agile Therapeutics announces proposed offering of common stock
Wednesday, 2 Aug 2017 

Aug 2 (Reuters) - Agile Therapeutics Inc :Agile Therapeutics announces proposed offering of common stock.Agile Therapeutics - ‍intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering​.  Full Article

Agile Therapeutics reports second quarter 2017 financial results
Friday, 28 Jul 2017 

July 28 (Reuters) - Agile Therapeutics Inc :Q2 loss per share $0.26.Q2 earnings per share view $-0.28 -- Thomson Reuters I/B/E/S.Agile Therapeutics Inc - FDA assigns Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2017.Agile Therapeutics Inc - cash expected to fund operations into Q2 2018.Agile Therapeutics - as of June 30, co had $33.9 million of cash and cash equivalents compared to $48.8 million of cash and cash equivalents as of December 31, 2016.  Full Article

Agile Therapeutics announces FDA acceptance of NDA resubmission of Twirla
Thursday, 27 Jul 2017 

July 27 (Reuters) - Agile Therapeutics Inc :Agile Therapeutics announces FDA acceptance of the NDA resubmission of Twirla®.Agile Therapeutics - FDA stated that it considers resubmission to be a complete response to CRL and established December 26, 2017 as PDUFA goal date.U.S. Food and Drug Administration has accepted for review company's new drug application resubmission for Twirla.  Full Article

Agile Therapeutics reports Q1 loss per share $0.26
Monday, 8 May 2017 

May 8 (Reuters) - Agile Therapeutics Inc :Agile Therapeutics reports first quarter 2017 financial results.Q1 loss per share $0.26.Q1 earnings per share view $-0.30 -- Thomson Reuters I/B/E/S.Agile Therapeutics Inc - Believes it has necessary information needed to complete resubmission of its NDA for Twirla.Agile Therapeutics Inc - Resubmission of NDA for Twirla is expected to be submitted by end of Q2 of 2017.  Full Article

Agile Therapeutics to resubmit Twirla NDA to FDA by Q2 2017-end
Thursday, 27 Apr 2017 

April 27 (Reuters) - Agile Therapeutics Inc ::Plans to resubmit its New Drug Application for Twirla to U.S. Food and Drug Administration by end of Q2 of 2017.  Full Article

Agile Therapeutics announces results of its pre-submission meeting with FDA
Tuesday, 11 Apr 2017 

Agile Therapeutics Inc : Agile Therapeutics announces results of its pre-submission meeting with FDA . Agile Therapeutics Inc- It has received final meeting minutes from its recent new drug application . Agile Therapeutics Inc - FDA indicated that based on preliminary information provided by company, secure trial results appear acceptable for resubmission . Agile Therapeutics - Has necessary information to complete resubmission of NDA, which is expected to be submitted by end of Q2 of 2017 for Twirla .Agile Therapeutics - FDA did not provide feedback on if results of secure trial and contents resubmitted NDA will be sufficient for approval of Twirla.  Full Article