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Agile Therapeutics Inc (AGRX.OQ)

AGRX.OQ on NASDAQ Stock Exchange Capital Market

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22 Aug 2019
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Latest Key Developments (Source: Significant Developments)

Agile Therapeutics Announces Pricing Of $12 Million Underwritten Public Offering Of Common Stock
Friday, 2 Aug 2019 

Aug 2 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS ANNOUNCES PRICING OF $12 MILLION UNDERWRITTEN PUBLIC OFFERING OF COMMON STOCK.SAYS PUBLIC OFFERING OF 12.6 MILLION COMMON SHARES PRICED AT $0.95PER SHARE.  Full Article

Agile Therapeutics Announces Proposed Underwritten Public Offering Of Common Stock
Friday, 2 Aug 2019 

Aug 1 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS ANNOUNCES PROPOSED UNDERWRITTEN PUBLIC OFFERING OF COMMON STOCK.  Full Article

Agile Therapeutics Says On July 8, 2019, CFO Informed He Has Accepted A Position With A Private Co
Thursday, 11 Jul 2019 

July 11 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS INC - ON JULY 8, 2019, SCOTT M. COIANTE, CFO, INFORMED HE HAS ACCEPTED A POSITION WITH A PRIVATE COMPANY.AGILE THERAPEUTICS INC - COIANTE WILL BE DEPARTING COMPANY AFTER FILING OF COMPANY'S QUARTERLY REPORT ON FORM 10-Q FOR PERIOD ENDING JUNE 30, 2019.AGILE THERAPEUTICS INC - COMPANY HAS INITIATED A SEARCH FOR HIS SUCCESSOR.AGILE THERAPEUTICS INC - JOSEPH D'URSO, CONTROLLER, WILL SERVE AS INTERIM PRINCIPAL FINANCIAL OFFICER AFTER COIANTE LEAVES COMPANY.  Full Article

Agile Therapeutics Announces FDA Acceptance Of The NDA Resubmission Of Twirla
Wednesday, 22 May 2019 

May 22 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF THE NDA RESUBMISSION OF TWIRLA.AGILE THERAPEUTICS INC - FDA ASSIGNS PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE OF NOVEMBER 16, 2019.  Full Article

Agile Therapeutics Resubmits New Drug Application (NDA) For Its Transdermal Low-Dose Contraceptive Patch, Twirla
Friday, 17 May 2019 

May 17 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS RESUBMITS NEW DRUG APPLICATION (NDA) FOR ITS TRANSDERMAL LOW-DOSE CONTRACEPTIVE PATCH, TWIRLA®.AGILE THERAPEUTICS INC - AGILE RESUBMITTED NDA IN RESPONSE TO A DECEMBER 2017 COMPLETE RESPONSE LETTER (CRL) FROM FDA.AGILE THERAPEUTICS - RESUBMITTED NDA INCLUDES RESULTS FROM COMPARATIVE WEAR STUDY CONDUCTED AT REQUEST OF FDA TO ADDRESS QUESTIONS ON IN VIVO ADHESION.AGILE THERAPEUTICS INC - EXPECT FDA TO ACKNOWLEDGE SUBMISSION AS A COMPLETE RESPONSE IN APPROXIMATELY THIRTY DAYS.AGILE THERAPEUTICS - EXPECT FDA TO PROVIDE WITH A PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE THAT WE ANTICIPATE WILL BE BASED ON A 6-MONTH REVIEW.AGILE THERAPEUTICS - RESUBMITTED NDA ALSO INCLUDES RESULTS FROM STUDY TO ADDRESS FDA'S QUESTIONS ON ADDITIONAL INFORMATION ON MANUFACTURING PROCESS.  Full Article

Agile Therapeutics - Twirla Meets Main Goal In Comparative Wear Study And Demonstrates Non-Inferior Adhesion To Xulane
Monday, 11 Feb 2019 

Feb 11 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS, INC. ANNOUNCES THAT TWIRLA® MEETS PRIMARY ENDPOINT IN COMPARATIVE WEAR STUDY AND DEMONSTRATES NON-INFERIOR ADHESION TO XULANE®.AGILE THERAPEUTICS INC - COMPANY NOW FOCUSED ON COMPLETING PLAN TO RESUBMIT NDA IN FIRST HALF OF 2019.AGILE THERAPEUTICS INC - NO COMPLETE DETACHMENTS OF TWIRLA OR XULANE OCCURRED DURING TRIAL.AGILE THERAPEUTICS INC - FINAL STUDY REPORT WILL CONTAIN ADDITIONAL ANALYSES PERTAINING TO SECONDARY ENDPOINTS AND SAFETY DATA.AGILE - PLANS TO INCLUDE RESULTS OF STUDY ALONG WITH ADDITIONAL INFORMATION RELATING TO MANUFACTURE OF TWIRLA IN RESPONSE TO CRL RECEIVED IN DEC. 2017.AGILE THERAPEUTICS INC - EXPECTS THAT FDA WILL CONDUCT A PRE-APPROVAL INSPECTION OF COMPANY'S THIRD-PARTY MANUFACTURER'S FACILITY.  Full Article

Agile Therapeutics Files For Common Stock Offering Of Up To $10.0 Million - SEC Filing
Wednesday, 23 Jan 2019 

Jan 23 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS INC FILES FOR COMMON STOCK OFFERING OF UP TO $10.0 MILLION - SEC FILING.  Full Article

Agile Therapeutics Q3 Loss Per Share $0.11
Friday, 2 Nov 2018 

Nov 1 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.Q3 LOSS PER SHARE $0.11.Q3 EARNINGS PER SHARE VIEW $-0.15 -- THOMSON REUTERS I/B/E/S.CASH EXPECTED TO ENABLE COMPANY TO FUND OPERATIONS INTO Q2 2019.  Full Article

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