Edition:
United Kingdom

Agile Therapeutics Inc (AGRX.OQ)

AGRX.OQ on NASDAQ Stock Exchange Capital Market

1.43USD
24 Jun 2019
Change (% chg)

-- (--)
Prev Close
$1.43
Open
--
Day's High
--
Day's Low
--
Volume
--
Avg. Vol
69,473
52-wk High
$1.70
52-wk Low
$0.23

Latest Key Developments (Source: Significant Developments)

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
Thursday, 1 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

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