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Agile Therapeutics Inc (AGRX.OQ)

AGRX.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Agile Therapeutics Inc Completes Formal Dispute Resolution Process With The FDA
Tuesday, 9 Oct 2018 

Oct 9 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS, INC. COMPLETES FORMAL DISPUTE RESOLUTION PROCESS WITH THE FDA.AGILE THERAPEUTICS INC - GOT RESPONSE FROM FDA'S OFFICE OF NEW DRUGS CONCERNING CO'S FORMAL DISPUTE RESOLUTION REQUEST.AGILE THERAPEUTICS INC - OND HAS FORMALLY DENIED COMPANY'S APPEAL.AGILE THERAPEUTICS - OND GAVE PATH FORWARD WITHOUT NEED TO REFORMULATE TWIRLA OR CONDUCT A BIOEQUIVALENCE STUDY BETWEEN FORMULATIONS.AGILE - OND SUGGESTED CO CONDUCT WEAR STUDY TO EVALUATE WHETHER TWIRLA DEMONSTRATES GENERALLY SIMILAR ADHESION PERFORMANCE TO XULANE.AGILE - OND RECOMMENDS CO FIRST MEET WITH DBRUP TO GET AGREEMENT ON SPECIFIC DESIGN & SUCCESS CRITERIA OF WEAR STUDY FOR TWIRLA.AGILE - AFTER AGREEING ON PARAMETERS OF WEAR STUDY, EXPECT GIVING FURTHER UPDATE REVIEWING CASH GUIDANCE & PLANNED RESUBMISSION TIMELINE.  Full Article

Agile Therapeutics Reducing Workforce By ~30 Pct
Thursday, 7 Jun 2018 

June 7 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS, INC. PROVIDES CORPORATE UPDATE AND REVISED CASH GUIDANCE.AGILE THERAPEUTICS INC - REDUCING WORKFORCE BY APPROXIMATELY 30% AND REDUCING OTHER PLANNED EXPENSES.AGILE THERAPEUTICS INC - REDUCTIONS IN WORKFORCE AND EXPENSES EXPECTED TO ALLOW EXISTING CASH TO FUND OPERATIONS INTO Q2 OF 2019.AGILE THERAPEUTICS INC - FORMAL DISPUTE RESOLUTION REQUEST HAS BEEN SUBMITTED TO FDA REGARDING TWIRLA.AGILE THERAPEUTICS - EXPECTS ITS CASH AND CASH EQUIVALENTS AS OF MARCH 31, 2018, WILL BE SUFFICIENT TO MEET ITS OPERATING REQUIREMENTS INTO Q2 OF 2019..  Full Article

Agile Therapeutics Provides Regulatory Update On Twirla® (Ag200-15) For The Prevention Of Pregnancy
Friday, 18 May 2018 

May 18 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS, INC. PROVIDES REGULATORY UPDATE ON TWIRLA® (AG200-15) FOR THE PREVENTION OF PREGNANCY.AGILE THERAPEUTICS - ANNOUNCED CONTENT OF OFFICIAL MINUTES FROM TYPE A MEETING WITH U.S. FOOD AND DRUG ADMINISTRATION HELD ON APRIL 16.AGILE THERAPEUTICS INC - IN CRL, FDA INFORMED COMPANY THAT TWIRLA NDA COULD NOT BE APPROVED.AGILE THERAPEUTICS - IN OFFICIAL MINUTES, FDA INFORMED CO IT CONTINUES TO HAVE SIGNIFICANT CONCERNS REGARDING ADHESION OF TWIRLA.AGILE THERAPEUTICS INC - FDA ALSO INFORMED CO IT WOULD NEED TO DEMONSTRATE BIOEQUIVALENCE TO DATA AND INFORMATION FOR ORIGINAL FORMULATION.AGILE - FDA SAID CO NEEDS TO ADDRESS TWIRLA ADHESION PROPERTIES BY REFORMULATING TRANSDERMAL SYSTEM, CONDUCT FORMAL ADHESION STUDY WITH NEW FORMULATION.AGILE THERAPEUTICS - FDA SAID AFTER CO SATISFIES QUESTIONS ON ADHESION, ADEQUATELY BRIDGES TO FINDINGS IN SECURE PHASE 3 TRIAL, IT ANTICIPATES DISCUSSING SAFETY & EFFICACY OF TWIRLA.AGILE THERAPEUTICS INC - TO EXTENT THAT CO REFORMULATES TWIRLA, IT MAY CREATE NEED FOR ADDITIONAL MANUFACTURING WORK AND REVIEW BY FDA.AGILE THERAPEUTICS INC - WHILE CO WILL CONTINUE TO EVALUATE ALL OPTIONS ON NEXT STEPS, EXPECT CO WILL PURSUE FORMAL DISPUTE RESOLUTION..  Full Article

Agile Therapeutics Reports Q4 Loss Per Share $0.18
Monday, 12 Mar 2018 

March 12 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS.Q4 LOSS PER SHARE $0.18.Q4 EARNINGS PER SHARE VIEW $-0.24 -- THOMSON REUTERS I/B/E/S.AGILE THERAPEUTICS - BELIEVES CASH AND CASH EQUIVALENTS AS OF DEC 31, 2017, TO BE SUFFICIENT TO MEET ITS OPERATING REQUIREMENTS THROUGH END OF 2018.  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