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.
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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..
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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..
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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.
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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.
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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".
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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.
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