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Agile Therapeutics Inc (AGRX.OQ)

AGRX.OQ on NASDAQ Stock Exchange Capital Market

1.12USD
11 Oct 2019
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$-0.01 (-0.88%)
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Latest Key Developments (Source: Significant Developments)

Agile Therapeutics Reports Q2 Loss Per Share $0.08
Thursday, 1 Aug 2019 

Aug 1 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS.Q2 LOSS PER SHARE $0.08.Q2 EARNINGS PER SHARE ESTIMATE $-0.11 -- REFINITIV IBES DATA.AGILE THERAPEUTICS- AS OF JUNE 30, CO HAD $10.6 MILLION OF CASH AND CASH EQUIVALENTS COMPARED TO $7.8 MILLION OF CASH AND CASH EQUIVALENTS AS OF DEC. 31, 2018.  Full Article

Agile Therapeutics Appoints CFO
Thursday, 18 Jul 2019 

July 18 (Reuters) - Agile Therapeutics Inc ::SAYS DENNIS P. REILLY APPOINTED CFO.AGILE THERAPEUTICS APPOINTS CHIEF FINANCIAL OFFICER.APPOINTMENT OF DENNIS P. REILLY AS CHIEF FINANCIAL OFFICER EFFECTIVE AUGUST 5, 2019.  Full Article

Agile Therapeutics Reports Q1 Loss Per Share $0.13
Friday, 3 May 2019 

May 2 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS.Q1 LOSS PER SHARE $0.13.Q1 EARNINGS PER SHARE ESTIMATE $-0.10 -- REFINITIV IBES DATA.CASH EXPECTED TO ENABLE COMPANY TO FUND OPERATIONS INTO Q4 OF 2019.COMPANY PLANS TO RESUBMIT TWIRLA NDA IN Q2 OF 2019.AS OF MARCH 31, 2019, AGILE HAD $11.6 MILLION OF CASH AND CASH EQUIVALENTS.  Full Article

Agile Therapeutics Q4 Loss Per Share $0.11
Wednesday, 13 Mar 2019 

March 12 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS.Q4 LOSS PER SHARE $0.11.Q4 EARNINGS PER SHARE ESTIMATE $-0.15 -- REFINITIV IBES DATA.CASH EXPECTED TO ENABLE COMPANY TO FUND OPERATIONS INTO Q4 OF 2019.COMPANY PLANS TO RESUBMIT TWIRLA NDA IN Q2 OF 2019.AS OF DECEMBER 31, 2018, AGILE HAD $7.8 MILLION OF CASH AND CASH EQUIVALENTS.  Full Article

Agile Therapeutics Inc - Will Require Additional Capital To Fund Operating Needs For Remainder Of Q2 Of 2019 And Beyond
Friday, 11 Jan 2019 

Agile Therapeutics Inc ::AGILE THERAPEUTICS, INC. PROVIDES REGULATORY UPDATE AND REITERATES CASH GUIDANCE.AGILE THERAPEUTICS INC - CASH EXPECTED TO ENABLE COMPANY TO FUND OPERATIONS INTO Q2 OF 2019.AGILE THERAPEUTICS INC - ALSO EXPECTS THAT FDA WILL CONDUCT A PRE-APPROVAL INSPECTION OF COMPANY'S THIRD-PARTY MANUFACTURER'S FACILITY.AGILE THERAPEUTICS INC - WILL REQUIRE ADDITIONAL CAPITAL TO FUND OPERATING NEEDS FOR REMAINDER OF Q2 OF 2019 AND BEYOND.AGILE THERAPEUTICS INC - AFTER CONSULTATION WITH DBRUP, COMPANY HAS INITIATED A CROSSOVER WEAR STUDY.  Full Article

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
Friday, 8 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
Tuesday, 13 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