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.
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Aug 1 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS ANNOUNCES PROPOSED UNDERWRITTEN PUBLIC OFFERING OF COMMON STOCK.
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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.
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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.
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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.
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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.
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Jan 23 (Reuters) - Agile Therapeutics Inc ::AGILE THERAPEUTICS INC FILES FOR COMMON STOCK OFFERING OF UP TO $10.0 MILLION - SEC FILING.
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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.
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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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