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DURECT Corp (DRRX.OQ)

DRRX.OQ on NASDAQ Stock Exchange Capital Market

0.68USD
15 Jul 2019
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Latest Key Developments (Source: Significant Developments)

Durect Announces Submission To FDA Of Full Response To Posimir Complete Response Letter
Thursday, 27 Jun 2019 

June 27 (Reuters) - DURECT Corp ::DURECT ANNOUNCES SUBMISSION TO FDA OF A FULL RESPONSE TO THE POSIMIR® COMPLETE RESPONSE LETTER.DURECT CORP - SUBMISSION IS INTENDED TO ADDRESS ISSUES RAISED IN CRL AND SEEKS FDA APPROVAL OF POSIMIR.DURECT - AS SUBMISSION IS INTENDED TO BE A FULL RESPONSE TO CRL, AS OPPOSED TO A NEW NDA SUBMISSION, COMPANY EXPECTS A SIX-MONTH FDA REVIEW PERIOD.  Full Article

DURECT Says Dose Escalation Committee Has Approved Commencement Of Dosing At 150 Mg Level In Severe Ah Patients
Tuesday, 18 Jun 2019 

June 18 (Reuters) - DURECT Corp ::DURECT ANNOUNCES COMPLETION OF THE 90 MG SEVERE COHORT AND DOSE ESCALATION COMMITTEE APPROVAL TO COMMENCE 150 MG DOSING IN PATIENTS WITH SEVERE ALCOHOLIC HEPATITIS (AH) IN ITS ONGOING DUR-928 PHASE 2A AH TRIAL.DURECT CORP - DOSE ESCALATION COMMITTEE (DEC) HAS APPROVED COMMENCEMENT OF DOSING AT 150 MG LEVEL IN SEVERE AH PATIENTS..  Full Article

Durect Corporation Qtrly Loss Per Share $0.04
Wednesday, 8 May 2019 

May 7 (Reuters) - DURECT Corp ::ANNOUNCES FIRST QUARTER 2019 FINANCIAL RESULTS AND UPDATE OF PROGRAMS.Q1 REVENUE $4.1 MILLION VERSUS REFINITIV IBES ESTIMATE OF $3.5 MILLION.QTRLY LOSS PER SHARE $0.04.  Full Article

Pain Therapeutics Says Sent Letter To Durect Corp Pursuant To Development And License Agreement
Saturday, 23 Mar 2019 

March 22 (Reuters) - DURECT Corp ::PAIN THERAPEUTICS - SENT LETTER TO DURECT CORP PURSUANT TO DEVELOPMENT AND LICENSE AGREEMENT.PAIN THERAPEUTICS - LETTER PROVIDED DURECT CORP WITH WRITTEN NOTICE OF TERMINATION WITHOUT CAUSE OF DLA.PAIN THERAPEUTICS INC - TERMINATION BECOMES EFFECTIVE NO LATER THAN 90 DAYS FROM MARCH 20.  Full Article

Durect Corp Reports Q4 Loss Per Share Of $0.05
Friday, 8 Mar 2019 

March 7 (Reuters) - DURECT Corp ::ORATION ANNOUNCES FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND UPDATE OF PROGRAMS.Q4 REVENUE $3.6 MILLION VERSUS REFINITIV IBES ESTIMATE OF $3.8 MILLION.QTRLY LOSS PER SHARE $0.05.  Full Article

Durect Plans To Submit To FDA A Full Response To The Posimir Complete Response Letter In H1 2019
Wednesday, 27 Feb 2019 

Feb 27 (Reuters) - DURECT Corp ::DURECT ANNOUNCES PLANS TO SUBMIT TO FDA A FULL RESPONSE TO THE POSIMIR® COMPLETE RESPONSE LETTER.DURECT - SUBMISSION WILL REQUEST FDA APPROVAL OF POSIMIR BASED ON WHAT COMPANY AND ITS ADVISORS BELIEVE IS ADEQUATE EVIDENCE OF BOTH SAFETY AND EFFICACY..DURECT CORP - EXPECTS TO MAKE SUBMISSION IN FIRST HALF OF 2019.  Full Article

DURECT Corporation Announces Q3 Loss Per Share $0.02
Thursday, 8 Nov 2018 

Nov 7 (Reuters) - DURECT Corp ::ORATION ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q3 REVENUE $8.0 MILLION VERSUS I/B/E/S VIEW $8.6 MILLION.QTRLY LOSS PER SHARE $0.02.  Full Article

DURECT Says Co And Oxford Finance Entered Into Second Amendment To Loan And Security Agreement
Monday, 5 Nov 2018 

Nov 5 (Reuters) - DURECT Corp ::DURECT CORP - ON NOVEMBER 1, CO AND OXFORD FINANCE ENTERED INTO A SECOND AMENDMENT TO ITS $20.0 MILLION LOAN AND SECURITY AGREEMENT.DURECT CORP - SECOND AMENDMENT MODIFIED TERMS OF LOAN AGREEMENT TO EXTEND FIRST PRINCIPAL PAYMENT DATE FROM DECEMBER 1, 2018 TO JUNE 1, 2020.  Full Article

Durect ADHD Capsules Receive Marketing Authorization In Taiwan
Tuesday, 18 Sep 2018 

Sept 18 (Reuters) - DURECT Corp ::DURECT ANNOUNCES METHYDUR SUSTAINED RELEASE CAPSULES RECEIVE MARKETING AUTHORIZATION FOR ADHD IN TAIWAN.DURECT - ORIENT PHARMA TOLD DURECT IT GOT MARKETING AUTHORIZATION FROM MINISTRY OF HEALTH & WELFARE IN TAIWAN FOR METHYDUR SUSTAINED RELEASE CAPSULES.DURECT CORP - ORIENT PHARMA ALSO STATED IT EXPECTS TO HAVE METHYDUR SUSTAINED RELEASE CAPSULES COMMERCIALLY AVAILABLE IN TAIWAN IN 2019.  Full Article

Durect Corp says U.S. FDA voted 14 to 3 against approval of Remoxy Er
Wednesday, 27 Jun 2018 

June 26 (Reuters) - DURECT Corp ::RESULTS OF FDA ADVISORY COMMITTEE MEETING FOR REMOXY® ER.DURECT - U.S. FDA VOTED 14 TO 3 AGAINST APPROVAL OF REMOXY ER FOR MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AROUND CLOCK, LONG-TERM OPIOID TREATMENT.PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE FOR COMPLETION OF REVIEW IS AUGUST 7, 2018.DEVELOPMENT AND COMMERCIALIZATION RIGHTS OF REMOXY ER ARE HELD BY PAIN THERAPEUTICS (NASDAQ: PTIE) UNDER A LICENSE FROM DURECT.  Full Article