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DURECT Corp (DRRX.OQ)

DRRX.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Durect ADHD Capsules Receive Marketing Authorization In Taiwan
8:00am EDT 

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
Tuesday, 26 Jun 2018 08:30pm EDT 

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

Durect Corporation Qtrly Earnings Per Share ‍$0.05​
Thursday, 1 Mar 2018 04:05pm EST 

March 1 (Reuters) - Durect Corp ::ORATION ANNOUNCES FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS AND UPDATE OF PROGRAMS.Q4 REVENUE $19.5 MILLION.QTRLY ‍TOTAL REVENUES WERE $19.5 MILLION VERSUS $3.5 MILLION​.QTRLY EARNINGS PER SHARE ‍$0.05​.  Full Article

Durect reports Q3 earnings per share of ‍$0.04​
Wednesday, 1 Nov 2017 04:05pm EDT 

Nov 1 (Reuters) - Durect Corp :Durect Corporation announces third quarter 2017 financial results and provides corporate update.Q3 revenue $20.7 million.Q3 revenue view $3.7 million -- Thomson Reuters I/B/E/S.Quarterly earnings per share ‍$0.04​.  Full Article

Durect announces top-line results from the persist phase 3 trial of Posimir® did not meet primary efficacy endpoint
Thursday, 19 Oct 2017 05:57pm EDT 

Oct 20 (Reuters) - Durect Corp :Durect announces top-line results from the persist phase 3 trial of Posimir® (saber®-bupivacaine) did not meet primary efficacy endpoint.Durect Corp - ‍phase 3 clinical trial for Posimir(®) (saber(®)-bupivacaine), did not meet its primary efficacy endpoint​.Durect Corp - results from phase 3 clinical trial for Posimir​ trended in favor of Posimir versus comparator, but did not achieve statistical significance.  Full Article

Durect Q2 loss per share $0.07
Tuesday, 8 Aug 2017 04:05pm EDT 

Aug 8 (Reuters) - Durect Corp :Durect Corporation announces second quarter 2017 financial results and provides corporate update.Q2 revenue $4.3 million.Q2 revenue view $3.4 million -- Thomson Reuters I/B/E/S.Qtrly loss per share $0.07.Q2 earnings per share view $-0.06 -- Thomson Reuters I/B/E/S.  Full Article

Durect says ‍on July 24, Impax Laboratories terminated asset transfer and license agreement dated Jan. 3, 2014​
Friday, 28 Jul 2017 04:25pm EDT 

July 28 (Reuters) - Durect Corp :Durect - ‍on July 24, Impax Laboratories provided notice to co, that Impax is terminating asset transfer and license agreement dated January 3, 2014​.Durect Corp - termination returns to durect development and commercialization rights to Eladur(transdur)-bupivacaine) - SEC filing.  Full Article

Durect completes enrollment in persist, phase 3 trial for Posimir
Thursday, 22 Jun 2017 07:00am EDT 

June 22 (Reuters) - Durect Corp :Durect completes enrollment in Persist, phase 3 trial for Posimir.Durect - Durect remains responsible for completion of ongoing persist phase 3 clinical trial for Posimir as well as FDA interactions through approval.Durect Corp - phase 3 trial for Posimir top-line data on track for Q4 2017.  Full Article

Durect's collaboration with Sandoz clears HSR review
Monday, 19 Jun 2017 07:00am EDT 

June 19 (Reuters) - Durect Corp::Durect's collaboration with Sandoz clears Hart-Scott-Rodino review and is effective.Durect Corporation - development and commercialization agreement with Sandoz AG to develop and market in U.S. Durect's Posimir has cleared Hart-Scott-Rodino review.  Full Article

Durect Corp, Sandoz AG sign U.S. development and commercialization agreement for posimir
Thursday, 11 May 2017 08:45am EDT 

May 11 (Reuters) - Durect Corp :Durect Corp - co and Sandoz AG, a division of Novartis, have signed a development and commercialization agreement for U.S. for posimir.Durect Corp - under terms of agreement, Sandoz will make an upfront payment to Durect of $20 million.Durect Corp - co remain's responsible for conducting persist Phase 3 trial, comparing posimir to bupivacaine HC1 after laparoscopic gall bladder removal.Durect Corp - company anticipates completing dosing patients in Q3/17 for persist Phase 3 trial and expects to have top-line data shortly thereafter.Durect - deal also includes potential for up to additional $43 million in development, regulatory milestones, up to additional $230 million in sales based milestones.  Full Article

BRIEF-Durect Announces Amendment To Licensing Agreement With Sandoz

* DURECT ANNOUNCES AMENDMENT TO LICENSING AGREEMENT WITH SANDOZ RELATED TO POSIMIR® (SABER®-BUPIVACAINE)