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Trevena Inc (TRVN.OQ)

TRVN.OQ on NASDAQ Stock Exchange Global Select Market

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18 Apr 2019
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Latest Key Developments (Source: Significant Developments)

Trevena Reports Q4, FY2018 Results
Wednesday, 13 Mar 2019 

March 13 (Reuters) - Trevena Inc ::TREVENA REPORTS FOURTH QUARTER AND FULL YEAR 2018 RESULTS.Q4 LOSS PER SHARE $0.10.SUCCESSFUL FUNDRAISING EXTENDS CASH RUNWAY INTO 3Q 2020.COMPANY ANNOUNCES SUBMISSION OF OLICERIDINE HEALTHY VOLUNTEER STUDY PROTOCOL AND ANALYSIS PLAN TO FDA.CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES WERE $61.5 MILLION AT DECEMBER 31, 2018.  Full Article

Trevena- In March 2019 FDA Informed Data For Oliceridine Not Sufficient To Support Continuation Of Previously Granted Breakthrough Therapy Designation
Thursday, 7 Mar 2019 

March 7 (Reuters) - Trevena Inc ::TREVENA- IN MARCH 2019 FDA INFORMED DATA FOR OLICERIDINE NOT SUFFICIENT TO SUPPORT CONTINUATION OF PREVIOUSLY GRANTED BREAKTHROUGH THERAPY DESIGNATION.  Full Article

Trevena announces receipt of type A meeting minutes and provides regulatory update for Oliceridine
Monday, 28 Jan 2019 

Jan 28 (Reuters) - Trevena Inc ::TREVENA ANNOUNCES RECEIPT OF TYPE A MEETING MINUTES AND PROVIDES REGULATORY UPDATE FOR OLICERIDINE.FDA HAS AGREED THAT COMPANY'S CURRENT SAFETY DATABASE WILL SUPPORT LABELING AT A MAXIMUM DAILY DOSE OF 27 MG.ANNOUNCED RECEIPT OF OFFICIAL TYPE A MEETING MINUTES FROM U.S. FDA REGARDING COMPLETE RESPONSE LETTER RECEIVED FOR OLICERIDINE NDA.TREVENA - FDA AGREED THAT CO CAN CONDUCT STUDY IN HEALTHY VOLUNTEERS TO COLLECT QT INTERVAL DATA AND STUDY SHOULD INCLUDE PLACEBO- AND POSITIVE-CONTROL ARMS.INTENDS TO SUBMIT A DETAILED PROTOCOL AND ANALYSIS PLAN TO FDA SHORTLY AND, ANTICIPATES INITIATING STUDY IN H1.TREVENA - INTENDS TO SUBMIT A DETAILED PROTOCOL AND ANALYSIS PLAN TO FDA SHORTLY.COMPANY IS NOT REQUIRED TO PROVIDE ANY ADDITIONAL EFFICACY DATA TO RESUBMIT OLICERIDINE NDA.FOLLOWING RECEIPT OF FDA FEEDBACK, ANTICIPATES INITIATING THE STUDY IN FIRST HALF OF THIS YEAR.IS NOT REQUIRED TO PROVIDE ANY ADDITIONAL EFFICACY DATA TO RESUBMIT OLICERIDINE NDA.  Full Article

Trevena Q3 Loss Per Share $0.06
Thursday, 8 Nov 2018 

Nov 8 (Reuters) - Trevena Inc ::TREVENA REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND ANNOUNCES WORKFORCE RESTRUCTURING.Q3 LOSS PER SHARE $0.06.Q3 EARNINGS PER SHARE VIEW $-0.15 -- THOMSON REUTERS I/B/E/S.TREVENA - REDUCING WORKFORCE BY ABOUT ONE-THIRD AND UNDERTAKING ADDITIONAL COST SAVING INITIATIVES THAT ARE EXPECTED TO SAVE MORE THAN $3.5 MILLION A YEAR.EXPECTS TO INCUR A CASH CHARGE IN Q4 OF 2018 OF APPROXIMATELY $1.3 MILLION RELATED TO RESTRUCTURING.  Full Article

Trevena Says Co, Pharmbio Korea Have Entered Into License Agreement For Development & Commercialization Of Oliceridine In S. Korea
Friday, 27 Apr 2018 

April 27 (Reuters) - Trevena Inc ::TREVENA - CO, PHARMBIO KOREA HAVE ENTERED INTO LICENSE AGREEMENT FOR DEVELOPMENT & COMMERCIALIZATION IN SOUTH KOREA OF CO'S PRODUCT OLICERIDINE.TREVENA INC - UNDER AGREEMENT WITH PHARMBIO KOREA, TREVENA WILL RECEIVE AN UPFRONT PAYMENT OF $3 MILLION.TREVENA - OLICERIDINE IS CURRENTLY UNDER REVIEW BY U.S. FDA FOR POTENTIAL APPROVAL IN U.S. FOR MANAGEMENT OF MODERATE-TO-SEVERE ACUTE PAIN.  Full Article

Trevena Reports Q4 Loss Per Share $0.24
Wednesday, 7 Mar 2018 

March 7 (Reuters) - Trevena Inc ::TREVENA REPORTS FULL YEAR 2017 EARNINGS.Q4 LOSS PER SHARE $0.24.COMPANY EXPECTS THAT EXPENSES WILL DECREASE IN 2018 COMPARED TO 2017.CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES WERE $66.1 MILLION AS OF DECEMBER 31, 2017.TREVENA-EXPECTS CURRENTLY AVAILABLE CASH, CASH EQUIVALENTS,&MARKETABLE SECURITIES, WITH INTEREST THEREON, TO BE ENOUGH TO FUND OPERATIONS INTO Q2 2019.Q4 EARNINGS PER SHARE VIEW $-0.27 -- THOMSON REUTERS I/B/E/S.  Full Article

Trevena Inc Says FDA Indicated To Co That PDUFA Date For Olinvo NDA Is Nov 2‍​
Friday, 5 Jan 2018 

Jan 5 (Reuters) - Trevena Inc ::TREVENA INC - ON JAN 5, FDA INDICATED TO THE CO THAT PDUFA REVIEW DATE FOR OLINVO NDA IS NOV 2‍​.TREVENA SAYS FDA ALSO INDICATED IT PLANS TO HOLD AN ADVISORY COMMITTEE MEETING TO DISCUSS NDA​ - SEC FILING.  Full Article

Trevena Announces FDA Acceptance For Review Of New Drug Application For OLINVO(Oliceridine) Injection
Tuesday, 2 Jan 2018 

Jan 2 (Reuters) - Trevena Inc ::TREVENA ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF NEW DRUG APPLICATION FOR OLINVO (OLICERIDINE) INJECTION.SAYS EXPECTS THAT PDUFA DATE FOR NDA WILL BE IN Q4 OF 2018.  Full Article

Trevena Inc says Q3 loss per share $0.27
Tuesday, 7 Nov 2017 

Nov 7 (Reuters) - Trevena Inc -:Trevena reports third quarter 2017 financial results and announces new positive clinical trial data.Q3 loss per share $0.27.Q3 earnings per share view $-0.29 -- Thomson Reuters I/B/E/S.Trevena Inc - ‍expects to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months​.  Full Article

Trevena announces submission of NDA to U.S. FDA for Olinvo
Thursday, 2 Nov 2017 

Nov 2 (Reuters) - Trevena Inc :Trevena announces submission of new drug application to U.S. FDA for Olinvo (oliceridine injection).Trevena Inc - "‍look forward to working with FDA during review process and to a potential NDA approval of Olinvo in 2018"​.  Full Article

UPDATE 2-U.S. FDA approves AcelRx Pharma's opioid pain drug

Nov 2 The U.S. Food and Drug Administration on Friday approved AcelRx Pharmaceuticals Inc's opioid-based treatment for pain to be used under strict medical supervision, with the agency's chief highlighting reasons for the approval in a rare move.