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Nabriva Therapeutics PLC (NBRV.OQ)

NBRV.OQ on NASDAQ Stock Exchange Global Select Market

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

Nabriva Therapeutics Says FDA Accepted Application For cUTI Treatment
Friday, 4 Jan 2019 07:00am EST 

Jan 4 (Reuters) - Nabriva Therapeutics PLC ::NABRIVA THERAPEUTICS ANNOUNCES ACCEPTANCE OF THE NEW DRUG APPLICATION FOR INTRAVENOUS CONTEPO TO TREAT COMPLICATED URINARY TRACT INFECTIONS BY FDA.NABRIVA THERAPEUTICS PLC - PDUFA GOAL DATE FOR COMPLETION OF FDA'S REVIEW OF CONTEPO NDA IS JUNE 30, 2019.NABRIVA THERAPEUTICS - CONTEPO HAS BEEN GRANTED QIDP AND FAST TRACK DESIGNATIONS BY FDA FOR TREATMENT OF SEVERAL SERIOUS INFECTIONS, INCLUDING CUTI.  Full Article

Nabriva Therapeutics Reports Third Quarter Financial Results
Tuesday, 6 Nov 2018 07:00am EST 

Nov 6 (Reuters) - Nabriva Therapeutics PLC ::NABRIVA THERAPEUTICS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND RECENT CORPORATE HIGHLIGHTS.Q3 LOSS PER SHARE $0.90.Q3 EARNINGS PER SHARE VIEW $-0.29 -- THOMSON REUTERS I/B/E/S.  Full Article

Nabriva Therapeutics Completes Submission Of NDA To U.S. FDA For Intravenous Contepo To Treat Complicated Urinary Tract Infections
Thursday, 1 Nov 2018 07:00am EDT 

Nov 1 (Reuters) - Nabriva Therapeutics PLC ::NABRIVA THERAPEUTICS COMPLETES SUBMISSION OF NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR INTRAVENOUS CONTEPO™ TO TREAT COMPLICATED URINARY TRACT INFECTIONS.  Full Article

Nabriva Announces Positive Results For Pneumonia Treatment
Monday, 21 May 2018 07:30am EDT 

May 21 (Reuters) - Nabriva Therapeutics PLC ::NABRIVA THERAPEUTICS ANNOUNCES POSITIVE TOPLINE RESULTS FROM PIVOTAL PHASE 3 CLINICAL TRIAL OF ORAL LEFAMULIN FOR THE TREATMENT OF COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA.NABRIVA THERAPEUTICS PLC - COMPANY PLANS TO FILE A NEW DRUG APPLICATION WITH U.S. FOOD AND DRUG ADMINISTRATION.NABRIVA THERAPEUTICS PLC - LEFAMULIN MET ALL FDA AND EMA PRIMARY ENDPOINTS AND WAS SHOWN TO BE GENERALLY WELL TOLERATED.NABRIVA THERAPEUTICS PLC - PLANS TO FILE A NEW DRUG APPLICATION WITH U.S. FOOD AND DRUG ADMINISTRATION IN Q4 OF 2018.  Full Article

Nabriva Therapeutics Reports Q1 Loss Per Share $0.36
Tuesday, 8 May 2018 07:00am EDT 

May 8 (Reuters) - Nabriva Therapeutics PLC ::NABRIVA THERAPEUTICS REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS AND RECENT CORPORATE HIGHLIGHTS.Q1 LOSS PER SHARE $0.36.Q1 EARNINGS PER SHARE VIEW $-0.59 -- THOMSON REUTERS I/B/E/S.NABRIVA THERAPEUTICS - TOPLINE DATA FROM SECOND PIVOTAL PHASE 3 TRIAL OF LEFAMULIN FOR CABP (LEAP 2) EXPECTED IN SPRING 2018.AS OF MARCH 31, 2018, NABRIVA THERAPEUTICS HAD $89.6 MILLION IN CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS.CASH BALANCE AS OF MARCH 31 IS EXPECTED TO FUND OPERATIONS INTO Q1 OF 2020.  Full Article

Nabriva Therapeutics PLC Files For Mixed Shelf Of Upto $225 Million - SEC Filing
Friday, 16 Mar 2018 05:39pm EDT 

March 16 (Reuters) - Nabriva Therapeutics Plc ::NABRIVA THERAPEUTICS PLC FILES FOR MIXED SHELF OF UPTO $225 MILLION - SEC FILING.  Full Article

Nabriva Therapeutics ‍had $86.9 Mln In Cash, Cash Equivalents as Of Dec 31
Friday, 16 Mar 2018 07:00am EDT 

March 16 (Reuters) - Nabriva Therapeutics Plc ::NABRIVA THERAPEUTICS REPORTS 2017 FINANCIAL RESULTS AND RECENT CORPORATE HIGHLIGHTS.NABRIVA THERAPEUTICS PLC - ‍AS OF DECEMBER 31, 2017, NABRIVA HAD $86.9 MILLION IN CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS​.NABRIVA THERAPEUTICS PLC - AS OF DEC 31, 2017, HAD $86.9 MILLION IN CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS VERSUS $83.9 MILLION AS OF DEC 31, 2016.NABRIVA THERAPEUTICS PLC - CASH BALANCE IS EXPECTED TO FUND OPERATIONS INTO Q4 OF 2018.  Full Article

Nabriva Therapeutics Announces Completion Of Enrollment In Leap 2, A Phase 3 Clinical Trial Evaluating Oral Lefamulin
Monday, 4 Dec 2017 07:00am EST 

Dec 4 (Reuters) - Nabriva Therapeutics Plc ::NABRIVA THERAPEUTICS ANNOUNCES COMPLETION OF ENROLLMENT IN LEAP 2, A PHASE 3 CLINICAL TRIAL EVALUATING ORAL LEFAMULIN FOR THE TREATMENT OF COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA IN ADULTS.NABRIVA THERAPEUTICS PLC - ‍ANTICIPATES TOPLINE CLINICAL RESULTS FROM LEAP 2 TO BE AVAILABLE IN SPRING OF 2018​.  Full Article

Nabriva Therapeutics reports Q3 loss per share $0.79
Thursday, 9 Nov 2017 07:00am EST 

Nov 9 (Reuters) - Nabriva Therapeutics Plc :Nabriva Therapeutics reports third quarter 2017 financial results and recent corporate highlights.Q3 loss per share $0.79.Q3 earnings per share view $-0.58 -- Thomson Reuters I/B/E/S.Nabriva - On track to complete patient enrollment for second phase 3 trial, leap 2, before year end 2017, & expects topline results in spring 2018​.Nabriva Therapeutics Plc - ‍$112.7 million cash and investments as of September 30, 2017​.Nabriva Therapeutics Plc - ‍Cash balance is expected to fund operations into Q4 of 2018​.  Full Article

Nabriva therapeutics announces positive topline results
Monday, 18 Sep 2017 07:00am EDT 

Sept 18 (Reuters) - Nabriva Therapeutics PLC :Nabriva Therapeutics announces positive topline results from global, phase 3 clinical trial evaluating IV and oral lefamulin for the treatment of community-acquired bacterial pneumonia.Nabriva Therapeutics PLC - ‍lefamulin met all primary FDA and EMA endpoints with a favorable tolerability profile​.Nabriva - ‍in leap 1 trial, similar rate of treatment-emergent adverse events observed in lefamulin arm and moxifloxacin with or without linezolid arm​.Nabriva Therapeutics PLC - ‍company expects to complete enrollment in Q4 of 2017, and to have topline data available in spring of 2018 for leap 2​.Nabriva Therapeutics PLC - ‍death occurred with similar frequency in both lefamulin arm and moxifloxacin with or without linezolid arm​.Nabriva Therapeutics PLC - ‍6 patients died in lefamulin arm and 5 patients died in moxifloxacin with or without linezolid arm​.  Full Article