NBRV - Nabriva Therapeutics plc

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
0.6885
-0.0028 (-0.41%)
At close: 4:00PM EDT
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Previous Close0.6913
Open0.6900
Bid0.6750 x 1800
Ask0.6898 x 800
Day's Range0.6730 - 0.6900
52 Week Range0.4850 - 2.7700
Volume2,079,853
Avg. Volume6,940,633
Market Cap98.431M
Beta (5Y Monthly)2.50
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
All
News
Press Releases
  • GlobeNewswire

    Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO™ (fosfomycin) for injection

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) resubmission seeking marketing approval of CONTEPO (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at our manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions.

  • GlobeNewswire

    Nabriva Therapeutics Announces $38 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has entered into a definitive agreement with several healthcare-focused institutional investors, including Fidelity Management & Research Company, LLC, for the purchase and sale of (i) an aggregate of 41,445,373 ordinary shares and (ii) warrants to purchase up to an aggregate of 41,445,373 ordinary shares in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds to Nabriva Therapeutics from the offering, before deducting the placement agent’s fees and other estimated offering expenses payable by Nabriva Therapeutics, are approximately $38 million.

  • GlobeNewswire

    Nabriva Therapeutics Receives Positive EU CHMP Opinion for XENLETA™ (lefamulin) for the Treatment of Community-Acquired Pneumonia (CAP)

    Nabriva Therapeutics plc (NBRV) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of XENLETA (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. The CHMP opinion will be reviewed by the European Commission (EC), which has the authority to approve medicines for all 28 countries of the European Union, Norway, Iceland, and Liechtenstein. “Today’s announcement brings us one step closer to the first approval of a new class of antibiotics for patients with community-acquired pneumonia in Europe in almost 20 years,” said Jennifer Schranz, MD, Chief Medical Officer of Nabriva.

  • GlobeNewswire

    Nabriva Therapeutics to Present at the Jefferies Virtual Healthcare Conference

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Ted Schroeder, Chief Executive Offer at Nabriva, will provide a company overview and business update at the Jefferies Virtual Healthcare Conference on Thursday, June 4, at 1:00p.m. ET. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

  • GlobeNewswire

    National Burden of Macrolide-Resistant Streptococcus Pneumoniae in the United States From Blood and Respiratory Tract Cultures Approaches 40 Percent

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the publication of a study entitled, A Multicenter Evaluation of the U.S. Prevalence and Regional Variation in Macrolide Resistant S. pneumoniae from Blood or Respiratory Cultures among Adult Patients (Abstract #5523), online in the proceedings of 30th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID). This study assessed 3,510 patients with a positive S. pneumoniae blood or respiratory culture in the ambulatory and inpatient setting at 329 hospitals across nine U.S. Census geographic regions over 12 months ending 3Q2019 to determine the prevalence and rates of macrolide resistance in S. pneumoniae.

  • GlobeNewswire

    Nabriva Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Updates

    -Cash runway extended into the fourth quarter of 2020 through judicious resource management- -XENLETA managed care coverage and patient reimbursement continues to.

  • GlobeNewswire

    Nabriva Therapeutics to Present at the BofA Securities 2020 Virtual Health Care Conference

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Ted Schroeder, Chief Executive Offer at Nabriva, will provide a company overview and business update at the BofA Securities 2020 Virtual Health Care Conference on Wednesday, May 13, at 11:00a.m. ET. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

  • GlobeNewswire

    Nabriva Therapeutics to Report First Quarter 2020 Financial Results on May 11, 2020

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its first quarter financial results after the close of the U.S. financial markets on Monday, May 11, 2020. Nabriva’s management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com.

  • GlobeNewswire

    XENLETA® (Lefamulin) Treatment Results in a Rapid Time-to-Clinical Response in Hospitalized Patients with Community-Acquired Bacterial Pneumonia (CABP)

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that Open Forum Infectious Diseases, an official journal of the Infectious Diseases Society of America (IDSA), has published results from a post-hoc analysis of clinical data from patients who initiated treatment in the hospital from the pivotal Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 clinical trials. The analyses indicate that lefamulin results in a rapid and similar time to clinical response, a proxy for hospital “discharge readiness,” compared to moxifloxacin.

  • GlobeNewswire

    Centers for Medicare & Medicaid Services Issues Product-Specific J-Code for XENLETA

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that the Centers for Medicare and Medicaid Services (CMS) confirmed its preliminary decision to assign a permanent product-specific Healthcare Common Procedure Coding System (HCPCS) J-code for XENLETA™ (lefamulin) 150 mg injection. Having a unique J-code for XENLETA will help facilitate more efficient billing for hospitals and will assist in the tracking of XENLETA in claims data. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.

  • GlobeNewswire

    Nabriva Therapeutics to Present at the 19th Annual Needham Virtual Healthcare Conference

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Ted Schroeder, Chief Executive Offer at Nabriva, will provide a company overview and business update at the 19th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, at 11:20a.m. ET. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

  • GlobeNewswire

    Nabriva Therapeutics Reports Fourth Quarter and Year End 2019 Financial Results and Recent Corporate Highlights

    -Prioritizing community opportunity for oral XENLETA given broad reimbursement coverage- -Reducing balance sheet risk through early paydown of a substantial portion of Hercules.

  • ACCESSWIRE

    Nabriva Therapeutics Plc to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / March 12, 2020 / Nabriva Therapeutics Plc (NASDAQ:NBRV) will be discussing their earnings results in their 2019 Fourth Quarter Earnings call to be held on March 12, 2020 at ...

  • GlobeNewswire

    Nabriva Therapeutics to Report 2019 Financial Results and Recent Corporate Highlights on March 12, 2020

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its fourth quarter and full year 2019 financial results after the close of the U.S. financial markets on Thursday, March 12, 2020. Nabriva’s management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com.

  • GlobeNewswire

    Nabriva Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has granted non-statutory stock options to purchase an aggregate of 21,000 ordinary shares of Nabriva Therapeutics as an inducement to one newly-hired employee. The award was made pursuant to the Nasdaq inducement grant exception as a component of the new hires’ employment compensation. The stock options were granted effective February 28, 2020 with an exercise price of $1.35 per share, which is equal to the closing price of Nabriva Therapeutics’s ordinary shares on the date of grant.

  • GlobeNewswire

    Nabriva Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has granted non-statutory stock options to purchase an aggregate of 161,000 ordinary shares of Nabriva Therapeutics as inducements to 5 newly-hired employees. The awards were made pursuant to the Nasdaq inducement grant exception as a component of the new hires’ employment compensation. The stock options were granted effective January 31, 2020 with an exercise price of $1.35 per share, which is equal to the closing price of Nabriva Therapeutics’ ordinary shares on the date of grant.

  • GlobeNewswire

    Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous CONTEPO™ (fosfomycin) for Injection

    Nabriva Therapeutics plc (NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs). In the acknowledgement letter for the resubmitted NDA, the FDA stated that Nabriva’s filing was a complete, class 2 response to the complete response letter the FDA issued on April 30, 2019.

  • GlobeNewswire

    Nabriva Therapeutics Announces $20 Million Registered Direct Offering

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale in a registered direct offering of (i) an aggregate of 13,793,106 ordinary shares and (ii) warrants to purchase up to an aggregate of 13,793,106 ordinary shares. Each ordinary share and accompanying warrant are being sold together at a combined purchase price of $1.45. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

  • GlobeNewswire

    Nabriva Therapeutics Resubmits New Drug Application for Intravenous CONTEPO™ (fosfomycin) for Injection

    Nabriva Therapeutics plc (NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva anticipates a six-month review period by the FDA.

  • GlobeNewswire

    Nabriva Therapeutics to Present at the 31st Annual Piper Jaffray Healthcare Conference

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Gary Sender Chief Financial Officer and Francesco Lavino Chief Commercial Officer, will provide a company overview and business update at the 31st Annual Piper Jaffray Healthcare Conference on Wednesday, December 4, 2019 at 4:30 p.m. ET. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

  • GlobeNewswire

    Nabriva Therapeutics Commends the CDC on the 2019 Antibiotic Resistance Threats Report, Highlighting the Need for New Antibiotics Aligned with Antibiotic Stewardship

    S. pneumoniae continues to be designated by the CDC as “Serious Threat” underscoring need for rapid detection and prevention strategies, particularly in community.

  • GlobeNewswire

    Nabriva Therapeutics Reports Third Quarter 2019 Financial Results and Recent Corporate Highlights

    -More than 200 hospital formulary reviews of XENLETA™ scheduled before the end of the year- -Approximately 50% of all covered lives have outpatient formulary access to XENLETA-.

  • GlobeNewswire

    Nabriva Therapeutics to Report Third-Quarter 2019 Financial Results on November 12, 2019

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its third-quarter 2019 financial results after the close of the U.S. financial markets on Tuesday, November 12, 2019. Nabriva’s management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com.

  • GlobeNewswire

    Nabriva to Present Data at the CHEST Annual Meeting Demonstrating the Safety and Efficacy of Newly FDA-Approved XENLETA (lefamulin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)

    Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that it will present data on the pooled results from completed Phase 3 trials of XENLETA™ (lefamulin) at the CHEST Annual Meeting 2019, to be held October 19-23 in New Orleans. XENLETA is a first-in-class pleuromutilin antibiotic for the intravenous (IV) and oral treatment of community-acquired bacterial pneumonia (CABP) in adults and is now commercially available in the United States. “The clinical community desperately needs new classes of antibiotics with different mechanisms of action that have targeted, potent antimicrobial activity and improved safety and tolerability over existing therapies,” said Jennifer Schranz, M.D., Chief Medical Officer of Nabriva Therapeutics.

  • GlobeNewswire

    Lefamulin Evaluation Against Pneumonia 2 (LEAP 2) Study Results Published in the Journal of the American Medical Association

    DUBLIN, Ireland, Sept. 27, 2019 -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative.