NBRV Nabriva Therapeutics plc

0.69
0  0%
Previous Close 0.69
Open 0.7
52 Week Low 0.485
52 Week High 2.77
Market Cap $98,832,038
Shares 142,965,483
Float 142,169,248
Enterprise Value $78,907,183
Volume 1,873,045
Av. Daily Volume 8,277,505
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Drug Pipeline

Drug Stage Notes
Contepo
Complicated urinary tract infections (cUTI)
CRL
CRL
CRL issued April 30, 2019. Further CRL received June 19, 2020.
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
Approved
Approved
FDA approval announced August 19, 2019.

Latest News

  1. WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA® (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available.

    XENLETA was discovered and developed by Nabriva (NASDAQ:NBRV), a commercial-stage biopharmaceutical company focused on commercialization and development of anti-infective agents. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with…

    WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA® (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available.

    XENLETA was discovered and developed by Nabriva (NASDAQ:NBRV), a commercial-stage biopharmaceutical company focused on commercialization and development of anti-infective agents. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. XENLETA is the first and only oral and IV pleuromutilin empiric antibiotic that acts against the pathogens that commonly cause CABP.

    Nabriva announced on May 29th that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XENLETA 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. A regulatory decision is anticipated during the second half of 2020.

    Under the terms of the NPP, XENLETA will be made available in two formulations - 150mg injection for intravenous administration and 600mg oral tablets - using named patient or expanded access managed by WEP to enable healthcare professionals to access XENLETA for patients that have an unmet clinical need. Once a request is approved, WEP will manage the distribution of XENLETA to the treating physician and will provide any necessary follow-up support and services.

    About WEP Clinical

    Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in the UK, US, Portugal and Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide. We are passionate about helping those in need. For more information, please visit www.wepclinical.com.

    About Nabriva Therapeutics

    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). XENLETA was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

    XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

    WARNINGS AND PRECAUTIONS

    XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

    Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

    Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    ADVERSE REACTIONS

    The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

    USE IN SPECIFIC POPULATIONS

    In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

    Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

    Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

    Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

    XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

    To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or

    https://www.fda.gov/safety/medwatch

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  2. DUBLIN, Ireland, June 19, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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…

    DUBLIN, Ireland, June 19, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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. In general, previously identified product quality and facility inspection related observations at our contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved.  The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL. Nabriva plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDA's plans for completing foreign facility inspections.  CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of serious infections, including cUTI.

    Complicated Urinary Tract Infection

    Complicated urinary tract infections represent a serious infection in patients with underlying functional or structural abnormality of the urinary tract or in the presence of catheterization, and includes patients with acute pyelonephritis, regardless of underlying abnormalities of the urinary tract. An estimated three million cases of Gram-negative cUTIs are treated in the U.S. hospital setting annually, where approximately 40 percent of cases are suspected to be caused by resistant strains. Ineffectively managed cUTIs can lead to increased treatment failure rates, which in turn, can result in prolonged hospital stays, recurrence, re-hospitalization, and mortality – each of which poses a substantial resource and economic burden on the healthcare and payer systems.

    Among the causes of cUTI is Enterobacteriaceae, which is a multi-drug resistance (MDR) strain of Gram-negative bacteria. Enterobacteriaceae produces extended spectrum beta-lactamases (ESBL), a chemical that can cause some antibiotics to be ineffective in treating bacterial infections such as cUTI. As a result, cUTI poses a serious and rapidly emerging health threat for hospitalized patients, especially those in intensive care units.

    About CONTEPO

    CONTEPO (fosfomycin) for injection is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.

    About Nabriva Therapeutics plc

    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). Nabriva Therapeutics is also developing CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis. For more information, please visit www.nabriva.com.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about Nabriva Therapeutics' plans for further interactions with the FDA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics' ability to resolve the matters set forth in the Complete Response Letter it received from the FDA in connection with its NDA resubmission for CONTEPO (fosfomycin) for injection; Nabriva Therapeutics' reliance on third-party manufacturers to manufacture the clinical and commercial supply of its product candidates and the ability of such third parties to comply with applicable regulatory requirements; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors

    Gary Sender

    Nabriva Therapeutics plc

    For Media

    Mike Beyer

    Sam Brown Inc.

    312-961-2502

    Primary Logo

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  3. DUBLIN, Ireland and KING OF PRUSSIA, Pa., May 29, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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.  Each ordinary share and accompanying warrant are being sold together at a combined purchase…

    DUBLIN, Ireland and KING OF PRUSSIA, Pa., May 29, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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.  Each ordinary share and accompanying warrant are being sold together at a combined purchase price of $0.91686.  The warrants have an exercise price of $0.792 per share, are exercisable on the issuance date and will expire on the two-year anniversary of the issuance date.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    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.  The offering is expected to close on or about June 2, 2020, subject to the satisfaction of customary closing conditions.

    The securities described above are being offered and sold in this registered direct offering pursuant to a shelf registration statement, including a prospectus, on Form S-3 that was filed by Nabriva Therapeutics with the Securities and Exchange Commission ("SEC") and was declared effective on April 27, 2018. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus and related prospectus supplement may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, via email at or via telephone at (646) 975-6996.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy Nabriva Therapeutics' securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Nabriva Therapeutics plc

    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). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about a prospective financing and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: market and other financing conditions, Nabriva Therapeutics' ability to satisfy customary closing conditions related to the registered direct offering and to consummate the offering, fluctuations in Nabriva Therapeutics' share price and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the SEC. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments may cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors
    Gary Sender
    Nabriva Therapeutics plc

    For Media
    Mike Beyer
    Sam Brown Inc.

    312-961-2502

    Primary Logo

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    • If approved, XENLETA has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous (IV) and oral treatment of adult patients with CAP in Europe
       
    • CHMP opinion supported by robust safety and efficacy data from two global pivotal Phase 3 trials of XENLETA
       
    • European Commission decision anticipated in the second half of 2020

    DUBLIN, Ireland, May 29, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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…

    • If approved, XENLETA has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous (IV) and oral treatment of adult patients with CAP in Europe
       
    • CHMP opinion supported by robust safety and efficacy data from two global pivotal Phase 3 trials of XENLETA
       
    • European Commission decision anticipated in the second half of 2020

    DUBLIN, Ireland, May 29, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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. A regulatory decision is anticipated during the second half of 2020.

    "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. "XENLETA has a novel mechanism of action and provides an urgently needed short course, empiric monotherapy treatment alternative for adult patients with CAP. We look forward to the European Commission's decision and the opportunity to bring this important medicine to patients."

    The CHMP recommendation for marketing authorization is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants.

    In the two Phase 3 clinical trials, the EMA co-primary endpoint was the Investigator Assessment of Clinical Response (IACR) at Test of Cure (TOC) in both the clinically evaluable (CE) and modified intent-to-treat (mITT) populations. Both studies established XENLETA to be non-inferior to the standard-of-care moxifloxacin in the treatment of adults with CAP independently and when the pooled data were analyzed across PORT scores of II-V.  In the pooled analysis, the IACR success rate at TOC in the modified Intent-to-Treat (mITT) population was 85 percent in the XENLETA group and 87.1 percent in the moxifloxacin group (treatment difference ‑2.2 percent; 95 percent confidence interval (CI): ‑5.9, 1.6), and 88.5 percent in the lefamulin group and 91.8 percent in the moxifloxacin group (treatment difference ‑3.3 percent; 95 percent CI: ‑6.8, 0.1) in the Clinically Evaluable population. In these trials, lefamulin was generally well-tolerated.  The most frequently reported adverse reactions are administration site reactions, diarrhea, nausea, vomiting, hepatic enzyme elevation, headache, hypokalemia, and insomnia.

    The European Commission will review the CHMP recommendation and typically delivers its final decision in approximately two months. The U.S. Food and Drug Administration (FDA) approved XENLETA in August 2019 for the treatment of adult patients with community-acquired bacterial pneumonia (CABP). 

    About Nabriva Therapeutics plc

    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). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit www.nabriva.com.

    About XENLETA

    XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.  In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most frequently reported adverse reactions are administration site reactions (7%), diarrhea (7%), nausea (4%), vomiting (2%), hepatic enzyme elevation (2%), headache (1%), hypokalaemia (1%), and insomnia (1%). Administration site reactions led to discontinuation in <1%; gastrointestinal disorders were predominantly associated with the oral formulation and led to treatment discontinuation in <1%.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the potential outcome of and timing of a decision by the European Commission with respect to regulatory approval for XENLETA in Europe, Nabriva Therapeutics' ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the European Commission, the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors
    Gary Sender
    Nabriva Therapeutics plc

    For Media
    Mike Beyer
    Sam Brown Inc.

    312-961-2502

    Primary Logo

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  4. DUBLIN, Ireland, May 27, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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.

    The presentation will be webcast live and may be accessed by visiting the "Investors" section of the Company's website under the "Events and Presentations" tab at www.nabriva.com. A replay of the webcast will be available for 90 days.

    About Nabriva Therapeutics plc

    Nabriva Therapeutics is a biopharmaceutical…

    DUBLIN, Ireland, May 27, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: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.

    The presentation will be webcast live and may be accessed by visiting the "Investors" section of the Company's website under the "Events and Presentations" tab at www.nabriva.com. A replay of the webcast will be available for 90 days.

    About Nabriva Therapeutics plc

    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). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit www.nabriva.com.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, the sufficiency of Nabriva Therapeutics' existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics' ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics' ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics' annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics' views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics' views as of any date subsequent to the date of this press release.

    CONTACTS:

    For Investors
    Gary Sender
    Nabriva Therapeutics plc

    For Media
    Mike Beyer
    Sam Brown Inc.

    312-961-2502

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