Nabriva Therapeutics plc - NBRV STOCK NEWS

Nabriva Therapeutics (NASDAQ: NBRV) announced that CEO Ted Schroeder will present a company overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference on August 12th at 2:20 PM ET. This presentation will cover the company's innovative anti-infective agents, including XENLETA®, the first systemic pleuromutilin antibiotic approved by the FDA for community-acquired bacterial pneumonia, and CONTEPO™, a potential treatment for complicated urinary tract infections. The presentation can be accessed live on their website with a replay available for 90 days.

Nabriva Therapeutics has received marketing authorization from the European Commission for XENLETA (lefamulin), the first new antibiotic class approved for the treatment of community-acquired pneumonia (CAP) in Europe in nearly 20 years. This decision is based on data from clinical studies showing it to be non-inferior to the standard treatment, moxifloxacin. XENLETA offers a short-course, monotherapy treatment option, aligning with antimicrobial stewardship principles. The company aims to address the significant global burden of pneumonia, which claims approximately 3 million lives annually.

Nabriva Therapeutics (NASDAQ: NBRV) announced promising pre-clinical results for lefamulin, showing anti-inflammatory effects comparable to dexamethasone in a lung model. The study demonstrated nearly complete reduction in cell and neutrophil recruitment after lefamulin treatment. The findings were accepted as a pre-print manuscript in bioRxiv. Additionally, Nabriva received grant funding from the Austrian Research Promotion Agency to further investigate these properties of lefamulin. This research may enhance understanding of its potential applications in treating inflammatory pulmonary diseases.

Nabriva Therapeutics (NASDAQ: NBRV) announced that its partner, Sunovion Pharmaceuticals Canada Inc., received Health Canada approval to market both oral and intravenous formulations of XENLETA (lefamulin) for treating community-acquired pneumonia (CAP) in adults. This approval follows a license agreement signed in March 2019. XENLETA, a novel antibiotic discovered by Nabriva, showed efficacy in clinical trials, with adverse reactions primarily related to gastrointestinal issues. The company continues to navigate market opportunities and challenges related to its product portfolio.

Nabriva Therapeutics (NASDAQ: NBRV) has entered an exclusive agreement with Merck & Co. to market and distribute SIVEXTRO® in the U.S. until December 31, 2023, with options for three-year extensions. This partnership aims to enhance Nabriva's revenue-generating capacity and streamline its commercialization process. Additionally, Nabriva has engaged Amplity Health for community-focused sales initiatives. SIVEXTRO is indicated for acute bacterial skin infections, and this collaboration is expected to optimize product uptake while adapting to challenges posed by the COVID-19 pandemic.

Nabriva Therapeutics plc (NASDAQ: NBRV) announced receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) resubmission for CONTEPO (fosfomycin) for injection aimed at treating complicated urinary tract infections (cUTI). The CRL is due to unresolved observations at contract manufacturing partners, hindered by FDA travel restrictions. The FDA did not raise concerns about safety or efficacy. Nabriva plans to request a Type A meeting with the FDA to discuss next steps. CONTEPO is designated as a Qualified Infectious Disease Product (QIDP) and Fast Track by the FDA.

Nabriva Therapeutics (NASDAQ: NBRV) has announced a definitive agreement for a registered direct offering with institutional investors, including Fidelity Management. The company will sell 41,445,373 ordinary shares and warrants for a combined purchase price of $0.91686 per share. The offering could generate approximately $38 million in gross proceeds before fees. The transaction is anticipated to close around June 2, 2020, subject to customary conditions. H.C. Wainwright & Co. is the exclusive placement agent, and the securities are offered under a shelf registration statement effective since April 27, 2018.

Dublin, Ireland, May 27, 2020 - Nabriva Therapeutics (NASDAQ: NBRV) announces that CEO Ted Schroeder will present a company overview at the Jefferies Virtual Healthcare Conference on June 4 at 1:00 p.m. ET. The presentation will be webcast live and can be accessed on the company's website under the 'Events and Presentations' section. Nabriva specializes in developing innovative anti-infective agents, including XENLETA™, the first pleuromutilin antibiotic approved for community-acquired bacterial pneumonia, and CONTEPO™, aimed at treating complicated urinary tract infections.

Nabriva Therapeutics (NASDAQ: NBRV) announced a study revealing a significant prevalence of macrolide-resistant S. pneumoniae in the U.S. This multicenter evaluation covered 3,510 patients, showing resistance rates of 47.3% from respiratory cultures and 29.6% from blood cultures. Overall, 39.5% prevalence was noted, with regional variations from 13.9% to 54.2%. The data underscores the urgency for innovative antibiotics like XENLETA, approved for treating community-acquired bacterial pneumonia (CABP), which targets resistant strains. The CDC classifies macrolide-resistant S. pneumoniae as a serious public health threat.