Nabriva Therapeutics to Report Second Quarter 2022 Financial Results and Recent Corporate Highlights on August 3, 2022
20 Luglio 2022 - 10:05PM
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 will report its second quarter financial results
along with recent company highlights after the close of the U.S.
financial markets on Wednesday, August 3, 2022. Nabriva’s
management will host a conference call at 4:30 p.m. ET to discuss
the financial results and recent corporate highlights.
To participate in the conference call, please dial 833-634-2311
for domestic participants and 412-902-4177 for international
participants and ask to join the “Nabriva Therapeutics’ Conference
Call”. A live webcast of the conference call can be accessed
through the “Investors” tab on the Nabriva Therapeutics website at
www.nabriva.com. A replay will be available on this website shortly
after conclusion of the event 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 entered into an
exclusive agreement with subsidiaries of Merck & Co. Inc.,
Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO®
(tedizolid phosphate) in the United States and certain of its
territories. 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.
About SIVEXTRO
SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and
Drug Administration in 2014. It is indicated in adults and
pediatric patients 12 years of age and older for the treatment of
acute bacterial skin and skin structure infections (ABSSSI) caused
by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including
methicillin-resistant (MRSA) and methicillin-susceptible (MSSA)
isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus anginosus group (including Streptococcus anginosus,
Streptococcus intermedius and Streptococcus constellatus), and
Enterococcus faecalis. To reduce the development of drug-resistant
bacteria and maintain the effectiveness of SIVEXTRO and other
antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
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 common adverse reactions associated with
XENLETA included diarrhea, nausea, reactions at the injection site,
elevated liver enzymes, and vomiting. For more information, please
visit www.XENLETA.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
commercialize XENLETA for the treatment of CABP, including the
managed care coverage for XENLETA, the distribution and promotion
of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO
for Complicated Urinary Tract Infections (cUTI), the clinical
utility of XENLETA for CABP and Cystic Fibrosis, SIVEXTRO for
ABSSSI and of CONTEPO for cUTI, the impact of macro events on sales
of SIVEXTRO and XENLETA, plans for and timing of the review of
regulatory filings for XENLETA and CONTEPO, efforts to bring
CONTEPO to market, the market opportunity for and the potential
market acceptance of XENLETA for CABP, SIVEXTRO for ABSSSI and
CONTEPO for cUTI, the prospects for future sales of SIVEXTRO, the
development of XENLETA and CONTEPO for additional indications, the
development of additional formulations of XENLETA and CONTEPO,
plans for making lefamulin available in the European Union, Canada
and China, plans to pursue research and development of other
product candidates, plans to pursue business development
initiatives, expectations regarding the impact of the interruptions
resulting from COVID-19 on its business, 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 execute its
commercialization plans for XENLETA and SIVEXTRO and whether market
demand for XENLETA and SIVEXTRO is consistent with its
expectations, Nabriva Therapeutics’ ability to build and maintain a
sales force for XENLETA and SIVEXTRO, 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.
CONTACT:
For Investors and MediaKim AndersonNabriva
Therapeutics plcir@nabriva.com
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