CorMedix Inc. Announces Regulatory Update
September 07 2021 - 8:30AM
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused
on developing and commercializing therapeutic products for the
prevention and treatment of infectious and inflammatory disease,
today provided an update with respect to its resubmission timeline
for the DefenCath New Drug Application (“NDA”).
CorMedix has encountered delays at its third-party contract
manufacturer (“CMO”). The Company was informed by the CMO that
there are issues that are unrelated to DefenCath manufacturing
activities. The timeline for CorMedix and the CMO to address
deficiencies at the facility that are required for resubmission of
the DefenCath NDA is uncertain at this time. We will provide an
update when more information becomes available.
About CorMedix
CorMedix Inc. is a biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of infectious and inflammatory
diseases. The Company is focused on developing its lead product
DefenCath™, a novel, antibacterial and antifungal solution designed
to prevent costly and life-threatening bloodstream infections
associated with the use of central venous catheters in patients
undergoing chronic hemodialysis. DefenCath has been designated by
FDA as Fast Track and as a Qualified Infectious Disease Product
(QIDP), and the NDA received priority review in recognition of its
potential to address an unmet medical need. QIDP provides for an
additional five years of marketing exclusivity, which will be added
to the five years granted to a New Chemical Entity upon approval of
the NDA. CorMedix also committed to conducting a clinical study in
pediatric patients using a central venous catheter for hemodialysis
when the NDA is approved, which will add an additional six months
of marketing exclusivity when the study is completed. The Company
received a Complete Response Letter from FDA stating that the NDA
could not be approved until satisfactory resolution of deficiencies
at the contract manufacturing facility, including in-process
controls for the filling operation. CorMedix also intends to
develop DefenCath as a catheter lock solution for use in oncology
and total parenteral nutrition patients. It is leveraging its
taurolidine technology to develop a pipeline of antimicrobial
medical devices, with programs in surgical sutures and meshes, and
topical hydrogels. The Company is also working with top-tier
researchers to develop taurolidine-based therapies for rare
pediatric cancers. Neutrolin® is CE Marked and marketed in Europe
and other territories as a medical device. For more information,
visit: www.cormedix.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks and uncertainties. All
statements, other than statements of historical facts, regarding
management’s expectations, beliefs, goals, plans or CorMedix’s
prospects, future financial position, financing plans, future
revenues and projected costs should be considered forward-looking.
Readers are cautioned that actual results may differ materially
from projections or estimates due to a variety of important
factors, including: the results of our discussions with the FDA
regarding the DefenCath development path for marketing
authorization; the resources needed to secure approval of the new
drug application for DefenCath from the FDA; the risks and
uncertainties associated with CorMedix’s ability to manage its
limited cash resources and the impact on current, planned or future
research, including the continued development of
DefenCath/Neutrolin and research for additional uses for
taurolidine; obtaining additional financing to support CorMedix’s
research and development and clinical activities and operations;
preclinical results are not indicative of success in clinical
trials and might not be replicated in any subsequent studies or
trials; and the ability to retain and hire necessary personnel to
staff our operations appropriately. We continue to assess to what
extent the uncertainty surrounding the Coronavirus pandemic may
impact our business and operations. These and other risks are
described in greater detail in CorMedix’s filings with the SEC,
copies of which are available free of charge at the SEC’s website
at www.sec.gov or upon request from CorMedix. CorMedix may not
actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. CorMedix assumes no obligation and
does not intend to update these forward-looking statements, except
as required by law.
Investor Contact:Dan
FerryManaging DirectorLifeSci Advisors(617) 430-7576
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