Iterum Therapeutics Provides Regulatory Update
July 01 2021 - 6:30PM
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a
clinical-stage pharmaceutical company focused on developing next
generation oral and IV antibiotics to treat infections caused by
multi-drug resistant pathogens in both community and hospital
settings, today announced that the Company received a letter from
the U.S. Food and Drug Administration (“FDA”) stating that, as part
of their ongoing review of the Company’s New Drug Application
(“NDA”) for sulopenem etzadroxil/probenecid, the agency has
identified deficiencies that preclude the continuation of the
discussion of labeling and post marketing requirements/commitments
at this time. No details with respect to deficiencies were
disclosed by the FDA in this notification and the letter further
states that the notification does not reflect a final decision on
the information under review. In a letter to the Company dated
January 21, 2021, the FDA had assigned a Prescription Drug User Fee
Act (“PDUFA”) goal date of July 25, 2021 for completion of its
review of the NDA.
The Company intends to work with the FDA to
understand the nature of the deficiencies and resolve them as
quickly as possible.
“While we are disappointed by this news, we
continue to believe in the potential of sulopenem to help
address the growing challenge of antibiotic resistance,” said Corey
Fishman, Chief Executive Officer of Iterum Therapeutics. “Our goal
now is to work with the FDA to identify and resolve the issues as
expeditiously as possible in order to continue advancing this much
needed antibiotic.”
About Iterum Therapeutics
plc
Iterum Therapeutics plc is a clinical-stage
pharmaceutical company dedicated to developing differentiated
anti-infectives aimed at combatting the global crisis of multi-drug
resistant pathogens to significantly improve the lives of people
affected by serious and life-threatening diseases around the world.
Iterum Therapeutics is advancing its first compound, sulopenem, a
novel penem anti-infective compound, in Phase 3 clinical
development with an oral formulation and IV formulation. Sulopenem
has demonstrated potent in vitro activity against a wide variety of
gram-negative, gram-positive and anaerobic bacteria resistant to
other antibiotics. Iterum Therapeutics has received Qualified
Infectious Disease Product (QIDP) and Fast Track designations for
its oral and IV formulations of sulopenem in seven indications. The
NDA for sulopenem etzadroxil/probenecid for the treatment of
uncomplicated urinary tract infections in patients with a quinolone
non-susceptible pathogen has been accepted for review by the FDA
and a PDUFA goal date of July 25, 2021 has been assigned to it.
Forward-Looking Statements
This press release contains forward-looking
statements. These forward-looking statements include, without
limitation, statements regarding the Company’s plans, strategies
and prospects for its business, including with respect to the
timing of review by the FDA of the NDA, the Company’s expectations
with regard to its interactions and communications with the FDA and
the Company’s expectations with regard to its ability address any
deficiencies the FDA may identify. In some cases, forward-looking
statements can be identified by words such as “may,” “believes,”
“intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,”
“should,” “assumes,” “continues,” “could,” “would,” “will,”
“future,” “potential” or the negative of these or similar terms and
phrases. Forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the Company’s
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements.
Forward-looking statements include all matters that are not
historical facts. Actual future results may be materially different
from what is expected due to factors largely outside the Company’s
control, including the uncertainties inherent in the initiation and
conduct of clinical trials, availability and timing of data from
clinical trials, changes in regulatory requirements or decisions of
regulatory authorities, the timing or likelihood of regulatory
filings and approvals, changes in public policy or legislation,
commercialization plans and timelines, if oral sulopenem is
approved, the actions of third-party clinical research
organizations, suppliers and manufacturers, the accuracy of the
Company’s expectations regarding how far into the future the
Company’s cash on hand will fund the Company’s ongoing operations,
the impact of COVID-19 and related responsive measures thereto,
risks and uncertainties concerning the outcome, impact, effects and
results of the Company’s evaluation of corporate, strategic,
financial and financing alternatives, including the terms, timing,
structure, value, benefits and costs of any corporate, strategic,
financial or financing alternative and the Company’s ability to
complete one at all and other factors discussed under the caption
“Risk Factors” in its Annual Report on Form 10- Q filed with the
Securities and Exchange Commission (the “SEC”) on May 14, 2021, and
other documents filed with the SEC from time to time.
Forward-looking statements represent the Company’s beliefs and
assumptions only as of the date of this press release. Except as
required by law, the Company assumes no obligation to update these
forward-looking statements publicly, or to update the reasons
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
Investor Contact:Judy
MatthewsChief Financial Officer312-778-6073IR@iterumtx.com
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