RADNOR,
Pa., Sept. 18, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that Stephen Willard,
J.D., Chief Executive Officer and Dr. Jonathan Javitt, Chief Scientist of NRx
Pharmaceuticals, will present a company overview at the Sidoti
Virtual Small Cap Conference on Thursday,
September 21, 2023, at 9:15AM
ET. Management will be available for one-on-one meetings
with conference attendees as well.
A webcast and subsequent archived replay will be
available on the Company's website at
https://ir.nrxpharma.com/events. The replay will be available for
90 days after the event.
About NRX-101
NRX-101, a fixed dose combination of
D-cycloserine and lurasidone, has been granted Fast Track
Designation, Breakthrough Therapy Designation, a Special Protocol
Agreement, and a Biomarker Letter of Support from the FDA for
Suicidal Treatment Resistant Bipolar Depression (S-TRBD).
Additionally, the product is being developed in chronic pain
and PTSD.
Up to 50% of individuals with bipolar disorder
attempt suicide over their lifetime, and estimates indicate that up
to 20% may succumb to suicide. The only FDA-approved treatment for
patients with treatment-resistant suicidal bipolar depression
remains electroconvulsive therapy.
Conventional antidepressants can increase the
risk of suicide in certain patients; hence their labels contain a
warning to that effect. NRX-101 is a patented, oral, fixed dose
combination of D-cycloserine and lurasidone, neither of which has
shown addiction potential in preclinical models. Based on the
results of a Phase 2 proof-of-concept study, NRX-101 received
Breakthrough Therapy Designation from the FDA for the treatment of
severe bipolar depression in patients with ASIB after initial
stabilization with ketamine or other effective therapy.
NRX-101 is one of the first oral antidepressants
currently in late-stage clinical studies targeting the
NMDA-receptor in the brain, which represents potentially a key new
mechanism to treat depression with and without suicidality, as well
as chronic pain, PTSD and other indications, as well as potential
use in Urinary Tract Infections (UTI).
About NRx Pharmaceutical
NRx
Pharmaceuticals is a clinical-stage biopharmaceutical company
developing therapeutics based on its NMDA platform for the
treatment of central nervous system disorders, specifically
suicidal bipolar depression, chronic pain and PTSD. The Company's
lead program NRX-101, an oral, fixed-dose combination of
D-cycloserine and lurasidone, targets the brain's
N-methyl-D-aspartate (NMDA) receptor and is being investigated in a
Phase 2b/3 clinical trial for
suicidal treatment-resistant bipolar depression (S-TRBD), which
includes patients with both acute and sub-acute suicidality, an
indication for which the only approved treatment is electroshock
therapy. The Company has partnered with Alvogen Pharmaceuticals,
who owns the worldwide rights to NRX-101 for treatment of S-TRBD,
to help bring NRX-101 to a global population of patients with unmet
medical need. NRx Pharmaceuticals is currently exploring NRX-101's
potential to act as a non-opioid chronic pain treatment option and
is continuing to plan to enroll patients in an Israeli-based trial
of patients suffering from post-traumatic stress disorder with
depression and suicidality.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes "forward-looking
statements" within the meaning of the "safe harbor" provisions of
the U.S. Private Securities Litigation Reform Act of 1995, which
may include, but are not limited to, statements regarding our
financial outlook, product development, business prospects, and
market and industry trends and conditions, as well as the Company's
strategies, plans, objectives, and goals. These forward-looking
statements are based on current beliefs, expectations, estimates,
forecasts, and projections of, as well as assumptions made by, and
information currently available to, the Company's management.
Actual results could differ materially from those contemplated by
the forward-looking statements. A discussion of these and other
factors, including risks and uncertainties with respect to the
Company, is set forth in the Company's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K,
as may be supplemented, or amended by the Company's Quarterly
Reports on Form 10-Q. Given these risks, uncertainties, and
factors, you are cautioned not to place undue reliance on such
forward-looking statements, which are qualified in their entirety
by these cautionary statements.
The Company assumes no obligation to revise any
forward-looking statement, whether as a result of new information,
future events or otherwise. Accordingly, you should not place
reliance on any forward-looking statement, and all forward-looking
statements are herein qualified by reference to the cautionary
statements set forth above.
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SOURCE NRx Pharma