RADNOR,
Pa., Dec. 11, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced the Company will be participating in-person at the
LifeSci Partners Corporate Access Event for three days from
January 8th through the
10th in San
Francisco.
2024 promises to be a year of substantial growth that will
likely include the filing of the Company's first New Drug
Application. The company welcomes the opportunity to update
investors on its extraordinary recent progress, upcoming clinical
and regulatory catalysts, and to answer questions.
Sign-up: LifeSci Partners Corporate Access Event
2024
NRx currently has four (4) near-term shots on goal with
meaningful commercial and/or monetization opportunities:
- NRX-100 – Intravenous Ketamine. With recent failures in
in attempts to develop nasal ketamine, NRx has the only potential
near-term path through the FDA for a labeled ketamine product that
will address the needs of patients with both bipolar and unipolar
depression. In March 2024, we aim to
submit a New Drug Application based on data from two
well-controlled, randomized trials together with GMP manufacturing
data, aiming for two-year stability at launch. NRx has
incorporated HOPE Therapeutics. Inc. as a vehicle for taking
ketamine to market. We are developing this as a spinout that will
focus on current income for investors in a market that could be
accessed by the end of 2024; we will discuss HOPE financing options
with investors as well.
- NRX-101 – Treatment-Resistant Bipolar Depression. Phase
2b/3 trial enrollment is nearing
completion with data expected in early 2024. NRx has partnered this
program with Alvogen, with $330
million in potential milestones and a 15% royalty, including
a $10 million milestone payment on
successful data readout and FDA comment; Alvogen is responsible for
all development and commercialization costs, following receipt of
positive data and FDA response.
- NRX-101 – Chronic Pain. D-cycloserine (DCS) has been
shown to reduce nociceptive pain (~$70b market opportunity) while demonstrating no
potential for addiction and potentially reducing opioid
craving. With data readout from a larger U.S. DoD-funded
study evaluating DCS in chronic, refractory low back pain expected
imminently, the company has submitted NRX-101 for HEAL funding from
NIH.
- NRX-101 – Complicated Urinary Tract Infection. While 90%
of organisms show resistance to common antibiotics, data show that
DCS is effective against many of these pathogens and is highly
concentrated in the urine. NRx has submitted an IND and is eligible
for FDA Qualified Infectious Disease Product status; response is
expected shortly. The company is exploring spin-out or licensing
opportunities.
NRx will be hosting 1x1 meetings at the Beacon Grand Hotel (450
Powell Street, a block away from the JP Morgan Conference at Union
Square). To schedule a meeting, please register at LifeSci
Partners Corporate Access Event 2024 and request a meeting
with management.
About NRx Pharmaceuticals
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 is
developing NRX-101, an FDA-designated investigational Breakthrough
Therapy for suicidal treatment-resistant bipolar depression and
chronic pain. NRx has partnered with Alvogen Pharmaceuticals around
the development and marketing of NRX-101 for the treatment of
suicidal bipolar depression. NRX-101 additionally has potential to
act as a non-opioid treatment for chronic pain.
NRx has recently announced plans to submit a New Drug
Application for ketamine in the treatment of suicidal depression,
based on results of well-controlled clinical trials conducted under
the auspices of the US National Institutes of Health and newly
obtained data from French health authorities, licensed under a data
sharing agreement. NRx was awarded Fast Track Designation for
development of ketamine (NRX-100) by the US FDA as part of a
protocol to treat patients with acute suicidality.
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SOURCE NRx Pharmaceuticals, Inc.