Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company pioneering neuroscience to deliver groundbreaking therapies
for individuals affected by psychiatric and neurological disorders,
today announced that it will present posters detailing clinical
trial data for fasedienol, an investigational pherine candidate in
Phase 3 development for the acute treatment of social anxiety
disorder (SAD), and PH80, a Phase 2 investigational pherine
candidate for treatment of women’s health disorders, at the Anxiety
and Depression Association of America (ADAA) Conference in Boston,
Massachusetts from April 11 to 14, 2024.
Poster Presentation Date: Saturday, April 13, 2024, 3:45
p.m. Eastern Time Title: Top-Line Results from Phase 3 PALISADE-2
Trial of Fasedienol (PH94B) Nasal Spray in Acute Treatment of
Social Anxiety Disorder Authors: Michael R. Liebowitz, MD; Ester
Salmán, MPH; Rita Hanover, PhD; Brittany Reed, PA; Ross A. Baker,
PhD; and Louis Monti, MD, PhD Poster Number: S256
Poster Presentation Date: Saturday, April 13, 2024, 3:45
p.m. Eastern Time Title: PH80 Nasal Spray for Acute Management of
the Symptoms of Premenstrual Dysphoric Disorder: Results from a
Phase 2a Study Authors: Louis Monti, MD, PhD; Ross A. Baker, PhD;
Ester Salmán, MPH; and Rita Hanover, PhD Poster Number: S125
The posters will be available on the Publications page of
Vistagen’s website on Monday, April 15, 2024.
ADAA 2024 Partner Recognition Award
In addition to presenting fasedienol and PH80 clinical data,
Vistagen will receive the ADAA 2024 Partner Recognition Award,
recognizing Vistagen as a partner organization that has
consistently contributed to the success of ADAA’s annual conference
and supported ADAA’s public and professional mission. Vistagen and
ADAA are committed to redefining the future of mental health care
and bringing hope to millions of individuals affected by
debilitating mental health disorders.
About Fasedienol Nasal Spray
Vistagen’s fasedienol (PH94B) is a first-in-class, rapid-onset
investigational pherine nasal spray with a novel proposed mechanism
of action (MOA) that is differentiated from all currently approved
anxiety medications, including the SSRIs and SNRI currently
approved for the treatment of social anxiety disorder (SAD), as
well as benzodiazepines prescribed off-label. Fasedienol’s proposed
MOA regulates the olfactory-amygdala neural circuits of fear and
anxiety and attenuates the tone of the sympathetic autonomic
nervous system, without systemic distribution, potentiation of
GABA-A receptors, or direct activity on neurons in the brain.
Vistagen’s registration-directed PALISADE Phase 3 program for
fasedienol is focused on the acute treatment of SAD.
The U.S. FDA has granted Fast Track designation for the
investigation of fasedienol for the acute treatment of SAD.
About PH80 Nasal Spray
PH80 is an investigational neuroactive pherine nasal spray.
Designed for intranasal administration in low microgram doses, the
proposed novel mechanism of action (MOA) of PH80 is fundamentally
differentiated from all currently approved treatment options in
women’s healthcare. The proposed MOA does not require systemic
absorption or direct activity on neurons in the brain. Vistagen is
developing PH80 as a potential new treatment for the management of
vasomotor symptoms (hot flashes) due to menopause, with potential
for development for PMDD, migraine, dysmenorrhea, and other
disorders.
About Vistagen
Vistagen (Nasdaq: VTGN) is a biopharmaceutical company
pioneering neuroscience to deliver groundbreaking therapies for
individuals affected by psychiatric and neurological disorders.
Five of Vistagen’s clinical-stage neuroscience pipeline candidates
belong to a new class of drugs known as pherines, which are
investigational neuroactive nasal sprays with innovative proposed
mechanisms of action that activate chemosensory neurons in the
nasal passages to impact fundamental neural circuitry in the brain
without the need for systemic absorption or binding to receptors in
the brain. Vistagen’s sixth investigational candidate is an oral
prodrug with potential to modulate NMDA receptor activity. At
Vistagen, we are passionate about delivering differentiated
treatments that set new standards of care for people living with
anxiety, depression, and other neurological disorders. Connect at
www.Vistagen.com.
Forward-looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by Vistagen (the “Company”) and
its management, are inherently uncertain. As with all
pharmaceutical products, there are substantial risks and
uncertainties in the process of development and commercialization
and actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Among
other things, there can be no guarantee that any of the Company’s
drug candidates will successfully complete ongoing or future
clinical trials, receive regulatory approval or be commercially
successful, or that the Company will be able to successfully
replicate the result of past studies of its product candidates,
including fasedienol, itruvone, PH80 or its other drug candidates.
Other factors that may cause such a difference include, without
limitation, risks and uncertainties relating to conducting and/or
completing ongoing clinical trials, including PALISADE-3, a Phase 3
study of fasedienol for acute treatment of social anxiety disorder;
launching planned clinical trials for any of our product
candidates, including fasedienol and PH80; the scope and
enforceability of the Company’s patents, including patents related
to the Company’s pherine drug candidates and AV-101; fluctuating
costs of materials and other resources and services required to
conduct the Company’s ongoing and/or planned clinical and
non-clinical trials; market conditions; the impact of general
economic, industry or political conditions in the United States or
internationally; and other technical and unexpected hurdles in the
development, manufacture and commercialization of the Company’s
product candidates. These risks are more fully discussed in the
section entitled “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K for the fiscal year ended March 31, 2023, and
in the Company’s Quarterly Report on Form 10-Q for the period ended
December 31, 2023, as well as discussions of potential risks,
uncertainties, and other important factors in our other filings
with the U.S. Securities and Exchange Commission (SEC). The
Company’s SEC filings are available on the SEC’s website at
www.sec.gov. You should not place undue reliance on these
forward-looking statements, which apply only as of the date of this
press release and should not be relied upon as representing the
Company’s views as of any subsequent date. The Company explicitly
disclaims any obligation to update any forward-looking statements
other than as may be required by law. If the Company does update
one or more forward-looking statements, no inference should be made
that the Company will make additional updates with respect to those
or other forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20240409260263/en/
Investors: Mark McPartland (650) 577-3606
markmcp@vistagen.com
Media: Caren Scannell (650) 577-3601 cscannell@vistagen.com
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