BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience and immuno-oncology, today announced that
CEO Vimal Mehta, Ph.D., will present at the Jefferies Global
Healthcare Conference in New York City. The presentation is set for
Wednesday, June 5 at 3 p.m. ET, and will highlight BioXcel
Therapeutics’ late-stage clinical programs with BXCL501 for the
acute treatment of agitation associated with Alzheimer’s dementia,
bipolar disorders, and schizophrenia. Dr. Mehta will be joined by
Vincent J. O’Neill, M.D., Executive Vice President, Chief of
Product Development and Medical Officer.
To access a live webcast of the presentation and accompanying
presentation materials, please visit the Events &
Presentations page under the “News/Events” tab in the
Investors & Media section of the company’s website at
bioxceltherapeutics.com. The webcast replay will be available for
90 days.
About BXCL501Outside of its approved indication
by the U.S. Food and Drug Administration as IGALMI™
(dexmedetomidine) sublingual film, BXCL501 is an investigational
proprietary, orally dissolving film formulation of dexmedetomidine,
a selective alpha-2 adrenergic receptor agonist. BXCL501 is under
investigation by BioXcel Therapeutics for the acute treatment of
agitation associated with Alzheimer’s dementia and for the acute
treatment of agitation associated with bipolar I or II disorder or
schizophrenia in the at-home setting. The safety and efficacy of
BXCL501 for these investigational uses have not been established.
BXCL501 has been granted Breakthrough Therapy designation by the
FDA for the acute treatment of agitation associated with dementia
and Fast Track designation for the acute treatment of agitation
associated with schizophrenia, bipolar disorders, and dementia.
About IGALMI™ (dexmedetomidine) sublingual
film
INDICATION
IGALMI™ (dexmedetomidine) sublingual film is a prescription
medicine, administered under the supervision of a health care
provider, that is placed under the tongue or behind the lower lip
and is used for the acute treatment of agitation associated with
schizophrenia and bipolar disorder I or II in adults. The safety
and effectiveness of IGALMI has not been studied beyond 24 hours
from the first dose. It is not known if IGALMI is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects,
including:
- Decreased blood pressure, low blood pressure upon
standing, and slower than normal heart rate, which may be more
likely in patients with low blood volume, diabetes, chronic high
blood pressure, and older patients. IGALMI is taken under
the supervision of a healthcare provider who will monitor vital
signs (like blood pressure and heart rate) and alertness after
IGALMI is administered to help prevent falling or fainting.
Patients should be adequately hydrated and sit or lie down after
taking IGALMI and instructed to tell their healthcare provider if
they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT interval
prolongation). IGALMI should not be given to patients with
an abnormal heart rhythm, a history of an irregular heartbeat, slow
heart rate, low potassium, low magnesium, or taking other drugs
that could affect heart rhythm. Taking IGALMI with a history of
abnormal heart rhythm can increase the risk of torsades de pointes
and sudden death. Patients should be instructed to tell their
healthcare provider immediately if they feel faint or have heart
palpitations.
- Sleepiness/drowsiness. Patients should not
perform activities requiring mental alertness, such as driving or
operating hazardous machinery, for at least 8 hours after taking
IGALMI.
- Withdrawal reactions, tolerance, and decreased
response/efficacy. IGALMI was not studied for longer than
24 hours after the first dose. Physical dependence, withdrawal
symptoms (e.g., nausea, vomiting, agitation), and decreased
response to IGALMI may occur if IGALMI is used longer than 24
hours.
The most common side effects of IGALMI in
clinical studies were sleepiness or drowsiness, a prickling or
tingling sensation or numbness of the mouth, dizziness, dry mouth,
low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients
should speak with their healthcare provider for medical advice
about side effects.
Patients should tell their healthcare provider about
their medical history, including if they suffer from any
known heart problems, low potassium, low magnesium, low blood
pressure, low heart rate, diabetes, high blood pressure, history of
fainting, or liver impairment. They should also tell their
healthcare provider if they are pregnant or breastfeeding or take
any medicines, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Patients should
especially tell their healthcare provider if they take any drugs
that lower blood pressure, change heart rate, or take anesthetics,
sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at
1-833-201- 1088 or medinfo@bioxceltherapeutics.com.
Please see full Prescribing Information.
About BioXcel Therapeutics, Inc.BioXcel
Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company
utilizing artificial intelligence to develop transformative
medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel
Therapeutics, is focused on the development of medicines in
immuno-oncology. The Company’s drug re-innovation approach
leverages existing approved drugs and/or clinically validated
product candidates together with big data and proprietary machine
learning algorithms to identify new therapeutic indications. For
more information, please visit bioxceltherapeutics.com.
Forward-Looking Statements This press release
includes “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. We intend such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements
contained in this press release other than statements of historical
fact should be considered forward-looking statements, including,
without limitation, statements related to the Company’s planned
participation in and content of the Company’s presentation at the
Jefferies Global Healthcare Conference. When used herein, words
including “anticipate,” “believe,” “can,” “continue,” “could,”
“designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,”
“may,” “might,” “plan,” “possible,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
though not all forward-looking statements use these words or
expressions. In addition, any statements or information that refer
to expectations, beliefs, plans, projections, objectives,
performance or other characterizations of future events or
circumstances, including any underlying assumptions, are
forward-looking. All forward-looking statements are based upon the
Company’s current expectations and various assumptions. The Company
believes there is a reasonable basis for its expectations and
beliefs, but they are inherently uncertain. The Company may not
realize its expectations, and its beliefs may not prove correct.
Actual results could differ materially from those described or
implied by such forward-looking statements as a result of various
important factors, including, without limitation: its limited
operating history; its incurrence of significant losses; its need
for substantial additional funding and ability to raise capital
when needed; the impact of the reprioritization; its significant
indebtedness, ability to comply with covenant obligations and
potential payment obligations related to such indebtedness and
other contractual obligations; the Company has identified
conditions and events that raise substantial doubt about its
ability to continue as a going concern; its limited experience in
drug discovery and drug development; risks related to the
TRANQUILITY program; its dependence on the success and
commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702
and other product candidates; its lack of experience in marketing
and selling drug products; the risk that IGALMI or the Company’s
product candidates may not be accepted by physicians or the medical
community in general; the Company still faces extensive and ongoing
regulatory requirements and obligations for IGALMI; the failure of
preliminary data from its clinical studies to predict final study
results; failure of its early clinical studies or preclinical
studies to predict future clinical studies; its ability to receive
regulatory approval for its product candidates; its ability to
enroll patients in its clinical trials; undesirable side effects
caused by the Company’s product candidates; its novel approach to
the discovery and development of product candidates based on
EvolverAI; the significant influence of and dependence on BioXcel
LLC; its exposure to patent infringement lawsuits; its reliance on
third parties; its ability to comply with the extensive regulations
applicable to it; impacts from data breaches or cyber-attacks, if
any; risks associated with the increased scrutiny relating to
environmental, social and governance (ESG) matters; risks
associated with federal, state or foreign health care “fraud and
abuse” laws; and its ability to commercialize its product
candidates, as well as the important factors discussed under the
caption “Risk Factors” in its Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2024, as such factors may be
updated from time to time in its other filings with the SEC, which
are accessible on the SEC’s website at www.sec.gov and the
Investors section of the Company’s website
at www.bioxceltherapeutics.com. These and other important
factors could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management’s
estimates as of the date of this press release. While the Company
may elect to update such forward-looking statements at some point
in the future, except as required by law, it disclaims any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon
as representing the Company’s views as of any date subsequent to
the date of this press release.
Contact Information
CorporateBioXcel Therapeutics Erik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor Relations BioXcel Therapeutics Brennan Doyle
1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso PartnersDavid
Schull1.858.717.2310David.schull@russopartnersllc.comScott
Stachowiak1.646.942.5630Scott.stachowiak@russopartnersllc.comSource:
BioXcel Therapeutics, Inc.
IGALMI™ is a trademark of BioXcel Therapeutics, Inc.BT BIOXCEL
THERAPEUTICS is a registered trademark of BioXcel Therapeutics,
Inc. All other trademarks are the properties of their respective
owners.Copyright © 2024, BioXcel Therapeutics, Inc. All rights
reserved.
BioXcel Therapeutics (NASDAQ:BTAI)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
BioXcel Therapeutics (NASDAQ:BTAI)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024