Tonix Pharmaceuticals Announces Presentation of Two Posters at the 2021 American Society of Clinical Psychopharmacology (ASCP...
May 26 2021 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company) a clinical-stage biopharmaceutical company, announced that
it will present two posters at the 2021 American Society of
Clinical Psychopharmacology (ASCP) Annual Meeting. The ASCP annual
meeting is being held virtually June 1-4, 2021. Copies of the
posters will be made available under the IR Events tab of the
Investors section of the Tonix website at the times of the
presentations at www.tonixpharma.com. Poster presentation details
are as follows:
Title |
|
Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for
the Treatment of Fibromyalgia in the RELIEF Study: Positive Results
of a Phase 3 Randomized, Double-Blind, Placebo-Controlled
Multicenter Trial |
Session |
|
Poster Session I |
Date |
|
June 2, 2021 |
Time |
|
11:00 a.m. – 12:00 p.m. ET |
Title |
|
Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on PTSD
Sleep-Dependent Emotional Memory Processing: Retrospective Analysis
of Phase 2 and 3 Trial Results in Military-Related and Civilian
PTSD |
Session |
|
Poster Session II |
Date |
|
June 3, 2021 |
Time |
|
10:00 a.m. – 11:00 a.m. ET |
Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
small molecules and biologics to treat and prevent human disease
and alleviate suffering. Tonix’s portfolio is primarily composed of
central nervous system (CNS) and immunology product candidates. The
Company’s CNS portfolio includes both small molecules and biologics
to treat pain, neurologic, psychiatric and addiction conditions.
Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3
development for the management of fibromyalgia, with positive data
from the Phase 3 RELIEF study reported in December 2020. The
Company expects interim data from the second Phase 3 study, RALLY,
in the third quarter of 20212 and topline data in the first quarter
of 2022. Tonix’s immunology portfolio includes vaccines to prevent
infectious diseases and biologics to address immunosuppression,
cancer, and autoimmune diseases. Tonix’s lead vaccine candidate,
TNX-18003, is a live replicating vaccine based on the horsepox
viral vector platform to protect against COVID-19, primarily by
eliciting a T cell response. Tonix reported positive efficacy data
from animal studies of TNX-1800 in the first quarter of 2021.
TNX-8013, live horsepox virus vaccine for percutaneous
administration, is in development to protect against smallpox and
monkeypox.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.
2Pending agreement from FDA on statistical
analysis plan.
3TNX-1800 and TNX-801 are investigational new
biologics and have not been approved for any indication.
This press release and further information about Tonix can be
found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on Tonix's
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; risks related to the timing and
progress of clinical development of our product candidates; our
need for additional financing; uncertainties of patent protection
and litigation; uncertainties of government or third party payor
reimbursement; limited research and development efforts and
dependence upon third parties; and substantial competition. As with
any pharmaceutical under development, there are significant risks
in the development, regulatory approval, and commercialization of
new products. Tonix does not undertake an obligation to update or
revise any forward-looking statement. Investors should read the
risk factors set forth in the Annual Report on Form 10-K for the
year ended December 31, 2020, as filed with the Securities and
Exchange Commission (the “SEC”) on March 15, 2021, and periodic
reports filed with the SEC on or after the date thereof. All
Tonix's forward-looking statements are expressly qualified by all
such risk factors and other cautionary statements. The information
set forth herein speaks only as of the date thereof.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo
(investors)Westwicke/ICRpeter.vozzo@westwicke.com(443) 213-0505
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