Tonix Pharmaceuticals to Present FDA Breakthrough Therapy-Designated PTSD Program at the MicroCap Conference in New York
April 04 2018 - 7:00AM
First 50 Percent of Participants Enrolled in
Phase 3 HONOR Study of Tonmya® (Cyclobenzaprine HCl Sublingual
Tablets) for the Treatment of Military-Related PTSD
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
clinical-stage biopharmaceutical company focused on developing
pharmaceutical products to treat serious neuropsychiatric
conditions and biological products to improve biodefense, announced
today that it will present at the MicroCap Conference being held
April 9-10, 2018, in New York City.
Tonix is in Phase 3 development of Tonmya®*, or TNX-102 SL, a
U.S. Food and Drug Administration-designated Breakthrough Therapy
for the treatment of posttraumatic stress disorder (PTSD).
Seth Lederman, M.D., President and Chief Executive Officer of
Tonix, will provide an update of the Tonix pipeline of development
programs. Details of the presentation are as follows:
Event: |
The MicroCap
Conference |
Date: |
Monday, April 9,
2018 |
Time: |
8:30 a.m. EDT |
Location: |
JW Marriott Essex
House, New York City |
The presentation will be webcast live and remain available for
90 days following the presentation. To access the webcast, please
visit the IR Events tab of the Investor Relations section of
Tonix’s website at www.tonixpharma.com.
*Tonmya has been conditionally accepted by the U.S. Food and
Drug Administration (FDA) as the proposed trade name for TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) for PTSD. TNX-102 SL is an
investigational new drug and has not been approved for any
indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat serious
neuropsychiatric conditions and biological products to improve
biodefense through potential medical counter-measures. Tonix’s lead
product candidate, Tonmya, or TNX-102 SL, is in Phase 3 development
as a bedtime treatment for PTSD. Tonix is also developing TNX-102
SL as a bedtime treatment for agitation in Alzheimer’s disease.
A Phase 2 IND (Investigational New Drug) application was
submitted in March 2018 after completion of a successful pre-IND
meeting with the FDA. TNX-601 (tianeptine oxalate) is in the
pre-IND application stage, also for the treatment of PTSD but
designed for daytime dosing. Tonix’s lead biologic candidate,
TNX-801, is a potential smallpox-preventing vaccine based on a live
synthetic version of horsepox virus, currently in the pre-IND
application stage.
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; 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, 2017, as filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2018, and periodic reports filed
with the SEC on or after the date thereof. All of 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 (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com(646) 942-5588
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Apr 2023 to Apr 2024