Tonix Pharmaceuticals to Present Breakthrough Therapy Designated-PTSD Program and Corporate Update at 9th Annual Biotech Show...
January 03 2017 - 7:00AM
TNX-102 SL, a Phase 3 Drug candidate, recently
granted Breakthrough Therapy designation by the FDA
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is
developing a next-generation treatment for PTSD, announced today
that it will present at the 9th Annual Biotech Showcase Conference
being held January 9-11, 2017 in San Francisco, CA.
Seth Lederman, M.D., president and chief executive officer of
Tonix, will provide a corporate update and an overview of Tonix’s
PTSD clinical program. Tonix recently announced that the U.S. Food
and Drug Administration (FDA) granted Breakthrough Therapy
designation to TNX-102 SL* for the treatment of PTSD. In August
2016, Tonix held a successful End-of-Phase 2/Pre-Phase 3 meeting
with the FDA based on positive data from its 12-week randomized,
double-blind, placebo-controlled Phase 2 AtEase clinical trial
evaluating TNX-102 SL in military-related PTSD. Tonix intends to
commence its 12-week Phase 3 HONOR study, evaluating TNX-102 SL,
5.6 mg, in military-related PTSD, in the first quarter of 2017,
upon FDA acceptance of the protocol and proposed interim analysis
plan.
Event: |
9th Annual
Biotech Showcase Conference |
Date: |
Tuesday, January
10, 2017 |
Time: |
9:30 am (PT) |
Location: |
Room 7 (Ballroom
Level), Parc 55 Hotel, San Francisco, CA |
The presentation will be webcast live and remain available for
90 days following the presentation. To access the webcast, please
visit the Events tab of the Investor Relations section of
Tonix’s website at www.tonixpharma.com.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
Investigational New Drug and has not been approved for any
indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing next-generation medicines for common
disorders of the central nervous system, with its lead program
focusing on posttraumatic stress disorder. This disorder is a
serious condition characterized by chronic disability, inadequate
treatment options, high utilization of healthcare services, and
significant economic burden. TNX-102 SL was recently granted
Breakthrough Therapy designation by the FDA for the treatment of
PTSD. 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, substantial
competition; 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 risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. 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, 2015, as filed
with the Securities and Exchange Commission (the “SEC”) on March 3,
2016, and future periodic reports filed with the SEC on or after
the date hereof. 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 hereof.
Contacts
Jessica Smiley
Investor Relations
investor.relations@tonixpharma.com
(212) 980-9155 x185
Edison Advisors (investors)
Tirth Patel
tpatel@edisongroup.com
(646) 653-7035
MSLGROUP Boston (media)
Sherry Feldberg
tonix@mslgroup.com
(781) 684-0770
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