Full Press Release Details
Tonix Pharmaceuticals 8k
Tonix Pharmaceuticals Launches TONIX ONETM,
a Fully-Integrated Digital Platform Designed
to Help Patients Better Understand and
Manage Their Migraine Condition
Tonix expands its all-in-one platform,
partnering with the world's leading migraine diary app, enhancing disease education and prescription access
CHATHAM, N.J., April 1, 2025 (GLOBE NEWSWIRE) -
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline
of development candidates, today announced the launch of TONIX ONE , a fully-integrated digital platform designed to help patients
better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx,
Blink Health and a leading mobile application specializing in disease tracking, reporting and symptom management, Tonix is streamlining
the migraine patient journey into a unified digital platform. Please visit www.tonixone.com for details.
"We developed TONIX ONE to leverage
innovation and deliver a full-service digital solution that seamlessly guides patients from their migraine diary app to prescription fulfillment
within hours. Our goal is not only to educate and empower patients seeking better treatment options but also to remove the barriers to
care that many individuals living with migraines face," said Scott Szymanski, Vice President of Sales and Marketing, Migraine, of
Tonix Pharmaceuticals.
TONIX ONE provides an intuitive, comprehensive
journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead
to delayed or ineffective symptom relief. The platform also connects patients directly to migraine specialists via telehealth services
and e-prescription requests, simplifying and accelerating access to treatment.
"With the launch of TONIX ONE, we are
further strengthening Tonix Pharmaceuticals' position as a leader in innovation, addressing barriers and inefficiencies that stand
between patients and the life-changing medications they need," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
"By offering a fully- integrated digital platform that streamlines disease state education, prescription acquisition, and fulfillment,
we are enhancing access for patients while creating value across our existing portfolio, pipeline, and future business development opportunities."
Gpmigraine.com provides patients with
valuable insights into migraine management by addressing the challenges associated with oral medications due to gastroparesis. The platform
helps patients explore alternative treatments and empowers them to make informed decisions about their care.
ProModRx provides patients with a
digital solution, dRx Request, to request an e-prescription from their established migraine clinician.
UpScript Health is the leading telemedicine
provider in the US. For patients who do not have an established migraine clinician or would rather use telemedicine, UpScript provides
patients real-time access to 100's of expert clinicians.
Blink Health is revolutionizing the
pharmacy experience, using digital cutting-edge technology to dramatically improve patient access for branded medications.
A leading mobile application operated
by a third party, and accessible on the TONIX ONE platform, designed to empower patients suffering from headaches and migraines through
data-driven insights, enabling tracking, reporting, and self-management. By providing valuable health data, the platform helps accelerate
diagnosis and optimize treatment options, ultimately enhancing the quality of life for people living with migraine symptoms, which in
turn can accelerate diagnosis and fine-tune treatment options.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company
focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is
focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management
of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia
and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.
The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to
treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS
study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in
Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported
by a grant from the National Institute on Drug Abuse. Tonix's immunology development portfolio consists of biologics to address
organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting
CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix
also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract
with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule
broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military
personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick,
Md. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan
nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix's product development candidates are
investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks
of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Please visit www.tonixone.com
for Tonix's fully-integrated digital platform designed to help patients better understand and manage their migraine condition.
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 the failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products;
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, 2024, as filed with the Securities and Exchange Commission (the "SEC") on March 18, 2025, 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.
Tonix Pharmaceuticals
Indication and Usage
Zembrace SymTouch (sumatriptan
succinate) injection (Zembrace) and Tosymra (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches
with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It
is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including
heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
Zembrace and Tosymra are not for people with risk factors for
heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam