Tonix Pharmaceuticals Announces Inclusion in the Russell 3000® and Russell 2000® Indexes

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced its inclusion in the broad-market Russell 3000® Index and small-cap Russell 2000® Index, effective June 30, 2025. This addition comes as part of the 2025 Russell indexes reconstitution, which captures the 4,000 largest US stocks based on market capitalization rankings as of April 30.

The company is currently awaiting an FDA decision on TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The FDA has granted Fast Track designation for this candidate. Additionally, Tonix has secured a contract worth up to $34 million over five years with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.

Tonix's commercial subsidiary, Tonix Medicines, currently markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment. The company's development portfolio includes various candidates targeting CNS disorders, immunology, and infectious diseases, with a state-of-the-art infectious disease research facility in Frederick, Md.

Positive

• Inclusion in Russell 3000® and Russell 2000® Indexes, potentially increasing visibility to investors
• FDA Fast Track designation for TNX-102 SL for fibromyalgia management
• Secured contract worth up to $34 million with U.S. DoD's Defense Threat Reduction Agency
• Established commercial presence with marketed migraine products Zembrace® SymTouch® and Tosymra®
• Owns and operates state-of-the-art infectious disease research facility

Negative

• TNX-102 SL and other pipeline candidates are still investigational with no guaranteed FDA approval
• Multiple product candidates in development requiring significant R&D investment
• Substantial competition in pharmaceutical development noted in risk factors

Insights

Biotech Investment Analyst

Russell index inclusion boosts TNXP's visibility while approaching critical FDA decision for fibromyalgia drug candidate with August PDUFA date.

Tonix's addition to the Russell 3000® and Russell 2000® indexes represents a significant visibility milestone that will expose the company to a broader institutional investor base. This inclusion is particularly timely given the approaching August 15, 2025 PDUFA date for TNX-102 SL for fibromyalgia management, which represents the company's most immediate potential catalyst.

The Russell indexes are tied to approximately $10.6 trillion in benchmarked assets, meaning passive funds tracking these indexes will now need to purchase TNXP shares, potentially providing technical support for the stock. Beyond the index inclusion, what's particularly noteworthy is that TNX-102 SL has already received Fast Track designation from the FDA and is supported by two statistically significant Phase 3 studies - suggesting a reasonable probability of approval.

The company's pipeline extends beyond TNX-102 SL, with programs in organ transplant rejection (TNX-1500), mpox/smallpox vaccines (TNX-801), and a $34 million DoD-funded antiviral contract (TNX-4200). Importantly, Tonix already generates revenue through its commercial subsidiary marketing migraine treatments Zembrace® SymTouch® and Tosymra®, providing some financial foundation while awaiting potential TNX-102 SL approval.

The upcoming fibromyalgia drug decision represents a particularly significant opportunity given the sizeable market for fibromyalgia treatments and limited effective options currently available. With FDA regulatory momentum (Fast Track designation) and positive late-stage clinical data, the August PDUFA date represents a transformational event that could shift Tonix from development-stage to commercial-stage in its core CNS portfolio.

CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000® Index, with automatic inclusion in the small-cap Russell 2000® Index, after the open of U.S. equity markets today, June 30, 2025, as part of the 2025 Russell indexes reconstitution.

The annual reconstitution of the Russell US indexes captures the 4,000 largest US stocks as of April 30, ranking them by total market capitalization. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“This milestone reflects the significant growth and development Tonix has experienced over the past year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We look forward to the increased visibility and awareness that inclusion in the Russell Indexes brings as we advance toward the potential FDA approval and planned launch of TNX-102 SL for the management of fibromyalgia later this year.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to data as of the end of June 2024, about $10.6 trillion in assets are benchmarked against the Russell US indexes, which belong to FTSE Russell, the global index provider.

For more information on the Russell 3000® Index and Russell 2000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

Tonix Pharmaceuticals Holding Corp.^*
Tonix is a fully-integrated biotech 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 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’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent 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; their efficacy and safety have not been established 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.

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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

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:

• discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
  

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 shows no problem.

Do not use Zembrace or Tosymra if you have:

• history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
• severe liver problems
• taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
• are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
• an allergy to sumatriptan or any of the components of Zembrace or Tosymra
  

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

• changes in color or sensation in your fingers and toes
• sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
• cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
• increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
• medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
• serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

FAQ

When will Tonix Pharmaceuticals (TNXP) be added to the Russell indexes?

Tonix will be added to the Russell 3000® and Russell 2000® Indexes after the open of U.S. equity markets on June 30, 2025.

What is the PDUFA date for Tonix's TNX-102 SL fibromyalgia treatment?

The FDA has assigned a PDUFA date of August 15, 2025 for a decision on TNX-102 SL's marketing authorization for fibromyalgia management.

How much is Tonix's contract with the U.S. Department of Defense worth?

Tonix has secured a contract worth up to $34 million over five years with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200 development.

What commercial products does Tonix currently market?

Tonix Medicines markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for acute migraine treatment in adults.

What is the significance of Tonix's Russell Indexes inclusion?

The inclusion provides increased visibility and awareness to Tonix, with approximately $10.6 trillion in assets benchmarked against Russell US indexes as of June 2024.