Tonix (TNXP) gets FDA IND clearance for MDD Phase 2 drug trial

Tonix Pharmaceuticals Holding Corp. reported that the U.S. FDA has cleared its Investigational New Drug application for TNX-102 SL 5.6 mg, enabling clinical development for treating major depressive disorder (MDD) in adults.

Rhea-AI Filing Summary

Tonix Pharmaceuticals Holding Corp. reported that the U.S. FDA has cleared its Investigational New Drug application for TNX-102 SL 5.6 mg, enabling clinical development for treating major depressive disorder (MDD) in adults. The company plans a potentially pivotal Phase 2 HORIZON study, a 6-week, randomized, double-blind, placebo-controlled trial of TNX-102 SL as first-line monotherapy in about 360 adults across approximately 30 U.S. sites. The primary goal is to measure change in Montgomery-Asberg Depression Rating Scale-II scores at Week 6, with additional measures of overall clinical impression, anxiety, and sleep disturbance, and enrollment is planned to begin in mid-year 2026.

Positive

• FDA cleared the IND for TNX-102 SL 5.6 mg in adults with major depressive disorder, enabling Tonix to begin clinical development in this large therapeutic area.
• Potentially pivotal Phase 2 HORIZON trial is planned as a 6-week, randomized, double-blind, placebo-controlled study in approximately 360 adults at about 30 U.S. sites.

Negative

• None.

Insights

Biotech and regulatory affairs analyst

FDA IND clearance lets Tonix advance TNX-102 SL into a pivotal Phase 2 MDD trial.

The FDA’s clearance of the IND for TNX-102 SL 5.6 mg allows Tonix to start clinical development of this candidate in adults with major depressive disorder. The proposed Phase 2 HORIZON trial is designed as a potentially pivotal, 6-week, randomized, double-blind, placebo-controlled study in approximately 360 adults at about 30 U.S. sites, positioning it as a substantial efficacy test rather than an early exploratory pilot.

The trial focuses on change in the Montgomery-Asberg Depression Rating Scale-II total score at Week 6, a standard depression severity measure, and also tracks global impression, anxiety, and sleep disturbance. The pharmacological profile is described as targeting disruptive sleep associated with MDD, aligning the mechanism with one of the condition’s common symptoms. Enrollment is planned to begin in mid-year 2026, so subsequent data updates will likely appear in later company disclosures once recruitment and interim progress are reported.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What did Tonix Pharmaceuticals (TNXP) announce in this 8-K filing?

Tonix Pharmaceuticals announced that the U.S. FDA cleared its Investigational New Drug application for TNX-102 SL 5.6 mg to support clinical development for treating major depressive disorder in adults.

What is TNX-102 SL and what condition is Tonix (TNXP) targeting?

TNX-102 SL is a cyclobenzaprine HCl sublingual tablet (5.6 mg) product candidate whose pharmacological profile is designed to target disruptive sleep often associated with major depressive disorder (MDD) in adults.

How is the Phase 2 HORIZON study for Tonix’s TNX-102 SL designed?

The HORIZON study is described as a potentially pivotal, 6-week, randomized, double-blind, placebo-controlled Phase 2 trial of TNX-102 SL 5.6 mg as a first-line monotherapy in adults with MDD, comparing bedtime sublingual dosing to placebo.

How many patients and sites are planned for the Tonix (TNXP) HORIZON trial?

Tonix expects to enroll approximately 360 patients at approximately 30 U.S. sites in the HORIZON Phase 2 study of TNX-102 SL for major depressive disorder.

What is the primary endpoint of Tonix’s HORIZON Phase 2 trial in MDD?

The primary endpoint of the HORIZON study is the change from baseline in the Montgomery-Asberg Depression Rating Scale-II total score at Week 6, a standard measure of depression severity.

When does Tonix Pharmaceuticals plan to start enrolling patients in HORIZON?

Tonix plans to initiate enrollment in the HORIZON Phase 2 study in mid-year 2026, following the FDA’s IND clearance for TNX-102 SL in major depressive disorder.

What secondary endpoints will the Tonix (TNXP) HORIZON study evaluate?

Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep disturbance, aiming to capture broader clinical and sleep-related effects of TNX-102 SL in MDD.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 11/24/2025 - 07:06 AM Learn about SEC filing dates

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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (date of earliest event reported): November 24, 2025

TONIX PHARMACEUTICALS HOLDING CORP. 

(Exact name of registrant as specified in its charter)

Nevada	001-36019	26-1434750
(State or Other Jurisdiction  of Incorporation)	(Commission  File Number)	(IRS Employer  Identification No.)

26 Main Street, Chatham, New Jersey, 07928

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (862) 799-8599

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	TNXP	The NASDAQ Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). 

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On November 24, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) cleared the Investigational New Drug (“IND”) application to support clinical development of the Company’s TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg product candidate for the treatment of major depressive disorder (“MDD”) in adults. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On November 24, 2025, the Company announced that the FDA cleared the IND application to support clinical development of TNX-102 SL 5.6 mg for the treatment of MDD in adults. The pharmacological profile of TNX-102 SL is designed to target the disruptive sleep often associated with MDD. The potentially pivotal Phase 2 HORIZON study is a 6-week, randomized, double-blind, placebo-controlled trial of TNX-102 SL as a first line monotherapy in adults with MDD. The Company expects approximately 360 patients will be enrolled at approximately 30 U.S. sites. Eligible participants are 18 years or older and currently experiencing a moderate to severe major depressive episode. The HORIZON study will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime, to placebo, with the primary endpoint being the Montgomery-Asberg Depression Rating Scale-II total score change from baseline at Week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep disturbance. The Company plans to initiate enrollment of the study in mid-year 2026.

Forward-Looking Statements 

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. 

Item 9.01 Financial Statements and Exhibits.

(d)		Exhibit No.		Description.
		99.01 104		Press Release of the Company, dated November 24, 2025 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	TONIX PHARMACEUTICALS HOLDING CORP.
Date: November 24, 2025	By:	/s/ Bradley Saenger
		Bradley Saenger
		Chief Financial Officer