Tonix (NASDAQ: TNXP) details FDA pre-IND plans for TNX-102 SL in MDD

Rhea-AI Filing Summary

Tonix Pharmaceuticals Holding Corp. reported that it completed a Type B Pre‑Investigational New Drug (Pre‑IND) meeting with the U.S. Food and Drug Administration for its TNX‑102 SL sublingual tablet, being developed for the treatment of major depressive disorder (MDD).

Based on feedback from the FDA, the company plans to pursue a supplemental new drug application to expand the therapeutic indication of TNX‑102 SL to include MDD, using exploratory findings that link improved sleep quality with better depressive symptoms. The FDA considered Tonix’s proposed long‑term safety data collection plan generally reasonable, which may streamline development. An Investigational New Drug filing for TNX‑102 SL in MDD is planned for the fourth quarter of 2025, with Phase 2 clinical trials expected to begin shortly thereafter.

Insights

Biotech regulatory and clinical development analyst

FDA Pre‑IND feedback supports Tonix’s plan to advance TNX‑102 SL into MDD studies starting around Q4 2025.

The company has completed a Type B Pre‑IND meeting with the FDA for TNX‑102 SL in major depressive disorder. This type of meeting is used to align on study design and data requirements before opening an IND. The FDA indicated that Tonix’s proposed long‑term safety data collection plan was generally reasonable, which can reduce uncertainty around clinical development expectations.

Tonix now intends to pursue a supplemental new drug application to broaden TNX‑102 SL’s indication to include MDD, leveraging exploratory findings that improving sleep quality may benefit depressive symptoms. The company plans an IND filing for MDD in Q4 2025 and expects to enter Phase 2 trials shortly thereafter. Actual progress will depend on successfully submitting the IND and executing the planned Phase 2 program as outlined.

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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): September 18, 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 September 18, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the completion of a Type B Pre-Investigational New Drug (“Pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding the development of its TNX-102 SL (sublingual cyclobenzaprine HCl) product candidate for the treatment of major depressive disorder (“MDD”). 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 September 18, 2025, the Company announced the completion of a Type B Pre-IND meeting with the FDA regarding the development of TNX-102 SL for the treatment of MDD. Based on feedback from the FDA, the Company intends to pursue a supplemental new drug application to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms. The FDA provided feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path for this product candidate. An Investigational New Drug filing for TNX-102 SL for the treatment of MDD is planned for the fourth quarter of 2025, and expected to enter Phase 2 clinical trials shortly thereafter.

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 September 18, 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: September 18, 2025	By:	/s/ Bradley Saenger
	Bradley Saenger
	Chief Financial Officer

FAQ

What did Tonix Pharmaceuticals (TNXP) announce regarding TNX-102 SL and major depressive disorder?

Tonix Pharmaceuticals announced it completed a Type B Pre‑IND meeting with the FDA about developing its TNX‑102 SL sublingual tablet as a treatment for major depressive disorder.

How does the FDA feedback affect TNXPs TNX-102 SL program for MDD?

The FDA found Tonixs proposed long‑term safety data collection plan for TNX‑102 SL in MDD generally reasonable, which may streamline the future development path for this product candidate.

What regulatory filings does Tonix plan for TNX-102 SL in major depressive disorder?

Tonix intends to pursue a supplemental new drug application to expand TNX‑102 SLs therapeutic indication to include major depressive disorder, following the FDA Pre‑IND meeting.

When does Tonix Pharmaceuticals expect to file the IND for TNX-102 SL in MDD?

Tonix plans to submit an Investigational New Drug filing for TNX‑102 SL in major depressive disorder in the fourth quarter of 2025.

When are Phase 2 clinical trials for TNX-102 SL in MDD expected to start?

Phase 2 clinical trials for TNX‑102 SL in major depressive disorder are expected to begin shortly after the planned IND filing in the fourth quarter of 2025.

What is the rationale for TNX-102 SL in treating major depressive disorder?

Tonix cites exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms, supporting the development of TNX‑102 SL for major depressive disorder.