[8-K] Tonix Pharmaceuticals Holding Corp. Reports Material Event

Rhea-AI Filing Summary

Tonix Pharmaceuticals Holding Corp. (TNXP) reported that its product TONMYA, a cyclobenzaprine HCl sublingual tablet, is now commercially available at pharmacies in the United States by prescription. This marks the move of TONMYA from development into the commercial marketplace, allowing eligible patients to obtain the drug through standard retail pharmacy channels.

The company released this information via a press release furnished as an exhibit, and emphasized that the disclosure includes forward-looking statements about its broader product development plans, regulatory timelines and market opportunities, which remain subject to various risks and uncertainties.

Insights

Biopharma equity analyst

TNXP announces U.S. pharmacy availability of TONMYA, moving the asset into its commercial phase.

Tonix Pharmaceuticals disclosed that TONMYA (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies in the United States by prescription. This indicates that distribution channels are in place and that the product has transitioned from development to commercial status within the U.S. market.

The announcement is limited to availability and does not include pricing, target indication details, sales expectations or reimbursement information in this excerpt. The company notes that broader outcomes for revenues, market penetration and competitive positioning remain subject to the typical risks highlighted in its SEC filings and forward-looking statements disclaimer.

Overall, this represents a milestone event for TONMYA’s lifecycle, but the financial magnitude and timing of any impact are not quantified here, so a clear change in the overall investment thesis cannot be determined from this information alone.

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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 17, 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 17, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced that TONMYA^TM (cyclobenzaprine HCl sublingual tablets) is commercially available at pharmacies by prescription in the United States. 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 17, 2025, the Company announced that TONMYA^TM is commercially available at pharmacies by prescription in the United States.

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		Press Release of the Company, dated November 17, 2025
		104		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 17, 2025	By:	/s/ Bradley Saenger
		Bradley Saenger
		Chief Financial Officer

FAQ

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

Tonix Pharmaceuticals announced that TONMYA (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies in the United States by prescription.

What is TONMYA as described by Tonix Pharmaceuticals (TNXP)?

TONMYA is described as cyclobenzaprine HCl sublingual tablets, indicating a sublingual formulation of cyclobenzaprine hydrochloride.

Where can patients obtain TONMYA according to the Tonix (TNXP) disclosure?

Patients can obtain TONMYA by prescription at pharmacies in the United States, meaning it is distributed through standard retail pharmacy channels.

How did Tonix Pharmaceuticals (TNXP) communicate the TONMYA launch?

The company issued a press release describing TONMYA’s commercial availability, which is furnished as Exhibit 99.01 and incorporated by reference in the Form 8-K.

Are the TONMYA statements in this Tonix (TNXP) filing considered filed or furnished?

The company states that the information in Item 7.01, including Exhibit 99.01, is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act.

Does Tonix (TNXP) provide financial guidance or sales figures for TONMYA in this filing?

No specific financial figures, sales data, or guidance related to TONMYA are included in the provided excerpt; the disclosure focuses on commercial availability.

What caution does Tonix Pharmaceuticals (TNXP) include with the TONMYA announcement?

The company includes a forward-looking statements section noting that statements about product development, regulatory timelines, market opportunity and future results involve risks and uncertainties.