TNXP 8-K
Tonix Pharmaceuticals Holding Corp. (TNXP)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On October 1, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) received a notice (the “Notice”) from Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”) stating that DRL filed an Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV patent certification with the U.S. Food and Drug Administration (“FDA”) for a generic version of the Company’s drug, TONMYA® (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg. The Notice states that the Paragraph IV patent certification was made with respect to U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175 listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. A Paragraph IV patent certification is a certification by a generic applicant that, in the opinion of that applicant, the patent listed in the Orange Book for a branded product is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of the generic product. Under the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations, the filing of a patent infringement lawsuit within 45 days of the receipt of notice of a Paragraph IV patent certification automatically prevents the FDA from approving the ANDA until the earliest of the expiration of a 30-month period beginning on the receipt of the Notice by the patent owner, the expiration of the patents, the entry of a settlement order or consent decree stating that the patents are invalid or not infringed, a decision in the infringement case that is favorable to the ANDA applicant, or such shorter or longer period as the court may order. The Company intends to vigorously enforce its intellectual property rights relating to TONMYA against infringement, but cannot predict the outcome of this matter or guarantee the outcome of any litigation. TONMYA is protected by four patents, all of which are listed in the Orange Book.
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, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s review of the Notice, the Company’s intention to enforce its intellectual property rights relating to TONMYA, the timing and outcome of any patent infringement litigation, the potential stay of FDA approval of the ANDA, the scope, validity and enforceability of the Company’s patents, the potential timing of generic competition for TONMYA, and other statements 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 the Company operates 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 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, including risks related to the outcome of any patent litigation, the possibility that one or more of the Company’s patents may be found invalid, unenforceable or not infringed, the possibility that the FDA may approve the ANDA or other generic applications, the costs and management attention associated with litigation, and the impact of generic competition on sales of TONMYA. Such factors also include those set forth in the Company’s filings with the Securities and Exchange Commission (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 Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
SIGNATURE
Pursuant to the requirements 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: | October 2, 2026 | By: | /s/ Bradley Saenger |
| Bradley Saenger | |||
| Chief Financial Officer | |||