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Tonix Pharmaceuticals Holding Corp. (TNXP-17.57%) has filed its annual report on Form 10-K filing for the fiscal year ended December 31, 2024.
The report details the company's focus on developing and commercializing therapeutics, with a primary emphasis on obtaining U.S. marketing authorization for TNX-102 SL for the management of fibromyalgia. The FDA has set a PDUFA goal date of August 15, 2025, for a decision on this application.
Tonix's pipeline includes products for central nervous system disorders, immunology, infectious diseases, and rare diseases. Key developments include TNX-1300 for cocaine intoxication, TNX-1500 for organ transplant rejection, and TNX-801 as a vaccine for smallpox and mpox.
The company reported a market value of $6,857,126 for its common equity held by non-affiliates as of June 30, 2024. As of March 17, 2025, there were 6,434,881 shares of common stock outstanding.
Tonix is preparing for a commercial launch of TNX-102 SL in the fourth quarter of 2025, conditional on FDA approval. The company is also focused on expanding its commercial operations to support the launch.
The filing outlines various risks, including the dependence on the success of TNX-102 SL, potential regulatory hurdles, and the competitive landscape. The company also highlights its reliance on third-party manufacturers and the potential impact of changes in government funding and healthcare regulations.
Tonix continues to invest in its research and development capabilities, with facilities in New Jersey, Maryland, Massachusetts, and international locations. The company is also expanding its intellectual property portfolio to protect its product candidates.
The filing includes a comprehensive list of patents and pending applications, underscoring the company's efforts to secure intellectual property rights for its innovations.
Tonix's strategic goals include pursuing indications with high unmet medical need, maximizing the commercial potential of its lead candidates, and exploring additional indications for its products.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Tonix Pharmaceuticals Holding Corp. annual 10-K report dated March 18, 2025. To report an error, please email earnings@qz.com.