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CHATHAM, NJ – Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company with a market capitalization of $114 million and a 183% stake in the U.S. Food and Drug Administration (FDA) on August 15, 2025 as the Soul Date for the Abschluss ihrer Prüfung des Zulassungsantrags (New Drug Application , NDA) for TNX-102 SL-festgelegt hat. This Prüfpräparat will not be investigated with the treatment of fibromyalgia, a chronic Schmerzerkrankung, of which more than 10 million cases are affected in the United States.
TNX-102 SL is not an opioid, but only analgesic effect, the FDA and the status of a beschleunigde Zulassung (Fast Track designation) are not available. This status is described by the Prüfungsprozess for Medikamente, which provides an uncovered medical address. The NDA filing is driven by data from the second Phase 3 trial conducted while the TNX-102 SL has reduced Schmerzen’s diagnosis in fibromyalgia patients.
The CEO of Tonix, Dr. Seth Lederman, has harnessed the potential of TNX-102 SL to create the first new drug class for the treatment of fibromyalgia in approximately 15 years. There is a very high disease profile, which is being conducted in clinical trials. InvestingPro’s data has shown strong market momentum with a 15.4% yield in the world at the current price and a current price of 3.33 providing solid, stable financial stability. The InvestingPro Analysis said that trading in the sale of the Fair Value value is an überbewertet.
Both 14-year clinical trials, RELIEF and RESILIENT met their primary endpoint and saw a meaningful reduction in symptoms compared to Placebo. The most important unerwünschte Nebenwirkung war was a vorübergehende Taubheit of the Zunge or des Mundes und de Verabreichungsstelle.
Fibromyalgia is long-lasting, but extensively described, not a single disease and cognitive dysfunction is caused. The time of treatment with patients and patients was often worried, there was talk of a new therapeutic option.
TNX-102 SL, a sublingual tablet form of Cyclobenzaprin-Hydrochlorid, so that the Schlafengehen get a soul on the niece erholsamen Schlaf of the fibromyalgia characteristic is. The formula is efficient in the broke market and ensures that the risks of tags are kept to a minimum.
Our colleagues are looking for other nervous system development candidates that could develop an expanded portfolio that could enable potential treatments for organ transplants, autoimmune diseases, and improvements in general health care. The InvestingPro Analysis said that the future of the economy would make more money if debt abroad, the time would make money quickly. Subscribers von InvestPro have 13 years of experience in financing Tonix’s financing and market knowledge.
This article is based on a press conference by Tonix Pharmaceuticals Holding Corp.
In other cases, Tonix Pharmaceuticals has developed a fortschritte at the Weiterentwicklung blessing Forschungs- und Entwicklungspipeline-gemacht. The biopharmaceutical companies that earn a maximum amount of combined benefits in the best-selling agreement with AGP/Alliance Global Partners from 150 million US dollars to 250 million US dollars. Dieser Schritt provides Tonix with a comprehensive financial framework for supporting future research and development activities.
The US Food and Drug Administration (FDA) has recommended the New Drug Application (NDA) for TNX-102 SL, not an opioid treatment for fibromyalgia. This treatment can last the first fibromyalgia treatment for up to 15 years. The NDA filing will be conducted during the Phase 3 clinical trial.
Tonix has received a US$34 million reimbursement from the Department of State worldwide for the antiviral drug TNX-4200 in combination with X-Chem, Inc. It is possible that the external data on the Mpox-Impfstoffcandidates TNX-801 will be disseminated, increasing the potential of the Mpox prevention and the control of the declining epidemiology.
Analysts from Noble Capital had adopted their “Outperform” rating for the Action of Tonix, were the Vertrauen in the young companies of the Unternehmens broader mirror. The involvement of the external parties in the Forschung and Entwicklung said that in these young companies the long-term of Wachstums initiatives would be adopted.
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