Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)
Tonix Pharmaceuticals Holding Corp. (TNXP)
Last tonix pharmaceuticals holding corp. earnings: 3/24 05:15 pm
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Source: GlobeNewswire
NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women If approved by FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally-acting analgesic that showed statistically significant reduction in the chronic, widespread pain associated with fibromyalgia i
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News
- Muscarinic Acetylcholine Receptor M1 Antagonists Pipeline Research Report 2024: Comprehensive Insights on 8+ Drugs Featuring Tonix Pharmaceuticals, BMS, WinSanTor, and Apnimed [Yahoo! Finance]Yahoo! Finance
- Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Tonix Pharmaceuticals to Present at the Winter 2024 Investor Summit VirtualGlobeNewswire
- Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology (ACR) Convergence 2024 Annual MeetingGlobeNewswire
TNXP
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/13/24 - Form 8-K
- TNXP's page on the SEC website