Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
Tonix Pharmaceuticals Holding Corp. (TNXP)
Last tonix pharmaceuticals holding corp. earnings: 3/24 05:15 pm
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Source: GlobeNewswire
FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter 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 TNX-102 SL has the potential to 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, if approved by FDA NDA based on two statistically significant Phase 3 studies of TNX-102 SL for the management of fibromyalgia; in which TNX-102 SL was generally well tolerated CHATHAM, N.J., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets)
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News
- Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia [Yahoo! Finance]Yahoo! Finance
- Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for FibromyalgiaGlobeNewswire
- Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia [Yahoo! Finance]Yahoo! Finance
- Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights [Yahoo! Finance]Yahoo! Finance
TNXP
Sec Filings
- 12/23/24 - Form 8-K
- 12/20/24 - Form 8-K
- 12/20/24 - Form 424B5
- TNXP's page on the SEC website