Tonix Pharmaceuticals Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for TNX-102 SL for the Management of Fibromyalgia
Tonix Pharmaceuticals Holding Corp. (TNXP)
Last tonix pharmaceuticals holding corp. earnings: 3/24 05:15 pm
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Source: GlobeNewswire
On track for August 15, 2025 FDA PDUFA goal date TNX-102 SL is a non-opioid analgesic; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Commercial planning for TNX-102 SL underway for launch in the fourth quarter of 2025 CHATHAM, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the Company’s New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. If approved, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) would be the first new treatment option for fibromyalgia patients in 15 years. “We are pleased that FDA will not require an advisory committee meeting as part of the regulatory review process for TNX-10
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News
- Tonix Pharmaceuticals Announces Licensing TNX-4900, a Selective Sigma-1 Receptor Antagonist for Chronic Neuropathic Pain from Rutgers University [Yahoo! Finance]Yahoo! Finance
- Tonix Pharmaceuticals Announces Licensing TNX-4900, a Selective Sigma-1 Receptor Antagonist for Chronic Neuropathic Pain from Rutgers UniversityGlobeNewswire
- Tonix Pharmaceuticals Appoints Irina Ishak as General CounselGlobeNewswire
- Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive DisorderGlobeNewswire
- Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment [Yahoo! Finance]Yahoo! Finance
TNXP
Earnings
- 11/10/25 - In-Line
TNXP
Sec Filings
- 12/16/25 - Form 8-K
- 12/9/25 - Form 8-K
- 11/24/25 - Form 8-K
- TNXP's page on the SEC website