Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval 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
Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025 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 first new drug for its treatment in more than 15 years 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. 23, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HC
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TNXP
News
- 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 Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market AccessGlobeNewswire
- Tonix Pharmaceuticals to Present at Two Upcoming January Investor ConferencesGlobeNewswire
- 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 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
TNXP
Sec Filings
- 1/8/25 - Form 8-K
- 1/3/25 - Form SCHEDULE
- 12/23/24 - Form 8-K
- TNXP's page on the SEC website