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Investing.com -- Shares of Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) surged 18% after the company announced that the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the New Drug Application for TNX-102 SL, a promising treatment for fibromyalgia.
The news, released on March 24, 2025, indicates that TNX-102 SL, a non-opioid analgesic, may become the first new drug for treating fibromyalgia in more than 15 years. This development is significant for the company and the over 10 million adults in the U.S. affected by this debilitating condition.
Tonix Pharmaceuticals’ President and Chief Executive Officer, Seth Lederman, M.D., expressed his satisfaction with the FDA’s decision, noting the potential of TNX-102 SL to be the first in a new class of medicines for managing fibromyalgia. The company is on track for an August 15, 2025 FDA Prescription Drug User Fee Act (PDUFA) goal date, with commercial planning already underway for a potential launch in the fourth quarter of 2025.
The FDA had previously granted Fast Track designation to TNX-102 SL in 2024, which is intended to expedite the review process for drugs that treat serious conditions and fill an unmet medical need. The absence of an Advisory Committee meeting is generally perceived as a positive sign, suggesting that the FDA may not have significant concerns about the drug’s safety or efficacy profile.
Investors have responded positively to the news, as evidenced by the stock’s significant rise in the trading session. If TNX-102 SL receives approval, it could mark a major milestone for Tonix Pharmaceuticals and offer a new treatment option for those suffering from fibromyalgia.
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