Why Did Tonix Pharmaceuticals Stock Soar 23.14%?

On March 24, 2025, Tonix's stock price surged by 23.14% in pre-market trading, reflecting significant investor optimism and market sentiment.

Tonix Pharmaceuticals has made notable progress with its TNX-102 SL drug, which is currently advancing through the FDA approval process. The company recently announced that the FDA has set an August 15, 2025, goal date for the Prescription Drug User Fee Act (PDUFA) review of TNX-102 SL. This development is crucial as it indicates the regulatory pathway for the drug is on track, potentially leading to market approval.

Additionally, the FDA has decided that an advisory committee meeting will not be required to discuss the New Drug Application for TNX-102 SL. This decision streamlines the approval process, reducing potential delays and uncertainties, which is generally positive for the stock.

Despite these positive developments, Tonix Pharmaceuticals' stock experienced a significant decline earlier, falling by 11.3% to $0.71 during a previous trading session. This volatility highlights the speculative nature of biotech stocks, where regulatory milestones can lead to dramatic price swings.