Tonix Pharma's Stock Plummets 21.97% Despite FDA Approval, $0.35B Trading Volume Surges 31.25% to 261st Rank

On August 18, 2025, Tonix Pharmaceuticals (TNXP) saw a trading volume of $0.35 billion, a 31.25% increase from the prior day, ranking it 261st in the market. The stock closed down 21.97%, marking a sharp decline despite recent regulatory milestones. Tonix secured FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets) as the first new therapy for fibromyalgia in over 15 years. The sublingual, non-opioid treatment demonstrated significant pain reduction in two Phase 3 trials involving nearly 1,000 patients, with results showing a clinically meaningful improvement in pain scores compared to placebo. The drug is expected to launch in Q4 2025, supported by Tonix’s existing commercial infrastructure and $125.3 million in cash reserves, which are projected to fund operations through Q3 2026.

The approval followed a “refusal to file” letter sent to competitor Axsome Therapeutics for its fibromyalgia candidate, highlighting the competitive landscape. Tonix’s leadership emphasized the drug’s rapid absorption and tolerability, though common side effects like oral discomfort and fatigue were noted. Despite the regulatory win, the stock’s volatility reflects market skepticism, with TNXP down sharply after a Monday press conference. The company’s reverse stock split in February 2025 and recent price swings underscore its high-risk profile, with a 21-day average true range of 12.08% indicating heightened short-term uncertainty.

The strategy of buying the top 500 stocks by daily trading volume and holding them for one day from 2022 to 2025 yielded a 1-day return of 0.98% and a total return of 31.52% over 365 days. This suggests limited success in capturing short-term momentum, reflecting broader market volatility and timing risks inherent in such strategies.