Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP ) was down about 20% on Monday despite securing that much-anticipated FDA approval on Friday for its fibromyalgia therapy. Tonmya, which had initially sent shares soaringI’m a retired Wall Street PM specializing in TMT; since kickstarting my career, I’ve spent over two decades in the market navigating the technology landscape, focusing on risk mitigation through the dot com bubble, credit default of ‘08, and, more recently, with the AI boom. In one word, wha ...

Tonmya Approval and Launch - TonmyaTM is the first FDA-approved medicine for fibromyalgia in over 15 years[1,13] - Tonix is well-positioned to support the commercial launch of TonmyaTM, expected in Q4 2025[13] - Tonix ended Q2 2025 with approximately $125 million in cash and cash equivalents and raised approximately $50 million in Q3 2025 through equity sales[41] - The company anticipates its cash runway will support the launch and other operations into Q3 2026[13,41] Clinical Efficacy and Safety - Clinical trials demonstrated durable reduction in fibromyalgia pain with TonmyaTM[22] - In Trial 1, the TONMYA group showed a change from baseline of -1.9 compared to -1.5 in the placebo group, with a p-value of 0.010[28] - In Trial 3, the TONMYA group showed a change from baseline of -1.8 compared to -1.2 in the placebo group, with a p-value of less than 0.001[29] - A greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo[35] - The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer[24,40,94] Market Opportunity and Commercial Strategy - Over 10 million people in the US are living with fibromyalgia[13,50] - Approximately 5% of fibromyalgia-diagnosing HCPs write approximately 70% of fibromyalgia prescriptions[62]