Tonix Pharmaceuticals (NASDAQ: TNXP) posted one of the biotech sector’s biggest single-day moves of the year. On February 6, 2025, the stock closed at $14.98, marking a 96.24 percent gain following positive Phase 3 trial results for its fibromyalgia treatment, TNX-102 SL.

The company has been working on a new option for fibromyalgia patients, a group with limited effective therapies. These latest results from the RESILIENT trial are a step forward and may shift how the condition is treated.

What the Data Showed

TNX-102 SL is a sublingual version of cyclobenzaprine hydrochloride, designed to treat fibromyalgia by targeting sleep disturbances and pain. In the Phase 3 trial, the drug delivered statistically significant results:

• Marked reduction in pain levels compared to placebo (p = 0.00005)
• Improvements in sleep, fatigue, and quality of life
• Lower incidence of side effects relative to existing treatments

These outcomes suggest a potential first-in-class therapy for fibromyalgia, which hasn’t seen a new FDA-approved treatment in more than 15 years.

Market Response and Path to Approval

Tonix submitted a New Drug Application (NDA) to the FDA in October 2024, positioning TNX-102 SL for a potential approval decision in late 2025. If approved, it would become the first new drug in over a decade for a condition affecting millions of patients globally.

The market’s reaction was immediate. Tonix stock hit an intraday high of $17.05 before closing slightly lower at $14.98, still reflecting nearly 100 percent upside in one session.