Tonix Pharma's TNX-102 SL Faces FDA Decision for Fibromyalgia Treatment.

Tonix Pharmaceuticals is awaiting FDA decision on TNX-102 SL for fibromyalgia management. The drug could become the first non-opioid analgesic for fibromyalgia and first new drug for the condition in over 15 years. Analysts expect peak sales of $500-$600 million if approved. The stock has surged over 500% in 5 months, with a current price of $59.58 after reaching an intraday high of $69.97 yesterday.

Tonix Pharmaceuticals is in the final stages of awaiting FDA approval for TNX-102 SL, a potential game-changer in the management of fibromyalgia. The drug, if approved, could be the first non-opioid analgesic specifically designed for fibromyalgia and the first new drug for the condition in over 15 years. Analysts have projected peak sales of $500-$600 million if the drug gains approval [1].

The stock of Tonix Pharmaceuticals has experienced a significant surge, rising over 500% in the last five months. As of July 2, 2025, the stock price is $59.58, having reached an intraday high of $69.97 yesterday. The company's stock has seen substantial growth due to the anticipation of the FDA's decision on TNX-102 SL [1].

TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine HCl, a centrally-acting, non-opioid analgesic. The drug has shown statistically significant pain reduction in patients with fibromyalgia in Phase 3 trials, including the RESILIENT study published in the peer-reviewed journal Pain Medicine [1].

The company's robust cash position, with $125.3 million in cash and cash equivalents as of June 30, 2025, provides a runway to fund operations until the third quarter of 2026. Tonix Pharmaceuticals has also made significant strides in its pipeline, with ongoing trials for TNX-102 SL addressing acute stress reaction and the development of TNX-1500 for organ transplant rejection [1].

Tonix Pharmaceuticals' stock has been added to the Russell 3000 and Russell 2000 indexes, increasing its visibility among institutional investors as it approaches key regulatory milestones. The company's recent financial results, while showing a decline in net product revenue and an increase in research and development expenses, reflect its commitment to innovation and the development of new therapies [1].

Investors and financial professionals should closely monitor the FDA's decision on TNX-102 SL, as it could significantly impact Tonix Pharmaceuticals' future performance and the broader fibromyalgia treatment landscape.

References:
[1] https://www.quiverquant.com/news/Tonix+Pharmaceuticals+Reports+Financial+Results+and+Highlights+PDUFA+Goal+Date+for+TNX-102+SL+in+Fibromyalgia+Treatment