Tonix Pharma Gears Up For Key FDA Decision Today, Stock Up Over 500% In 5 Months

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) is expected to hear from the FDA its decision on the investigational drug TNX-102 SL, proposed for the management of fibromyalgia, today.

Fibromyalgia is a chronic pain disorder resulting from amplified sensory and pain signaling within the central nervous system. This condition afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Pfizer's Lyrica, Lilly's Cymbalta, and AbbVie's Savella are some of the FDA-approved drugs for fibromyalgia.

TNX-102 SL, the company's lead drug candidate, is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and is a centrally acting analgesic that helps in relieving pain by improving sleep.

If approved by the U.S. regulatory agency, it would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years.

Analysts expect the drug to achieve peak sales of $500 million to $600 million in the indication of fibromyalgia, if approved.

We alerted readers to TNXP on Mar.6, 2025, when it was trading at $10.85. The stock touched an intraday high of $69.97 yesterday, before closing at $59.58, down 3.23%.

Had you bought the stock in March, you could have gained over 500% now.