Tonix Pharmaceuticals (TNXP) announced that the U.S. Food and Drug Administration will not require an Advisory Committee meeting to discuss the ...

Tonix Pharmaceuticals Holding Corp. announced that the FDA has set a PDUFA goal date of August 15, 2025, for TNX-102 SL, which, if approved, would be the first new drug for fibromyalgia in over 15 ...

The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious ...

The biopharmaceutical company said that, if approved, TNX-102 SL tablets would be the first new treatment option for fibromyalgia patients in 15 years. The FDA previously granted Fast Track ...

TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia. TNX-102 SL demonstrated statistically significant ...

Tonix's priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) this month for TNX-102 SL, a product candidate for which two statistically ...

FDA reviews TNX-102 SL for Fibromyalgia by August 2025, with no advisory required. See why we recommend a buy on TNXP stock.

Tonix Pharma (TNXP) has submitted an NDA for its candidate TNX-102 SL for fibromyalgia, with a PDUFA date set for August 15, 2025. See why I'm on the sidelines.

Tonix Pharmaceuticals (NASDAQ: TNXP) is gaining attention as it advances TNX-102 SL, a non-opioid investigational therapy for fibromyalgia, toward po ...

Tonix Pharmaceuticals shares are trading higher by 22.5% during Monday's session. The company announced that the FDA will not ...

Shares of Tonix Pharmaceuticals are pulling back 12.7% during Thursday's session. The stock is pulling back following a regulatory update on its experimental fibromyalgia treatment, TNX-102 SL.