Tonix Pharmaceuticals Holding Corp. Stock News

Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue T...

CHATHAM, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D.

The Tonix Pharmaceuticals Holding Corp. stock price has pulled back so much, and they hold a clear campaign runway for Tonmya into 2026. Despite approval, TNXP shares dropped due to concerns over valuation, potential dilution, and uncertainty around commercialization and pricing. Tonmya's novel formulation and high unmet need could drive strong adoption, with revenue potential of $219M–$365M an...

Tonmya is the first FDA-approved fibromyalgia drug in more than 15 years.

Tonix's Tonmya received FDA approval, marking the first new fibromyalgia therapy in 15 years and driving a post-market stock surge. Despite the approval, I maintain a Hold rating due to Tonix's limited cash, ongoing losses, and likely need for dilutive fundraising. Tonmya's unique sublingual formulation and unmet market need are positives, but safety concerns and commercial execution risks remain.

The U.S. Food and Drug Administration has approved Tonix Pharmaceuticals' drug to manage pain related to a type of chronic condition, the company said on Friday.

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated Commercial availability of Tonmya is expected in the fou...

FDA PDUFA goal date of   August   15 , 2025, for TNX ‑ 102   SL for fibromyalgia: if approved by FDA, TNX ‑ 102   SL would be the first new drug for fibromyalgia in more than 16   years