Tonix Pharmaceuticals (NASDAQ:TNXP) announced the appointment of Ganesh Kamath as its head of market access, effective September 29, 2025. The biotechnology company said Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix.
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 annually at modest market penetration.
I'm initiating Tonix Pharmaceuticals Holding Corp. with a Buy rating, eyeing a rally on potential FDA approval for flagship drug Tonmya in August. Tonmya targets fibromyalgia, a large, underserved market; FDA decision is due August 15th, and approval could dramatically boost Tonix's revenue. Tonix has its work cut out for it, but I'm a firm believer that they could have a first-mover advantage in this market.
Tonix Pharmaceuticals' TNX-102 SL shows a high probability of FDA approval for fibromyalgia, supported by positive Phase 3 trials and an acceptable safety profile. A recent $500M shelf offering caused a stock dip but does not impact approval odds; current valuation does not include TNX-102 approval. Risks include modest efficacy and challenging market adoption; therefore, we recommend buying TNXP stock before PDUFA and reassessing before commercial launch.
PDUFA date of August 15th of 2025 set to review on whether or not TNX-102 SL should be approved to treat patients with Fibromyalgia. The company announced that the FDA will not require an Advisory Committee Meeting of TNX-102 SL for the treatment of patients with Fibromyalgia. TNX-102 SL met primary endpoints in two Phase 3 studies, showing significant pain reduction, positioning it as the first new Fibromyalgia drug in 15 years.
The biotechnology sector has experienced a jolt of volatility over the past few days, spearheaded by the dramatic price surges in Tonix Pharmaceuticals NASDAQ: TNXP and Lexeo Therapeutics NASDAQ: LXEO. The biotech industry is known for its volatile price swings, often influenced by clinical trial results and regulatory decisions.
Clinical-stage biopharmaceutical company Tonix Pharmaceuticals NASDAQ: TNXP is gaining significant attention from investors and market participants. The company develops therapies for conditions with high unmet needs, with a focus on pain management, CNS disorders, and public health vaccines.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.