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.
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Biotechnology Industry | Healthcare Sector | Seth Lederman CEO | NASDAQ (CM) Exchange | 890260839 Cusip |
US Country | 81 Employees | - Last Dividend | 5 Feb 2025 Last Split | 10 May 2012 IPO Date |