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
Related Questions
What are the potential upside and downside scenarios if the FDA approves or rejects TNX‑102 SL, and how should position sizing be adjusted accordingly?
What historical price reaction has Tonix experienced around similar FDA decision milestones, and can that inform expected volatility?
How will the earnings results and operational highlights reported for Q2 2025 influence the broader market narrative around Tonix’s growth trajectory?
How will the FDA PDUFA goal date of August 15, 2025 for TNX‑102 SL affect the stock’s short‑term price movement?
What is the market’s perception of TNX‑102 SL being the first new fibromyalgia drug in over 16 years, and how might that influence demand and valuation?
How does the projected revenue and profit potential of TNX‑102 SL compare to existing fibromyalgia treatments and other pipeline candidates at Tonix?
What is the current level of analyst coverage and consensus on Tonix Pharmaceuticals, and are there any upcoming upgrades or downgrades linked to this filing?
How might the approval timeline impact the company’s cash runway and need for additional financing or dilution?
What competitive threats exist from other companies developing fibromyalgia therapies, and how could they affect market share if TNX‑102 SL is approved?
Are there any contingent milestones or partnership agreements tied to the approval of TNX‑102 SL that could further move the stock?