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Tonix Awaits FDA Decision on Breakthrough Fibromyalgia Treatment

8/16/2025

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Summary

Story summary

Tonix Pharmaceuticals is awaiting an FDA decision on TNX-102 SL for fibromyalgia treatment.
Fibromyalgia impacts 6-12 million U.S. adults, mainly women, leading to chronic pain and fatigue.
Approval would mark the first new non-opioid treatment in over 15 years.
Analysts estimate peak sales for TNX-102 SL could reach $500-$600 million.

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Story summary

Tonix Pharmaceuticals is awaiting an FDA decision on TNX-102 SL for fibromyalgia treatment.
Fibromyalgia impacts 6-12 million U.S. adults, mainly women, leading to chronic pain and fatigue.
Approval would mark the first new non-opioid treatment in over 15 years.
Analysts estimate peak sales for TNX-102 SL could reach $500-$600 million.