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Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) plans to develop TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for Long COVID Syndrome (Long COVID), which is now known officially as Post-Acute Sequelae of COVID-19 (PASC1).
Tonix plans to meet the FDA in Q3 of 2021 to seek agreement on designing a potential Phase 2 study and the overall clinical development plan.
TNX-102 SL is in the second Phase 3 trial (RALLY) for fibromyalgia. The interim analysis results are expected in Q3 of 2021, and topline results in Q1 of 2022.
Earlier this month, data from the Phase 3 RELIEF trial in fibromyalgia showed TNX-102 SL significantly reduced daily pain compared to placebo and improved sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery.
Price Action: TNXP shares are up 3.28% at $1.26 during the premarket session on the last check Monday.
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