Tonix Pharmaceuticals Submits NDA For TNX-102 SL To FDA For Fibromyalgia Treatment; Non-Opioid Analgesic Shows Significant Pain Reduction In Phase 3 Studies And Receives Fast Track Designation
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Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia treatment. The drug showed significant pain reduction in Phase 3 studies and has received Fast Track designation.
October 16, 2024 | 12:10 pm
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Tonix Pharmaceuticals has submitted an NDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia, to the FDA. The drug has shown significant pain reduction in Phase 3 studies and received Fast Track designation, indicating potential for expedited review.
The submission of an NDA to the FDA is a critical step for Tonix Pharmaceuticals, as it indicates the drug's potential market entry. The significant pain reduction results from Phase 3 studies and the Fast Track designation suggest a higher likelihood of approval, which could positively impact TNXP's stock price.
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