Tonix Pharmaceuticals Reports Final Pre-NDA Meeting With FDA For Tonmya For Management Of Fribromyalgia
Portfolio Pulse from Benzinga Newsdesk
Tonix Pharmaceuticals has reported its final pre-NDA meeting with the FDA for Tonmya, a potential new non-opioid analgesic for fibromyalgia. The NDA submission is targeted for the second half of 2024, with potential FDA approval in the second half of 2025.
July 08, 2024 | 12:08 pm
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Tonix Pharmaceuticals has completed its final pre-NDA meeting with the FDA for Tonmya, a new non-opioid analgesic for fibromyalgia. The NDA submission is planned for the second half of 2024, with potential approval in the second half of 2025.
The completion of the final pre-NDA meeting with the FDA is a significant milestone for Tonix Pharmaceuticals. The confirmation of the NDA submission and potential approval timeline provides clarity and could positively impact investor sentiment in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100