Tonix Pharmaceuticals Receives Formal Minutes From FDA Pre-NDA Meeting For Tonmya For Fibromyalgia Management; Achieves Alignment On Key CMC Topics Including Drug Specifications, Shelf Life, Manufacturing, And Packaging
Portfolio Pulse from Benzinga Newsdesk
Tonix Pharmaceuticals has received formal minutes from the FDA for a pre-NDA meeting regarding Tonmya for fibromyalgia management. The company has aligned with the FDA on key CMC topics and completed the second pre-NDA meeting. Tonix plans to submit the NDA in the second half of 2024.
June 20, 2024 | 12:03 pm
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Tonix Pharmaceuticals has aligned with the FDA on key CMC topics for Tonmya and completed the second pre-NDA meeting. The company is on track to submit the NDA in the second half of 2024.
The alignment with the FDA on key CMC topics and the completion of the second pre-NDA meeting are positive developments for Tonix Pharmaceuticals. These steps indicate progress towards the NDA submission for Tonmya, which is expected in the second half of 2024. This news is likely to have a positive short-term impact on TNXP's stock price.
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