Tonix Pharmaceuticals' Fibromyalgia Treatment Receives FDA Fast Track Designation
Portfolio Pulse from Benzinga Newsdesk
Tonix Pharmaceuticals (NASDAQ:TNXP) has received FDA Fast Track designation for its fibromyalgia treatment, TNX-102 SL. This designation facilitates the development and review process, potentially bringing the drug to market sooner. TNX-102 SL has shown significant improvements in fibromyalgia symptoms in Phase 3 trials and is well tolerated. Tonix plans to submit a New Drug Application (NDA) in the second half of the year and may request Priority Review.
August 01, 2024 | 11:49 am
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Tonix Pharmaceuticals has received FDA Fast Track designation for its fibromyalgia treatment, TNX-102 SL. This could expedite the drug's development and review process, potentially bringing it to market sooner. Positive Phase 3 trial results and a planned NDA submission later this year could drive the stock price up.
The FDA Fast Track designation is a significant regulatory milestone that can expedite the drug's approval process. Positive Phase 3 trial results and the upcoming NDA submission are likely to boost investor confidence and drive the stock price up in the short term.
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