Tonix Pharmaceuticals Announces FDA Fast Track Designation For Tonmya To Treat Fibromyalgia; NDA Submission On Track For Second Half Of 2024; Potential To Be First New Fibromyalgia Drug In Over 15 Years
Portfolio Pulse from Benzinga Newsdesk
Tonix Pharmaceuticals has received FDA Fast Track designation for its drug Tonmya, aimed at treating fibromyalgia. The company plans to submit a New Drug Application (NDA) in the second half of 2024. If approved, Tonmya could be the first new fibromyalgia drug in over 15 years.
July 25, 2024 | 12:03 pm
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Tonix Pharmaceuticals has received FDA Fast Track designation for its drug Tonmya, aimed at treating fibromyalgia. The company plans to submit a New Drug Application (NDA) in the second half of 2024. If approved, Tonmya could be the first new fibromyalgia drug in over 15 years.
The FDA Fast Track designation is a significant milestone for Tonix Pharmaceuticals, indicating that Tonmya addresses an unmet medical need. This designation can expedite the review process, potentially leading to earlier market entry. The news is likely to positively impact TNXP's stock price in the short term due to increased investor optimism.
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