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Tonix获得FDA批准纤维肌痛药物Tonmya
2025-08-16 04:31
- Tonix製藥控股(TNXP) 0
- 纳比特(NA) 0
- 盛大科技(SDA) 0
- The U.S. FDA has granted approval to Tonix Pharmaceuticals' (NASDAQ:TNXP) Tonmya (cyclobenzaprine sublingual tablets) for fibromyalgia.
- The company said that Tonmya is the first new treatment for the condition in more than 15 years.
- It is to be taken at bedtime. As a sublingual therapy, it is rapidly absorbed into the bloodstream.
- Approval was based on efficacy results of around 1,000 patients in two phase 3 double-blind, placebo-controlled trials.
- In March, shares jumped after the company announced the FDA wouldn't require an advisory committee meeting for the then candidate.
- Tonmya should be available starting in Q4.
- After closing down ~14% Friday, the stock is up ~19% in after-hours trading.
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