Tonix Pharmaceuticals (TNXP) shares soared in premarket trading after the company said the US Food and Drug Administration has accepted its filing of a new drug application for TNX-102 SL to treat fibromyalgia.
The biopharmaceutical company said the FDA is expected to assign the application a target action date within 74 days from the date of its NDA submission.
Tonix said its application is supported by data from two phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia.
Tonix shares were 177% higher in recent premarket trading.
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