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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。