橫幅
16
2026.04
The Company announces that its subsidiary,Tulex Pharmaceuticals, has submitted an NDA for TLX-042 (505(b)(2)) to the U.S. FDA.
1.Date of occurrence of the event:2026/04/16
2.New drug name or code:TLX-042, a 505(b)(2) oral liquid medication for epilepsy.
3.Indication:for the treatment of epilepsy.
4.Planned development stages:has completed the development stage required for a U.S. 505(b)(2) New Drug Application (NDA) submission..
5.Current development stage:
(1) Application Submission / Approval Status / Clinical Trial Results (including interim analysis) / Other Major Events Affecting New Drug Development: Application Submission.
(2) In the event of disapproval by the competent authority, lack of statistical significance in clinical trial results (including interim analysis), or other major events affecting new drug development – potential risks and response measures:None.
(3) In the event of approval by the competent authority,statistically significant clinical trial results (including interim analysis), or other major events affecting new drug development – future business plans:None.
(4) Cumulative R&D expenses incurred:In consideration of potential future partnerships in other countries,disclosure is withheld at this time to avoid affecting negotiation terms.
6.Upcoming development plan:
(1) Expected completion time: None.
(2) Expected obligations to be undertaken: None.
7.Market situation:According to the IMS Health Inc.market research database, the product recorded an estimated sales value of approximately USD 420 million in the U.S. market in 2025.
8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):None.
9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.