SillaJen Seeks FDA Clearance to Modify BAL0891 Trial to Target Urothelial Cancer

• SillaJen filed a US FDA application on Nov. 5, 2026, to amend its Phase 1 trial of BAL0891.
• The amendment would focus Part 2 dose expansion on BAL0891 with paclitaxel for unresectable, locally advanced or metastatic urothelial cancer.
• Earlier trial results informed the proposed change in the Part 2 target disease.
• The expansion will assess preliminary antitumor activity, safety and tolerability once a recommended combination dose is selected.
• The overall trial targets approximately 200 participants, with completion scheduled for June 2029.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. SillaJen Inc. published the original content used to generate this news brief via DART, the regulatory disclosure system operated by the South Korea Financial Supervisory Service (FSS) (Ref. ID: 20261105900521), on November 05, 2026, and is solely responsible for the information contained therein.