By Chris Wack


ABVC BioPharma Inc. shares more than doubled to $1.51 after the company said it was notified by the U.S. Food & Drug Administration that the Investigational New Drug application for the proposed clinical investigation of BLEX 404 has been approved and the study can proceed.

The treatment, which is being co-developed by BioKey Inc., a wholly owned subsidiary of ABVC, and by the Rgene Corp., was submitted to the FDA by Rgene on Nov. 30.

BLEX 404 is the primary active ingredient in ABV-1519 for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer

The application, designated IND 161602, was approved Dec. 30.

ABVC said that as a result of the approval, its BioKey subsidiary has earned a milestone payment of $600,000 from Rgene.

ABVC BioPharma shares are up 66% in the past three months.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

01-05-23 1010ET