Baudax Bio Shares Double After Orphan Drug Designation for TI-168

Dow Jones2023-09-28

By Chris Wack

Baudax Bio shares doubled to 67 cents after the company said that U.S. Food and Drug Administration has granted orphan drug designation to its lead clinical candidate, TI-168, for the treatment of Hemophilia A with inhibitors.

The stock hit its 52-week low of 30 cents on Wednesday, and is down 94% in the past 12 months.

The Investigational New Drug application for TI-168 has already been cleared by the FDA, and the company plans to advance this therapy to further clinical investigation in early 2024.

The FDA's Office of Orphan Products Development grants orphan status to drugs being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the U.S.

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

(END) Dow Jones Newswires

September 28, 2023 09:46 ET (13:46 GMT)

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