Baudax Bio: FDA Grants Orphan Drug Designation To TI-168 For Hemophilia A With Inhibitors

(RTTNews) - Baudax Bio, Inc. (BXRX), a biotechnology company, announced Thursday that the U.S. Food and Drug Administration or FDA has granted orphan drug designation to its lead clinical candidate TI-168 for the treatment of Hemophilia A with inhibitors.

In pre-market activity on Nasdaq, Baudax Bio shares were surging around 86.67 percent.

TI-168 is the company's next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors.

The FDA 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 United States.

Gerri Henwood, President and Chief Executive Officer of Baudax Bio, said, "We believe this is an important therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in Hemophilia A with inhibitors in animal models. With an Investigational New Drug (IND) application already FDA-cleared, we believe we can activate the Phase 1/2a Clinical Trial of TI-168 for Treatment of hemophilia A with inhibitors with a modest initial budget, and advance this therapy to further clinical investigation in early 2024."

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