Shares of small cap biotech stock Baudax Bio added 80% after it announced its lead clinical candidate targeting Hemophilia A with inhibitors has been awarded orphan drug status by the United States Food and Drug Administration (FDA).
Its lead candidate TI-168 is a FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors.
“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,” Baudax Bio CEO Gerri Henwood 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.”
The Malvern, Pennsylvania-based biotechnology company added 80% to US$0.54 shortly after midday on Thursday.
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