Photo: investing.com
Benitec Biopharma Shares Surge 20% Following FDA Fast Track for OPMD Treatment
Benitec Biopharmas stock surged 20% after receiving Fast track (FDA) designation and reporting a 100% response rate in its clinical trial for treating Oculopharyngeal Muscular Dystrophy.
- Benitec Biopharmas shares jumped 20% on Monday following the announcement of positive interim results from its clinical trial for the BB-301 gene therapy treatment.
- The Food and Drug Administration granted Fast track (FDA) designation to BB-301, which aims to address dysphagia related to Oculopharyngeal Muscular Dystrophy.
- All six patients in Cohort 1 of the Phase 1b/2a clinical trial for BB-301 achieved a formal statistical response, resulting in a 100% response rate.
Por Qué Es Relevante
This development is significant as it underscores the potential of gene therapies in treating rare diseases like Oculopharyngeal Muscular Dystrophy. The Orphan drug designation could expedite the path to market, benefiting patients with limited treatment options.