The European Commission (EC) has granted orphan medicinal product designation to Inhibrx’s INBX lead asset INBRX-109 for the treatment of chondrosarcoma.
The regulatory grant was based on a positive opinion issued by the European Medicines Agency (EMA).
Mark Lappe, Chief Executive Office, stated, ”We are highly optimistic about the potential of INBRX-109 in chondrosarcoma to address a high unmet medical need. The positive opinion issued by the EMA is excellent news and acknowledges the potential of INBRX-109 as a treatment for patients throughout Europe who suffer from this debilitating, rare condition.”
Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union. There are currently no therapeutics approved for the treatment of chondrosarcoma.
The Orphan drug designation in the EU can provide certain benefits, including reduced regulatory fees, clinical protocol assistance and the potential for up to ten years of market exclusivity following regulatory approval.
Price Action : Inhibrx shares trading around 1 percent higher at $25 on Monday during after-hours session.
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