Biotechnology company BiVictriX Therapeutics plc (AIM: BVX) announced on Wednesday that it has received FDA Orphan Drug Designation (ODD) for BVX001 in Acute Myeloid Leukaemia (AML) treatment.
FDA INTERACT meeting completion aligns with development plans for BVX001, a novel twin antigen targeting bispecific Antibody Drug Conjugate (bxADC), offering potential financial incentives and market exclusivity.
ODD provides tax credits and potential seven-year marketing exclusivity upon FDA approval for therapies targeting diseases affecting less than 200,000 people in the US.
BiVictriX focuses on developing highly selective cancer therapeutics, leveraging a proprietary pipeline of Bi-Cygni Antibody Drug Conjugates designed to target cancer-specific antigen pairs.
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