Therapy Areas: Oncology
BiVictriX receives FDA Orphan Drug Designation for AML treatment candidate
17 April 2024 -

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.