AND-C4 Receives Orphan Drug Designation from the European Commission

FEBRUARY 23, 2026 - REGULATORY MILESTONE

AND-C4 Receives Orphan Drug Designation from the European Commission for the Treatment of Glioma

A formal recognition that validates the clinical relevance of AND-C4 and unlocks the regulatory incentives granted to orphan medicines in the European Union.

The European Commission has granted AND-C4 orphan medicinal product designation for the treatment of glioma, acknowledging the scientific rationale behind Andremacon's approach and the significant unmet medical need in neuro-oncology.

AND-C4 is a humanized IgG1 kappa monoclonal antibody designed to selectively neutralize EV-3, an isoform of erythropoietin identified as a driver of tumour progression and immune modulation in glioblastoma. The designation, granted under Regulation (EC) No 141/2000, confers a set of meaningful regulatory benefits — including protocol assistance, fee reductions and ten years of market exclusivity — and marks a concrete step towards the structured clinical development of the programme.

REGULATORY - EMA ORPHAN DRUG

Commission Implementing Decision C(2026) 1327 final, European Commission, 23.02.2026 · EU Orphan Medicines Register: EU/3/26/3196