Bioniz Therapeutics Inc, a clinical-stage biopharmaceutical company, announced on Tuesday that it has received orphan designation from the European Commission for its BNZ-1, intended for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer.
Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorised. The product had earlier received orphan drug designation from the United States Food and Drug Administration (FDA).
The company has completed a phase two study of BNZ-1 in cutaneous T-cell lymphoma in the United States and aims to start a phase three clinical trial of the product intended for the treatment of patients with relapsed or refractory CTCL. It is likely to start enrolling for the phase three trial in the second half of 2021.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval