BioNxt completes IMPD for sublingual cladribine film ahead of first human bioequivalence study

• BioNxt completed the IMPD for BNT23001, its sublingual cladribine oral dissolvable film for relapsing multiple sclerosis.
• The dossier is in final technical and regulatory review ahead of inclusion in a European Clinical Trial Application.
• Program work includes GMP development and manufacture of a clinical trial batch, preclinical pharmacokinetic comparisons, local tolerability studies.
• A randomized, open-label, crossover bioequivalence study versus Mavenclad in healthy volunteers is planned, pending regulatory clearance.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioNxt Solutions Inc. published the original content used to generate this news brief on August 19, 2026, and is solely responsible for the information contained therein.