BioNxt completes IMPD, moves toward first human bioequivalence trial for sublingual cladribine film in MS

• BioNxt completed the IMPD for BNT23001, a sublingual cladribine oral dissolvable film for relapsing multiple sclerosis, clearing a key step toward trials.
• No clinical results were presented; a first-in-human bioequivalence study is planned, pending European regulatory review of the CTA package.
• The trial is set to compare BNT23001 with Mavenclad in healthy volunteers, focusing on whether the new formulation can match exposure.
• Successful readout would support BioNxt’s hybrid European regulatory strategy, strengthening the commercial case for its oral dissolvable film platform.

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 via ACCESS Newswire (Ref. ID: 202608190305ACCESSWRNAPR_____1209054) on August 19, 2026, and is solely responsible for the information contained therein.