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Under-tongue MS drug film enters licensing push, Mavenclad made €1.2B in 2025

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BioNxt Solutions Inc. is advancing its sublingual Cladribine orally dissolvable film (ODF) formulation, BNT23001, for multiple sclerosis (MS) treatment. They have engaged a Business Development & Licensing (BD&L) advisor to spearhead commercialization and partnership strategies, aiming to leverage the unique drug delivery system's potential. The company is also preparing for a human bioavailability study to compare BNT23001 against an established competitor.
  • BioNxt is developing BNT23001 as a sublingual ODF alternative to traditional Cladribine tablets, targeting MS patients who have difficulty swallowing.
  • The company is seeking licensing, co-development, regional commercialization, and strategic partnership opportunities for BNT23001.
  • A BD&L advisor will assist BioNxt in market positioning, identifying pharmaceutical partners, and structuring potential deals.
  • BioNxt is preparing for a human bioavailability study comparing BNT23001 to Merck KGaA's Mavenclad®, focusing on pharmacokinetic parameters, safety, and tolerability.
  • The company's broader innovation includes various drug delivery platforms and diagnostic screening systems, with a focus on European markets and improving healthcare outcomes.
  • BioNxt is listed on the CSE, OTCQB, and trades in Germany.
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