BioNxt Solutions Secures Key European Patent for Innovative MS Treatment

A significant regulatory milestone is approaching for BioNxt Solutions. The European Patent Office (EPA) indicated on November 4, 2025, its intention to grant a patent covering the Canadian biotech firm's novel multiple sclerosis therapy. This approval would establish intellectual property protection across as many as 54 countries, potentially opening access to a multi-billion dollar market.

The commercial potential is substantial. Europe's multiple sclerosis market was valued at approximately $7.95 billion in 2024, with projections indicating growth to $13.56 billion by 2032—representing a compound annual growth rate of 6.9%. Oral therapies currently dominate nearly half (49%) of this market, reflecting strong preference among physicians and patients for non-invasive treatment options.

More than 1.2 million Europeans live with multiple sclerosis. MAVENCLAD®, the tablet formulation of cladribine, already serves over 100,000 patients globally. BioNxt aims to capitalize on this established therapeutic agent by introducing a more patient-friendly delivery system.

Sublingual Film Technology Offers Clinical Advantages

The patent covers a sublingual thin-film formulation of cladribine, a well-established MS treatment. Unlike conventional tablets or injections, this dissolvable film administers medication under the tongue without requiring water or swallowing.

This technological approach combines cladribine with a cyclodextrin complex and hydrophilic polymers including starch and pullulan, enabling rapid absorption through the oral mucosa. For many MS patients who experience swallowing difficulties, this swallow-free administration could significantly improve both treatment tolerance and adherence—critical factors in managing chronic conditions.

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The patent, identified as EP 23 729 446.7, potentially secures protection across all EPA member states plus validation and extension countries.

Expanding Global Intellectual Property Portfolio

The EPA's patent intention complements a previously announced "Readiness to Grant" decision from the Eurasian Patent Organization (EAPO). Collectively, these intellectual property rights could provide market access to nearly one billion people. Concurrent patent applications are progressing in the United States (under Fast-Track review), North America, Japan, and additional regions.

CEO Hugh Rogers described this development as "a major step forward in our global IP and commercialization strategy." The company is currently conducting preclinical bioequivalence studies using large animal models to optimize dosing for anticipated human trials.

Strategic Development and Partnership Approach

BioNxt is actively pursuing licensing opportunities, seeking co-development and licensing partnerships with pharmaceutical manufacturers interested in patient-friendly formulations of established therapeutics. Beyond multiple sclerosis, the company's pipeline includes sublingual therapies for myasthenia gravis, lupus nephritis, rheumatoid arthritis, plus a platform for targeted chemotherapy.

BioNxt Solutions shares trade on the Canadian Securities Exchange (CSE: BNXT), the OTCQB Venture Market (BNXTF), and in Germany (WKN: A3D1K3). With expanded patent protection and ongoing development work, the biotechnology firm could become increasingly attractive to strategic partners and investors—provided clinical data validates the technology's potential.