Welcome to our dedicated page for BioNxt Solutions news (Ticker: BNXTF), a resource for investors and traders seeking the latest updates and insights on BioNxt Solutions stock.
BioNxt Solutions Inc. reports developments in bioscience and advanced drug delivery systems, with recurring updates on sublingual oral thin films, transdermal skin patches, oral enteric-coated tablets, diagnostic screening systems and active pharmaceutical ingredient development. Its lead program, BNT23001, is a proprietary sublingual cladribine oral thin film designed for relapsing forms of multiple sclerosis and other autoimmune neurodegenerative diseases.
Company news also covers patent protection for its oral thin-film technology, GMP manufacturing of clinical-grade cladribine film through a European CDMO, semaglutide as an initial GLP-1 oral thin-film application, commercialization planning, and capital-structure actions such as shares issued to settle debt.
BioNxt (OTCQB:BNXTF) advanced its Semaglutide oral dissolvable film (ODF) program into active pharmaceutical development with partner Gen-Plus in Germany. The first phase, expected to last 6–9 months, covers formulation, analytical method development, compatibility testing, and proof-of-concept work once Semaglutide API is received.
The sublingual thin film targets the expanding GLP-1 market for obesity, metabolic disorders, and type 2 diabetes. BioNxt plans to leverage experience and preclinical results from its Cladribine ODF program to support future optimization, scale-up, and potential IP for Semaglutide and other candidates.
BioNxt (OTCQB:BNXTF) completed GMP manufacturing of a clinical-grade sublingual Cladribine oral thin film (BNT23001) at a Munich CDMO on April 14, 2026.
The GMP batch will serve as Investigational Medicinal Product supply for the planned CBN26001 human bioavailability study versus Mavenclad, and stability studies have been initiated to support Qualified Person release.
BioNxt (OTCQB:BNXTF) secured unitary effect for European Patent No. 4539857 covering its sublingual cladribine oral thin film (ODF) platform, registered March 31, 2026 with effect from March 11, 2026.
The unitary patent provides centralized protection across 18 European countries, strengthens IP for lead candidate BNT23001, and supports regional licensing, co-development and commercialization efforts. The patent claims a cladribine-cyclodextrin complex in a hydrophilic polymer ODF for transmucosal delivery; preclinical data show comparable systemic exposure to Mavenclad and a human bioavailability study is underway.
BioNxt (OTCQB:BNXTF) announced that semaglutide is its lead candidate to validate a sublingual oral thin-film (ODF) GLP-1 delivery platform. The program is in early-stage formulation and proof-of-concept work while the company targets broader peptide applications and intellectual property around carrier systems and films.
The release cites a large GLP-1 market (USD 62.83B in 2025, projected to USD 254.19B by 2034) and positions the platform for licensing and lifecycle management opportunities.
BioNxt Solutions (OTCQB:BNXTF) is shifting into commercialization after expanding global patent protection for its sublingual thin-film drug delivery platform and pursuing an accelerated U.S. Track One patent review.
Key items: European patent granted March 11, 2026; Eurasian patent granted Nov 14, 2025; U.S. Track One filing with ~9–12 month expected review; national phase filings in Canada, Japan, Australia, New Zealand. The lead product BNT23001 targets multiple sclerosis and myasthenia gravis.
BioNxt (OTCQB:BNXTF) signed a non-binding LOI on March 17, 2026, to negotiate exclusive commercialization terms for its sublingual cladribine oral thin film (ODF) across one or more EAPO member states, with a 60-day exclusive negotiation period.
BioNxt has EAPO Patent No. 051510 (issued Nov 14, 2025) covering eight Eurasian states and European Patent No. 4539857 (published Mar 11, 2026); both patents are stated as valid through at least June 14, 2043. The LOI contemplates upfronts, royalties, and revenue sharing, and BioNxt is preparing a human bioequivalence study.
BioNxt (OTCQB:BNXTF) issued an aggregate of 6,008,883 common shares at a deemed price of $0.45 per share to settle $2,704,000 of debt (principal $2,600,000; accrued interest $104,000) from 8% convertible debentures dated December 7, 2022.
The company also issued 300,444 compensation shares to Canaccord Genuity Corp. at a deemed price of $0.63 per share for facilitating the debt settlement. All shares are subject to a statutory four-month-and-one-day hold period under Canadian securities laws.
BioNxt (OTCQB:BNXTF) received a European Patent Office Decision to Grant European Patent No. 4539857 for its proprietary sublingual cladribine oral thin film drug delivery technology.
The grant becomes effective on publication in the European Patent Bulletin on March 11, 2026, and can be validated in up to 39 EPC states, with a patent term through at least June 14, 2043.
BioNxt (OTCQB:BNXTF) signed a non-binding LOI on February 5, 2026 to secure exclusive rights to a third‑party chaperone-enabled drug delivery technology for oral dissolvable thin films. The deal would grant BioNxt IP ownership within the oral field, a development roadmap, patent filing plans in the US and Europe, and a right of first refusal for non-oral formats. The transaction is subject to definitive agreements and may not close as contemplated.
BioNxt (OTCQB:BNXTF) reported preclinical results showing a >40% improvement in bioavailability for its lead cladribine oral thin film (ODF) versus conventional formulations, supporting progression toward a first human clinical study in Multiple Sclerosis.
The company is focusing on clinical planning, manufacturing readiness, and regulatory alignment with CRO support, and is expanding the ODF strategy into Myasthenia Gravis. Market context cited: Mavenclad® 2024 net sales >USD 1 billion and MS market USD 32.8B (2024).