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. (BNXTF) generates news centered on its work in next-generation drug delivery technologies, particularly sublingual thin films for autoimmune and neurological diseases. Many recent announcements focus on BNT23001, the company’s proprietary sublingual thin-film formulation of cladribine for multiple sclerosis (MS), and on efforts to address pill-swallowing difficulties (dysphagia) with rapid-dissolving “melt-in-your-mouth” dosage forms.
Investors and observers following BNXTF news will find updates on preclinical and bioequivalence studies, including small- and large-mass animal studies designed to define dosing parameters ahead of planned human comparative bioequivalence trials. Company releases also cover intellectual property milestones, such as patent grants and “intention to grant” notifications from the Eurasian Patent Organization and the European Patent Office, as well as a Track One priority patent filing with the U.S. Patent and Trademark Office.
News items further highlight collaboration and pipeline development, including a letter agreement with a European-based chemotherapy company to co-develop a sublingual formulation for oncology and immunosuppressant treatments. Additional disclosures touch on corporate and shareholder matters, such as annual general meeting logistics and investor relations activities.
By reviewing the BNXTF news feed, readers can track how BioNxt advances its sublingual thin-film platform, expands its patent coverage in major pharmaceutical markets, and positions its drug delivery technologies within therapeutic areas like multiple sclerosis, autoimmune conditions, and oncology-related immunosuppression.
BioNxt Solutions (OTCQB:BNXTF) announced progress for its rapid-dissolving, sublingual thin-film drug platform targeting swallowing difficulties common in chronic autoimmune diseases.
Key facts: BioNxt received a Eurasian patent for BNT23001 valid through 2043 covering >200 million people, completed GMP clinical batch manufacturing, and plans a comparative human bioequivalence study in Q1 2026. The drug references cladribine tablets (Mavenclad) which exceeded $1.0B annual sales, supporting commercial potential for a swallow-free alternative.
BioNxt Solutions (OTCQB:BNXTF) is advancing a next‑generation "Melt in Your Mouth" cladribine oral dissolvable film (ODF), BNT23001, designed for rapid sublingual absorption to help multiple sclerosis (MS) patients with dysphagia who struggle to swallow tablets.
The company cites a meta‑analysis finding ~45% of MS patients experience dysphagia and notes cladribine tablets generated ~USD 1.28 billion in 2024. Market data show cladribine sales of >USD 950M through Q3 2025 and a projected cladribine market CAGR of 8.5% to 2032; the oral transmucosal market is forecast to grow from USD 45.8B (2025) to USD 96.8B (2033).
BioNxt Solutions (OTCQB:BNXTF) signed a letter agreement with a European chemotherapy company to acquire 100% of IP rights to a novel sublingual high‑potency formulation for oncology and immunosuppressant uses.
Under the agreement the Codeveloper will receive a 20% royalty on license fees, capped at USD 50,000,000 aggregate. The parties plan prototype development, IP filings, preclinical and clinical studies, and regulatory filings, and aim to execute a definitive IP and collaboration agreement within 60 days. BioNxt expects to file provisional patents for the product by year‑end, positioning the program alongside its cladribine sublingual thin‑film lead program.
The release cites a market estimate: the global immunosuppressant market reaching USD 61.05 billion in 2025.
BioNxt (OTCQB:BNXTF) announced that the Eurasian Patent Organization granted Patent No. 051510 (issued November 14, 2025) covering sublingual delivery of anticancer drugs, including BioNxt's lead candidate BNT23001, a sublingual cladribine thin-film for multiple sclerosis. The patent provides protection across all eight EAPO member states—Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan—covering a combined population of more than 200 million, and is valid through June 14, 2043.
BioNxt said an ongoing two-week large-mass animal bioequivalence study is underway and a human bioequivalence study is planned. The company noted an EPO Intention to Grant and ongoing Track One U.S. priority filing plus nationalization efforts in Canada, Australia, New Zealand, and Japan as part of its global IP and commercialization strategy.
BioNxt Solutions (OTCQB:BNXTF) announced that its German subsidiary received an "Intention to Grant" from the European Patent Office for European patent application no. 23 729 446.7 covering a sublingual cladribine thin-film for multiple sclerosis. Combined with an EAPO "Readiness to Grant," filings could provide potential protection across up to 54 jurisdictions and an addressable population of nearly 1 billion people, subject to national validation and maintenance. The patents claim a cladribine-cyclodextrin complex thin film intended for rapid transmucosal absorption. BioNxt is also pursuing U.S., North America, and Japan filings, completing a large-mass animal bioequivalence study, and planning a human bioequivalence trial while seeking co-development and out-licensing partners.
BioNxt (OTCQB:BNXTF) received a Readiness to Grant notice from the Eurasian Patent Organization for a patent family covering sublingual delivery of anticancer drugs aimed at treating autoimmune neurodegenerative diseases, including BioNxt's lead product BNT23001 (sublingual Cladribine for MS).
The company will pay a publication fee this week to secure formal grant in the EAPO region, which covers 8 countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan) representing a combined population of >200,000,000. BioNxt is days away from starting a two-week large-mass animal bioequivalence study to set dosing for an upcoming human bioequivalence study, and is pursuing patent nationalization in the EU, US (Track One), Canada, Australia, New Zealand, and Japan.
BioNxt Solutions (OTCQB:BNXTF) has begun a 15-day dosing optimization crossover study for BNT23001, a sublingual cladribine thin-film for multiple sclerosis, marking the final preclinical step before human testing.
The large-mass animal study starts within two weeks, runs ~3 weeks, expects completion in November and results in December, ahead of a comparative human bioequivalence trial planned for early 2026. Small-animal tests showed bioequivalence and no toxicity. Patent nationalization is advancing with EPO and Eurasian intent-to-grant communications and a US Track One filing.
BioNxt (OTCQB:BNXTF) launched a 15-day large-mass animal crossover bioequivalence study for BNT23001, its sublingual cladribine thin-film, to refine dosing prior to a human comparative bioequivalence study planned for early 2026.
The animal study will begin in the next 2–3 weeks, run for 15 days, is expected to complete in November 2025, and results are expected in December 2025. A prior small-mass (40 kg) animal study reportedly confirmed dosage bioequivalence and guided dosing direction.
BNT23001 aims for improved bioavailability, faster onset, and easier dosing for patients with dysphagia. The company is pursuing patent nationalization in key markets; the European Patent Office and Eurasian Patent Office issued notices of intentions to grant, and a Track One priority filing is active in the United States.
BioNxt (OTCQB:BNXTF) advised shareholders that its 2025 annual general meeting will be held in person on November 7, 2025 at 10:00 a.m. (Vancouver). Due to the Canada Post strike, shareholders are directed to electronic copies of the Notice of Meeting, Information Circular and proxy via SEDAR+ and the company website, or to contact Investor Relations for copies.
The company outlined alternative proxy submission methods (fax, hand delivery, online via Computershare) and a 48-hour proxy deadline. BioNxt disclosed a service agreement with Native Ads for a digital marketing campaign with a retainer up to US$200,000 and term up to six months. The company confirmed compliance with NI 51-102 proxy filing rules and reliance on the CSA blanket order exemption.
BioNxt (OTCQB:BNXTF) completed a USPTO Track One priority patent filing for BNT23001, a sublingual thin-film cladribine formulation for multiple sclerosis on October 9, 2025. A USPTO office action is expected within 60–90 days with final disposition targeted in 9–12 months. The filing also covers sublingual products for other neurological autoimmune diseases including myasthenia gravis and lupus nephritis.
Patent nationalization is underway in the EU, US, Canada, Australia, Eurasia, New Zealand, and Japan; the European and Eurasian patent offices issued notices of intention to grant, citing novelty and inventive step.
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