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 (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).
BioNxt (OTCQB:BNXTF) reported final preclinical pig study results on January 21, 2026 showing its proprietary sublingual oral dissolvable film (ODF) formulation of cladribine achieved approximately 40% higher systemic exposure than a conventional oral tablet over 48 hours. Mean AUC(0-48h) was 39.46 ng·h/mL for the sublingual ODF versus 28.11 ng·h/mL for the tablet. The single-dose study used adult miniature pigs (40-50 kg) with controlled restraint to isolate transmucosal absorption. BioNxt says the data support advancing the ODF to human pharmacokinetic and bioequivalence studies while continuing GMP manufacturing and regulatory preparation.
BioNxt (OTCQB:BNXTF) completed a comparative pharmacokinetics study in adult pigs (Nov–Dec 2025) evaluating its swallow-free sublingual 10 mg cladribine ODF versus a reference 10 mg tablet, with each dose administered as a 5 mg-equivalent per animal. Blood sampling over 24 hours produced preliminary results the company says support superior bioavailability for the ODF under study conditions. BioNxt has begun full internal analysis of the final dataset and expects to disclose detailed PK calculations later. The company also confirmed patent protection for the cladribine ODF program with national grants expected shortly and plans a human bioequivalence study to optimize dosing.
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.