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) 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).
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.