BioNxt Solutions Inc Stock Price, News & Analysis

BioNxt Solutions has reported significant progress in developing BNT23001, a sublingual thin-film formulation of Cladribine for Multiple Sclerosis treatment. In 2024, the company achieved key milestones including successful preclinical trials showing high absorption rates and bioequivalence to Mavenclad®, transfer of production to GMP-certified manufacturer Gen-Plus GmbH, and favorable patent reports.

For 2025, BioNxt plans to complete GMP manufacturing of clinical trial batches in Q2, submit regulatory filings by mid-year, and launch a pilot clinical study in the second half comparing BNT23001 to Mavenclad®. The product offers advantages including convenient administration, rapid absorption through sublingual delivery, and improved patient compliance.

BioNxt Solutions announces the development of BNT24005, a sublingual thin-film oral dissolvable film for Semaglutide, aiming to address limitations of existing injection methods. The innovation targets the growing diabetes and obesity treatment market, where Semaglutide (marketed as Ozempic® and Wegovy®) generated over $14 billion in revenue globally in 2023. The new delivery system offers key benefits including needle-free convenience, rapid absorption, enhanced bioavailability, and improved patient compliance. The product is currently under development and subject to regulatory review and approval.

BioNxt Solutions (CSE:BNXT, OTC:BNXTF) announces expansion of its next-generation product pipeline, focusing on proprietary drug delivery systems for autoimmune diseases and longevity markets. The pipeline includes BNT23001 for Multiple Sclerosis using sublingual Cladribine formulation, targeting a market projected to exceed $41B by 2033. Additional developments include treatments for Myasthenia gravis ($6.7B market by 2032), Lupus nephritis ($3.2B by 2032), Rheumatoid arthritis ($27B by 2033), and anti-aging solutions for the longevity sector ($93B by 2027).

BioNxt Solutions has initiated national patent filings for sublingual anticancer drugs treating autoimmune neurodegenerative diseases. Following a positive International Preliminary Report on Patentability from the European Patent Office, the company is advancing patent protection across multiple jurisdictions including independent filing nations and European/Eurasian Patent Organizations. The patents, valid until 2045, cover multiple drug products.

The company's lead program focuses on a sublingual Cladribine product for Multiple Sclerosis, a market expected to reach $41 billion by 2033. A second program targets Myasthenia Gravis, with a market potential of $6.7 billion by 2032. Both products aim to benefit patients with dysphagia, a common symptom in these conditions.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) has announced that Terry Lynch has joined as a capital markets advisor. Lynch brings extensive experience in start-up and emerging growth capital markets, particularly in resource and bioscience sectors. He is currently the CEO of Power Nickel Inc. and a cofounder of Cardiol Therapeutics.

BioNxt's lead program is developing a proprietary sublingual Cladribine dosage form for the MS market. The company recently reported positive results from animal toxicity and pharmacokinetics studies for this product. A human comparative bioequivalence study is planned for early Q1 2025.

The company also received a positive international examination report from the European Patent Office for its patent application on sublingual delivery of anticancer drugs for autoimmune neurodegenerative diseases. BioNxt is also developing a sublingual drug delivery system for Myasthenia Gravis as its second clinical indication.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) has provided an update on its flagship sublingual Cladribine drug formulation program for Multiple Sclerosis (MS) treatment. The company reported positive results from animal toxicity and pharmacokinetics studies, with plans for a human comparative bioequivalence study in early Q1 2025.

BioNxt also announced a positive international examination report from the European Patent Office for its patent application on sublingual delivery of anticancer drugs for autoimmune neurodegenerative diseases. The company expects EU patent grant within four weeks and plans to file in other major jurisdictions.

Additionally, BioNxt confirmed Myasthenia Gravis as its second clinical indication using anticancer compounds in a sublingual drug delivery system. The company has also engaged two consultants for investor relations activities starting October 1, 2024, for a six-month period.

BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT) has received a positive international examination report from the European Patent Office for its patent application on sublingual delivery of anticancer drugs for treating autoimmune neurodegenerative diseases. The company expects EU patent grant within eight weeks and plans to enter the national phase of the PCT process in multiple jurisdictions.

BioNxt's lead program focuses on developing a proprietary orally dispersible film (ODF) Cladribine dosage form for the multiple sclerosis (MS) market. The company is also expanding into Myasthenia Gravis (MG) treatment using anticancer compounds in ODF delivery systems. Both MS and MG patients often experience dysphagia, potentially giving ODF drug products an advantage over conventional tablets.

The global MS drug market is projected to reach $41 billion by 2033, while the MG market is expected to hit $6.7 billion by 2032. The broader market for CNS disease treatments is anticipated to grow to $238.8 billion by 2032.

BioNxt Solutions Inc. (CSE:BNXT, OTCQB:BNXTF, FSE:BXT) has signed a non-binding letter of intent (LOI) with Gen-Plus GmbH & Co KG, a German-based international contract research, development, and manufacturing company. The LOI outlines potential collaborations in areas such as intellectual property development, clinical trial planning, and thin film commercial manufacturing.

BioNxt is developing a proprietary oral dissolving film (ODF) Cladribine dosage form for the multiple sclerosis (MS) market. Cladribine tablets are currently approved in over 75 countries, with annual sales exceeding $1 billion USD. The global MS drug market is projected to reach $41 billion by 2033. BioNxt has filed provisional patent applications for its Cladribine ODF, with potential patent protection extending to 2044.

BioNxt Solutions Inc. (CSE:BNXT, OTCQB:BNXTF, FSE:BXT) has signed a statement of work (SOW) with a German-based international contract research, development, and manufacturing organization (CRDMO) for its Cladribine oral dissolvable film (ODF) development program. The SOW includes key deliverables such as technology transfer, GMP material production, stability testing, and preparation for EU submission.

BioNxt is developing a proprietary ODF Cladribine dosage form for the multiple sclerosis (MS) market, which has an expected global value of USD 41 billion by 2033. Cladribine tablets are currently approved in over 75 countries, including by the FDA and EMA, with annual sales exceeding USD 1 billion. The company has filed provisional patent applications for its Cladribine ODF, with potential protection extending to 2044.