BioNxt Solutions Prepares for Human Bioequivalence Study For MS
23.4.2025 03:05:00 CEST | ACCESS Newswire | Press release
VANCOUVER, BC / ACCESS Newswire / April 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to report advanced preparation for its human bioequivalence study for its lead Multiple Sclerosis (MS) treatment.
BioNxt's lead product, BNT23001, is a proprietary sublingual thin-film formulation of Cladribine for the treatment of MS. Preclinical studies, as reported in internal research data and third-party evaluations, have demonstrated high absorption rates and bioequivalence compared to existing oral tablet therapies. The Company has purchased Cladribine active pharmaceutical ingredient which is necessary to complete the technology transfer process with Gen-Plus, its European Contract Research and Development Organization (CRDO), in Munich, Germany. Once commenced, the bioequivalence study is relatively short, scheduled for less than 30 days from start to finish.
The Company plans to make further updates in the coming weeks regarding its bioequivalent study preparation and scheduling, as well integration of its research and development operations with Gen-Plus.
BNT23001 offers a novel approach to MS management by addressing limitations in traditional oral therapies. Its sublingual thin-film format provides:
Convenience: Easy-to-use and portable, ideal for patients with difficulty swallowing or active lifestyles.
Rapid Absorption: Direct delivery through the sublingual mucosa for faster therapeutic action.
Improved Compliance: A patient-friendly alternative designed to enhance adherence to prescribed regimens.
By delivering these advantages, BNT23001 aligns with BioNxt's mission to improve outcomes for patients living with chronic diseases like MS.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding "Forward-Looking" Information
This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
BioNxt Solutions Inc.
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
IFS Softeon Announces Successful First Go-Live with BF Global Group in Europe13.8.2026 14:00:00 CEST | Press release
First deployment marks a major milestone in strategic multi-site warehouse modernisation initiative. RESTON, VA / ACCESS Newswire / August 13, 2026 / IFS Softeon, the warehouse management system (WMS) provider delivering visibility from the boardroom to the warehouse floor, today announced the successful go-live of its warehouse management system at the first BF Global Group distribution centre, marking a significant milestone in the companies' strategic partnership announced earlier this year. The first deployment supports a leading premium stroller and baby products brand and represents the initial phase of BF Global Group's broader rollout of IFS Softeon Warehouse Management System across facilities throughout Europe in partnership with Lanark. The implementation was completed through a carefully coordinated weekend cutover, with operations transitioning successfully to the new platform. Since go-live, the facility has successfully processed and shipped both B2B and B2C customer ord
U.S. Polo Assn. Takes No. 1 Spot for All Sports Brands and Climbs to No. 22 Overall on License Global's 2026 'Top Global Licensors' Ranking13.8.2026 13:00:00 CEST | Press release
WEST PALM BEACH, FL / ACCESS Newswire / August 13, 2026 / U.S. Polo Assn.®, the official sports brand of the United States Polo Association (USPA), was named the highest-ranking sports brand on License Global's annual Top Global Licensor list for the second consecutive year, surpassing the NFL Players Association, PGA Tour, and Formula 1. Marking another milestone, U.S. Polo Assn. climbs to No. 22 overall on the global licensor list spanning the entertainment, fashion, lifestyle, and sports industries. This achievement reflects the continued expansion of the multi-billion-dollar brand globally as it delivered a record year on all fronts with $2.7B in retail sales in 2025. U.S. Polo Assn.®, the official sports brand of the United States Polo Association (USPA), ranked the No. 1 Sports Licensor on License Global's annual Top Global Licensor list. This achievement reflects the continued expansion of the multi-billion-dollar sport brand globally as it delivered a record year on all fronts
Fermi Announces Second Quarter 2026 Results and Delivers on All Five 90-Day Objectives13.8.2026 13:00:00 CEST | Press release
Company Signed Its First Anchor Customer, Named a CEO, Added a Strategic Alliance and Premier Contractors, Received Three F-Series Turbines and Raised More Than $431 Million of Shareholder-Friendly Capital DALLAS, TX / ACCESS Newswire / August 13, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), today announced full execution of the 90-day plan provided in May. The Company established significant momentum and took a major step toward delivering its large-scale, reliable private power grid for AI and advanced computing. The Company also reported second quarter 2026 financial results. A conference call is scheduled for 9 a.m. Eastern Time / 2 p.m. British Time today, August 13, 2026. Accompanying slides and prepared remarks can be found at https://investor.fermiamerica.com. Participation details are included in this release. Delivering on Commitments "Roughly 90 days ago, we put ourselves on the clock with a clear set of aggressive object
Fermi Names Lee McIntire as Chief Executive Officer12.8.2026 22:01:00 CEST | Press release
Engineering executive with more than 40 years of experience building and operating complex global industrial and governmental projects at Bechtel, CH2M Hill, and TerraPower DALLAS, TX / ACCESS Newswire / August 12, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), today named Lee McIntire Chief Executive Officer, effective Tuesday, August 11, 2026. McIntire has served as an independent director on Fermi's Board since September 2025. "Fermi's next chapter is a construction and power delivery story, and we believe Lee is the ideal executive to lead Fermi through that process," said Marius Haas, Chairman of the Board of Fermi Inc. "The job now is to build on schedule, on budget, and safely. Lee has spent 40 years delivering exactly this kind of large, complex project. He also knows Fermi from the inside, having served on our board through our latest period of growth, and he brings a reputation for integrity that Fermi's customers, employees
Model ML Secures Investment From HSBC Asset Management to Scale Its Agentic Operating System for Financial Services12.8.2026 18:05:00 CEST | Press release
The investment reflects growing demand for specialist AI platforms designed specifically for financial services. LONDON, UK / ACCESS Newswire / August 12, 2026 / Model ML has announced an investment from HSBC Asset Management, made through its flagship Venture Capital (VC) strategy. The funding will support Model ML's growth as the focus of enterprise AI shifts from individual models to the systems required to implement them. Model ML's platform is purpose-built for financial services. The company works with many of the world's leading banks, asset managers and advisory firms, helping to automate complex workflows across research, due diligence, financial analysis and client-ready document creation, while maintaining governance, accuracy and consistency. Its model-agnostic approach routes each task to the AI model best suited to the job, enabling firms to benefit from advances across the AI ecosystem without changing the way teams work. The company has grown rapidly since launching les
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom