BioNxt Solutions Inc.
18.3.2024 08:08:12 CET | ACCESS Newswire | Press release
VANCOUVER, BC / ACCESSWIRE / March 18, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that based on the recent success of its toxicity and comparative pharmacokinetic ("PK") studies the Company is advancing towards human comparative bioavailability studies on an expedited basis. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the upcoming planned human comparative bioequivalence study. Sample manufacturing is planned for Q2 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission also planned for Q2 2024.
On February 7, 2024, the BioNxt announced positive animal toxicity study results with no adverse clinical abnormalities or indications of toxicity observed in any participants after consecutive days of dosing. On March 13, 2024, the Company announced positive animal PK study results that demonstrated highly comparable rapid absorption and bioequivalence between the Company's ODF product and the name-brand reference drug for all administered samples. The upcoming planned human comparative bioequivalence study will be carried out by a European contract research organization in accordance with EU medical regulatory guidelines.
BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us.
The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
BioNxt's wholly owned subsidiary is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global pharmaceutical drug delivery market size was valued at USD 1,525 billion in 2022 and expected to surpass approximately USD 2,047 billion by 2030.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
BioNxt Solutions Inc.
Hugh Rogers, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422
Cautionary Statement Regarding "Forward-Looking" Information
Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as "expects", "intends", "is expected", "potential", "suggests" or variations of such words or phrases, or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company's control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.
SOURCE: BioNxt Solutions Inc.
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
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
U.S. Marine Corps Selects GA-ASI for MUX TACAIR Collaborative Combat Aircraft Program10.2.2026 21:00:00 CET | Press release
GA-ASI's YFQ-42A Platform to Support Next-Generation Expeditionary Air Operations SAN DIEGO, CALIFORNIA / ACCESS Newswire / February 10, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) was competitively selected by the U.S. Marine Corps (USMC) for evaluation in the Marine Air-Ground Task Force Uncrewed Expeditionary Tactical Aircraft (MUX TACAIR) Collaborative Combat Aircraft (CCA) program. The agreement integrates GA-ASI's expertise in autonomy and uncrewed aircraft systems with a government-provided mission package, usingthe YFQ-42A platform as a surrogate to evaluate integration with crewed fighters. The contract initiates integration of a Marine Corps mission kit into the YFQ-42A surrogate platform for assessment within the Marine Air Ground Task Force (MAGTF). The USMC contract includes the rapid development of autonomy for the government-supplied mission kit - a cost-effective, sensor-rich, software-defined suite capable of delivering kinetic and non-kinetic effects -
Changing Your Dog's Diet May Help the Planet More Than Changing Your Own, Study Finds10.2.2026 17:30:00 CET | Press release
LONDON, UK / ACCESS Newswire / February 10, 2026 / Diets high in meat, eggs, and dairy products incur significant environmental costs. But a new study has revealed that, in many cases, switching your dog to a more sustainable diet may have a bigger impact on the planet and farmed animals than changing your own diet. The research, published in the journal Animals by veterinary Professor Andrew Knight, found that the average dog consumes around 13 farmed land animals annually within its diet, compared with nine for the average person--a difference of roughly 40%. This gap exists largely because a greater proportion of a typical dog's dietary energy comes from animal-based ingredients--about 34%--compared to around 19% for people. These figures represent global averages and vary by country. In high-income nations such as the United States, consumption is higher across the board. There, an average person consumes 24 farmed land animals annually, compared with 20 for a dog--a smaller differ
Reco Raises $30M B Round for a Total of $85M to Meet Rapidly Growing Demand for AI SaaS Security Among Enterprises10.2.2026 16:30:00 CET | Press release
After growing ARR by 400% in 2025, Reco secures new backing months after its last funding to secure AI SaaS usage NEW YORK CITY, NEW YORK / ACCESS Newswire / February 10, 2026 / Reco, a leader in securing AI SaaS environments, today announced a $30 million Series B funding round led by Zeev Ventures, with participation from all existing investors including Insight Partners, boldstart ventures, while adding new corporate investors Workday Ventures, TIAA Ventures, S Ventures, and Quadrille Capital. The new funding comes less than 10 months after Reco's previous raise to meet the exponential demand to discover and secure AI SaaS at any modern enterprise. The round follows another year of exceptional growth for Reco. After growing 500% year-over-year in 2024, the company scaled an additional 400% in 2025 on a significantly larger base, driven by a sharp increase in enterprise AI adoption and the rapid rise of shadow AI, where 71% of knowledge workers now use AI tools without IT approval an
Logista Strator and Shekel Sign an Agreement to Bring Innovendi Elite to Spain - The Autonomous Sales Solution That Boosts Sales10.2.2026 14:05:00 CET | Press release
The goal is to put a technology in the hands of tobacconists and the Spanish retail sector to open new revenue channels. MADRID, ES / ACCESS Newswire / February 10, 2026 / Logista Strator, the technology platform specialized in retail management and part of Logista, has reached a strategic agreement with Shekel, developer of WeightAI™ technology and manufacturer of Innovendi Elite, for its distribution in Spain and Portugal. The companies will present the Innovendi Elite at the Hospitality Innovation Planet (HIP) trade fair in Madrid from February 16-18, 2026. Innovendi Elite is a next-generation smart fridge that redefines the future of vending experience: an advanced autonomous retail solution that combines patented weighing technology with artificial intelligence to deliver a completely frictionless shopping experience. Customers pay by card or app, open the cooler, select their products, and continue on their way without waiting. Its ability to operate in continuous mode and adapt
Datavault AI Recaps High-Impact Super Bowl LX Weekend with NFL Alumni, Live ADIO(R) Activations, DVHOLO(TM) and Tokenization10.2.2026 14:00:00 CET | Press release
PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / February 10, 2026 / Datavault AI Inc. (NASDAQ:DVLT) ("Datavault AI" or the "Company"), a leader in data monetization, credentialing, digital engagement and real-world asset (RWA) tokenization technologies, today announced the successful execution of multiple high-visibility activations throughout Super Bowl LX weekend, highlighted by a strategic partnership with NFL Alumni in health, national Radio Row engagement, and live demonstrations of its proprietary technologies including ADIO ® , DVHOLO ™ , and tokenized digital assets. Throughout Super Bowl weekend, Datavault AI operated at Radio Row as a real-world proving ground for its data-over-sound and immersive engagement platforms. The Company's technologies were actively deployed in live environments, demonstrating how authenticated audience engagement, digital credentials, and tokenized content can be captured, verified, and monetized at scale. Radio Row & Super Bowl Activations Datavaul
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