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
Pitches and Keynote Speakers Are Confirmed for Blue Magic Netherlands on November 174.11.2026 17:00:00 CET | Press release
SAN DIEGO, CA / ACCESS Newswire / November 4, 2026 / Blue Magic Ventures by General Atomics Aeronautical Systems, Inc. (GA-ASI) returns on November 17 for the next Blue Magic Netherlands (BMNL) Dual-Use Innovation & Investment Conference in Eindhoven. This is the third year that Netherlands-based technology companies have been invited to pitch innovative, transformative solutions addressing critical defense and security challenges. This year's event will feature remarks from key figures in the defense community: Brigadier General Peter Gielen, Military Advisor on Integrated Air and Missile Defence of the Netherlands; Mark Lengton, Deputy Commissioner Military Production, Ministry of Economic Affairs & Climate Policy; and Kadri Tammai, Chief Programme Officer, Regional Director, NATO DIANA (Defence Innovation Accelerator for the North Atlantic). "We've been successful in tapping into the Dutch ecosystem, which has a great wealth of knowledge and know-how," said Brad Lunn, managing direc
RE Royalties Launches $5 Million Series 5 Green Bond Offering and Provides Strategic Growth Update4.11.2026 00:00:00 CET | Press release
VANCOUVER, BC / ACCESS Newswire / November 3, 2026 / RE Royalties Ltd. (TSXV:RE)(OTCQB:RROYF)(FSE:Y2V) ("RE Royalties" or the "Company") is pleased to announce the launch of its fifth secured Green Bond offering, seeking to raise up to $5 million to support the continued growth of its renewable energy royalty portfolio. Building on the success of its previous Green Bond issuances, the Company will offer Series 5 secured Green Bond Units through a non-brokered private placement of Series 5 secured green bond units (the "Green Bond Units") at the price of either $1,000 or US$1,000 per Green Bond Unit for gross proceeds of up to $5,000,000 (the "Private Placement Offering"). Each Green Bond Unit will be comprised of $1,000 or US$1,000 principal amount of green bonds (the "Green Bonds") and 1,000 common share purchase warrants (each a "Warrant"). For the purposes of calculating the Private Placement Offering's aggregate gross proceeds, issuances of the United States dollar denominated Gree
OMP Extends UnisonIQ with Agent Library and Agent Studio: AI Agents that Produce Executable Supply Chain Plans3.11.2026 15:00:00 CET | Press release
ANTWERPEN, BE / ACCESS Newswire / November 3, 2026 / OMP, a leader in supply chain orchestration, today extended UnisonIQ, the AI framework in its Unison Planning™ platform, with the Agent Library of ready-to-deploy AI agents and Agent Studio, where companies build their own. The agents run on the optimization engines in Unison Planning™ and produce executable supply chain plans. Bekaert is among the early adopters of UnisonIQ. Supply chain organizations face board-level pressure to show progress on AI, but many struggle to move beyond experiments. Generic AI models and decision-intelligence tools miss the industry-specific context and semantics that planning depends on, while planning tools with an AI layer on top lack reasoning depth. Both can produce a confident answer that ignores real-world constraints such as shelf life, co-products, and shared capacity. In UnisonIQ, by contrast, each agent works from a reality-based digital twin of the customer's own supply chain and calls on th
Fermi Provides Update on Lease Agreement as Parties Work Toward Closing3.11.2026 13:00:00 CET | Press release
DALLAS, TX / ACCESS Newswire / November 3, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), today issued the following statement on the Data Center Lease and Services Agreement (the "Lease") between its wholly owned subsidiary, Fermi Campus 1 LLC, and TensorWave TEX1, LLC ("TensorWave"), after the October 31, 2026 closing date passed without extension. "Both Fermi and TensorWave remain committed to this lease, and we are continuing to work through the remaining conditions prior to close," said Lee McIntire, Fermi Chief Executive Officer. "We expect to provide more information on the discussions during our earnings call next week, or sooner if appropriate." The Lease, signed in August 2026, provides that its effectiveness is subject to the satisfaction or waiver of specified closing conditions. Those conditions include executing and delivering related work letters and guaranties; finalizing operations schedules and a service-level agreem
IXOPAY Announces IXO One, a Modular Payments Platform Built for an Era of Fluid Commerce3.11.2026 10:00:00 CET | Press release
DALLAS, TX / ACCESS Newswire / November 3, 2026 / IXOPAY, the leader in payment infrastructure enabling fluid commerce, today announced the launch of IXO One, an AI-native, modular payment platform that unifies orchestration, payments intelligence, and tokenization. It gives merchants the flexibility to buy what they need, build what they want, and adapt as commerce evolves. Built to power an era of fluid commerce and technology-driven payment experiences, IXO One provides the dynamic infrastructure needed to adapt quickly without ripping out or replacing their current payment stack. Traditional payment infrastructure makes it difficult for merchants to embrace fluid commerce and a rapidly changing payment market. From fragmented systems to rigid provider relationships, a new opportunity can require a heavy integration lift, slow time-to-market, and increased costs. IXO One's modular platform helps merchants mitigate the payment friction that leads to provider dependency, expensive mig
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