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
LiberNovo Previews Treat Yourself Halloween Flash Sale Across Europe29.10.2026 08:40:00 CET | Press release
HONG KONG, HK / ACCESS Newswire / October 29, 2026 / LiberNovo is bringing Halloween treats to the desk with its Treat Yourself Halloween Flash Sale, opening October 29 across the European Union and United Kingdom. The event pairs savings of up to 40% on selected Maxis and LiberNovo Omni Pro configurations with limited seasonal gifts for qualifying early shoppers. Spooky extras for your desk Limited Halloween-themed gift packs are available to the first 300 eligible customers in the European Union and the first 100 in the United Kingdom, on a first-come, first-served basis while supplies last. Gift contents, qualifying purchases and availability follow the terms on each regional campaign page. More room for Big and Tall users Maxis is designed around larger frames, with a wider seat and 52 cm seat depth for greater thigh support and room to shift naturally. Maxis Manual provides adjustment by hand. Maxis Electric adds motorised lumbar adjustment and OmniStretch guided back stretching.
IAVI Awarded $36 Million From BARDA for Bundibugyo Virus Vaccine Development28.10.2026 16:50:00 CET | Press release
NEW YORK, NY, SINGAPORE, SG INCHEON, SOUTH KOREA, AND DESSAU-ROSSLAU, DE / ACCESS Newswire / October 28, 2026 / Today IAVI, a global nonprofit biomedical research organization, together with partners Hilleman Laboratories, SK bioscience, and IDT Biologika announced that IAVI has been awarded US $36 million of a contract valued up to US $99 million from the Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to advance development, manufacturing, and clinical evaluation of its one-dose vaccine candidate against Bundibugyo virus (BDBV), the cause of the ongoing Ebola epidemic in the Democratic Republic of the Congo (DRC). The award supports manufacturing of vaccine doses for clinical evaluation and outbreak response, clinical and regulatory activities including a Phase 1 trial, and options for expanded manufacturing to support future preparedness needs, as
GA-ASI and Saab Perform Advanced AEW Flight Testing on Uncrewed MQ-9B28.10.2026 16:00:00 CET | Press release
SAN DIEGO, CA / ACCESS Newswire / October 28, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) has partnered with Saab to perform advanced flight testing of an Airborne Early Warning (AEW) system on an Uncrewed Aircraft System (UAS). The flight testing was conducted over the past few months using a GA-ASI-produced MQ-9B carrying a Saab LoyalEye radar operating from GA-ASI's Desert Horizon flight operations facility in Southern California. The flight test demonstrated simultaneous tracking of several airborne and maritime targets at long ranges. The airborne targets tracked included multiple instrumented red fighter jets and several commercial aircraft. MQ-9B is GA-ASI's flagship UAS, offering unmatched endurance, type certification and all-weather performance. GA-ASI is discussing unmanned AEW capabilities on MQ-9B with several customers. "This has been one of the most highly anticipated flight tests we have performed," said GA-ASI President David R. Alexander. "The level of
Juno Corp. Closes $25 Million Non-Brokered Private Placement28.10.2026 12:00:00 CET | Press release
TORONTO, ON / ACCESS Newswire / October 28, 2026 / Juno Corp. ("Juno" or the "Company"), the largest mineral claim holder and most active explorer in Ontario's Ring of Fire, is pleased to announce that it has completed a non-brokered private placement (the "Offering") for aggregate gross proceeds of $25,290,609. Pursuant to the Offering, the Company issued an aggregate of (i) 165,750 common shares of Juno ("HD Juno Shares"), on a non-flow-through basis at a price of $4.00 per HD Juno Share, (ii) 404,890 common shares of Juno that qualify as "flow-through shares" as defined in subsection 66(15) of the Income Tax Act (Canada) (the "Tax Act") (the "FT Juno Shares"), at a price of $4.50 per FT Juno Share, and (iii) 4,131,450 common shares of Juno, which qualify as "flow-through shares" as defined in subsection 66(15) of the Tax Act (the "Premium FT Juno Shares", and together with the HD Juno Shares and the FT Juno Shares, the "Juno Securities"), at a price of $5.52 per Premium FT Juno Shar
DistillerSR Launches Smart Chat, an AI Chat Interface Built Into Its Evidence Platform27.10.2026 15:55:00 CET | Press release
OTTAWA, ON / ACCESS Newswire / October 27, 2026 / DistillerSR® Inc., the pioneer and market leader in AI-enabled literature review automation and evidence management, today announced the launch of Smart Chat. Smart Chat brings DistillerSR's Agentic AI capabilities in-platform. Since September 2025, DistillerSR Agentic AI has eliminated evidence silos at customer organizations by connecting Large Language Models to a repository of expertly validated literature evidence. Smart Chat now makes that same capability available natively within DistillerSR's secure platform. "While researchers recognize the power of generative AI, many life sciences organizations cannot risk connecting external LLMs to their sensitive research data," said Peter O'Blenis, CEO of DistillerSR. "Smart Chat removes that barrier. It is built directly into the platform teams already use, works exclusively with their own DistillerSR projects, and is included with every version of DistillerSR." Smart Chat works only wit
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