Novo Nordisk Ignites the Next Stage
Novo Nordisk is setting the pace in weight-loss medications. In fiscal year 2024, the drug portfolio centred on semaglutide generated over USD 29.3 billion in revenue for the Scandinavian company. To break through the magic barrier of a 20% weight loss, the company is introducing combination therapies. The REDEFINE 1 study program shows that the combination of semaglutide and cagrilintide can reduce body weight by up to 22.7% after 68 weeks. In the later-published REDEFINE 4 comparative study, CagriSema achieved a 23% weight loss after 84 weeks—though it fell just short of tirzepatide (25.5%). Meanwhile, developers are refining the candidate Amycretin, which has delivered similarly strong results in initial tests, depending on the dosage form. The industry news service Patsnap reports that early clinical trials of subcutaneous Amycretin show about 22% weight loss after 36 weeks. An oral formulation is also being tested, although Novo Nordisk believes such molecules are more difficult to absorb orally.
Merck: A Targeted Strategy Against Fatty Liver and Innovations in Tablets
According to industry publications, Merck is seeking lucrative niches outside the mass market. The focus is on severe cardiometabolic complications, particularly fatty liver disease. In a Phase 2a study, the licensed drug efinopegdutide significantly reduced patients’ dangerous liver fat levels more effectively than the competitor semaglutide, Fierce Biotech reports. The company is taking a different approach to the dosage form to circumvent the instability of peptide tablets. In late 2024, Merck secured the worldwide exclusive rights to the non-peptide drug candidate HS-10535 for USD 112 million. Such chemically synthesized small molecules survive stomach acid unscathed and can be taken regardless of fasting requirements. In doing so, the American company skillfully circumvents known weaknesses of weight-loss pills.
BioNxt Solutions and the End of Weight-Loss Injections?
While industry giants search for new molecular structures, BioNxt Solutions is taking a completely different approach. The company is addressing the biggest problem with current therapies in patients’ daily lives: delivery. Weekly injections deter many patients. A study in the Journal of Managed Care and Specialty Pharmacy (Gleason et al., 2024) shows that about two-thirds of patients discontinue injection therapy within the first year. Standard tablets, by contrast, are prone to errors because the gastrointestinal tract breaks down the sensitive active ingredients, as Merck’s shift in strategy also shows. This is where BioNxt Solutions comes in.
The idea: the active ingredient, semaglutide, is encapsulated in an ultra-thin film that dissolves under the tongue in seconds. This allows the molecule to enter the bloodstream directly through the oral mucosa, bypassing the digestive tract. Patients are delighted: no needle pricks—no need to drink water on an empty stomach. In September 2025, BioNxt Solutions announced the successful completion of all feasibility tests for these semaglutide prototypes. The tests confirmed excellent mechanical stability and an extremely fast dissolution time for the matrix. Management is now pursuing patents for the specialized carrier structure. This would generate property rights without conflicting with the expiring basic patents held by the original manufacturers.
Next Steps for BioNxt: GMP Manufacturing and Licensing
Of major operational importance to BioNxt is its wholly-owned German subsidiary, Vektor Pharma. At its Biberach site, BioNxt Solutions has certified cleanroom facilities tailored to these delivery systems. The semaglutide program is still in the pharmaceutical formulation development phase, with preclinical animal studies planned. The company’s parallel cladribine program is further along, with a human bioavailability study scheduled for the second half of 2026. The commercial potential of these initiatives lies in the validation of the platform approach. If the company can reliably deliver the active ingredient into the bloodstream, it could become an attractive partner for the pharmaceutical industry. As the exclusive rights to many blockbuster drugs are set to expire soon, major corporations are seeking patented dosage forms to extend their product lifecycles.
BioNxt Solutions’ stock has stabilized in recent weeks. Its market capitalization currently stands at approximately CAD 46 million. Upcoming preclinical results and the planned start of human trials in 2026 could serve as catalysts for the share price. A technical proof of concept could pave the way for licensing deals with established pharmaceutical giants. Nevertheless, the stock remains a high-risk bet. In biotechnology, experience shows that there are many different paths to the same goal. BioNxt’s approach is one of them. The coming weeks and months should give the market more insight into the company’s potential. This fall is shaping up to be exciting.
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