Bayer and Novo Nordisk Celebrate a Comeback! Is BioNxt Solutions Next?

BioNxt Shares Poised for a Comeback?

BioNxt Solutions focuses on developing innovative dosage forms for already-approved blockbuster active ingredients. Using its sublingual, thin-film dissolvable technology, the Canadian-German biotech company aims to bring new drug variants to market within a few years. Compared to developing entirely new active ingredients, this reduces development costs and research risks.
The stock has nearly halved in value this year. This could present a buying opportunity. The company is well on its way to commercializing the drug candidate BNT23001. BioNxt is currently preparing a human bioavailability study to compare BNT23001 with Mavenclad, both at a dosage of 10 mg. BNT23001 is a patented, sublingual cladribine formulation in the form of an orally dissolvable film for the treatment of multiple sclerosis. The product is intended to offer an alternative to cladribine tablets, such as Mavenclad and could be particularly beneficial for patients who have difficulty swallowing.

At the same time, BioNxt is preparing for commercialization. To this end, the company has hired a specialized consultant for business development and licensing. Together, they will explore potential licensing agreements, regional marketing partnerships, joint development models, and other strategic collaborations. Another factor driving this effort is the high market potential. Mavenclad generated global sales of approximately EUR 1.2 billion in 2025.

In addition, BioNxt Solutions is continuing to advance the development of a sublingual, orally soluble semaglutide film. The goal is to provide a needle-free and patient-friendly alternative to injectable GLP-1 therapies for type 2 diabetes, obesity, and weight management. The thin films are designed to dissolve under the tongue and, upon absorption through the oral mucosa, bypass the gastrointestinal tract and hepatic first-pass metabolism. The company is thus targeting a rapidly growing market worth billions.

Novo Nordisk Reports Research Success

With its GLP-1 therapy in tablet form, Novo Nordisk has returned to success on the stock market. Since April, the Danish pharmaceutical company's stock has risen by nearly 50% to around EUR 43. But Novo Nordisk is not relying solely on its blockbuster drugs Wegovy and Ozempic, or on acquisitions. The company continues to invest heavily in its own research and is now reporting promising study data from an entirely different therapeutic area.

At the ISTH 2026 conference, Novo Nordisk presented positive interim results from the Phase 3 long-term FRONTIER4 study on denecimig, also known as Mim8. The drug, which has not yet been approved, is administered as a preventive subcutaneous injection for hereditary bleeding disorders. The study included 426 children, adolescents, and adults with and without so-called inhibitors—antibodies that can render conventional factor preparations ineffective. Denecimig demonstrated overall stable efficacy and a favourable safety profile when administered weekly, biweekly, and monthly.

The average annualized bleeding rate, that is, the calculated number of treatment-requiring bleeds per year, was 0.75 for adults and adolescents and 0.37 for children. Approximately 71% of adults and adolescents and 89% of children had no treatment-requiring bleeds during treatment.

In addition, Novo Nordisk presented data on concizumab from the Phase 3 Explorer10 study involving 24 children under the age of 12 with hemophilia A or B and inhibitors. Prophylactic treatment reduced the annualized bleeding rate by 82% compared with on-demand therapy alone. Most side effects were mild, although 29% of participants experienced serious adverse events. Denecimig has been undergoing the approval process with the US Food and Drug Administration (FDA) since September 2025. Both active ingredients are intended to improve blood clotting, but they act on different parts of the coagulation system.

Bayer Raises Fresh Capital

Following the US Supreme Court's landmark glyphosate ruling, there is a sense of optimism at Bayer. The decision strengthens the company's position in ongoing legal disputes and could significantly mitigate the liability risks that have weighed on the company for years. Since early June, the stock has climbed from EUR 34 to 50. This is the highest price level since September 2023. Hopes are growing that the company will once again be able to focus more strongly on its core business, its pharmaceutical pipeline, and long-term growth.

To continue accelerating its operations, Bayer has secured EUR 3 billion in equity through an agreement with the asset manager Apollo. In return, Apollo will receive a minority stake in a new company into which Bayer is spinning off its business with reversible long-acting contraceptives. Bayer retains both the majority stake and full operational control. The business will remain part of the Pharmaceuticals division and will continue to be fully consolidated in the Group's financial statements. With this transaction, Bayer aims to strengthen its capital structure and create additional financial flexibility to cushion higher liquidity pressures resulting from maturing bonds and legal disputes. The transaction is expected to close in the third quarter of 2026, subject to regulatory approvals.

Bayer and Novo Nordisk demonstrate how quickly stocks can turn and make a comeback. This could also be on the horizon for BioNxt Solutions. The news flow from the biotech company is positive. Bayer and Novo Nordisk have performed well in recent months. A breather for both stocks would come as no surprise.