Bayer: Billions for the Pharmaceutical Division of Tomorrow
Bayer is planning for the long term. On October 2, the company announced it would invest USD 2.2 billion in a new pharmaceutical site in New Albany, Ohio. Initially, the site will produce oncology, cardiology, and nephrology drugs. The first module for active ingredient production is scheduled to be operational in 2031, while the second, for finished product manufacturing, is planned for 2034. The timeline shows that Bayer is counting on a steady supply from its own R&D. If the company succeeds in filling its pipeline, the facility will play into the group’s hands in the long term.
This aligns with current developments in nephrology. On September 17, the US Food and Drug Administration (FDA) approved Kerendia for adults with chronic kidney disease associated with type 1 diabetes. According to Bayer, it is the first new treatment option for this group in more than 30 years. On October 8, the FDA also accepted the application for patients without diabetes, based on the FIND-CKD study. On October 22, Bayer presented new analysis of the study at the ASN Kidney Week conference. If the indication is expanded, Kerendia could give the pharmaceutical division a boost.
Progress is also being made in cancer treatment. On October 24, Bayer reported that darolutamide, which the company is developing in collaboration with Orion, reduced the risk of metastasis or death by 58% compared with placebo in an interim analysis of the DASL-HiCaP trial in patients with high risk prostate cancer. The treatment was administered in addition to androgen deprivation therapy and radiotherapy.
However, the legal dispute over the glyphosate-based herbicide Roundup continues to weigh on the company. According to mid-October media reports, the settlement of up to USD 7.25 billion, payable over up to 21 years, still awaits final court approval. This leaves billions hanging in the balance. The risk remains.
BioNxt Solutions: Established Active Ingredient, New Formulation, First Human Trial
BioNxt Solutions is working on established active ingredients in new formulations. On October 19, the company announced that approximately 1,500 test films containing sublingual cladribine for multiple sclerosis had been produced. On October 16, its development partners submitted an application for the first clinical trial via the European CTIS portal. The company estimates that the regulatory review of the Clinical Trial Application (CTA) will take approximately three months. In an interview published on October 25, co-founder and CEO Hugh Rogers explained that the study is intended only to assess bioequivalence with the Mavenclad tablet, since efficacy and safety have long been established. In this case, there is no need to reinvent the wheel.
Rogers cites the next steps as approval of the test films, which he expects within 30 to 60 days, and a human study expected to last only two to three weeks. Added to this is the company’s patent portfolio. Patents have been granted in Europe and Eurasia, and he expects news from North America in a few weeks. This could ultimately lead to a potential licensing agreement. At the same time, BioNxt is expanding its platform. On September 8, the company launched an animal study involving six beagle dogs to evaluate an everolimus film for use in transplant medicine. Rogers also cited myasthenia gravis as another potential application for cladribine. This could open up new opportunities for BioNxt.
BioNxt is also making inroads in the market for metabolic agents. On August 4, in a press release regarding the development of its pipeline, the company identified sublingual semaglutide, the active ingredient in Ozempic and Wegovy, as another building block. The initial focus is to determine whether the thin-film platform suits peptides, with an emphasis on metabolic diseases. According to the company, the shared platform is intended to cover several therapeutic areas, ranging from neurology to metabolism. Is the film also suitable for peptides? If so, BioNxt would be entering a field where Novo Nordisk currently sets the tone.
Novo Nordisk: Oral Candidate and CagriSema Fill the Pipeline
Novo Nordisk is sourcing new additions to its development pipeline from outside the company. On September 29, the company agreed with Hengrui Pharma on an exclusive license for HRS-1596, an oral obesity drug that targets two hormone receptors and may need to be taken only once a week. The upfront payment is USD 300 million, and the potential total value, including milestones, is up to USD 2.6 billion. The transaction is expected to close in the fourth quarter, subject to antitrust approvals. As early as September 21, Novo had announced its goal of expanding capacity by 2030 so that ten times as many people with obesity can receive an oral treatment. To achieve this, the company is digging deep into its pockets.
New data is available for CagriSema. On October 20, Novo presented analyses from the REDEFINE 1 study at the Menopause Society conference in San Diego. Among 2,309 women with obesity or overweight, the average weight loss after 68 weeks was 25.0%, compared to 3.0% in the placebo group. The company emphasises that these are post-hoc analyses that require further review. The FDA’s decision on approval is expected in the fourth quarter. If approved, it would be a major success.
There have also been setbacks. On October 2, Novo announced that the FDA is extending the review of Denecimig for haemophilia A because deficiencies at the manufacturing facility are still being addressed. The agency did not identify any issues with efficacy or safety. The US market launch is now targeted for the first half of 2027, while Novo says its 2026 guidance remains unchanged. Meanwhile, the share buyback program continues. As of October 16, Novo had purchased 39,074,179 Class B shares since February 4 for approximately DKK 10.88 billion. The next quarterly results will be released on November 4 before the market opens.
Conclusion
To replenish their pipelines, pharmaceutical companies must invest first. Bayer is investing USD 2.2 billion in a new facility and expanding its nephrology division with Kerendia, while the comparison with Roundup remains unresolved. BioNxt Solutions has manufactured test films for cladribine and submitted an application for the first human clinical trial, while also expanding the platform to include everolimus and semaglutide. Novo Nordisk has secured an oral candidate from Hengrui and is awaiting the FDA’s decision on CagriSema in the fourth quarter. All three companies are working to replenish their pipelines.
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