BioNTech, Formycon, Biogen: Pharma billions are being redistributed

BioNTech: 16 cancer studies set to spark fresh stock market enthusiasm

BioNTech aims to shift from a vaccine manufacturer to a broadly diversified oncology specialist. The Mainz-based biotech company announced it will present 16 scientific contributions at the European cancer congress ESMO. The focus is on new clinical data on Pumitamig, a promising drug candidate targeting various tumour diseases.

Of particular importance are the first results from the global Phase 2 ROSETTA Lung-107 study. This investigates Pumitamig in combination with the chemotherapy drug docetaxel in patients with advanced non-small cell lung cancer whose disease has progressed following previous treatment.

Pumitamig targets two biological pathways at once: PD-L1 and VEGF-A. This is intended to strengthen the immune response against tumours and inhibit the formation of new blood vessels cancer cells need to grow. BioNTech is developing the drug jointly with Bristol Myers Squibb.

Data on combining Pumitamig with the antibody-drug conjugate Elftetabart Drozuntecan are likely to attract additional attention. This approach combines immunotherapy with the targeted delivery of a cytotoxic agent into tumour tissue.

The presentations from October 23 to 27 could provide important indications of the oncology pipeline’s potential. However, the drugs still need to prove themselves in further clinical trials. For BioNTech, the aim is to develop new revenue generators from its extensive research pipeline over the long term and to reduce dependence on the declining COVID-19 vaccine business.

Formycon: Taking on the USD 32 Billion Blockbuster

The German pharmaceutical company, headquartered in Planegg-Martinsried near Munich, has reached an important milestone. Last week, the biosimilar specialist announced that the US Food and Drug Administration (FDA) has accepted the marketing application for FYB206 for review. The active ingredient developed by Formycon is a biosimilar of the cancer drug Keytruda, which was developed and is marketed by the US pharmaceutical company MSD (Merck & Co.). According to the company, this is the first publicly disclosed Keytruda biosimilar application to have cleared this regulatory hurdle.

The economic implications are enormous. In 2025, Keytruda, including Keytruda Qlex, generated global sales of USD 31.7 billion. In the first half of 2026 alone, sales totalled USD 16.4 billion. Formycon is thus positioning itself in one of the world’s most lucrative drug markets.

Notably, the company is developing FYB206 without a comparative Phase III efficacy trial. The approval pathway agreed upon with the FDA shortened the development time and significantly reduced costs. A decision by the agency on market approval could be made in the third quarter of 2027.

Approval of the application will also trigger a milestone payment from Zydus Lifesciences Limited. The Indian pharmaceutical group holds the exclusive marketing rights for the US and Canada. Formycon also receives a share of the gross profits generated by its marketing partners for FYB206.

The latest company announcement offers additional growth potential. Formycon is expanding its development pipeline with a new biosimilar candidate, FYB286, and is collaborating with South American speciality pharmaceutical company Biocelys to do so. While Formycon contributes its development expertise, Biocelys will handle key manufacturing tasks. Pre-financing is provided by Santo Biosimilar GmbH, which, like Biocelys, belongs to the corporate group of Formycon’s major shareholder, Athos.

Formycon will receive payments for its development services and a share of Santo’s future revenues. According to a supplementary regulatory filing, the rights and services contributed by Formycon have an estimated fair value of EUR 40 to EUR 45 million. The first distributions from the revenue share, which take effect only after project costs, including interest, have been deducted, are expected to begin in 2036. FYB286 targets a rare disease with growing market potential, particularly in emerging markets, according to the company.

Analysts see enormous potential based on the current share price of EUR 19.30. H.C. Wainwright raised its price target from EUR 36 to EUR 42 and reaffirmed its Buy recommendation. Berenberg also rates the stock as a Buy, with a price target of EUR 30.

Biogen: New long-term data strengthen the billion-dollar rare disease market

Biogen continues to expand its business beyond traditional multiple sclerosis therapies. The US biotechnology group announced new long-term data on the drug Empaveli. The results are to be presented at ASN Kidney Week from October 22-25 and concern two rare, severe kidney diseases.

The focus is on C3 glomerulopathy and primary immune complex-mediated membranoproliferative glomerulonephritis. Both diseases can permanently damage the kidneys and, in the worst case, lead to a complete loss of function.

According to the company, the new data show that Empaveli sustainably reduced protein excretion in the urine over a period of 76 weeks and stabilised kidney function. The long-term safety profile also remained consistent.

The recent expansion of the US approval is particularly important. Empaveli can now be used in patients aged 12 and over not only to reduce proteinuria, but also to reduce kidney function loss.

Biogen is also working on further therapies for immune-mediated kidney diseases. The antibody felzartamab is already being investigated in three Phase III trials. Initial data from the programme targeting antibody-mediated rejection following kidney transplants are expected in the first half of 2027.

Conclusion

This gives Biogen access to additional markets for highly specialised biological medicines. Successful therapies can be commercially attractive, particularly for rare diseases with few treatment options. BioNTech aims to lay the foundations for its next growth phase with new cancer drugs. Biogen is expanding its business with innovative therapies for rare kidney diseases. With FYB206, Formycon is targeting a drug market whose originator product generates annual sales of more than USD 30 billion. The accepted FDA submission and the latest price target increase provide new arguments in favour of the share.

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