News

Novartis is to pay $2 billion upfront and up to $1 billion in milestone payments for a US company with a therapy that has shown early, significant impact in treating breast cancer. The therapy, SNV4818, is a small molecule drug which entered clinical development in February 2025. It is currently being evaluated in a Phase 1/2 clinical study in patients with breast cancer and other solid tumours. The breast cancer indication was highlighted by Novartis in an announcement on 20 March because of the prevalence of cancers caused by mutations in the PIK3CA gene. 

R1 Therapeutics Inc of California, US, has made its market debut with $77.5 million in venture finance and an exclusive global license to develop and commercialise a new product for a disorder caused by chronic kidney disease. Announced on 17 March, the financing was co-led by Abingworth LLP of the UK, F-Prime Capital of Cambridge, US, and the US DaVita Venture Group.

Evotec SE expects to reduce its workforce by up to 800 people and close down more business sites in its drive to regain momentum following a two-year slowdown in the market for drug discovery and preclinical development. The Germany-based company is one of Europe’s larger biotech service and drug development organisations with a global presence in manufacturing. It is a Nasdaq-listed company which had a market capitalisation of €969 million on 31 December 2025.

Immunic Inc, a US-based biotech with a research arm in Germany, announced the awarding of a key patent by the European Patent Office on 10 March, strengthening its position ahead of the anticipated commercialisation of its lead product vidofludimus calcium (IMU-838) for multiple sclerosis. Vidofludimus is currently in Phase 3 with top line data expected at the end of 2026. If the data are positive, a regulatory review would follow.

Ugur Sahin and Özlem Türeci, co-founders of BioNTech SE, developer of the first vaccine to prevent Covid-19, are to embark on a new venture focused on exploring the therapeutic potential of messenger RNA. They will leave BioNTech, founded in 2008, in order to work on foundational science. For its part, BioNTech will concentrate on advancing a late clinical-stage pipeline of cancer therapies, “For us, this is the right time to prepare to hand over the baton,” said Dr Sahin in a statement issued on 10 March. “At the same time, Öziem and I are ready to become pioneers once again.”

The Roche Group announced on 9 March that one of five trials of a Phase 3 development programme for giredestrant, a small molecule drug for breast cancer, failed to demonstrate progression-free survival. The Phase 3 trial, persevERA, was being conducted globally in 992 patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Giredestrant was being tested as a first-line therapy in combination with palbociclip (Ibrance), an approved cyclin-dependent kinase (CDK) 4/6 inhibitor. 

Vinay Prasad, the chief medical and chief scientific officer at the US Food and Drug Administration and director of its biologics’ drug division, is to leave the FDA at the end of April. Dr Prasad’s departure was announced on 6 March by Marty Makary, the FDA Commissioner, and follows a period of disquiet within industry and patient advocacy groups about the way decisions have been made on new drug applications.

The gene therapy developer, uniQure NV, has asked for a second meeting with the US Food and Drug Administration to discuss the agency’s recommendation for further clinical development of its candidate therapy for Huntington’s disease AMT-130. The gene therapy is intended as a one-time treatment for Huntington’s, a rare neurodegenerative disorder. uniQure produced data from a Phase 1/2 trial in September 2025 which was intended as a pivotal study leading to a regulatory submission.

argenx SE delivered an operating profit of $1.1 billion for 2025 – its first ever annual operating profit. This was due to a near doubling of the company’s net sales even as large outlays were made for research and development. A continuous, high level of spending on R&D has enabled the company to expand the scope of a novel target for llama-derived antibodies for autoimmune diseases. The company’s main focus is neurology and the lead product is Vyvgart (efgartigimod), which has three approved indications.

The following article is a review of the 2025 earnings of a cohort of European companies and their expectations for 2026