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
Gilead Sciences Inc has decided to turn a successful collaboration into ownership with an agreement to buy Arcellx Inc, a developer of cell therapies. The offer is for $115 per share in cash and one contingent value right of $5 per share which represents an implied equity value of $7.8 billion payable at the close. The two companies have been collaborating since 2022 on a chimeric antigen receptor (CAR) T cell therapy for patients with multiple myeloma.
Regulatory activity is underway to bring a new treatment for patients with thymidine kinase 2 deficiency (TK2d) to the European market, an ultra-rare disease that is characterised by progressive and severe muscle weakness. On 30 January, the European Medicines Agency issued a positive opinion for the treatment, Kygevvi (doxecitine and doxribtimine). It is expected to be reviewed by the European Commission in the second quarter for a marketing authorisation decision.
France-based Abivax SA has disclosed evidence that obefazimod, its small molecule drug candidate for inflammatory bowel disease and the subsets Crohn’s disease and ulcerative colitis, has shown evidence of anti-fibrotic activity. This has been illustrated in both preclinical human fibroblast and in vivo animal models of the disease. The data were presented at the European Crohn’s and Colitis Organization’s 21st Annual Congress in Stockholm on 21 February.