Novartis has announced positive topline results from its phase 3 REMODEL-1/-2 trials of remibrutinib in relapsing multiple sclerosis (RMS). Remibrutinib, a highly selective and potent oral Bruton’s tyrosine kinase (BTK) inhibitor, demonstrated superiority versus teriflunomide in reducing annualised relapse rate (ARR) and inflammatory brain lesions with a favourable safety profile.

MS is a chronic inflammatory disease of the central nervous system characterised by myelin destruction and axonal damage in the brain, optic nerves and spinal cord. Affecting nearly three million people worldwide, it can be characterised into three main types: non-active secondary progressive (SPMS), primary progressive (PPMS) and RMS.

RMS is the most common form and includes clinically isolated syndrome (CIS), relapsing-remitting (RRMS) and active SPMS. The various forms of MS are distinguished by how the disease presents and progresses, including whether patients experience relapses, worsening disability over time or a combination of both.

The results of the REMODEL trials establish remibrutinib as a BTK inhibitor that achieved significant reductions in annualised relapse rate across two phase 3 trials in adults with relapsing multiple sclerosis (RMS).

Aravax has received Fast Track designation from the US FDA for PVX108, an investigational immunotherapy for the treatment of peanut allergy. The company is focused on revolutionising the treatment of food allergies with next-generation, disease-modifying immunotherapies and is also developing a broader pipeline of peptide-based immunotherapies targeting additional food allergies.

PVX108 is a peptide-based immunotherapy designed to retrain the immune system to tolerate peanut proteins while minimising the risk of treatment-induced acute allergic reactions. The therapy is currently being evaluated in an international phase 2 clinical trial involving sites in the US and Australia, with topline data expected later this year.

PVX108 is a next-generation immunotherapy that uses proprietary peptides designed to precisely retrain the immune system to tolerate peanuts while avoiding treatment-induced acute allergic reactions. Phase 2 studies of PVX108 are ongoing at clinics in the US and Australia with key data anticipated to be reported later in 2026.

People with a peanut allergy face a lifelong risk of severe allergic reactions, including anaphylaxis, and treatment options remain limited. Current management largely relies on strict allergen avoidance and emergency treatment of accidental exposures.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the DESTINY-Breast09 phase 3 trial.

In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus ataxane, trastuzumab and pertuzumab (THP) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease.

Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP.
Following this approval in the EU, Daiichi Sankyo is due to received a milestone payment of $100m from AstraZeneca for the first-line unresectable or metastatic HER2-positive breast cancer indication.