AI-generated from publicly available materials.This week in European biotech, Novartis has halted its Alzheimer’s program, Windward Bio is pursuing an IPO, and GSK has received FDA approval for a new hepatitis B treatment.
Novartis has decided to discontinue its Phase 2 clinical trial for lifonebart (VHB937), an antibody targeting TREM2, which is crucial for brain immune regulation. This decision follows a review of biomarker data by a monitoring committee, although specific findings have not been disclosed. This marks another challenge for Novartis, which recently faced setbacks in other trials, including an ALS program.
Windward Bio, based in Basel, is aiming for a Nasdaq listing to support its antibody trials focused on respiratory and inflammatory diseases, including severe asthma and eczema. The company has not yet revealed details regarding the share count or pricing for its IPO. Windward has raised approximately $365 million since its inception, building a robust clinical pipeline primarily through external innovations.
In regulatory news, GSK's bepirovirsen has gained FDA approval for use in adults with chronic hepatitis B without cirrhosis, offering a new treatment avenue alongside existing antivirals. Notably, 19% of patients maintained viral control after ceasing treatment, although the drug carries significant warnings regarding liver health. Additionally, Idorsia is exploring the use of its insomnia medication, daridorexant, in autism spectrum disorder, inspired by promising preliminary results from a pediatric study.
These developments underscore the dynamic nature of the biotech sector, highlighting both the challenges and opportunities present in drug development. The push for innovative treatments continues, as companies like Windward and Idorsia explore new therapeutic avenues while established firms like GSK navigate regulatory landscapes to bring new solutions to market.