UniQure restates FDA's negative feedback on Huntington's trial; Neurimmune's expanded AstraZeneca alliance

UniQure Restates FDA's Negative Feedback on Huntington's Trial

UniQure has reiterated the FDA's previously communicated negative feedback regarding its clinical trial for Huntington's disease. The regulatory agency expressed concerns about the trial's design and endpoints, which could impact the trial's progression and ultimate approval prospects.

Neurimmune Expands Alliance with AstraZeneca

Neurimmune has broadened its collaboration with AstraZeneca, strengthening their partnership. This expanded alliance aims to accelerate the development of therapeutic antibodies targeting diseases with high unmet medical needs.

Other Industry Updates

Pliant Therapeutics: Announced recent advancements in their fibrosis-focused pipeline.
Replicate Bioscience: Reported progress in cell therapy approaches.
Denali Therapeutics: Continued to advance programs in neurodegenerative diseases.
Laigo Bio: Moving forward with their oncology pipeline.
Auxilius Pharma: Highlighted developments in their drug delivery technologies.

"UniQure's reaffirmation of the FDA's concerns underscores the challenges of developing effective treatments for Huntington's disease," an industry analyst noted.

This news highlights persistent regulatory hurdles in Huntington's therapy development, while partnerships like Neurimmune and AstraZeneca's aim to boost innovation in antibody therapeutics.

Endpoints News — 2025-12-04