More than 100 biopharma executives and experts told Scrip their predictions for therapeutic area advances in the coming year. The recent commercial success of GLP-1s in diabetes and obesity and their potential in further disease areas fuelled excitement around the metabolic space. Expectations were also positive in neurology following the launch of Leqembi for Alzheimer’s disease in 2023, while the multiple opportunities to improve cancer treatment kept oncology top of the pile overall.

FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.

The US firm’s lead oligonucleotide asset, ENTR-601-44, has received a clinical hold notice after IND submission, adding to a growing list of companies in the Duchenne space facing setbacks.

Entrada gets $250m cash and equity up front under four-year deal, which extends its runway and will enable it to focus on Duchenne muscular dystrophy. Vertex further diversifies its pipeline with a novel drug class.