Ionis will seek US and EU approvals to treat familial chylomicronemia syndrome in the first half of 2024. Phase III data in the larger severe hypertriglyceridemia indication are due in late 2024 or early 2025.

Biotech has always been a volatile sector, and it is important for investors to recognize the phases its stocks go through. In particular, the journey through the post-bubble wilderness can be a protracted affair.

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.

Public Company Edition: Neumora grossed $250m and RayzeBio raised $311m in the first initial public offerings since early August. Also, ImmunityBio completes $470m in equity and debt financings, Bausch + Lomb sells $1.4bn worth of notes and Arbutus is among firms making cuts to conserve cash.