Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.

Restructuring Edition: Impel eliminated R&D spending earlier this year to focus on Trudhesa commercialization, but is examining all options, including bankruptcy, as its funding runs out. Also, Alaunos, BioXcel and others announce job cuts and strategic shifts during second quarter updates.

Valneva is sticking by its forecast of getting US approval, and getting hold of a lucrative priority review voucher before the end of the year, despite the Food and Drug Administration needing more time to evaluate the French vaccine specialist’s single shot for chikungunya.

Bavarian Nordic is planning regulatory submissions on both sides of the Atlantic next year for its vaccine against chikungunya virus, CHIKV VLP, after it demonstrated protection from the mosquito-borne disease in a second Phase III study.