Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s antibody-drug conjugate (ADC) ifinatamab deruxtecan produced a confirmed 48.2% objective response rate in a phase II study of previously treated patients with extensive-stage small-cell lung cancer.
Epigenic Therapeutics Co. Ltd. closed a $60 million series B round to support clinical development of lead gene therapy candidates EPI-003 for chronic hepatitis B virus and EPI-001 for hypercholesterolemia.
Results from the global phase III Harmoni trial presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer (WCLC) showed a statistically significant increase in progression-free survival after treatment with ivonescimab plus chemotherapy compared to chemotherapy alone, but failed to show a statistically significant benefit in overall survival (OS).
Robust efficacy, competitive tolerability and ease of administration. Those are the qualities for a potential blockbuster antiseizure medication, according to Abe Ceesay, CEO of Rapport Therapeutics Inc., which reported a successful phase IIa trial testing RAP-219 in patients with drug-resistant focal onset seizures and aims to move into a large-scale phase III program in 2026.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Agios, Aquestive, Arcutis, Boehringer Ingelheim, Eli Lilly, Pulmovant, Sol-Gel.