Novartis (NYSE: NVS) said that its ligelizumab antibody treatment against recurring hives did not meet the goal of superiority to standard treatment Xolair (omalizumab) in a late-stage study.
Novartis' PEARL 1 and PEARL 2 Phase 3 studies met the goal for ligelizumab to show higher efficacy against chronic spontaneous urticaria (CSU) compared to placebo at week 12, but not compared to omalizumab.
CSU is a systemic skin disease characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema, or both for at least six weeks.
"We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU," said Chief Medical Officer John Tsai.
Full PEARL 1 and 2 Phase 3 data will be made publicly available after study completion in 2H of 2022.
Novartis recently began Phase 3 studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that previously showed rapid and effective CSU disease control.
Novartis was in the news last week as the company announced plans to initiate up to $15B share buyback by the end of 2023. The buyback is funded through the proceeds from the recent sale of 53.3 million Roche bearer shares. The share buyback will be executed on the second trading line, is expected to commence in the coming days and to conclude by the end of 2023.
NVS shares are down 82 cents to $85.38 early Monday.
