Plus, news about Valar Labs, Pharming Group and Day One Pharmaceuticals:
Novartis outlines one-year data for BTK inhibitor: The drug, called remibrutinib, demonstrated symptom improvements up to one year in a pair of Phase 3 studies for chronic spontaneous urticaria. The measures include improvements in disease activity, itch severity and hive severity. “We see about 50% of patients having no itch anymore,” Novartis immunology development chief Angelika Jahreis told Endpoints News. “That is quite impressive, because about 60% of the patients that start in the trial have severe disease.” — Max Gelman
Astellas resubmits BLA for cancer drug: The FDA is now due to make a decision on zolbetuximab for certain first-line gastric or gastroesophageal junction adenocarcinoma patients by Nov. 9. Astellas was handed a CRL in January after the regulator highlighted problems at a third-party manufacturing site. — Ayisha Sharma
Valar Labs bags $22M Series A for AI diagnostic: The Palo Alto, CA-based biotech plans to use the funds to advance its first AI diagnostic test designed to predict treatment responses in first-line bladder cancer. The fundraise was led by DCVC and Andreessen Horowitz, with support from Pear VC. — Ayisha Sharma
EU delays decision on Pharming’s rare disease drug: The EMA’s Committee for Medicinal Products for Human Use requested more information about manufacturing leniolisib, including details on starting materials. Pharming is seeking approval for leniolisib for activated phosphoinositide 3-kinase delta syndrome. It said it has already started to work on providing the requested manufacturing procedures, which are due by January 2026. — Anna Brown
Day One sells priority review voucher for $108M: The company received the voucher after getting accelerated approval for Ojemda, its pediatric brain tumor treatment. It did not disclose the name of the buyer. Day One also said it’s paying $8.1 million to Viracta Therapeutics, with which it has a licensing agreement. — Jaimy Lee