Shanghai Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-GIP001, its iPSC-derived allogeneic cell therapy for focal epilepsy. A phase I study will evaluate UX-GIP001 in patients with drug-resistant epilepsy.
Rapport Therapeutics Inc. added $20 million to its cash runway for its lead phase III oral seizure drug, RAP-219, through a potential $328 million license deal signed with Tenacia Biotechnology Co. Ltd.
Great Novel Therapeutics Biotech & Medicals Corp.’s epigenetic immunoactivator, GNTbm-38, has received IND clearance from the FDA, enabling initiation of a phase I trial in the U.S.
Kestrel Therapeutics Inc. has obtained IND approval from the FDA for KST-6051, an oral, small-molecule pan-KRAS inhibitor being developed for the treatment of KRAS-driven cancers.
Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing a potential $1.1 billion deal to license Antengene Corp.’s ATG-201. ATG-201 is a CD19/CD3 bispecific TCE antibody aimed at autoimmune disorders, though specific indications were not disclosed.
In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
Sanaregen Vision Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of SVT-001, an investigational cell therapy for individuals with familial drusen.
In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
CSPC Pharmaceutical Group Ltd. has obtained IND approval from the FDA for SYH-2082 injection, a GLP-1/GIP receptor dual-biased agonist polypeptide long-acting injection for weight management for individuals with obesity or overweight and at least one weight-related comorbidity.
Viking Therapeutics Inc. said after-market hours Feb. 11 that it plans to advance its oral dual GLP-1/GIP receptor, VK-2735, into a phase III trial for obesity in the third quarter of 2026. VK-2735 is a novel dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist.
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