Cartography Biosciences Inc. has received IND approval from the FDA for CBI-1214, a T-cell engager being developed for the treatment of colorectal cancer.

Viatris Inc. has announced FDA clearance of its IND application for MR-146, an Enriched Tear Film (ETF) AAV gene therapy candidate for the treatment of neurotrophic keratopathy. The company plans to initiate a phase I/II trial in patients with neurotrophic keratopathy in the first half of next year.

Recludix Pharma Inc. has obtained IND clearance from the FDA to advance REX-8756 (SAR-448755), an oral STAT6 inhibitor for inflammatory diseases, into phase I testing. REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain.

Immusoft of CA Inc., a wholly owned subsidiary of Immusoft Corp., has announced that the FDA has granted orphan drug designation to ISP-002, the company’s investigational engineered B-cell therapy for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.

Abpro Holdings Inc. and Celltrion Inc. have announced the submission of an IND application to the FDA for ABP-102 (CT-P72), a HER2 x CD3 T-cell engager. Pending clearance, a phase I trial in patients with HER2-positive cancers, including breast and gastric cancers, is anticipated to begin in the first half of next year.

Pilatus Biosciences Inc. has obtained IND clearance from the FDA for PLT-012, a first-in-class anti-CD36 monoclonal antibody, for the treatment of solid tumors. Pilatus plans to initiate a first-in-human phase I trial with this metabolic checkpoint antibody in the first quarter of next year.

CSPC Pharmaceutical Group Ltd. has obtained IND clearance from the FDA to conduct clinical trials in the U.S. with SYH-2069 for weight management in individuals with obesity or overweight and at least one weight-related comorbidity.

On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.”