Fibrobiologics Inc. has filed an IND application with the FDA seeking to begin first-in-human trials of CYPS-317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis.

Enveda has obtained IND clearance from the FDA and initiated a phase I trial of ENV-6946, a first-in-class oral small molecule for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.

Enveda has obtained IND clearance from the FDA and commenced dosing in a phase I study of ENV-308, a once-daily oral therapy designed for chronic weight management.

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.

ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a U.S. phase I study.

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.

Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.