Curasight A/S has received clinical trial approval from the EMA for phase I evaluation of Utreat as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. The trial will enroll participants with newly diagnosed verified or suspected glioblastoma, and dosing is expected to commence in the fourth quarter of this year.

On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.

Shattuck Labs Inc. has reported that its IND from the U.S. FDA for SL-325 for the treatment of inflammatory bowel disease is now in effect. The company expects to commence a phase I trial in healthy volunteers in the third quarter of this year.

South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.

Vasthera Co. Ltd. has received IND clearance from the U.S. FDA, enabling it to initiate a phase I trial for VTB-10 for pulmonary arterial hypertension (PAH). Vasthera identified a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions and used its Redoxizyme platform to develop VTB-10, a small-molecule enzyme that precisely replicates PRX function.

Opus Genetics Inc. has obtained IND clearance from the U.S. FDA application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1 (BEST1)-related inherited retinal disease (IRD).

Hangzhou Qihan Biotech Co. Ltd. has gained IND approval by the FDA for QT-019B, a universal, dual-target CAR T-cell therapy for refractory systemic lupus erythematosus (SLE). A phase I/II trial will be conducted in the U.S.

Evolveimmune Therapeutics Inc. has gained IND clearance from the U.S. FDA for EVOLVE-104, a novel trispecific T-cell engager for the treatment of solid tumors. The company will begin a phase I trial this year.

K36 Therapeutics Inc. has obtained IND clearance from the U.S. FDA for KTX-2001, a selective, oral, small-molecule inhibitor of nuclear receptor-binding SET domain protein 2 (NSD2), a histone methyltransferase and oncogene that activates gene expression in some cancers.

Proteinqure Inc. has received regulatory clearances from the U.FDA and Health Canada to initiate a phase I trial of lead candidate, PQ-203. The trial will begin in Canada and expand to U.S. sites later in 2025. The FDA also granted PQ-203 fast track designation for triple-negative breast cancer (TNBC).