Innocare Pharma Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of the B7-H3 targeted antibody-drug conjugate.

Brightpath Biotherapeutics Co. Ltd.’s iPS cell-derived BCMA CAR-natural killer T cell therapy candidate has been awarded orphan drug designation by the FDA for the treatment of multiple myeloma.

GLIX-1 is a first-in-class small-molecule therapeutic targeting DNA repair vulnerabilities in cancer cells.

The U.S. FDA has cleared Rocket Pharmaceuticals Inc.’s IND application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated dilated cardiomyopathy (BAG3-DCM), a severe form of heart failure.

Archeus Technologies Inc. has obtained IND clearance from the FDA for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.

Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.

Medicovestor Inc.’s Adobind MC-001 has been awarded orphan drug designation by the FDA for the treatment of pancreatic cancer. Adobind MC-001 is a chemoimmunotherapy antibody-drug conjugate that integrates proprietary enhancements to antibody structure, payload delivery and tumor engagement.

MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.

Myrio Therapeutics Pty Ltd. is set to advance lead product PHOX2B PC-CAR T (PHOX2B peptide-centric chimeric antigen receptor autologous T cells) into clinical trials for relapsed neuroblastoma following IND clearance by the FDA. The first patient will be enrolled around mid-year.