Halozyme: Bristol Myers receives positive CHMP opinion for Opdivo/Enhanze

Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, recommending approval of a new Opdivo subcutaneous formulation developed with Enhanze, Halozyme’s proprietary recombinant human hyaluronidase enzyme, across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union. A decision on the European extension of marketing authorization for the subcutaneous formulation of Opdivo is expected by June 2, 2025.