|Curevac NV, of Tübingen, Germany||CVnCoV||mRNA-based COVID-19 vaccine||COVID-19 prophylaxis||Initiated a rolling submission with the EMA|
|Immunitybio Inc., of Culver City, Calif., and Nantkwest Inc., of El Segundo, Calif.||hAD5 T-cell vaccine||Vaccine targeting outer spike protein and inner nucleocapsid protein||COVID-19 prophylaxis||Received FDA authorization to expand a phase I trial of the subcutaneous version; FDA also authorized a second phase I study to examine the addition of an oral boost to the subcutaneous prime administration; as a result, the companies will enroll another 105 participants in the U.S. trials|
|Lysogene SA, of Paris||LYS-GM101||Adeno-associated viral vector serotype rh.10 expressing beta-galactosidase||GM1 gangliosidosis||FDA cleared the IND application|
|Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y.||Evkeeza (evinacumab-dgnb)||Monoclonal antibody targeting angiopoietin-like 3||Homozygous familial hypercholesterolemia||FDA approved it as an adjunct to other low-density lipoprotein cholesterol lowering therapies to treat adult and pediatric patients 12 and older|
|Seagen Inc., of Bothell, Wash.||Tukysa (tucatinib)||HER2 tyrosine kinase inhibitor||Locally advanced or metastatic HER2-positive breast cancer||European Commission granted marketing authorization, in combination with trastuzumab and capecitabine, for the treatment of adult patients who have received at least 2 prior anti-HER2 treatment regimens|
|Xeris Pharmaceuticals Inc., of Chicago||Ogluo (glucagon) injection||Peptide hormone||Severe hypoglycemia in diabetes mellitus||European Commission approved it in all 27 EU countries, plus Iceland, Norway and Liechtenstein|
For more information about individual companies and/or products, see Cortellis.