Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.