|Agenus Inc., of Lexington, Mass.||Balstilimab||Anti-PD-1 antibody||Cervical cancer||FDA granted fast track designation|
|Alnylam Pharmaceuticals Inc., of Cambridge, Mass.||Lumasiran||Subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1||Primary hyperoxaluria type 1||Completed the rolling submission of an NDA to the FDA; also submitted an MAA to the EMA|
|Ascentage Pharma Group International, of Suzhou, China||APG-2575||Bcl-2 selective inhibitor||Relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma||The NMPA approved the start of the phase Ib/II study in China|
|Blaze Bioscience Inc., of Seattle||Tozuleristide (BLZ-100)||Targeting peptide and a fluorescent dye||Pediatric central nervous system tumors||FDA granted fast track designation|
|Immunomedics Inc., of Morris Plains, N.J.||Sacituzumab govitecan||Antibody-drug conjugate||Locally advanced or metastatic urothelial cancer||FDA granted fast track designation|
|Merck & Co. Inc., of Kenilworth, N.J.||Keytruda (pembrolizumab)||Monoclonal antibody targeting PD-1||Unresectable or metastatic solid tumors||Received priority review from the FDA for its sBLA; the FDA has set a PDUFA date of June 16, 2020|
For more information about individual companies and/or products, see Cortellis.