Company Product Description Indication Status
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.

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