Company Product Description Indication Status
Agenus Inc., of Lexington, Mass. AgenT-797 Allogeneic iNKT therapy Cancer FDA accepted IND; clinical study expected to start in second half of 2020
Arbor Pharmaceuticals LLC, of Atlanta AR-19 (amphetamine sulfate) Adrenergic receptor agonist Attention deficit hyperactivity disorder FDA accepted NDA filing, setting PDUFA date of Nov. 15, 2020
Ascletis Pharma Inc., of Hangzhou, China ASC-41 Thyroid hormone receptor beta agonist Nonalcoholic steatohepatitis China NMPA approved IND for phase I trial
Bristol Myers Squibb Co., of New York, and Bluebird Bio Inc., of Cambridge, Mass. Idecabtagene vicleucel (ide-cel; BB-2121) 
APRIL receptor modulator
Multiple myeloma FDA issued RTF on BLA, citing need for additional details on CMC module
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) Adrenergic receptor agonist HIV infection Remaining portions of BLA submitted to FDA for combination therapy with HAART
Dcprime BV, of Leiden, the Netherlands DCP-001 Allogeneic dendritic cell vaccine Acute myeloid leukemia FDA accepted IND application to expand ongoing phase II Advance-II trial into U.S. in individuals with disease who are ineligible for hematopoietic stem cell transplantation
Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland Carbetocin Ferring (heat-stable formulation) Oxytocin receptor agonist Uterine hemorrhage  Swissmedic approved drug under procedure for scientific advice and Marketing Authorization for Global Health Products to prevent excessive bleeding after childbirth
Novocure Ltd., of St. Helier, Jersey, U.K., and Zai Lab Ltd., of Shanghai Optune Device delivering tumor treating fields Glioblastoma China NMPA approved MAA in combination with temozolomide to treat newly diagnosed disease and as monotherapy to treat recurrent disease
Rhythm Pharmaceuticals Inc., of Boston Setmelanotide Melanocortin-4 receptor agonist Obesity FDA accepted NDA for treatment of pro-opiomelanocortin deficiency and leptin receptor deficiency obesity, granting priority review and setting Nov. 27, 2020, PDUFA date; no advisory committee meeting expected
Sunovion Pharmaceuticals Inc., of Marlborough, Mass. Dasotraline Dopamine/norepinephrine reuptake inhibitor Binge eating disorder/attention deficit hyperactivity disorder NDAs withdrawn on eve of May 14, 2020, PDUFA date; company halting program, citing presumed need for additional studies to support approval

Notes

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

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