Company Product Description Indication Status
AB Science SA, of Paris Masitinib Tyrosine kinase inhibitor that targets mast cells and macrophages Amyotrophic lateral sclerosis FDA cleared the IND for a phase III study (AB19001); company aims to initiate study as soon as conditions in U.S. clinical sites stabilize post-COVID-19 pandemic
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat  Allosteric activator of wild-type and a variety of mutated pyruvate kinase-R enzymes Pyruvate kinase deficiency EMA granted orphan drug designation
Astrazeneca plc, of Cambridge, U.K. Lokelma (sodium zirconium cyclosilicate) Binds potassium Hyperkalemia on stable hemodialysis EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on a dosing and administration label update
Bristol Myers Squibb Co., of New York, and Bluebird Bio Inc., of Cambridge, Mass. Idecabtagene vicleucel (bb-2121) CAR T targeting B-cell maturation antigen Multiple myeloma Submitted a BLA to the FDA
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) Monoclonal antibody targeting CCR5 COVID-19 FDA cleared the start of a phase II study in patients with mild to moderate indications
Essa Pharmaceuticals Inc., of Vancouver, British Columbia EPI-7386 Inhibits the N-terminal domain of the androgen receptor Metastatic castration-resistant prostate cancer Submitted an IND to the FDA for a phase I study
GW Pharmaceuticals plc, of Carlsbad, Calif. Epidiolex Cannabidiol Tuberous sclerosis complex FDA accepted the supplemental NDA with a priority review; PDUFA date of July 21, 2020
Intellia Therapeutics Inc., of Cambridge, Mass., and Novartis AG, of Basel, Switzerland OTQ-923  CRISPR/Cas9 expressing fetal hemoglobin Sickle cell disease FDA accepted the IND for a phase I/II study
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, Adcetris (brentuximab vedotin) Antibody-drug conjugate targeting CD30 Previously untreated systemic anaplastic large-cell lymphoma EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the extension of the marketing authorization in combination with cyclophosphamide, doxorubicin and prednisone
Zealand Pharma A/S, of Copenhagen Dasiglucagon Hypopal Rescue Pen Glucagon analogue  Hypoglycemia in patients with diabetes Submitted an NDA to the FDA

Notes

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

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