Company Product Description Indication Status
Amgen Inc., of Thousand Oaks, Calif. Riabni (rituximab-arrx) B-lymphocyte antigen CD20 inhibitor; biosimilar Non-Hodgkin lymphoma; chronic lymphocytic leukemia; Wegener granulomatosis; microscopic polyangiitis FDA approved for the treatment of adults with NHL, CLL, WG, and MPA; will be made available in the U.S. in January 2021
Antengene Ltd., of Shanghai ATG-010 (selinexor) Selective inhibitor of nuclear export Relapsed/refractory multiple myeloma China's NMPA accepted the IND for a 150-patient phase III study testing selinexor in combination with bortezomib and dexamethasone
Astrazeneca plc, of Cambridge, U.K. Tagrisso (osimertinib) Protein tyrosine kinase inhibitor; epidermal growth factor receptor antagonist Non-small-cell lung cancer FDA approved for adjuvant therapy after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations; review was conducted under Project Orbis
Canbridge Pharmaceuticals Inc., of Beijing and Cambridge, Mass. CAN-106 Recombinant human MAb targeting complement C5 Paroxysmal nocturnal hemoglobinuria IND approved by Health Sciences Authority in Singapore
Fibrogen Inc., of San Francisco Roxadustat Oral, small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor Anemia of chronic kidney disease FDA extended the review period of the NDA; the updated PDUFA action date is 3-20-21
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Exportin 1 inhibitor Multiple myeloma (MM) FDA approved for use in combination with bortezomib and dexamethasone for second line treatment of adults with MM
Novaremed AG, of Basel, Switzerland NRD135S.E1 Blk tyrosine kinase stimulator; Lyn tyrosine kinase stimulator Pain; diabetic peripheral neuropathy FDA granted fast track status for treatment of painful diabetic peripheral neuropathy
Novartis AG, of Basel, Switzerland Inclisiran (KJX-839)  siRNA targeting PCSK9  Hyperlipidemia in adults with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia FDA issued a complete response letter citing unresolved facility inspection-related conditions; those conditions will be conveyed to the European manufacturing facility within 10 business days from 12-18-20; the third-party facility is responsible for drug  manufacturing and satisfactory resolution of the unresolved inspection-related conditions is required before the NDA may be approved; no onsite inspection was conducted but if one is needed, the FDA will define an approach for scheduling once safe travel may resume 
Novo Nordisk A/S, of Bagsvaerd, Denmark Semaglutide Glucagon-like peptide-1 analog Chronic weight management Submitted MAA to EMA; potential indication is for the treatment of adults with obesity or overweight with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity
Oyster Point Pharma Inc., of Princeton, N.J. OC-01 (varenicline) Nasal formulation of varenicline Xerophthalmia Submitted a 505(b)(2) NDA to FDA
Polaryx Therapeutics Inc., of Paramus, N.J. PLX-300 Small molecule that activates PPARα Niemann Pick Disease Types A and B FDA granted both rare pediatric disease and orphan drug designations, following similar grants for candidate in GM2 gangliosidosis
Synairgen plc, of Southampton, U.K. SNG-001 Interferon beta ligand  COVID-19 infection Following discussions with the regulatory agencies, amended trial to remove lower dose arm, add second primary endpoint and assessments for long COVID-19 symptoms

Notes

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