Company Product Description Indication Status
Adverum Biotechnologies Inc., of Redwood City, Calif. ADVM-022 VEGF gene inhibitor Wet age-related macular degeneration Gained alignment with FDA on the clinical development path and plans to initiate 2 global phase III trials to support an anticipated BLA submission in 2024
Argenx SE, of Breda, the Netherlands Efgartigimod Antibody fragment targeting neonatal Fc receptor Generalized myasthenia gravis FDA accepted for review the BLA, with a PDUFA date of Dec. 17, 2021
Beigene Ltd., of Beijing Brukinsa (zanubrutinib) BTK inhibitor Waldenström's macroglobulinemia Health Canada approved it
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. Orladeyo (berotralstat) Plasma kallikrein inhibitor Prevention of recurrent hereditary angioedema attacks Submitted an MAA to the U.K.'s MHRA
Biogen, of Cambridge, Mass. Aducanumab Monoclonal antibody targeting amyloid beta Alzheimer’s disease Submitted for regulatory assessment in Brazil
Eisai Co. Ltd., of Tokyo Dayvigo (lemborexant) Binds to orexin receptors OX1R and OX2R Insomnia Subsidiary Eisai (Hong Kong) Co. Ltd. obtained approval in Hong Kong
Eyenovia Inc., of New York Mydcombi Fixed combination mydriatic (pupil dilation) agent Ocular therapeutic for use in eye exams FDA accepted the NDA
Fibrogen Inc., of San Francisco, and Astrazeneca plc, of Cambridge, U.K. Roxadustat Oral, small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor Anemia of chronic kidney disease FDA will hold an adcom meeting to review the NDA, but company has not received a confirmed meeting date; the news means the previously announced March 20, 2021, PDUFA date will not be met
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 antibody Metastatic small-cell lung cancer The company is voluntarily withdrawing the U.S. indication, in consultation with FDA; accelerated approval was granted in June 2019, with continued approval contingent upon completion of the postmarketing requirement establishing superiority determined by overall survival (OS); the confirmatory phase III trial met 1 of its dual primary endpoints of progression-free survival but did not reach statistical significance for the other primary endpoint of OS; the decision does not affect other indications
Molecular Targeting Technologies Inc., of West Chester, Pa. Ebtate (177Lu-dota-ebtate) Targets somatostatin receptors Neuroendocrine tumors FDA approved the IND application
Oyster Point Pharma Inc., of Princeton, N.J. OC-01 (varenicline) nasal spray Nicotinic acetylcholine receptor agonist Dry eye disease FDA accepted for filing the NDA, with a PDUFA date of Oct. 17, 2021
Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Approved for use in Slovakia
Sorrento Therapeutics Inc., of San Diego STI-6643 Anti-CD47 monoclonal antibody Selected relapsed or refractory malignancies FDA cleared it for an initial clinical trial
Strongbridge Biopharma plc, of Dublin Recorlev (levoketoconazole) Cortisol synthesis inhibitor Cushing's syndrome Submitted an NDA to FDA

Notes

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