Company Product Description Indication Status
Ascentage Pharma Group International, of Suzhou, China APG-115  MDM2-p53 inhibitor  Gastric cancer FDA granted orphan drug designation
Cycle Pharmaceuticals Ltd., of Boston Nityr (nitisinone) Inhibits catabolism of tyrosine Hereditary tyrosinemia type 1 FDA approved once-daily dosing of the drug
Essa Pharmaceuticals Inc., of Houston EPI-7386  N-terminal domain inhibitor of the androgen receptor Metastatic castration-resistant prostate cancer resistant to standard-of-care treatment FDA granted fast track designation
Gan & Lee Pharmaceuticals Co. Ltd., of Beijing GLR-2007 Cyclin-dependent kinase 4/6 inhibitor Malignant glioma FDA granted orphan drug designation
Gannex Pharma Co. Ltd., of Shanghai ASC-42 Farnesoid X receptor agonist Nonalcoholic steatohepatitis Filed an IND with the FDA
Kiadis Pharma NV, of Amsterdam K-NK-ID101  Kiadis-NK cells Post-exposure pre-emptive therapy for COVID-19 FDA approved the IND
Mateon Therapeutics Inc., of Agoura Hills, Calif. Artemisinin  Inhibits TGF-beta COVID-19 Protocol for study cleared for patient enrollment in India
Novartis AG, of Basel, Switzerland Beovu (brolucizumab)  Antibody fragment targeting VEGF-A Age-related macular degeneration EMA's Committee for Medicinal Products for Human Use approved an update to the summary of product characteristics to include additional information regarding retinal vasculitis and retinal vascular occlusion
Pharmacyte Biotech Inc., of Laguna Hills, Calif. Cypcaps Genetically engineered human cells encapsulated using the Cell-in-a-Box technology  Locally advanced, inoperable pancreatic cancer Completed 6-month stability testing required by the FDA
Reven Holdings Inc., of Golden, Colo. Rejuveinix  Anti-inflammatory/antioxidant COVID-19 Received positive feedback from the FDA on its pre-IND submission
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Dupixent (dupilumab) Monoclonal antibody targeting interleukin-4 Eosinophilic esophagitis FDA granted breakthrough designation
Seneca Therapeutics Inc., of Philadelphia SVV-001 Naturally occurring Seneca Valley virus active against cancer cells Neuroendocrine cancer Received positive feedback from the FDA on the reactivation of the IND; plans to start a phase I/II study in the second quarter of 2021
SK Biopharmaceuticals Co. Ltd., of Pangyo, Korea Cenobamate  Inhibits voltage-gated sodium currents Partial-onset seizures in adults Korean Ministry of Food and Drug Safety accepted the IND for a phase III study
Supernus Pharmaceuticals Inc., of Rockville, Md. Apomorphine infusion pump (SPN-830)  Dopamine agonist  Parkinson’s disease Submitted NDA to the FDA
Vaxart Inc., of South San Francisco COVID-19 vaccine Oral vaccine COVID-19 prophylaxis FDA cleared the IND for a phase I study
Vertex Pharmaceuticals Inc., of Boston Trikafta (ivacaftor/tezacaftor/elexacaftor) CFTR modulator/stimulator  Cystic fibrosis  FDA issued a rare pediatric disease product priority review voucher
Vertex Pharmaceuticals Inc., of Boston Trikafta (ivacaftor/tezacaftor/elexacaftor) CFTR modulator/stimulator  Cystic fibrosis  EMA validated the type II variation marketing authorization for patients 12 and older with at least 1 copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene
Ziopharm Oncology Inc., of Boston Ad-RTS-hIL-12 with veledimex  Controlled IL-12 Diffuse intrinsic pontine glioma FDA granted rare pediatric disease designation

Notes

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