Company Product Description Indication Status
Aligos Therapeutics Inc., of South San Francisco ALG-010133 Oligonucleotide S-antigen transport inhibiting oligonucleotide polymer Chronic hepatitis B Submitted clinical trial application for phase Ia/b study
Beigene Ltd., of Beijing, China Brukinsa (zanubrutinib) BTK inhibitor Waldenström’s macroglobulinemia EMA accepted the MAA
Cynata Therapeutics Ltd., of Melbourne, Australia CYP-004  Mesenchymal stem cells Osteoarthritis Therapeutic Goods Administration advised the company that the study can be conducted under the Clinical Trial Notification scheme
Dicerna Pharmaceuticals Inc., of Lexington, Mass. Nedosiran RNAi targeting lactate dehydrogenase Primary hyperoxaluria FDA granted rare pediatric disease designation
Epizyme Inc., of Cambridge, Mass. Tazverik (tazemetostat) Methyltransferase inhibitor Follicular lymphoma FDA approved supplemental NDA expanding use for adults with relapsed or refractory FL whose tumors are positive for EZH2 mutation as detected by FDA-approved test and who have received at least 2 prior systemic therapies; and for adults with relapsed or refractory FL who have no satisfactory alternative treatment options; accelerated approvals may be contingent upon data from confirmatory trials
Hutchison China Meditech Ltd., of London Fruquintinib Inhibits vascular endothelial growth factor receptor 1/2/3 Metastatic colorectal cancer FDA granted fast track designation for the drug as a treatment after fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy
Linnaeus Therapeutics Inc., of Haddonfield, N.J. LNS-8801 Agonist of GPER Metastatic or unresectable melanoma who have progressed on or after anti-PD-1/L1 therapy FDA granted fast track designation
Pear Therapeutics Inc., of Boston Reset Prescription digital therapeutic Substance use disorder Health Science Authority of Singapore authorized the treatment
Protagonist Therapeutics Inc., of Newark, Calif. PTG-300 Synthetic peptide mimetic of hepcidin Polycythemia vera FDA granted orphan drug designation
TFF Pharmaceuticals Inc., of Austin, Texas Tacrolimus inhalation powder Immunosuppressant Prophylaxis of lung allograft rejection FDA granted orphan drug designation
Ultragenyx Pharmaceutical Inc., of Novato, Calif., and Kyowa Kirin Co. Ltd., of Tokyo Crysvita (burosumab) Recombinant fully human monoclonal IgG1 antibody against FGF23 FGF23-related hypophosphatemia in tumor-induced osteomalacia  FDA approved for use in TIO associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 and older


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

No Comments