Company Product Description Indication Status
Abeona Therapeutics Inc., of New York EB-101 COL7A1 gene stimulator Recessive dystrophic epidermolysis bullosa Type B meeting with FDA resulted in alignment with proposed co-primary endpoints for pivotal phase III Viital study, which are proportion of RDEB wound sites with >/= 50% healing from baseline vs. untreated wound sites and pain reduction associated with wound dressing change, both at week 24; trial expected to enroll 10 to 15 people with RDEB for treatment of about 35 large chronic wound sites
Albireo Pharma Inc., of Boston Odevixibat Ileal sodium bile acid cotransporter inhibitor Progressive familial intrahepatic cholestasis FDA accepted NDA filing to treat pruritus in PFIC, granting priority review and setting July 20, 2021, PDUFA date
Arrowhead Pharmaceuticals Inc., of Pasadena, Calif. ARO-ANG3 ANGPTL3 gene inhibitor Mixed dyslipidemia IND submitted to FDA for phase IIb dose-finding study
Astrazeneca plc, of Cambridge, U.K. Calquence (acalabrutinib) BTK inhibitor Chronic lymphocytic leukemia Japan's MHLW approved agent to treat adults with relapsed/refractory disease, including small lymphocytic lymphoma
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia Lupkynis (voclosporin) Calcineurin inhibitor Lupus nephritis FDA approved in combination with background immunosuppressive therapy to treat adults with active disease
EMD Serono, unit of Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York Bavencio (avelumab) PD-L1 inhibitor Urothelial carcinoma  European Commission approved as monotherapy for first-line maintenance in adults with locally advanced or metastatic disease who are progression-free following platinum-based chemotherapy
Eusa Pharma Ltd., of Hemel Hempstead, U.K., and Beigene Co. Ltd., of Beijing Sylvant (siltuximab) IL-6-neutralizing monoclonal antibody Castleman’s disease China's NMPA accepted BLA to treat adults with idiopathic multicentric disease, granting priority review
Iterum Therapeutics plc, of Dublin Sulopenem etzadroxil Penem beta-lactam antibiotic prodrug Urinary tract infection FDA accepted NDA to treat uncomplicated infections in people with quinolone non-susceptible pathogen, granting priority review and setting July 25, 2021, PDUFA date
Pfizer Inc., of New York Comirnaty (tozinameran) COVID-19 spike glycoprotein modulator COVID-19 infection Australia’s Therapeutic Goods Administration granted provisional approval
Shanghai Junshi Biosciences Co. Ltd., of Shanghai Toripalimab Anti-PD-1 monoclonal antibody Mucosal melanoma FDA granted fast track designation for first-line treatment and approved IND application for phase III trial of agent in combination with Inlyta (axitinib, Pfizer Inc.) vs. Keytruda (pembrolizumab, Merck & Co. Inc.) to treat first-line advanced disease
Waymade Australia Pty. Ltd., of Sydney Trientine dihydrochloride Copper chelating agent Wilson disease Australia's Therapeutic Goods Administration approved drug

Notes

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