Pipeline

September 30, 2019
Company Drug/Device Medical Condition Status
BioLineRx Ltd. AGI-134 solid tumors Phase 1/2a trial initiated enrolling subjects at 15 sites in the U.S., U.K. and Israel
Neuralstem Inc. NSI-566 chronic ischemic stroke Phase 2 trial initiated enrolling 22 subjects with sustained chronic motor deficits due to an ischemic stroke
Oragenics, Inc. AG013 severe oral mucositis Phase 2 trial initiated enrolling 200 subjects at 59 sites in the U.S. and Europe
ImaginAB, Inc. 89Zr-Df-IAB22M2C cancer Phase 2 trial initiated enrolling subjects with advanced and metastatic cancer at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham
Oncopeptides AB melflufen in combination with dexamethasone relapsed/refractory multiple myeloma (RRMM) Phase 2 trial initiated enrolling 150 subjects
Rigel Pharmaceuticals, Inc.
 Kissei Pharmaceuticals Co., Ltd.		 fostamatinib disodium hexahydrate chronic immune thrombocytopenia (ITP) Phase 3 study initiated enrolling adult subjects with ITP
Protalix BioTherapeutics, Inc.
Chiesi Farmaceutici S.p.A.		 PRX 102 (pegunigalsidase alfa) Fabry disease with impaired renal function Phase 3 trial initiated enrolling subjects previously treated with an enzyme replacement therapy: agalsidase alfa or agalsidase beta
Ocular Therapeutix, Inc. DEXTENZA allergic conjunctivitis (AC) Phase 3 trial initiated enrolling 80 subjects
Annexon Biosciences ANX005 Guillain-Barré Syndrome (GBS) Fast Track approval granted by the FDA
Merck & Company PIFELTRO (in combination with other antiretroviral agents) HIV-1 in adult subjects who are virologically suppressed sNDA approval granted by the FDA
Merck & Company DELSTRIGO HIV-1 in adult subjects who are virologically suppressed sNDA approval granted by the FDA
Abiomed Impella 5.5 with SmartAssist minimally invasive forward flow heart pump residual myocardial function PMA approval granted by the FDA
Novo Nordisk Rybelsus (semaglutide) oral tablets type 2 diabetes Approval granted by the FDA
Exact Sciences Corp. Cologuard noninvasive colorectal cancer screening test for subjects ages 45 and older Approval granted by the FDA
Bavarian Nordic A/S Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating smallpox and monkeypox disease in adults 18 years of age and older Approval granted by the FDA

 

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