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September 30, 2019
|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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