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New Pipeline Updates from NeuClone, Diamyd Medical and SurgiMab

October 21, 2019

Company Drug/Device Medical Condition Status
NeuClone NeuLara plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis Phase 1 trial initiated enrolling 200 healthy subjects
Alder BioPharmaceuticals, Inc. ALD1910 Migraine Phase 1 trial initiated enrolling 100 healthy subjects between the ages of 18 and 55
Amphivena Therapeutics, Inc. AMV564 Tumors Phase 1 trial initiated enrolling subjects in San Antonio, TX, MD Anderson Cancer Center and Peninsula Cancer Institute in Newport News, VA
Nektar Therapeutics NKTR-255 relapsed or refractory non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) Phase 1 trial initiated enrolling 40 subjects
DiaMedica Therapeutics Inc. DM199 Chronic kidney disease Phase 2 trial initiated enrolling 60 African American subjects with CKD caused by IgA nephropathy (IgAN) and hypertensive with CKD at 10 sites in the U.S.
PhaseBio Pharmaceuticals PB2452 with low-dose aspirin blood thinning Phase 2b trial initiated enrolling 200 elderly subjects aged 50-80
Diamyd Medical Diamyd Latent Autoimmune Diabetes in Adults (LADA) Phase 2 trial initiated enrolling 15 subjects newly diagnosed with LADA not yet on insulin therapy at the Norwegian University of Science and Technology in Trondheim
Can-Fite BioPharma Ltd. Namodenoson Nonalcoholic steatohepatitis (NASH)/nonalcoholic fatty liver disease (NAFLD) Phase 2 trial initiated enrolling 60 subjects with NAFLD with or without NASH
Denovo Bipharma LLC DB102 glioblastoma (GBM) in combination with radiation and temozolomide Phase 2b trial initiated enrolling 200 patients with newly-diagnosed GBM
Boehringer Ingelheim BI 1265162 cystic fibrosis Phase 2 trial initiated enrolling subjects with relapsed or refractory lymphoma at sites in the U.S. and Europe
Hope Biosciences HB-adMSCs Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy Phase 1/2 trial initiated enrolling 24 subjects
Imbrium Therapeutics IMB-115 insomnia associated with alcohol cessation (IAAC) Phase 2 trial initiated enrolling adults with moderate or severe alcohol use disorder (AUD) experiencing IAAC
Diffusion Pharmaceuticals TSC stroke Phase 2 trial initiated enrolling 160 subjects at 23 hospitals in the Virginia and Los Angeles County
Amygdala Neurosciences ANS-6637 alcohol use disorder AUD) Phase 2 trial initiated enrolling 81 treatment seeking subjects with at least moderate alcohol use disorder at three sites
Novavax Inc. NanoFlu Influenza Phase 3 trial initiated enrolling 2,650 adult subjects aged 65 and over at 19 sites in the U.S.
Axsome Therapeutics, Inc. AXS-05 major depressive disorder (MDD) Phase 3 trial initiated enrolling 300 subjects with moderate to severe MDD
SurgiMab SGM-101 colorectal cancer Phase 3 trial initiated enrolling 300 subjects with colorectal cancer in ten clinical centers in Europe and the U.S.
AstraZeneca DS-8201 breast cancer Priority review granted by the FDA
Akorn, Inc. betamethasone dipropionate lotion USP (augmented) inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses ANDA approval granted by the FDA
Subtle Medical SubtleMR image processing to improve medical imaging 510 (k) clearance granted by the FDA
Cleveland Diagnostics, Inc. IsoPSA prostate cancer diagnostic test Breakthrough device designation granted by the FDA
Genentech, Inc. Xofluza influenza complications Approval granted by the FDA
Noven Pharmaceuticals, Inc. SECUADO transdermal drug delivery system schizophrenia Approval granted by the FDA
Janssen Pharmaceuticals XARELTO (rivaroxaban) blood clots Approval granted by the FDA
Eli Lilly Reyvow migraines Approval granted by the FDA