New Pipeline Updates from AgeneBio, Second Genome and Imperative Care

January 28, 2019

Company Drug/Device Medical Condition Status
Ironwood Pharmaceuticals IW-6463 serious and orphan Central Nervous System (CNS) disorders Phase I trial initiated enrolling healthy volunteer subjects
Concert Pharmaceuticals CTP-692 adjunctive treatment for schizophrenia Phase I trial initiated
Curis, Inc. CA-170 (oral dual inhibitor of VISTA and PDL1) mesothelioma Phase I trial initiated
Second Genome, Inc. SGM-1019 nonalcoholic steatohepatitis (NASH) Phase II trial initiated enrolling 100 subjects in the U.S.
Bio-Thera Solutions BAT1806 (tocilizumab biosimilar) Rheumatoid Arthritis (RA) Phase III trial initiated enrolling more than 600 subjects around the world
AgeneBio AGB101 amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD) Phase III trial initiated enrolling 830 subjects in the U.S., Canada and Europe
Daiichi Sankyo Company, Limited [fam-] trastuzumab deruxtecan (DS-8201) HER2 low, unresectable and/or metastatic breast cancer Phase III trial initiated enrolling 540 subjects at approximately 160 sites in regions including, but not limited to, North America, Western Europe and Asia
Imperative Care, Inc. neurovascular access catheters minimally invasive neurovascular procedures for aneurysms, stroke and other brain blood vessel conditions 510(k) clearance granted by the FDA
Rebound Therapeutics Corporation AURORA Surgiscope System single-use disposable Neurosurgical Endoscope for minimally invasive access, visualization and illumination of the target neuro anatomy 510(k) clearance granted by the FDA
Aerie Pharmaceuticals, Inc. AR-1105 (dexamethasone intravitreal implant) macular edema due to Retinal Vein Occlusion (RVO) IND approval granted by the FDA
I-Mab Biopharma TJD5 (TJ004309) advanced solid tumors IND approval granted by the FDA
Nexus Pharmaceuticals, Inc. Busulfan Injection chronic myelogenous leukemia ANDA approval granted by the FDA
Biom’up HEMOBLAST Bellows Laparoscopic Applicator minimally-invasive procedures PMA approval granted by the FDA
Sanofi Pasteur 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to children age 6 through 35 months influenza Approval granted by the FDA