|Adial Pharmaceuticals Inc., of Charlottesville, Va.||AD-04 (repurposed ondansetron)||5-HT 3 receptor antagonist||Alcohol use disorder||Received all necessary approvals to commence the Onward pivotal phase III trial in Poland|
|Biovie Inc., of Santa Monica, Calif.||BIV-201||Continuous infusion terlipressin||Refractory ascites due to liver cirrhosis||Received guidance from FDA and plans 24-patient phase II study this year, with larger pivotal phase III trial to begin first half of 2021; agency noted that pending positive phase II study results, a sufficiently large and well-controlled phase III trial, with supportive data from the phase II study (statistical significance not required), could potentially yield the data needed to apply for marketing approval|
|Kite Pharma, a unit of Gilead Sciences Inc., of Foster City, Calif.||Yescarta (axicabtagene ciloleucel)||CAR T therapy targeting CD19||Cancer||Received approval to implement a variation to the marketing authorization from the EMA for end-to-end manufacturing; with this approval, Kite’s European manufacturing facility is now fully operational|
|Leap Therapeutics Inc., of Cambridge, Mass.||DKN-01||Humanized monoclonal antibody targeting DKK1 protein||Gastric and gastroesophageal junction cancer||FDA granted orphan drug designation|
|Viela Bio Inc., of Gaithersburg, Md.||Uplizna (inebilizumab-cdon)||Humanized anti-CD19 monoclonal antibody||Neuromyelitis optica spectrum disorder||FDA approved for the treatment of adult patients who are anti-AQP4 antibody-positive as a twice-a-year maintenance regimen following initial doses|
|ZZ Biotech LLC, of Houston||3K3A-APC||Genetically engineered variant of the naturally occurring activated protein C||Acute ischemic stroke||FDA granted fast track designation|
For more information about individual companies and/or products, see Cortellis.