Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.

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