Company Product Description Indication Status
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. ALN-HSD HSD17B3 gene modulator Nonalcoholic steatohepatitis CTA application submitted to U.K. MHRA to initiate a phase I study, expected to begin in late 2020
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. BCX-9930 Complement factor D inhibitor Paroxysmal nocturnal hemoglobinuria FDA granted fast track designation
Calidi Biotherapeutics Inc., of San Diego Adipose-derived mesenchymal stem cells Stem cell therapy COVID-19 infection FDA cleared IND for phase I trial by partner Personalized Stem Cells Inc. in 20 hospitalized patients
Cerecor Inc., of Rockville, Md. CERC-006 Dual mTOR complex 1/2 inhibitor Lymphatic malformations  FDA granted orphan drug designation
GW Pharmaceuticals plc, of London, and U.S. subsidiary Greenwich Biosciences Inc., of Carlsbad, Calif. Epidiolex (cannabidiol) Cannabinoid CB1/2 receptor modulator Epilepsy FDA approved to treat seizures associated with tuberous sclerosis complex in individuals 1 and older and expanded age range to treat seizures associated with Lennox-Gastaut or Dravet syndromes to those 1 and older
Janssen Pharmaceutical Cos., unit of Johnson & Johnson, of New Brunswick, N.J. Spravato (esketamine, intranasal)  NMDA receptor antagonist Major depressive disorder FDA approved sNDA to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior
Morphosys AG, of Planegg, Germany Monjuvi (tafasitamab-cxix) Anti-CD19 antibody Diffuse large B-cell lymphoma FDA approved in combination with lenalidomide to treat adults with relapsed/refractory disease, including that arising from low-grade lymphoma, ineligible for autologous stem cell transplant 
Novartis AG, of Basel, Switzerland Cosentyx (secukinumab)  IL-17 antagonist Plaque psoriasis European Commission approved to treat moderate to severe disease in children and adolescents 6 to <18 years
Polypid Ltd., of Petah Tikva, Israel D-Plex100 Drug-device using controlled-release antibiotic  Post-abdominal surgical site infection FDA granted fast track designation
Roche Holding AG, of Basel, Switzerland Rozlytrek (entrectinib)  ROS1/TRKA/B/C kinase inhibitor Solid tumors; non-small-cell lung cancer European Commission granted conditional marketing authorization to treat adults and children 12 and older with solid tumors expressing neurotrophic tyrosine receptor kinase (NTRK) gene fusion and locally advanced or metastatic disease who did not receive prior NTRK inhibitor and also to treat adults with ROS1-positive, advanced NSCLC not previously treated with ROS1 inhibitor
Sonoran Biosciences Inc., of Tempe, Ariz. SBG-003 (tobramycin and vancomycin hydrogel) Antibiotic combination Post-abdominal surgical site infection FDA granted qualified infectious disease product designation
Tyme Technologies Inc., of Bedminster, N.J. SM-88 (racemetyrosine) Cytochrome P450 2A6 inhibitor; cytochrome P450 3A4 stimulator Pancreatic cancer FDA granted orphan drug designation
Vanda Pharmaceuticals Inc., of Washington Hetlioz (tasimelteon) Melatonin MT1/MT2 receptor agonist Smith-Magenis syndrome FDA accepted sNDA for capsule formulation and NDA to treat adults and children, respectively, with SMS, granting priority review and setting PDUFA date of Dec. 1, 2020


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

No Comments