Company Product Description Indication Status
Basilea Pharmaceutica Ltd., of Basel, Switzerland Ceftobiprole Penicillin binding protein inhibitor Staphylococcus aureus bacteremia infection FDA approved protocol amendment enabling pivotal phase III Eradicate study of intravenous (I.V.) ceftobiprole vs. I.V. daptomycin, with or without I.V. aztreonam, to advance to pre-planned second cohort and to extend maximum treatment duration from 4 to up to 6 weeks; overall target enrollment (n=390) unchanged
Bird Rock Bio Inc., of La Jolla, Calif. Nimacimab (RYI-018) Cannabinoid CB1 receptor antagonist Renal disease IND filed with FDA to initiate phase II trial in individuals with diabetic kidney disease, focal segmental glomerulosclerosis or IgA nephropathy
Cardiff Oncology Inc., of San Diego Onvansertib Polo-like kinase 1 inhibitor Metastatic colorectal cancer FDA granted fast track designation to treat individuals with KRAS-mutated disease
Cerecor Inc., of Rockville, Md. CERC-002 Tumor necrosis factor 14 ligand inhibitor COVID-19-induced acute respiratory distress syndrome  FDA cleared IND for proof-of-concept study expected to enroll 82 individuals hospitalized with COVID-19 ARDS; primary outcome measure is respiratory failure and death vs. standard of care over 28 days; first participant expected to enroll in June 2020, with top-line data expected in fourth quarter of 2020
Immodulon Therapeutics Ltd., of Uxbridge, U.K. IMM-101 Heat-killed mycobacterial immunomodulator  Advanced sarcoma FDA approved IND for phase I/II combination study with standard-of-care chemotherapy and checkpoint inhibitor in up to 42 individuals with advanced leiomyosarcoma or dedifferentiated liposarcoma; efficacy endpoints include overall and progression-free survival
Macrogenics Inc., of Rockville, Md. Margetuximab ERBB-2 tyrosine kinase receptor inhibitor Metastatic breast cancer During mid-cycle communication, FDA disclosed that it is no longer planning to hold advisory committee meeting to discuss BLA, reconfirming Dec. 18, 2020, PDUFA date
Moleculin Biotech Inc., of Houston WP-1122 2-deoxy-D-glucose ester-type prodrug COVID-19 infection FDA granted request for pre-IND meeting
Orpheris Inc., subsidiary of Ashvattha Therapeutics LLC, of Redwood City, Calif. OP-101 Hydroxyl PAMAM dendrimer COVID-19 infection FDA agreed to phase II study in severe infection, in addition to standard-of-care therapy, to assess reduction of pro-inflammatory cytokine storm and oxidative stress
Phasebio Pharmaceuticals Inc., of Malvern, Pa.  PB-1046 VIP 2 receptor agonist COVID-19 infection FDA authorized IND for potentially pivotal Vangard trial expected to enroll about 210 hospitalized COVID-19 patients at high risk for clinical deterioration and acute respiratory distress syndrome; primary endpoint is days alive and free of respiratory failure
Protalix Biotherapeutics Inc., of Carmiel, Israel, and Chiesi Global Rare Diseases, unit of Chiesi Farmaceutici SpA, of Parma, Italy Pegunigalsidase alfa Alpha-galactosidase stimulator Fabry disease Submitted BLA to FDA via accelerated approval pathway
Roche Holding AG, of Basel, Switzerland Ocrevus (ocrelizumab)
B-lymphocyte antigen CD20 inhibitor
Multiple sclerosis EMA approved shorter 2-hour infusion time, dosed twice yearly, to treat relapsing or primary progressive disease
Theraly Fibrosis Inc., of Germantown, Md. TLY-012 TRAIL receptor modulator Systemic sclerosis FDA granted orphan drug designation in the indication

Notes

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

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