Company Product Description Indication Status
Akari Therapeutics plc, of New York Nomacopan C5 complement inhibitor Bullous pemphigoid EMA issued a positive opinion on application for orphan status
Alethia Biotherapeutics Inc., of Montreal AB-16B5 Inhibitor of epithelial to mesenchymal transition Metastatic non-small-cell lung cancer FDA cleared the IND for a phase II study testing combination with docetaxel in previously treated patients who have experienced disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody
Anavex Life Sciences Corp., of New York ANAVEX 3-71 Small molecule targeting sigma-1 and M1 muscarinic receptors Neurodegenerative diseases, initially frontotemporal dementia Australia’s Human Research Ethics Committee cleared start of first-in-human study; phase I trial will enroll at least 36 healthy male and female subjects
Appili Therapeutics Inc., of Halifax, Nova Scotia Favipiravir Broad-spectrum antiviral COVID-19 Health Canada cleared phase II study testing drug from Fujifilm Toyama Chemical as preventive measure against COVID-19 outbreaks; recruitment expected to begin imminently
Astellas Pharma Inc., of Tokyo, and Fibrogen Inc., of San Francisco Roxadustat Inhibitor of hypoxia-inducible factor prolyl¬ hydroxylase Anemia in chronic kidney disease Marketing authorization application accepted by EMA for regulatory review
Calcimedica Inc., of La Jolla, Calif. Auxora (CM-4620-IE) Selective small-molecule CRAC channel inhibitor COVID-19 pneumonia Received guidance from FDA recommending transition from current randomized open-label study to a blinded placebo-controlled trial as soon as possible; FDA provided that recommendation following submission of recent interim analysis
Chiesi Global Rare Diseases, of Boston, a unit of Chiesi Farmaceutici SpA Ferriprox (deferiprone) Iron chelator Transfusional iron overload due to thalassemia syndromes Approved by FDA as twice-a-day tablets for use when current chelation therapy is inadequate
I-Mab Biopharma Co. Ltd., of Shanghai, and Genexine Co. Ltd., of Seoul, South Korea TJ-107/Hyleukin-7 (efineptakin alfa) Long-acting recombinant human interleukin-7  Glioblastoma multiforme China’s NMPA cleared initiation of phase II trial in lymphopenic patients with newly diagnosed disease
Passage Bio Inc., of Philadelphia PBGM-01 AAV-delivery gene therapy GM1 gangliosidosis FDA granted rare pediatric disease designation

Notes

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

No Comments