Company Product Description Indication Status
Apogenix AG, of Heidelberg, Germany Asunercept  Extracellular domain of CD95 receptor and Fc domain of IgG1 antibody fusion protein  Severe COVID-19 Received regulatory approval to start the 400-patient phase II Asunctis study in Russia; study will compare 3 doses of drug plus standard of care (SOC) to SOC alone; plans to expand into other European countries, including Spain
Black Diamond Therapeutics Inc., of Cambridge, Mass. BDTX-189 Irreversible small-molecule inhibitor  Solid tumors FDA granted fast track for use in patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options
Foresee Pharmaceuticals Co. Ltd., of Taipei, Taiwan Camcevi (FP-001) 6-month depot formulation of leuprolide mesylate Advanced prostate cancer Submitted NDA to FDA under 505(b)(2) pathway, seeking approval as palliative treatment
Hemoshear Therapeutics Inc., of Charlottesville, Va. HST-5040 Oral, small molecule Methylmalonic acidemia and propionic acidemia Received FDA fast track and rare disease designations
Hutchison China Meditech Ltd., of Hong Kong Savolitinib Small-molecule MET inhibitor Non-small-cell lung cancer China’s NMPA granted priority review status to the NDA seeking approval for use in treating NSCLC with MET exon 14 skipping mutations
Larimar Therapeutics Inc., of Bala Cynwyd, Pa. CTI-1601 Recombinant fusion protein intended to deliver human frataxin into mitochondria Friedreich’s ataxia EMA’s Committee for Orphan Medicinal Products issued a positive opinion recommending orphan designation
Momenta Pharmaceuticals Inc., of Cambridge, Mass. Nipocalimab Fully human aglycosylated, effectorless IgG1 anti-FcRn monoclonal antibody Prevention of hemolytic disease of the fetus and newborn FDA granted rare pediatric disease designation; agency also granted orphan status
Nabriva Therapeutics plc, of Dublin Xenleta (lefamulin) Semisynthetic pleuromutilin antibiotic Community-acquired pneumonia European Commission approved MAA for use in adults when considered inappropriate to use antibacterial agents that are commonly recommended for initial treatment or when those agents have failed
Protara Therapeutics Inc., of New York TARA-002  Cell-based therapy based on immunopotentiator OK-432 Lymphatic malformations FDA granted rare pediatric disease designation
Realta Life Sciences Inc., of Norfolk, Va. RLS-0071 Peptide designed to inhibit complement and anti-inflammatory immune responses Acute lung injury secondary to COVID-19 FDA accepted IND; phase I study in adults with pneumonia and early respiratory failure set to start in the third quarter of 2020

Notes

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