Company Product Description Indication Status
Antengene Corp. Ltd., of Shanghai ATG-010 (selinexor) Selective inhibitor of nuclear export Endometrial cancer Submitted an IND to China's National Medical Products Administration for the global Siendo phase III study
Arcturus Therapeutics Holdings Inc., of San Diego ARCT-021 mRNA-based vaccine COVID-19 prophylaxis Received allowance from the FDA of an IND for a phase II study
Ascentage Pharma Group International, of Suzhou, China APG-2575 Bcl-2 inhibitor Acute myeloid leukemia FDA granted orphan drug designation
Atriva Therapeutics GmbH, of Tübingen, Germany ATR-002 MEK inhibitor Hospitalized moderate to severe COVID-19 German Federal Institute for Drugs and Medical Devices approved the start of the pivotal phase II Respire study of 220 patients
Cure Pharmaceutical Holding Corp., of Oxnard, Calif. Curefilm Blue Oral soluble film formulation of sildenafil citrate Erectile dysfunction FDA cleared an IND for a study to support approval through the 505(b)(2) regulatory pathway
Genentech, a unit of Basel, Switzerland-based Roche Holding AG Tiragolumab Monoclonal antibody targeting TIGIT Metastatic non-small-cell lung cancer with high PD-L1 expression with no EGFR or ALK genomic tumor aberrations FDA granted breakthrough therapy designation for the drug in combination with Tecentriq (atezolizumab)
Marius Pharmaceuticals, of Raleigh, N.C. Kyzatrex Oral testosterone replacement Hypogonadism Submitted NDA to the FDA
Marker Therapeutics Inc., of Houston MT-401 Multitumor-associated antigen-specific T-cell product Post-transplant acute myeloid leukemia FDA lifted the partial clinical hold on the phase II study
Moderna Inc., of Cambridge, Mass. COVID-19 vaccine mRNA-based vaccine COVID-19 prophylaxis Israel’s Ministry of Health authorized import of the vaccine
Ovoca Bio plc, of Dublin BP-101  Synthetic peptide Hypoactive sexual desire disorder Marketing application submitted to the Russian Ministry of Health
Precigen Inc., of Germantown, Md. PRGN-2012 Therapeutic vaccine against HPV 6 or HPV 11 Recurrent respiratory papillomatosis FDA cleared an IND for a phase I dose-escalation study designed to determine safety and tolerability and recommended phase II dose
Shenzhen Chipscreen Biosciences Co. Ltd., of Shenzhen, China Chiauranib Aurora B kinase, colony-stimulating factor 1 receptor and vascular endothelial growth factor receptor/platelet-derived growth factor receptor/c-Kit inhibitor Small-cell lung cancer following progression or recurrence after 2 lines of prior systematic chemotherapy Center for Drug Evaluation granted breakthrough therapy designation
Zosano Pharma Corp., of Fremont, Calif. Qtrypta (zolmitriptan transdermal microneedle system) 5-HT 1b receptor agonist; 5-HT 1d receptor agonist  Migraine  Requested a type A meeting with the FDA to review plans for resubmission of the NDA following a complete response letter received on Oct. 20, 2020

Notes

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