Company Product Description Indication Status
Adamis Pharmaceuticals Corp., of San Diego Tempol  Superoxide dismutase modulator COVID-19 Submitted IND to FDA
Aptorum Group Ltd., of New York ALS-4 Oral, small-molecule antiviral Infectious caused by Staphylococcus aureus, including MRSA Received clearance from Health Canada to begin phase I trial
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-154 (topical roflumilast foam) PDE4 inhibitor Seborrheic dermatitis Following end-of-phase II meeting with FDA, company plans to start single pivotal trial in second or third quarter of 2021
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) Antibody-drug conjugate targeting HER2 HER2-positive breast cancer Granted conditional approval in European Union as monotherapy for treating adults with unresectable or metastatic disease who have received 2 or more prior anti-HER2-based regimens
Biocelect Pty Ltd., of Melbourne, Australia, on behalf of Novavax Inc., of Gaithersburg, Md. NVX-CoV2373 COVID-19 vaccine Prevention of COVID-19 Therapeutic Goods Administration granted provisional determination 
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) Anti-PD-1 antibody Advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma FDA accepted supplemental BLA seeking approval for use in combination with fluoropyrimidine- and platinum-containing chemotherapy; agency granted priority review and set PDUFA date of May 25, 2021
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) Anti-PD-1 antibody Esophageal or gastroesophageal junction cancer FDA accepted the supplemental BLA seeking approval for treating patients with resected disease in the adjuvant setting, after neoadjuvant chemoradiation therapy; application was granted priority review, with PDUFA date of May 20, 2021
Eutilex Co. Ltd., of Seoul, South Korea EU-101 CDw137 agonist Solid tumors FDA approved IND
Haisco-USA Pharmaceuticals Inc., of San Diego HSK-3486 GABA A receptor agonist Anesthesia Trial application for phase III study approved by FDA
Histogen Inc., of San Diego, Calif. HST-003 Human extracellular matrix Acute knee injury FDA clinical issued verbal clinical hold for phase I/II trial due to pending CMC information that is required to complete their review
Impel Neuropharma Inc., of Seattle INP-104 Dihydroergotamine mesylate  Acute migraine headaches with or without aura in adults FDA accepted NDA 
Lytix Biopharma AS, of Oslo, Norway LTX-315 Oncolytic molecule  Various solid tumors FDA approved IND
Merck & Co. Inc., of Kenilworth, N.J. Verquvo (vericiguat) Soluble guanylate cyclase stimulator Heart failure Approved by FDA for use in reducing risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%
Novo Nordisk A/S, of Bagsværd, Denmark Ozempic (semaglutide) Glucagon-like peptide-1 analogue Type 2 diabetes Filed label expansion with FDA to introduce a new dose of 2 mg; Ozempic is currently approved in the U.S. in 0.5-mg and 1-mg doses for type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
Swedish Orphan Biovitrum AB, of Stockholm, Sweden Doptelet (avatrombopag)  Thrombopoietin receptor agonist Primary chronic immune thrombocytopenia European Commission approved an extension of the indication for Doptelet (avatrombopag) to include the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)
Taysha Gene Therapies Inc., of Dallas, Texas TSHA-105  AAV-based gene therapy SLC13A5-related epilepsy FDA issued both rare pediatric disease and orphan drug designations
Terns Pharmaceuticals Inc., of Foster City, Calif. TERN-501 Selective thyroid hormone receptor beta Non-alcoholic steatohepatitis  FDA cleared IND 

Notes

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