Company Product Description Indication Status
Beigene Ltd., of Beijing Tislelizumab Anti-PD-1 antibody Non-small-cell lung cancer China's NMPA approved in combination with chemotherapy in first-line advanced squamous disease
Innovation Pharmaceuticals Inc., of Wakefield, Mass. Brilacidin Dual PDE3/4 inhibitor COVID-19 infection FDA granted fast track designation
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas Sotagliflozin Dual sodium glucose transporter-1/transporter-2 inhibitor Heart failure FDA provided feedback that phase III Soloist and Scored studies can support NDA submission to reduce risk of cardiovascular death, hospitalization and urgent visits for heart failure in adults with type 2 diabetes with worsening or additional risk factors for the indication
Novartis AG, of Basel, Switzerland Ligelizumab (QGE-031) Anti-IgE antibody Urticaria FDA granted breakthrough therapy designation to treat chronic idiopathic disease in people with inadequate response to H1-antihistamines
Orchard Therapeutics plc, of London OTL-200 Autologous hematopoietic stem cell gene therapy Metachromatic leukodystrophy FDA granted regenerative medicine advanced therapy designation to treat early-onset disease
Theratechnologies Inc., of Montreal TH-1902 Sortilin receptor antagonist Advanced solid tumors Received “study may proceed” letter from FDA for phase I trial, expected to begin in second quarter of 2021
Theratechnologies Inc., of Montreal Tesamorelin GHRH receptor agonist Nonalcoholic steatohepatitis Received “study may proceed” letter from FDA for phase III trial with recommendation to request a meeting with agency to discuss proposed trial design, which company expects to pursue
Vor Biopharma Inc., of Boston VOR-33 CD33-targeted engineered hematopoietic stem cell therapy Acute myeloid leukemia FDA cleared IND for phase I/IIa trial, expected to begin in first half of 2021 in people at high risk of relapse

Notes

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