Company Product Description Indication Status
Active Biotech AB, of Lund, Sweden, and Neotx Therapeutics Ltd., of Dublin Naptumomab estafenatox Fusion protein targeting 5T4 tumor antigen with immunomodulating and antineoplastic activities Checkpoint inhibitor pretreated, advanced or metastatic non-small-cell lung cancer FDA cleared the IND for a phase IIa study; primary endpoint is objective response rate; trial will also evaluate safety, duration of response, progression-free survival, pharmacokinetics and pharmacodynamics of naptumomab estafenatox
Aerie Pharmaceuticals Inc., of Durham, N.C. Roclanda (latanoprost + netarsudil) Rho kinase inhibitor and prostanoid selective FP receptor agonist Primary open-angle glaucoma or ocular hypertension U.K. Medicines and Healthcare Products Regulatory Agency authorized the drug in patients for whom monotherapy with a prostaglandin or netarsudil provides insufficient intraocular pressure reduction
Agenus Inc., of Lexington, Mass. Balstilimab Monoclonal antibody targeting PD-1 Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy Submitted the BLA to the FDA
Alk Inc., of Round Rock, Texas Ragwitek (short ragweed pollen allergen extract) Sublingual allergy immunotherapy Short ragweed pollen-induced allergic rhinitis FDA approved the expanded indication to include children and adolescents 5 through 17 years of age
Allogene Therapeutics Inc., of South San Francisco ALLO-605 Allogeneic CAR T therapy targeting BCMA Relapsed or refractory multiple myeloma FDA cleared the IND for a phase I dose-escalating study expected to begin in mid-2021
Anixa Biosciences Inc., of San Jose, Calif., and the Moffitt Cancer Center FSHR CAR T CAR T targeting follicle stimulating hormone receptor Ovarian cancer After review of the IND, the FDA requested additional information and placed the study under the IND on clinical hold
Astellas Pharma Inc., of Tokyo, and Seagen Inc., of Bothell, Wash. Padcev (enfortumab vedotin-ejfv) Poliovirus receptor-related protein 4 modulator Urothelial cancer FDA accepted sBLAs under Real-Time Oncology Review pilot program requesting conversion of accelerated to regular approval and label expansion to include locally advanced or metastatic disease previously treated with PD-1/L1 inhibitor and ineligible for cisplatin; agency granted priority review, setting PDUFA date of Aug. 17, 2021
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) Monoclonal antibody targeting PD-1 Advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression FDA approved the drug in combination with fluoropyrimidine- and platinum-containing chemotherapy
Curevac Swiss AG, of Tubingen, Germany CVnCoV MRNA-based vaccine COVID-19 prophylaxis Started a rolling submission to Swissmedic
Curis Inc., of Lexington, Mass. CA-4948 IRAK4 inhibitor Acute myeloid leukemia and myelodysplastic syndromes FDA granted orphan drug designation
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist COVID-19 Submitted the CMC section of the application for an interim order to Health Canada under a rolling review; remaining sections expected to be submitted in the very near future
Eli Lilly and Co., of Indianapolis Bamlanivimab Monoclonal antibody targeting SARS-CoV-2 Mild to moderate COVID-19 As requested by the company, the FDA revoked the emergency use authorization for use of the drug as a monotherapy
Istari Oncology Inc., of Durham, N.C. PVS-RIPO Intratumoral viral immunotherapy Advanced solid tumors FDA cleared IND to initiate phase I/II Luminos-103 trial, with or without PD-1/L1 inhibitors, in adults; trial expected to begin enrolling in mid-2021 with 2 bladder cancer cohorts
Mannkind Corp., of Westlake Village, Calif., and United Therapeutics Corp., of Silver Spring, Md. Tyvaso DPI (inhaled treprostinil) PGI2 agonist Pulmonary arterial hypertension NDA submitted to FDA using priority review voucher
Mayne Pharma Group Ltd., of Adelaide, Australia, and  Mithra Pharmaceuticals SA, of Liege, Belgium Nextstellis (drospirenone + estetrol) Estrogen receptor modulator Contraception FDA approved NDA, with commercial launch expected by mid-2021
Sanofi SA, of Paris Sarclisa (isatuximab)  Anti-CD38 monoclonal antibody Multiple myeloma European Commission approved additional indication for drug in combination with carfilzomib and dexamethasone to treat adults with relapsed disease who received at least 1 prior therapy
Stuart Therapeutics Inc., of Stuart, Fla. ST-100 Collagen mimetic peptide Dry eye disease FDA cleared IBD for phase II study, expected to begin by mid-2021
Xbiotech Inc., of Austin, Texas XB-2001 IL-1 alpha inhibitor Pancreatic cancer FDA cleared IND for I/II study of agent + Onivyde/5-FU combination therapy

Notes

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