Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) Monoclonal antibody targeting PD-L1 First-line extensive-stage small-cell lung cancer EMA's Committee for Medicinal Products for Human Use issued a positive opinion for use of the drug in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin
Beigene Ltd., of Beijing Pamiparib PARP1 and PARP2 inhibitor Third-line advanced ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline BRCA mutations Center for Drug Evaluation of the China National Medical Products Administration granted a priority review
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson  A3 adenosine receptor agonist Moderate COVID-19 Submitted IND to FDA for a 40-patient phase II study
Carisma Therapeutics Inc., of Philadelphia CT-0508 Anti-HER2-targeted chimeric antigen receptor macrophage Recurrent or metastatic HER2-overexpressing solid tumors after failure of approved HER2-targeted agents FDA cleared the IND for a phase I study
Celltrion Healthcare, of Incheon, South Korea Remsima (infliximab, CT-P13) Subcutaneous biosimilar of Remicade (Johnson & Johnson) Ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis European Commission granted marketing application for the drug
Checkmate Pharmaceuticals Inc., of Cambridge, Mass. CMP-001 Toll-like receptor 9 agonist Melanoma  FDA granted fast track designation for the drug in combination with a PD-1-blocking antibody for initial treatment of patients with unresectable stage III or stage IV melanoma and for unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade
Diffusion Pharmaceuticals Inc., of Charlottesville, Va. Trans sodium crocetinate Increases oxygen availability COVID-19 FDA provided guidance on the IND for a phase Ib study, suggesting the company change endpoints and statistical considerations; company plans to submit the same changes to the Romanian National Agency for Medicines and Medical Devices for the Romanian part of the study; first patient now expected to be enrolled by the end of August
Eton Pharmaceuticals Inc., of Deer Park, Ill. DS-100 Dehydrated alcohol Methanol poisoning Submitted NDA to the FDA
Generex Biotechnology Corp., of Miramar, Fla. Ii-Key-SARS-CoV-2 Vaccine COVID-19 prophylaxis FDA accepted the pre-IND briefing package and is expected to issue a written response by Aug. 24, 2020
Kite Pharma Inc., a unit of Foster City, Calif.-based Gilead Sciences Inc. Tecartus (brexucabtagene autoleucel) Autologous, anti-CD19 CAR T-cell therapy Relapsed or refractory mantle cell lymphoma FDA granted accelerated approval for the treatment
Kyowa Kirin Co. Ltd., of Tokyo Crysvita (burosumab) Monoclonal antibody targeting phosphaturic hormone fibroblast growth factor 23 X-linked hypophosphatemia  EMA's Committee for Medicinal Products for Human Use issued a positive opinion for expanded use of the drug
Merus NV, of Utrecht, the Netherlands Zenocutuzumab  Bispecific antibody targeting HER2 and HER3 receptors Pancreatic cancer FDA granted orphan drug designation
Neoimmunetech Inc., of Rockville, Md. NT-I7 (efineptakin alfa) Long-acting human IL-7 Locally recurrent squamous cell carcinoma of head and neck FDA cleared the IND for a window-of-opportunity study
Neoimmunetech Inc., of Rockville, Md. NT-I7 (efineptakin alfa) Long-acting human IL-7 COVID-19 FDA cleared the IND for an investigator-initiated phase I study
Ocugen Inc., of Malvern, Pa. OCU-400  Gene therapy expressing NR2E3 RHO mutation-associated retinal degeneration FDA granted orphan drug designation
Oculis SA, of Lausanne, Switzerland OCS-01 Dexamethasone in a solubilizing nanoparticle Diabetic macular edema and inflammation and pain following cataract surgery Completed end-of-phase-II meeting; plans to start phase III studies for both indications in the first half of 2021
Pharmacyte Biotech Inc., of Laguna Hills, Calif. Cypcaps Cell-in-a-box encapsulated cell product Locally advanced, inoperable pancreatic cancer Manufacturing partner Austrianova submitted a drug master file to the FDA
Scpharmaceuticals Inc., of Burlington, Mass. Furoscix Furosemide solution formulated to a neutral pH Worsening heart failure due to congestion FDA accepted the resubmitted NDA as a class 2 response and assigned a PDUFA action date of Dec. 30, 2020
Solid Biosciences Inc., of Cambridge, Mass. SGT-001 Gene therapy expressing microdystrophin Duchenne muscular dystrophy FDA issued written communication requesting additional information on manufacturing, updated safety and efficacy data for all patients dosed and requested plans for total viral load to be administered per patient; Ignite DMD study remains on clinical hold

Notes

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