Company Product Description Indication Status
Aegle Therapeutics Corp., of Boston AGLE-102 Mesenchymal stem cell-derived extracellular vesicles that deliver proteins, genetic material and regenerative healing factors Dystrophic epidermolysis bullosa FDA granted rare pediatric disease designation
Amag Pharmaceuticals Inc., of Waltham, Mass. Makena Hydroxyprogesterone caproate Preterm birth FDA sent a letter proposing to withdraw approval of Makena; company has 15 days to request a hearing
Amphastar Pharmaceuticals Inc., of Rancho Cucamonga, Calif. Atropine Sulfate Antimuscarinic  Bradycardia, reduce salivation and bronchial secretions before surgery, and antidote for overdose of cholinergic drugs or mushroom poisoning FDA approved the abbreviated NDA for the drug that's been sold as a grandfather exception for the past 40 years
Biontech SE, of Mainz, Germany, and Pfizer Inc., of New York BNT-162b2 mRNA-based vaccine COVID-19 prophylaxis Started rolling submission of the marketing application with the EMA
Curtana Pharmaceuticals Inc., of Austin, Texas CT-179 Olig2 inhibitor Medulloblastoma FDA granted rare pediatric disease designation
Gemvax & Kael Co. Ltd., of Seoul, South Korea GV-1001 (tertomotide) Telomerase modulator Alzheimer's disease Announced the decision to apply for an expanded access IND based on a recent analysis of results from a phase II trial 
Glycomimetics Inc., of Rockville, Md. Rivipansel Glycomimetic candidate that binds to E-, P- and L-selectin Sickle cell disease  FDA granted rare pediatric disease designation for patients 18 and younger
Huya Bioscience International LLC, of San Diego HBI-8000 Targets class I histone deacetylase Relapsed or refractory adult T-cell leukemia-lymphoma Submitted a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency 
Iovance Biotherapeutics Inc., of San Carlos, Calif. Lifileucel Tumor-infiltrating lymphocyte therapy Metastatic melanoma Company and the FDA reached agreement on the duration of follow-up for its pivotal cohort 4 to support the planned BLA submission; as part of a recent type B meeting, the company and FDA have not been able to agree on the required potency assays to fully define its TIL therapy, which is required as part of a BLA submission, and the company anticipates a BLA submission to occur in 2021
Oncternal Therapeutics Inc., of San Diego TK-216 ETS transcription factor inhibitor Ewing sarcoma FDA granted rare pediatric disease designation
Oragenics Inc., of Tampa, Fla. Terra CoV-2 SARS-CoV-2 vaccine COVID-19 prophylaxis Received feedback to its type B pre-IND meeting request that FDA is in broad agreement with the planned approach to clinical development, and the company said it expects to file an IND by the end of the first quarter of 2021 and to start enrollment in a phase I study early in the second quarter of 2021
Samsung Bioepis Co. Ltd., of Incheon, Korea, and Biogen Inc., of Cambridge, Mass. SB-11 Biosimilar of ranibizumab Retinal vascular disorders EMA accepted for review the MAA
Y-mabs Therapeutics Inc., of New York Omburtamab Monoclonal antibody targeting B7-H3 Pediatric CNS/leptomeningeal metastasis from neuroblastoma Received a refusal to file letter from FDA regarding BLA; upon preliminary review, FDA determined that certain parts of the chemistry, manufacturing and control module and the clinical module of the BLA require further detail, and no additional nonclinical data have been requested or are required

Notes

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