Company Product Description Indication Status
Acadia Pharmaceuticals Inc., of San Diego Pimavanserin 5-HT 2a receptor inverse agonist Dementia-related psychosis During its review of sNDA for treatment of hallucinations and delusions associated with indication, FDA said it identified deficiencies that preclude discussion of labeling and postmarketing requirements
Affibody AB, of Solna, Sweden, and Inmagene Biopharmaceuticals Co. Ltd., of Shanghai Izokibep (ABY-035) IL-17 inhibitor Non-anterior uveitis FDA cleared IND for phase II trial in non-infectious intermediate, posterior and pan-uveitis
Alphamab Oncology Co. Ltd., of Suzhou, China KN-046 PD-L1/CTLA4 bispecific antibody Thymic carcinoma FDA cleared IND for pivotal phase II Enreach-Thymic trial
Altrubio Inc., of Redwood City, Calif. Neihulizumab (AbGn-168H) P-selectin glycoprotein ligand-1 Graft-vs.-host disease FDA granted fast track designation to treat steroid-refractory acute disease
Amylyx Pharmaceuticals Inc., of Cambridge, Mass. AMX-0035 (ursodoxicoltaurine + sodium phenylbutyrate) Histone deacetylase inhibitor Amyotrophic lateral sclerosis New drug submission to Health Canada planned for first half of 2021
Cyclo Therapeutics Inc., of Gainesville, Fla Trappsol Cyclo (hydroxypropyl beta cyclodextrin) Lipid metabolism modulator; cholesterol binding agent Niemann-Pick type C  EMA's pediatric committee issued positive opinion confirming agreement with proposed pediatric investigation plan for pivotal phase III study, expected to begin in second quarter of 2021
Huya Bioscience International LLC, of San Diego Jublia (efinaconazole) Lanosterol-14 demethylase inhibitor Onychomycosis Joint venture with Tianjin Institute of Pharmaceutical Research submitted NDA to China's NMPA
Melior Pharmaceuticals Inc., of Exton, Pa. Tolimidone Lyn kinase activator COVID-19 infection FDA cleared IND for phase II study in 236 recently diagnosed, non-hospitalized people with early symptoms
Oncopeptides AB, of Stockholm Pepaxto (melphalan flufenamide)  Peptide-drug conjugate  Multiple myeloma Opened early access program in Europe and, in second quarter of 2021, plans to seek conditional marketing authorization from EMA to treat, in combination with dexamethasone, triple class refractory disease
Rocket Pharmaceuticals Inc., of Cranbury, N.J. RP-L201 ITGB2 gene stimulator Leukocyte adhesion deficiency-I FDA granted regenerative medicine advanced therapy designation 

Notes

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