Company Product Description Indication Status
Acadia Pharmaceuticals Inc., of San Diego, and Neuren Pharmaceuticals Ltd., of Melbourne, Australia Trofinetide Synthetic analogue of the amino‐terminal tripeptide of IGF-1 Rett syndrome FDA granted rare pediatric disease designation
Cytokinetics Inc., of South San Francisco Reldesemtiv Fast skeletal muscle troponin activator Amyotrophic lateral sclerosis EMA granted orphan designation
Janssen Pharmaceuticals Cos., of Allschwil, Switzerland, part of Johnson & Johnson Ponesimod S1P1R modulator Relapsing multiple sclerosis Submitted MAA to EMA seeking approval for use in adults
Lipocine Inc., of Salt Lake City Tlando  Oral testosterone Hypogonadism FDA acknowledged receipt of resubmitted NDA seeking approval of the TRT candidate for use in adult males for conditions associated with a deficiency of endogenous testosterone
Nucana plc, of Edinburgh, U.K. Acelarin Derived from nucleoside analogue gemcitabine Biliary tract cancer EMA’s Committee for Orphan Medicinal Products issued positive opinion for orphan designation
Zosano Pharma Corp., of Fremont, Calif. Qtrypta  Formulation of zolmitriptan delivered using intracutaneous microneedle system Migraine FDA accepted the NDA under the 505(b)(2) pathway, setting a PDUFA date of Oct. 20, 2020


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

No Comments