Upcoming PDUFA Dates

mitapivat — sickle cell disease

B

74/100

INO (Inovio Pharmaceuticals, Inc.) — PDUFA date

C

59/100

IBTROZI — advanced ROS1-positive non-small cell lung cancer (ROS1+ NSCLC)

C

56/100

BBP-418 — BBIO PDUFA

D

36/100

CAPR (Capricor Therapeutics, Inc.) — PDUFA date

D

37/100

IGALMI — BTAI PDUFA

C

56/100

VRTX (Vertex Pharmaceuticals) — PDUFA date

C

61/100

Pitolisant

D

46/100

LIBERVANT — acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above

F

21/100

LIBERVANT — acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above

F

18/100

PRAX (Praxis Precision Medicine) — PDUFA date

F

18/100

Lorundrostat — Adults with Hypertension and Topline Explore-OSA Tr

D

35/100

IBRX (ImmunityBio, Inc.) — PDUFA date

C

58/100

Generalized — VNDA PDUFA

C

52/100

Zipalertinib — CGEM PDUFA

F

24/100

ZORYVE — ARQT PDUFA

C

52/100

relacorilant — Cushing's syndrome

C

54/100

Ivonescimab — SMMT PDUFA

C

53/100

Ozekibart — Conventional Chondrosarcoma No filing review issues

D

47/100

RPRX (Royalty Pharma plc Class A) — PDUFA date

F

7/100

Varegacestat — IMNM PDUFA

F

26/100

PHVS (Pharvaris NV) — PDUFA date

D

39/100

AXSM (Axsome Therapeutics) — PDUFA date

D

38/100