Upcoming Hematology FDA decisions & readouts

PDUFA target dates and trial readouts in blood and hematologic disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.

Cancer & Oncology Obesity & Metabolic CNS & Neurology Immunology & Inflammation Cardiovascular Rare Disease Infectious Disease & Vaccines

Trial readouts (8)

AGIO · Jun 2026 (est.)

Mitapivat — Anemia

CERS · Jul 2026 (est.)

S-303 Treated Red Blood Cells — Anemia

AKBA · Aug 2026 (est.)

Vadadustat — Anemia of Chronic Kidney Disease

KPTI · Sep 2026 (est.)

Selinexor — Myelofibrosis

CSLLY · Oct 2026 (est.)

Recombinant Single-Chain Factor Viii — Congenital Hemophilia A

GERN · Feb 2027 (est.)

Imetelstat — Myelofibrosis

IRON · Jun 2027 (est.)

DISC-1459 — Sickle Cell Disease

KPTI · Jun 2027 (est.)

Selinexor — Myelofibrosis

We don't show an approval percentage for these hematology catalysts — here's why.