Yeji
PDUFAoutcome: unknownconf 0.95

narsoplimab — PDUFA

$OMER · OMEROS CORP · hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Event date
September 25, 2025
254 days ago
Sponsor runway
28 mo
$135.3M liquid

Evidence

“pursuant to the Prescription Drug User Fee Act ("PDUFA"), was assigned an initial target action date for the FDA decision of September 25, 2025”
Source: 8-K filed 2025-07-25View on EDGAR ↗0001104659-25-070554

Comparable historical pdufas· last 5 years · same indication

0% hit rate (0/1)
TickerDrugDateOutcome
$OMERnarsoplimab2021-10-17failure

Recent insider activity· ±90 days

10 insiders · 0 buys · 0 sells
Gift
2025-10-13
Demopulos Gregory A MD
Chairman, CEO & President
600,000 @ ——
Gift
2025-10-13
Demopulos Gregory A MD
Chairman, CEO & President
300,000 @ ——
Grant
2025-06-30
Borges David J.
VP, Finance & CAO
95,000 @ ——
Grant
2025-06-30
Cancelmo Peter B
VP, General Counsel
100,000 @ ——
Grant
2025-06-30
Demopulos Gregory A MD
Chairman, CEO & President
865,000 @ ——
Grant
2025-06-27
Perkinson Diana T.
Director
15,000 @ ——
Grant
2025-06-27
HANISH ARNOLD C
Director
15,000 @ ——
Grant
2025-06-27
Hood Leroy E. MD PhD
Director
15,000 @ ——
Grant
2025-06-27
Shah Rajiv
Director
15,000 @ ——
Grant
2025-06-27
Bumol Thomas F.
Director
15,000 @ ——
Grant
2025-06-27
Cable Thomas J.
Director
15,000 @ ——
Grant
2025-06-27
Demopulos Peter A MD
Director
15,000 @ ——
← All catalysts for $OMER