Yeji
PDUFAoutcome: failureconf 0.95

narsoplimab — PDUFA

$OMER · OMEROS CORP · hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Event date
October 17, 2021
1693 days ago
Sponsor runway
28 mo
$135.3M liquid

Evidence

the Company does not currently expect any such resolution to occur by the October 17, 2021 target action date under the Prescription Drug User Fee Act.
Source: 8-K filed 2021-10-01View on EDGAR ↗0001558370-21-012911

Comparable historical pdufas· last 5 years · same indication

TickerDrugDateOutcome
$OMERnarsoplimab2025-09-25unknown

Recent insider activity· ±90 days

1 insider · 0 buys · 0 sells
Exercise
2021-09-08
HANISH ARNOLD C
Director
10,000 @ $9.44$94K