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NDA/BLA filedconf 0.85

narsoplimab — NDA/BLA filed

$OMER · OMEROS CORP · hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Event date
Date TBD
Sponsor runway
28 mo
$135.3M liquid

Evidence

“in March 2025, the Company resubmitted to U.S. Food and Drug Administration ("FDA") the biologics license application ("BLA") seeking regulatory approval for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA"). The resubmission was accepted for review by FDA as a class 2 resubmission”
Source: 8-K filed 2025-07-25View on EDGAR ↗0001104659-25-070554

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM—2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

No insider Form 4 activity reported on $OMER in the 90 days around this event.
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