Yeji
CRLconf 0.99

narsoplimab — CRL

$OMER · OMEROS CORP · hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Event date
October 18, 2021
1692 days ago
Sponsor runway
28 mo
$135.3M liquid

Evidence

On October 18, 2021, the Company issued a press release announcing the receipt of a complete response letter from the U.S. Food and Drug Administration (the "FDA") regarding the Company's Biologics License Application ("BLA") for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy ("HSCT-TMA").
Source: 8-K filed 2021-10-18View on EDGAR ↗0001558370-21-013245

Comparable historical crls· last 5 years · same event type

No comparable historical outcomes in our database yet — backfill of past readouts arrives next ingestion cycle.

Recent insider activity· ±90 days

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