Omeros Stock Falls As FDA Asks For More Clinical Narsoplimab Data In HSCT-TMA

The FDA issued a Complete Response Letter (CRL) related to Omeros Corporation's OMER marketing application for narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Related: Why Are Omeros Shares Plunging On Friday?
TMA is defined by the presence of hemolytic anemia (destruction of red blood cells), low platelets, and organ damage due to the formation of microscopic blood clots in capillaries and small arteries.
In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asked for additional information to support regulatory approval.
No chemistry, manufacturing, and controls (CMC), safety, or non-clinical issues precluding approval were raised in the CRL.
Omeros remains confident in the efficacy and safety data for narsoplimab in HSCT-TMA.
Omeros plans to request a Type A meeting as soon as possible with FDA to discuss the CRL.
Related content: Benzinga's Full FDA Calendar.
Price Action: OMER shares closed down 26.7% at $5.67 on Monday.