Omeros Gets CRL From FDA For Narsoplimab BLA In Treatment Of HSCT-TMA

Omeros Corp. (OMER), a commercial-stage biopharmaceutical company, Monday said it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration. The CRL is regarding its Biologics License Application or BLA for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy or HSCT-TMA.

In pre-market activity on Nasdaq, Omeros shares were losing around 13.3 percent to trade at $6.70.

Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA. It has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.

The company noted that patients, following hematopoietic stem cell transplantation or HSCT, generally have complex clinical courses and are often severely ill. HSCT-TMA increases that complexity and worsens outcomes. In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval.

There were no chemistry, manufacturing and controls or CMC, safety, or non-clinical issues precluding approval raised in the CRL.

Omeros said it remains confident in the efficacy and safety data for narsoplimab in HSCT-TMA. The company worked closely with FDA on the clinical development plan, including with respect to both the single-arm trial to support approval and the definition of response as the primary endpoint.

The company plans to request a Type A meeting as soon as possible with FDA to discuss the CRL and determine the most expeditious path forward for the approval of narsoplimab in the treatment of HSCT-TMA.

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