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OMEROS CORPORATION

(OMER)
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Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA

10/18/2021 | 06:30am EST

Omeros Corporation announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Following HSCT, patients 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 (CMC), safety, or non-clinical issues precluding approval raised in the CRL. Omeros 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. Omeros 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. 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.


ę S&P Capital IQ 2021
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Financials (USD)
Sales 2021 130 M - -
Net income 2021 -88,1 M - -
Net Debt 2021 306 M - -
P/E ratio 2021 -4,91x
Yield 2021 -
Capitalization 430 M 430 M -
EV / Sales 2021 5,68x
EV / Sales 2022 6,04x
Nbr of Employees 277
Free-Float 95,9%
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Mean consensus OUTPERFORM
Number of Analysts 7
Last Close Price 6,87 $
Average target price 18,50 $
Spread / Average Target 169%
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Managers and Directors
Gregory A. Demopulos Chairman, President & Chief Executive Officer
Michael A. Jacobsen Chief Financial Officer, Treasurer & VP
George A. Gaitanaris Chief Scientific Officer & Vice President-Science
J. Steven Whitaker Chief Medical Officer & Vice President
Thomas J. Cable Lead Independent Director
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