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OMEROS CORPORATION

(OMER)
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Omeros Says FDA Needs More Information to Support Regulatory Approval for Narsoplimab

10/18/2021 | 04:57am EST

By Dave Sebastian

Omeros Corp. said the U.S. Food and Drug Administration, in a complete response letter for a biologics license application, expressed the need for more information for the regulatory approval of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

The biopharmaceutical company on Monday said the FDA expressed difficulty in estimating narsoplimab's treatment effect. It said the letter didn't raise chemistry, manufacturing and controls, safety or non-clinical issues precluding approval.

The company said it plans to ask for a type A meeting with the FDA as soon as possible.

Omeros said its management will host a conference call Monday at 8:30 a.m. eastern time about the development.

Write to Dave Sebastian at dave.sebastian@wsj.com

(END) Dow Jones Newswires

10-18-21 0657ET

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Analyst Recommendations on OMEROS CORPORATION
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Financials (USD)
Sales 2021 130 M - -
Net income 2021 -88,1 M - -
Net Debt 2021 181 M - -
P/E ratio 2021 -4,98x
Yield 2021 -
Capitalization 430 M 430 M -
EV / Sales 2021 4,71x
EV / Sales 2022 7,01x
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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