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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 112 M - -
Net income 2021 -108 M - -
Net Debt 2021 306 M - -
P/E ratio 2021 -4,44x
Yield 2021 -
Capitalization 465 M 465 M -
EV / Sales 2021 6,90x
EV / Sales 2022 5,45x
Nbr of Employees 277
Free-Float 95,9%
Chart OMEROS CORPORATION
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Omeros Corporation Technical Analysis Chart | OMER | US6821431029 | MarketScreener
Technical analysis trends OMEROS CORPORATION
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Mean consensus OUTPERFORM
Number of Analysts 7
Last Close Price 7,43 $
Average target price 18,50 $
Spread / Average Target 149%
EPS Revisions
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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