Omeros receives FDA Complete Response Letter for narsoplimab BLA; director Ray Aspiri retires

OMEROS CORP

Ray Aspiri retired from Omeros board effective Oct 14, 2021, with no disagreement with the company.
FDA issued a Complete Response Letter for narsoplimab BLA for HSCT-TMA, citing difficulty estimating treatment effect.
FDA stated additional information is needed to support regulatory approval of narsoplimab for HSCT-TMA.
No CMC, safety, or non-clinical issues precluding approval were raised in the FDA Complete Response Letter.
Omeros plans to request a Type A meeting with FDA to discuss the most expeditious path for narsoplimab approval.

item 5.02 item 7.01 item 8.01 item 9.01

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Departed

Ray Aspiri

Director

OMER · OMEROS CORP

Effective: 2021-10-14
Filed: October 18, 2021, 7:59 PM ET

Ray Aspiri has retired from the board of directors of Omeros Corporation (the “Company”).

Key facts

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Executive change SEC 8-K Item 5.02 confidence 1.0

Ray Aspiri retired as Director at OMEROS CORP.

Action: retired
Role: Director

Exact text from the filing

Ray Aspiri has retired from the board of directors of Omeros Corporation (the “Company”).

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OMEROS CORP filing history →

Source: SEC EDGAR

accession 0001558370-21-013245

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