Item 8.01 Other Events.
On May 20, 2021, Omeros Corporation (the "Company") announced that the U.S. Food
and Drug Administration (the "FDA") has extended the review period for the
biologics license application ("BLA") for narsoplimab for the treatment of
hematopoietic stem cell transplant-associated thrombotic microangiopathy
("HSCT-TMA"). In a notice received from the FDA on May 19, 2021, the Company was
informed that the new Prescription Drug User Fee Act ("PDUFA") target action
date for its Priority Review of narsoplimab is October 17, 2021.
As part of the ongoing BLA Priority Review, the Company recently submitted a
response to an FDA information request. FDA has classified the response as a
major amendment, which requires additional time to review.
The Company's press release, dated May 20, 2021, announcing the extension in the
PDUFA target action date is filed with this Form 8-K as Exhibit 99.1 and is
incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number Description
99.1 Press Release dated May 20, 2021.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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