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format="ixt-sec:exchnameen" name="dei:SecurityExchangeName" id="Tc_DVqiOJEYL0Grdz5W1kBKAQ_1_2">The Nasdaq Stock Market LLC</ix:nonNumeric></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:6pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule&#160;405 under the Securities Act of 1933 (17 CFR&#160;230.405) or Rule&#160;12b-2&#160;under the Securities Exchange Act of 1934&#160;(17 CFR&#160;240.12b-2).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:6pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:right;margin:0pt;">Emerging growth company <ix:nonNumeric contextRef="Duration_5_20_2021_To_5_20_2021_R6nY3IHHL0GSVeiW4i3ADg" format="ixt-sec:boolballotbox" name="dei:EntityEmergingGrowthCompany" id="Narr_xXz7Kxamu0KuEcGTWqG_8g"><span style="font-family:'Segoe UI Symbol';">&#9744;</span></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:6pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. <span style="font-family:'Segoe UI Symbol';">&#9744;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;"><span style="font-size:6pt;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-bottom:1pt;padding-top:1pt;text-indent:0pt;border-bottom:3.0pt solid #000000;border-top:1px solid #000000;margin:0pt;"><span style="font-size:1pt;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;"><span style="font-size:6pt;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="display:none;font-family:'Times New Roman','Times','serif';line-height:0pt;margin:0pt;"><span style="font-size:0pt;visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:45pt;text-indent:-45pt;margin:0pt 0pt 6pt 0pt;"><b style="font-weight:bold;">Item 8.01 Other Events.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">On May 20, 2021, Omeros Corporation (the &#8220;Company&#8221;) announced that the U.S. Food and Drug Administration (the &#8220;FDA&#8221;) has extended the review period for the biologics license application (&#8220;BLA&#8221;) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (&#8220;HSCT-TMA&#8221;). In a notice received from the FDA on May 19, 2021, the Company was informed that the new Prescription Drug User Fee Act (&#8220;PDUFA&#8221;) target action date for its Priority Review of narsoplimab is October 17, 2021.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">The Company&#8217;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. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:2.35pt;padding-right:2.35pt;width:100%;"><tr style="height:1pt;"><th style="font-weight:normal;text-align:left;vertical-align:top;width:15.43%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></th><th style="font-weight:normal;text-align:left;vertical-align:top;width:3.12%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div></th><th style="font-weight:normal;text-align:left;vertical-align:bottom;width:81.44%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></th></tr><tr><th style="font-weight:normal;text-align:left;vertical-align:top;width:15.43%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><b style="font-weight:bold;">Item&#160;9.01</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;">(d) Exhibits.</p></th><th style="font-weight:normal;text-align:left;vertical-align:top;width:3.12%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p></th><th style="font-weight:normal;text-align:left;vertical-align:bottom;width:81.44%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><b style="font-weight:bold;">Financial Statements and Exhibits.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p></th></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td></tr><tr><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;text-decoration:underline;text-decoration-color:#000000;">Exhibit&#160;Number</b></p></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;text-decoration:underline;text-decoration-color:#000000;">Description</b></p></td></tr><tr><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">99.1</p></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><a style="-sec-extract:exhibit;" href="omer-20210520xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;text-align:left;">Press Release dated May 20, 2021.</span></a></p></td></tr><tr><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">104</p></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Cover Page Interactive Data File (embedded within the Inline XBRL document)</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-align:center;margin:0pt 0pt 12pt 0pt;">SIGNATURES</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p></td><td colspan="2" style="vertical-align:bottom;width:49.91%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">OMEROS CORPORATION</b></p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:middle;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Date: May 20, 2021</p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">By:</p></td><td style="vertical-align:bottom;width:46.21%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Gregory A. Demopulos</p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;border-top:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Gregory A. Demopulos, M.D.</p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">President, Chief Executive Officer and</p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Chairman of the Board of Directors</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;margin-left:10.35%;margin-right:10.35%;margin-top:30pt;page-break-after:avoid;width:79.3%;border:0;"></div></body></html>
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​
​
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT REPORT
​
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
​
Date of Report (Date of earliest event reported):
May 20, 2021
OMEROS CORPORATION
(Exact name of Registrant as Specified in Its Charter)
​
Washington
001-34475
91-1663741
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
201 Elliott Avenue West
Seattle
,
WA
98119
(Address of Principal Executive Offices)
(Zip Code)
​
Registrant's Telephone Number, Including Area Code: (
206
)
676-5000
​
(Former Name or Former Address, if Changed Since Last Report)
​
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
​
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
​
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
​
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
​
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
​
Securities Registered Pursuant to Section 12(b) of the Act:
​
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common stock, $0.01 par value per share
OMER
The Nasdaq Stock Market LLC
​
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 under the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 under the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
​
Emerging growth company
☐
​
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
​
​
​
​
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
(d) Exhibits.
​
Financial Statements and Exhibits.
​
​
​
​
​
Exhibit Number
Description
99.1
Press Release dated May 20, 2021.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
​
​
​
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
​
​
​
​
OMEROS CORPORATION
​
​
​
Date: May 20, 2021
By:
/s/ Gregory A. Demopulos
​
​
Gregory A. Demopulos, M.D.
​
​
President, Chief Executive Officer and
​
​
Chairman of the Board of Directors
​
​