UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
As previously planned and disclosed, Ray Aspiri has retired from the board of directors of Omeros Corporation (the “Company”). His resignation was submitted and effective on October 14, 2021, and was not the result of any disagreement with the Company or any matter relating to the Company’s operations, policies or practices.
Item 7.01 Regulation FD Disclosure.
On October 18, 2021, the Company issued a press release announcing the receipt of a complete response letter from the U.S. Food and Drug Administration (the “FDA”) regarding the Company’s Biologics License Application (“BLA”) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”).
A copy of the press release is furnished as Exhibit 99.1 hereto.
Item 8.01 Other Events.
On October 18, 2021, the Company issued a press release announcing the receipt of a complete response letter from FDA regarding the Company’s BLA for narsoplimab in the treatment of HSCT-TMA.
In the complete response letter, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval. There were no chemistry, manufacturing and controls (CMC), safety, or non-clinical issues precluding approval raised in the complete response letter.
The Company plans to request a Type A meeting as soon as possible with FDA to discuss the complete response letter and determine the most expeditious path forward for the approval of narsoplimab in the treatment of HSCT-TMA.
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including expectations with regard to interactions and communications with FDA and the Company’s pursuit of regulatory approval for narsoplimab in HSCT-TMA, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, regulatory processes and oversight, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Item 9.01 (d) Exhibits. | Financial Statements and Exhibits. |
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Exhibit Number | Description |
99.1 | |
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: October 18, 2021 | By: | /s/ Gregory A. Demopulos |
Gregory A. Demopulos, M.D. | ||
President, Chief Executive Officer and | ||
Chairman of the Board of Directors | ||