Item 8.01 Other Events.
On October 1, 2021, Omeros Corporation (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) notified the Company that, as part of FDA’s ongoing review of the Company’s Biologics License Application (“BLA”) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. FDA stated that the notification does not reflect a final decision on the information under review.
FDA did not provide specific details of the deficiencies in its notification; however, in a meeting held September 30, 2021, FDA expressed its intention to work with the Company to resolve any issues as expeditiously as possible, but the Company does not currently expect any such resolution to occur by the October 17, 2021 target action date under the Prescription Drug User Fee Act. The Company is evaluating potential next steps as it awaits additional information from FDA and plans to obtain FDA approval for narsoplimab in HSCT-TMA, a frequently lethal complication of HSCT for which there is no FDA-approved treatment, as quickly as possible.
The Company’s press release, dated October 1, 2021, announcing the notification from FDA is filed with this Form 8-K as Exhibit 99.1 and is incorporated by reference herein.
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, FDA’s review of the Company’s BLA for narsoplimab in HSCT-TMA 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.
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Item 9.01 (d) Exhibits. | | Financial Statements and Exhibits. |
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