Omeros Confirms Submission of Response to FDA Regarding the BLA for Narsoplimab in the Treatment of HSCT-TMA

Rhea-AI Summary

Omeros Corporation (NASDAQ: OMER) has submitted its response to the FDA regarding the Complete Response Letter (CRL) for narsoplimab, aimed at treating HSCT-TMA. The comprehensive package was developed with external experts to address the FDA's concerns. Omeros has also requested a Type A meeting to clarify remaining issues. Narsoplimab is the first candidate for HSCT-TMA treatment, holding Breakthrough Therapy and Orphan designations. The company focuses on developing therapeutics for immunologic diseases and has ongoing late-stage clinical programs.

Positive

• Submission of response to FDA's CRL for narsoplimab demonstrates commitment to regulatory approval.
• Narsoplimab is the first drug candidate for HSCT-TMA, potentially positioning Omeros as a leader in this niche market.

Negative

• The submission of the CRL indicates previous issues with the drug's approval process.
• Ongoing regulatory uncertainty could delay commercialization and impact financial performance.

SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today confirmed that earlier this month the company submitted to the U.S. Food and Drug Administration (FDA) its response to the Agency’s Complete Response Letter (CRL) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory and legal experts that addresses in detail the points raised by FDA in its CRL for narsoplimab. Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.

Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA. It has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

Forward-Looking Statements

This press release 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 Omeros’ 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. Omeros’ 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220119006120/en/

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

Source: Omeros Corporation

FAQ

What is the latest update from Omeros Corporation regarding narsoplimab?

Omeros submitted a response to the FDA's Complete Response Letter for narsoplimab, aimed at HSCT-TMA.

What does the Complete Response Letter mean for Omeros Corporation?

The CRL indicates that the FDA has identified issues that must be resolved before narsoplimab can be approved.

What are the designations held by narsoplimab?

Narsoplimab holds Breakthrough Therapy and Orphan designations for HSCT-TMA and IgA nephropathy.

What steps is Omeros taking to address the FDA's concerns?

Omeros is collaborating with external experts to respond comprehensively to the FDA's concerns and has requested a Type A meeting.

How might the FDA's response impact Omeros stock (OMER)?

Regulatory outcomes and timelines can significantly impact Omer's stock performance, influencing investor sentiment.