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Cerus (CERS) guidance and outlook

Cerus (CERS) reaffirmed its guidance on Nov 2, 2026: Revenue (segment) $229M–$231M for FY2026; Revenue (segment) +11% to +12% for FY2026. Cerus' 10-Q filed Nov 2, 2026 makes 46 forward-looking statements.

Guidance and outlook

Latest guidance

From the earnings release filed Nov 2, 2026 (8-K on EDGAR).

Forward-looking statements, 10-Q filed Nov 2, 2026

• future sales of and anticipated demand for, and our ability to effectively commercialize and achieve market acceptance of the INTERCEPT™ Blood System, including our ability to comply with applicable United States, or U.S., and foreign laws, regulations and regulatory requirements;
• the timing or likelihood of regulatory submissions and approvals and other regulatory actions or interactions, including whether existing clinical data will be sufficient in order to obtain a CE Certificate of Conformity and affix a CE Mark to the red blood cell system and whether our planned modular premarket approval, or PMA, application for the red blood cell system will be submitted to the U.S.
• Food and Drug Administration, or FDA, on the timeline we anticipate or at all;
• the ability of our products to inactivate the emerging viruses and other pathogens that we may target in the future;
• We cannot predict if or when we will be able to provide sufficient data or if a decision concerning certification will occur in the time frame we anticipate or at all.
• In addition, as a result of the resubmission of our MDR application, our product development costs will be ongoing.
• We continue to believe that we will need to generate additional data and complete other necessary activities before the FDA will consider our red blood cell system for potential approval, including completion of our recently initiated prospective, open-label, controlled Phase 2 study, known as the Challenge study, designed to determine whether INTERCEPT RBC transfusions into patients with pre-existing antibodies…
• If treatment emergent antibody reactions associated with hemolysis are observed, the FDA will require us to place a clinical hold and we will need to investigate the underlying cause.
• In any event, for our planned modular PMA application, we will seek to introduce supplemental clinical data we obtained from European clinical trials, though we cannot provide assurance that we will be able to demonstrate comparability or that the FDA will allow supplemental clinical European data, or that we will be able to generate European data in a timely manner.
• In addition, if we are unable to generate the additional data needed for licensure, we will need to reach agreement with the FDA on a new pathway to generate sufficient data for the red blood cell system.
• We do not know whether or not the FDA will have a similar perspective on the information regarding the medicinal product as CBG, or that we will be able to answer such questions satisfactorily, should they arise.
• If we are unable to access all of the activities and associated reimbursement amounts for the remaining options available under our 2024 BARDA Agreement or if we are unable to add additional options and respective reimbursement amounts to fund further activities that may be required to meet licensure requirements, we will need to self-fund the activities required to satisfy the requirements for PMA licensure in…

Cerus' latest quarter

Questions

Did Cerus raise or lower its guidance?

Cerus (CERS) reaffirmed its guidance on Nov 2, 2026: Revenue (segment) $229M–$231M for FY2026; Revenue (segment) +11% to +12% for FY2026.

What does Cerus expect?

future sales of and anticipated demand for, and our ability to effectively commercialize and achieve market acceptance of the INTERCEPT™ Blood System, including our ability to comply with applicable United States, or U.S., and foreign laws, regulations and regulatory requirements; the timing or likelihood of regulatory submissions and approvals and other regulatory actions or interactions, including whether existing clinical data will be sufficient in order to obtain a CE Certificate of Conformity and affix a CE Mark to the red blood cell system and whether our planned modular premarket approv

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.