Welcome to our dedicated page for Cerus news (Ticker: CERS), a resource for investors and traders seeking the latest updates and insights on Cerus stock.
Cerus Corporation (NASDAQ: CERS) is a biomedical products company focused on blood transfusion safety through its INTERCEPT Blood System and related technologies. This news page aggregates company announcements, financial updates, clinical milestones, and partnership news that Cerus releases through channels such as Business Wire and SEC-furnished press releases.
Readers can find coverage of quarterly and annual financial results, where Cerus reports product revenue from INTERCEPT platelet, plasma, and INTERCEPT Fibrinogen Complex (IFC) sales, along with government contract revenue tied to research and development programs. These releases often include updated product revenue guidance ranges and commentary on commercial performance in various geographies.
The news flow also highlights clinical and regulatory developments, including progress of the INTERCEPT red blood cell system in late-stage clinical development, Phase 3 trials such as RedeS, and regulatory review activities in Europe and the United States. Updates on the INT200 LED-based illumination device and development of lyophilized IFC (LyoIFC), supported by U.S. Department of Defense funding, are also featured.
In addition, Cerus issues news about strategic collaborations and industry engagement, such as group purchasing agreements with organizations like Blood Centers of America and participation in professional meetings, workshops, and conferences in transfusion medicine. These items describe efforts to expand access to pathogen-protected blood components and to share data on INTERCEPT technologies.
Investors, clinicians, and other stakeholders can use this page to follow Cerus’ latest disclosures on product adoption, revenue trends, government-supported projects, and scientific presentations related to blood safety and pathogen reduction.
Cerus Corporation (Nasdaq: CERS) has secured an additional $7.2 million contract amendment from the U.S. Department of Defense (DoD) to advance the development of lyophilized INTERCEPT Fibrinogen Complex (LyoIFC) for treating trauma-related bleeding. This supplements their existing $18 million DoD contract for developing room-temperature, shelf-stable LyoIFC.
The new funding will support the CRYO-FIRST study, a 320-patient randomized trial comparing pre-thawed IFC to conventional cryoprecipitated antihemophilic factor in trauma patients with hemorrhagic shock. The study aims to evaluate the effectiveness of early fibrinogen administration in trauma patients and will begin enrollment in early 2026.
Since receiving initial DoD funding in November 2022, Cerus has achieved key milestones including FDA pathway discussions, successful process scale-up, and prototype delivery to the DoD.
Cerus Corporation (Nasdaq: CERS) announced progress in its European regulatory review for the INTERCEPT Red Blood Cells (RBC) system. The company's Notified Body, TÜV-SÜD, has completed reviewing the clinical module of the CE Mark submission and transferred information to the Czech Republic's State Institute for Drug Control (SÚKL).
The clinical module includes positive results from the U.S. Phase 3 ReCePI trial, expanding the CE Mark submission to cover all patient indications for RBC transfusion. SÚKL will now review the API module before TÜV-SÜD conducts manufacturing facility audits for final CE Mark decision.
Cerus Corporation (CERS) will present clinical data for its INTERCEPT Blood System at the 35th Regional International Society of Blood Transfusion Congress in Milan from May 31 to June 4, 2025. The presentations will highlight data on the system's applications for platelets, plasma, cryoprecipitated fibrinogen complex, and red blood cells.
Key presentations include positive results from the Phase 3 ReCePI study in red blood cells, INTERCEPT treated cold stored platelets, and effective inactivation of California encephalitis virus. The event features a Cerus-sponsored symposium focusing on INTERCEPT's impact on adverse events, platelet use, and inventory management in France, along with its safety in neonates.
Multiple oral and poster presentations will cover topics including cold-stored platelet concentrates, reduced hemoglobin use in cardiac surgery, and pathogen reduction effectiveness.
Cerus (CERS) has scheduled the release of its first quarter 2025 financial results for Thursday, May 1, 2025, after market close. The company will host a conference call and webcast at 4:30 P.M. ET on the same day to discuss financial performance and provide business updates.
Management will present detailed financial results and offer a general business overview and outlook during the call. A replay of the event will be accessible on Cerus' website until May 22, 2025.
Cerus (CERS) has received CE mark approval for its next-generation LED-based illumination device (INT200) for the INTERCEPT Blood System for platelets and plasma under the EU Medical Device Regulation (MDR). This approval enables Cerus to market the INT200 throughout the European Union and regions recognizing CE mark certification.
The INT200 represents a significant upgrade featuring enhanced physical design and new software interface while maintaining compatibility with existing processing sets. This approval completes the authorization of the INTERCEPT Blood System for both platelets and plasma within the EU MDR framework, following the 2023 CE mark approvals of INTERCEPT processing sets.
The CE mark represents the first regulatory approval for Cerus' next-generation illuminator, with additional regulatory submissions planned over coming years. The INT200 will serve as the foundation for geographic expansion and future growth of the INTERCEPT business.
Cerus (CERS) reported strong financial results for full-year and Q4 2024. Full-year product revenue reached $180.3 million, up 15% year-over-year, while Q4 product revenue was $50.8 million, a 9% increase. The company achieved significant financial improvements, including a 40% reduction in GAAP net loss to $20.9 million and positive non-GAAP adjusted EBITDA of $5.7 million for 2024.
Notable achievements include four consecutive quarters of positive operating cash flows, totaling $11.4 million for the year, a $55 million improvement from 2023. The INTERCEPT Fibrinogen Complex (IFC) product showed strong growth, with full-year revenue of $9.2 million, up 42% from the previous year.
The company reiterated its 2025 product revenue guidance of $194-200 million, including $12-15 million for IFC, projecting 8-11% growth from 2024.
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