Cerus advances European regulatory review for INTERCEPT RBC system

CONCORD, Calif. - Cerus Corporation (NASDAQ:CERS), a $283 million market cap biotech company whose stock has surged over 12% in the past week according to InvestingPro data, announced Wednesday that the European regulatory review for its INTERCEPT Red Blood Cells (RBC) system is progressing ahead of schedule. The company’s Notified Body, TÜV-SÜD, has completed its review of the clinical module for the CE Mark submission and transferred information to the Czech Republic’s State Institute for Drug Control (SÚKL) for consultation.

This regulatory milestone allows SÚKL to begin reviewing the active pharmaceutical ingredient (API) module. The Czech authority has agreed to serve as the Competent Authority for the submission, as anticipated by Cerus.

"We are looking forward to working collaboratively with both TÜV-SÜD and SÚKL to facilitate the completion of the review process for our enhanced CE Mark submission for the INTERCEPT RBC system," said William "Obi" Greenman, Cerus’ president and chief executive officer, according to the press release. The company has shown promising revenue growth of 13% over the last twelve months, though InvestingPro analysis indicates analysts don’t expect profitability this year. Get deeper insights into Cerus’s financial health and growth prospects with InvestingPro’s comprehensive research report, available along with 6 additional ProTips.

The clinical module reviewed by TÜV-SÜD included results from the U.S. Phase 3 ReCePI clinical trial, which expands the CE Mark submission to cover all patient indications for RBC transfusion. Following SÚKL’s review of the API module, the submission will return to TÜV-SÜD for completion of manufacturing facility audits and certification prior to a CE Mark decision.

Under the European Medical Device Regulation, CE Mark submission reviews for Class III devices like the INTERCEPT RBC system require evaluation by both Notified Bodies and Competent Authorities.

The INTERCEPT Blood System for platelets and plasma is already available globally with both CE Mark and FDA approval. In the U.S., the INTERCEPT RBC system remains in late-stage clinical development.

The information in this article is based on a press release statement from Cerus Corporation. With a current ratio of 2.32, the company maintains strong liquidity to support its regulatory initiatives and product development. Access detailed financial metrics and expert analysis for CERS and 1,400+ other stocks through InvestingPro’s exclusive research reports.

In other recent news, Cerus Corporation reported its Q1 2025 earnings with a net loss of $7.7 million, or $0.04 per share, aligning with analyst expectations. The company’s revenue reached $48.9 million, slightly below the projected $49.61 million, despite a 13% year-over-year increase in product revenue. North American sales were particularly strong, with a 22% increase, while the EMEA region saw a slight decline. Additionally, Cerus received regulatory approvals for its INT200 blood safety device in France and Switzerland, following a CE Mark authorization in March. These approvals are part of the company’s strategy to transition its existing devices to the INT200 model in the EMEA region over the next three years.

Cantor Fitzgerald maintained an Overweight rating on Cerus stock, emphasizing the growth potential in the platelet market due to these regulatory advancements. Cerus is also preparing further regulatory submissions, including a planned premarket approval submission to the U.S. FDA in 2026. Moreover, Cerus shareholders recently approved an amendment to the company’s 2024 Equity Incentive Plan during their Annual Meeting. The company plans to present new clinical data on its INTERCEPT Blood System at the upcoming ISBT Congress, highlighting its commitment to enhancing blood safety.

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