CONCORD, Calif. - Cerus (NASDAQ:CERS) Corporation (NASDAQ:CERS) received approval from the U.S. Food and Drug Administration (FDA) to extend the shelf life of its INTERCEPT Platelet Processing Sets to 12 months.
This extension, effective immediately, adds six months to the product's previous shelf life and is applicable to all sizes of the INTERCEPT sets available in the United States.
The company's chief operating officer, Vivek Jayaraman, expressed satisfaction with the FDA's timely decision, anticipating that the longer shelf life will ease inventory management for customers and reduce the risk of product expiration. Cerus Corporation is also gathering additional data to potentially further extend the shelf life beyond 12 months.
Cerus, headquartered in Concord, California, focuses on enhancing the safety of the global blood supply. The INTERCEPT Blood System, including the platelet and plasma processing sets, is the only pathogen reduction system approved by both the FDA and CE marked for these blood components. The company is also working on regulatory approval in Europe for the INTERCEPT red blood cell system and has an FDA-approved INTERCEPT Blood System for Cryoprecipitation in the U.S.
The approval is based on the company's regulatory filing with the FDA and is expected to provide operational benefits to Cerus's customers by allowing for more flexible inventory management. This announcement is based on a press release statement from Cerus Corporation.
InvestingPro Insights
Cerus Corporation (NASDAQ:CERS), a company dedicated to safeguarding the global blood supply, recently received FDA approval to extend the shelf life of its INTERCEPT Platelet Processing Sets. While this development is a positive step for the company, a look at the financial metrics from InvestingPro provides a broader picture of the company's current market standing.
InvestingPro Data indicates a market capitalization of $317.24 million, reflecting the company's valuation in the market. Despite the promising FDA approval, Cerus has been facing financial headwinds, as evidenced by a negative price-to-earnings (P/E) ratio of -9.02 for the last twelve months as of Q4 2023. This suggests that the company has not generated profit relative to shareholder investments during this period. Additionally, the Price / Book ratio stands at 6.03, which is considered high, indicating that the stock may be overvalued compared to the company's book value.
InvestingPro Tips highlight some concerns, including the company's rapid cash burn and the lack of profitability over the last twelve months. Analysts are not optimistic about Cerus turning a profit this year. Moreover, the stock has seen a significant decline over the past week, month, and year, with a one-year price total return of -39.66%, signaling a period of underperformance in the market.
On a positive note, Cerus's liquid assets do exceed its short-term obligations, which can provide some financial stability in the near term. The company also operates with a moderate level of debt, which could be a mitigating factor in its financial strategy. However, it's worth noting that Cerus does not offer a dividend, which may influence investor decisions, especially those seeking regular income from their investments.
For readers looking to delve deeper into Cerus Corporation's financial health and stock performance, there are additional InvestingPro Tips available at https://www.investing.com/pro/CERS. And for those interested in a subscription, use the coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking even more insights and data to inform your investment decisions.
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