SeaStar Medical (ICU) stock took a beating on Thursday after the company provided an update on its NEUTRALIZE-AKI pivotal trial. This trial is focused on the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT).
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SeaStar Medical noted that an independent Data Safety Monitoring Review Board has given its approval to continue the clinical trial. The board found no device-related safety concerns and noted signs of potential clinical benefit. It also recommended increasing enrollment from 200 to 339 patients. Currently, 137 patients have been enrolled in the clinical trial.
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, stated, “Sample size re-estimations are well established practices in pivotal trials, and while an upward re-estimation will extend the trial timeline, we are optimistic it will strengthen the statistical power and provide critical care teams with greater confidence in the results.”
SeaStar Medical Stock Movement Today
SeaStar Medical stock was down 45.65% in pre-market trading on Thursday, following a 6.9% rally yesterday. Investors were likely unhappy with talk of extending the clinical trial, which means it will be longer before results are published. The stock has also fallen 36.08% year-to-date and 69.46% over the past 12 months.
Today’s news triggered heavy trading of SeaStar Medical stock, as more than 2.3 million shares changed hands. For comparison, the company’s three-month daily average trading volume is about 1.24 million units.
Is SeaStar Medical Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for SeaStar Medical is Moderate Buy, based on a single Buy rating over the past three months. With that comes a $2 price target for ICU stock, representing a potential 61.29% upside for the shares.
