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Why Is SeaStar Medical (ICU) Stock Down 32% Today?


  • SeaStar Medical (ICU) stock is dropping on an update from the Food and Drug Administration (FDA).
  • The FDA didn’t approve an application for one of SeaStar’s medical devices.
  • That sent shares of ICU down today as the rejection hurt investor morale.
ICU Stock - Why Is SeaStar Medical (ICU) Stock Down 32% Today?

Source: Roman Zaiets / Shutterstock.com

SeaStar Medical (NASDAQ:ICU) stock is falling on Wednesday after the medical technology company got an update from the Food and Drug Administration (FDA).

What’s hitting ICU stock is the FDA not approving its Humanitarian Device Exemption (HDE) application for pediatric Selective Cytopheretic Device (SCD). This device is designed to treat children suffering from acute kidney injury (AKI) on continuous kidney replacement therapy (CKRT).

According to a news release from SeaStar Medical, the rejection letter comes from the FDA’s Center for Biologics Evaluation and Research (CBER). While CEBR says the application isn’t approvable in its current form, it did provide guidance for the company to adjust its application. This may allow a resubmission that meets the FDA’s standards.

Eric Schlorff, CEO of SeaStar Medical, said the following about the FDA news hitting ICU stock today:

“We believe that each of the current deficiencies cited by the Agency in their letter are readily addressable. However, we intend to initially request FDA’s administrative review and submit an appeal if needed. In parallel, we plan to implement other mitigations, where appropriate, and continue working with CBER with the goal of achieving pediatric HDE approval.”

How This Affects ICU Stock Today

Shares of ICU stock are seeing decent on Wednesday as investors sell shares on the FDA news. More than 60,000 shares of the stock have changed hands before markets opened today. That’s quickly approaching the company’s daily average trading volume of roughly 100,000 shares.

ICU stock is down 32.1% as of Wednesday morning.

There’s more stock market news traders will want to know about below!

We’ve got all of the most important stock market coverage traders need for Wednesday! That includes everything happening with shares of Babylon (NYSE:BBLN), CTI BioPharma (NASDAQ:CTIC), and Unique Fabricating (NYSEMKT:UFAB) stock today. All of that news is ready to go at the following links!

More Wednesday Stock Market News

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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Article printed from InvestorPlace Media, https://investorplace.com/2023/05/why-is-seastar-medical-icu-stock-down-32-today/.

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