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NSPR 8-K: Fda approval

InspireMD

Filed with the SEC on · accession 0001493152-26-051453

NSPR filed a 8-K (current report) with the SEC on Nov 12, 2026. A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more. The stock moved -3.3% by the first close after the filing.

Summary of the filing

InspireMD announced that the U.S. FDA approved its Premarket Approval Supplement for the CGuard Prime TransCarotid Stent System for use in transcarotid artery revascularization (TCAR) procedures.

For details, click here →How to read a 8-K →

Key details

RegistrantInspireMD, Inc.
Regulatory agency granting approvalU.S. Food and Drug Administration
Chief executive officerMarvin Slosman

How NSPR stock reacted

Close before

$0.80

Nov 11, 2026

First close after

-3.25%

$0.77

5 trading days

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Since filing

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Frequently asked questions

What did NSPR file with the SEC on Nov 12, 2026?

NSPR filed a 8-K (Fda approval). InspireMD announced that the U.S. FDA approved its Premarket Approval Supplement for the CGuard Prime TransCarotid Stent System for use in transcarotid artery revascularization (TCAR) procedures.

What does a fda approval mean for NSPR stock?

For a small biotech one drug can be most of the company’s value. Approval opens sales; a rejection (complete response letter) can delay it by years.

How do I read a 8-K?

A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more. The "Item" number tells you the topic (e.g. 2.02 results, 5.02 executive change, 1.01 new agreement, 1.03 bankruptcy). Exhibits (99.1 press release) usually hold the details.

Why are SEC filings important?

Public companies must tell the SEC about anything that can change their value — results, leadership changes, big deals, new shares, bankruptcy. Filings are the official source, often before the news. A 8-K (current report): A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more.

How did NSPR stock react to this filing?

NSPR closed at $0.80 before the filing and $0.77 on Nov 12, 2026 (-3.25%).

Other NSPR SEC filings

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