NTHI 8-K: Fda approval
NeOnc Technologies
Filed with the SEC on · accession 0001829126-26-012414
NTHI filed a 8-K (current report) with the SEC on Nov 13, 2026. NeOnc Technologies announced that the FDA granted a Type B End-of-Phase meeting to discuss a potential accelerated approval pathway for intranasal NEO100 in recurrent or progressive IDH-mutant grade 4 astrocytoma, scheduled for early January 2027. The stock moved +1.2% by the first close after the filing.
Summary of the filing
NeOnc Technologies announced that the FDA granted a Type B End-of-Phase meeting to discuss a potential accelerated approval pathway for intranasal NEO100 in recurrent or progressive IDH-mutant grade 4 astrocytoma, scheduled for early January 2027. Separately, CEO Amir Heshmatpour purchased 80,000 shares of common stock in open-market transactions.
Key details
How NTHI stock reacted
Close before
$4.85
Nov 12, 2026
First close after
+1.24%
$4.91
5 trading days
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Since filing
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Click hereFrequently asked questions
What did NTHI file with the SEC on Nov 13, 2026?
NTHI filed a 8-K (Fda approval). NeOnc Technologies announced that the FDA granted a Type B End-of-Phase meeting to discuss a potential accelerated approval pathway for intranasal NEO100 in recurrent or progressive IDH-mutant grade 4 astrocytoma, scheduled for early January 2027. Separately, CEO Amir Heshmatpour purchased 80,000 shares of common stock in open-market transactions.
What does a fda approval mean for NTHI 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 NTHI stock react to this filing?
NTHI closed at $4.85 before the filing and $4.91 on Nov 13, 2026 (+1.24%).
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