secwatch.observer — SEC 8-K summary
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Issuer:     ZEVRA THERAPEUTICS, INC. (ZVRA)
CIK:        0001434647
Form:       8-K
Filed at:   2024-03-04T23:59:59+00:00
Accession:  0001437749-24-006365
Event type: regulatory
Sentiment:  negative
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends arimoclomol review; new PDUFA date Sept 21, 2024
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- FDA extended review of arimoclomol NDA for Niemann-Pick disease type C; new PDUFA action date Sept 21, 2024 (was June 21, 2024).
- FDA determined additional analyses submitted by Zevra constitute a Major Amendment, causing the extension.
- FDA reaffirmed intent to present the resubmission at an advisory committee meeting to be scheduled.
- CEO McFarlane notes NPC patient advocacy petition; early access program continues.
- Zevra previously announced acceptance of NDA resubmission in early January 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1434647/000143774924006365/0001437749-24-006365-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1434647/000143774924006365/zvra20240303_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-006365

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer