secwatch.observer — SEC 8-K summary
======================================

Issuer:     ZEVRA THERAPEUTICS, INC. (ZVRA)
CIK:        0001434647
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0001437749-24-034565
Event type: earnings
Sentiment:  neutral
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zevra Q3 net loss $33.2M; FDA approval of MIPLYFFA for NPC marks key milestone
------------------------------------------------------------------------------

- Net loss of $33.2M ($0.69 per share) vs. $10.4M loss in Q3 2023; revenue $3.7M from French EAP and AZSTARYS royalties.
- FDA approved MIPLYFFA (arimoclomol) on Sept. 20 for Niemann-Pick type C; first-ever NPC drug approved.
- Cash, equivalents, and investments $95.5M as of Sept. 30; cash runway forecast into 2027, excluding PRV sale.
- Completed $64.5M public offering of 10.6M shares at $6.50; closed Iowa/Virginia labs, outsources early R&D.
- OLPRUVA revenue minimal; 90 prescription enrollment forms for MIPLYFFA received by Oct. 31, 30% approved for reimbursement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1434647/000143774924034565/0001437749-24-034565-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1434647/000143774924034565/zvra20240819_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-034565

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