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

Issuer:     AEON Biopharma, Inc. (AEON)
CIK:        0001837607
Form:       8-K
Filed at:   2023-10-19T23:59:59+00:00
Accession:  0001104659-23-110119
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

AEON Biopharma Phase 2 migraine trial misses primary endpoint; secondary endpoints statistically significant
--------------------------------------------------------------------------------

- Primary endpoint not met: mean MMD reduction of 4.8 days (150U) and 5.0 days (195U) vs 4.2 days placebo; p-values not significant (0.2844, 0.1711).
- Secondary endpoint: 69% of 195U dose achieved ≥50% MMD reduction vs 52% placebo (p=0.0132); 75% reduction significant for both doses.
- Safety profile favorable; Company plans to advance to Phase 3 and request end-of-phase 2 FDA meeting in H1 2024.
- Ongoing Phase 2 for chronic migraine to complete enrollment in Q4 2023; topline data expected in H2 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1837607/000110465923110119/0001104659-23-110119-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1837607/000110465923110119/tm2328542d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-110119

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