secwatch.observer — SEC 8-K summary
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Issuer:     Veradermics, Inc (MANE)
CIK:        0001827635
Form:       8-K
Filed at:   2026-10-19T13:06:14+00:00
Accession:  0001827635-26-000036
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Veradermics VDPHL01 hits all Phase 3 '304' endpoints; TAHC up 28.6-36.4 hairs/cm² vs 6.6 placebo
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- Study '304' randomized 536 males with mild-to-moderate pattern hair loss to VDPHL01 8.5mg once-daily, twice-daily or placebo; all primary and secondary endpoints met (p<0.0001).
- Non-vellus target area hair count rose 28.6 hairs/cm² (QD) and 36.4 hairs/cm² (BID) at Month 6 vs 6.6 for placebo; significant separation from placebo seen as early as Month 2.
- 55.7% (QD) and 68.7% (BID) reported 'improved' or 'much improved' hair coverage on AAIRS vs 15.0% placebo; investigator IGA rated 78.4% and 82.7% improved.
- No treatment-related SAEs and no cardiac AESIs; hypertrichosis was the only TEAE >5% with an imbalance (2.2% QD, 9.0% BID); peripheral edema 2.8%/4.5% vs 0.6% placebo.
- Part B 12-month data from Study '302' expected later in 2026; female pattern hair loss Study '306' topline anticipated in H1 2027.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1827635/000182763526000036/0001827635-26-000036-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1827635/000182763526000036/mane-20261019.htm
  HTML page:      https://secwatch.observer/filing/0001827635-26-000036

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