---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-344571"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2026-08-11T20:04:40+00:00"
generated_at: "2026-08-11T20:06:36.949412+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Achieve Life Sciences Q2 net loss $74.8M, closes $354M raise, plans NDA resubmission Q4 2026

## Summary
- Q2 net loss $74.8M incl $48.7M non-cash warrant fair-value charge; cash $187.3M at June 30, 2026.
- Closed $354M private placement ($180M upfront; $174M warrants exercisable before/up to 20 days after FDA approval).
- FDA CRL June 20, 2026: no efficacy/safety issues; cGMP and labeling only; NDA resubmission Q4 2026, potential approval H1 2027.
- New CEO Andrew D. Goldberg; six new board members; commercial hires from Verona Pharma (Ohtuvayre launch team).
- ORCA-OL 52-week safety data presented; ORCA-2/3 cancer subgroup: 24.4% vs 15.8% placebo abstinence.

## SEC filing metadata
- accession: 0001193125-26-344571
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2026-08-11T20:04:40+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000119312526344571/0001193125-26-344571-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000119312526344571/achv-20260811.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-344571
- JSON: https://secwatch.observer/filing/0001193125-26-344571.json
- Plain text: https://secwatch.observer/filing/0001193125-26-344571.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.