secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2026-08-11T20:04:40+00:00
Accession:  0001193125-26-344571
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000119312526344571/0001193125-26-344571-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000119312526344571/achv-20260811.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-344571

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