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

ACHIEVE LIFE SCIENCES, INC.

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.

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