Achieve Life Sciences Q2 FY26 net loss widens to $74.77 million
ACHV•Q2 loss widens as warrant charge weighs on results
Achieve Life Sciences posted a GAAP net loss of $74.77 million for Q2 2026, widening from $12.72 million a year earlier.
GAAP operating expenses rose to $18.39 million from $12.56 million; the loss included a $48.7 million non-cash warrant liability charge.
Cash, cash equivalents and marketable securities climbed to $187.3 million at June 30, 2026, from $36.4 million at Dec. 31, 2025.
FDA response on cytisinicline and updated manufacturing plan
The FDA issued a Complete Response Letter on cytisinicline tied to cGMP observations at a prior third-party manufacturer; no efficacy or clinical safety deficiencies were cited.
Finished drug product manufacturing is shifting to Adare Pharma Solutions; NDA resubmission is targeted for Q4 2026 with potential FDA approval in H1 2027.
