Achieve Life Sciences Q2 FY26 net loss widens to $74.77 million
Reuters2026/08/11 12:32- Achieve Life Sciences posted a GAAP net loss of USD 74.77 million for Q2 2026, widening from USD 12.72 million a year earlier.
- GAAP operating expenses rose to USD 18.39 million from USD 12.56 million; the loss included a USD 48.7 million non-cash warrant liability charge.
- Cash, cash equivalents and marketable securities climbed to USD 187.3 million at June 30, 2026, from USD 36.4 million at Dec. 31, 2025.
- 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.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
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