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Achieve Life Sciences announced Q4 and full year 2025 financial results, reporting net losses of $14.7 million and $54.7 million, respectively, with $36.4 million in cash as of December 31, 2025. Updates include FDA acceptance of cytisinicline NDA with PDUFA date of June 20, 2026, completion of ORCA-OL trial, and partnership with Adare Pharma Solutions for U.S. manufacturing ahead of potential 2027 launch.
Event Type
Disclosure
Mandatory
Variant
8-K
of this Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934
. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 104 Press release of Achieve Life Sciences, Inc. dated March 24, 2026 Cover Page
| Metric | Value | Basis |
|---|---|---|
| Total Operating Expenses | $14.70 | GAAP |
| Total Operating Expenses | $54.90 | GAAP |
| Net Loss | $14.70 | GAAP |
| Net Loss | $54.70 | GAAP |
| Basic and Diluted Net Loss per Share | $-0.28 | GAAP |
| Basic and Diluted Net Loss per Share | $-1.25 | GAAP |