UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On February 10, 2025, Achieve Life Sciences, Inc. (the “Company”) announced that the Data Safety Monitoring Committee (“DSMC”) recently completed its second independent review of the Company’s ongoing ORCA-OL trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine.
Following this second comprehensive review of available safety data, the DSMC stated that it did not identify any unexpected treatment-related adverse events and that the participants’ adherence to their cytisinicline medication was excellent. Overall safety data remained consistent with previous findings. The DSMC concluded the study may continue as planned without any modifications.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1
104 |
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Press release of Achieve Life Sciences, Inc. dated February 10, 2025 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ACHIEVE LIFE SCIENCES, INC. |
Date: February 10, 2025 |
/s/ Mark Oki |
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Mark Oki Chief Financial Officer (Principal Financial Officer) |