Company: ACHV
Filing Date: 2025-02-10
Form Type: 8-K
Source: 0000950170-25-017068
Chunk: 0

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-02-10
Form: 8-K
Item: Item 8.01
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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.      Description                                                                  
  99.1             Press release of Achieve Life Sciences, Inc. dated February 10, 2025         
                                                                                                
                   Cover Page Interactive Data File (embedded within the Inline XBRL document)  
                                                                                                
  104                                                                                           
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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.

                               ACHIEVE LIFE SCIENCES, INC.                            
  Date: February 10, 2025      /s/ Mark Oki                                           
                               Mark Oki