Achieve Life Sciences: 1st Half 2025 NDA Filing On Track With FDA Agreement

Terry Chrisomalis
Investing Group Leader
(16min)

Summary

  • Achieve Life Sciences, Inc. initiated an open-label ORCA-OL trial using cytisinicline for smoking cessation; the Efficacy of the drug already established in several prior studies.
  • Alignment with FDA that successful completion of ORCA-OL trial is necessary for NDA filing of cytisinicline in the 1st half of 2025.
  • The global smoking cessation product market is estimated to reach $69.8 billion by the end of 2034.
  • Potential label expansion opportunity exists of using cytisinicline for e-cigarettes or vaping cessation patients; End-of-phase 2 meeting expected in 2024.
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Woman biologist using micro pipette with test tube and beaker

Dragos Condrea/iStock via Getty Images

Achieve Life Sciences, Inc. (NASDAQ:ACHV) has done well to advance its main clinical program, which would be the use of its drug cytisinicline for smoking cessation. The company has had an extensive program, where it

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This article was written by

Terry Chrisomalis
13.46K Followers

Terry Chrisomalis is a private investor in the Biotech sector with years of experience utilizing his Applied Science background to generate long term value from Healthcare.

He is the author of the investing group Biotech Analysis Central which contains a library of 600+ Biotech investing articles, a model portfolio of 10+ small and mid-cap stocks with deep analysis for each, live chat, and a range of analysis and news reports to help Healthcare investors make informed decisions.

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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