ACHV: New Insights from ORCA-3 Study to Be Shared at 2025 Conference | ACHV Stock News

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May 20, 2025
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Achieve Life Sciences (ACHV, Financial) is set to unveil further insights from its Phase 3 ORCA-3 study at the 2025 American Thoracic Society International Conference in San Francisco, CA. The presentation will showcase the unique advantages of cytisinicline treatment, particularly in minimizing nicotine cravings, which also led to a decrease in nicotine consumption, even among those who did not completely quit smoking. These findings emphasize the significance of cytisinicline's dual function as a selective partial agonist and antagonist at the nicotinic acetylcholine receptor.

Wall Street Analysts Forecast

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Based on the one-year price targets offered by 6 analysts, the average target price for Achieve Life Sciences Inc (ACHV, Financial) is $14.50 with a high estimate of $20.00 and a low estimate of $10.00. The average target implies an upside of 338.07% from the current price of $3.31. More detailed estimate data can be found on the Achieve Life Sciences Inc (ACHV) Forecast page.

Based on the consensus recommendation from 7 brokerage firms, Achieve Life Sciences Inc's (ACHV, Financial) average brokerage recommendation is currently 1.7, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

ACHV Key Business Developments

Release Date: May 13, 2025

  • Cash, Cash Equivalents, and Marketable Securities: $23.2 million as of March 31, 2025.
  • Total Operating Expenses: $12.9 million for the first quarter of 2025.
  • Net Loss: $12.8 million for the first quarter of 2025.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Achieve Life Sciences Inc (ACHV, Financial) is on track to submit the NDA for cytisinicline next month, marking a significant milestone.
  • Cytisinicline has shown excellent efficacy and tolerability in helping patients quit smoking and vaping, with promising results from the ORCA-3 clinical trial published in JAMA Internal Medicine.
  • The ORCA-OL open-label study has over 100 patients with the FDA's required 1-year exposure to cytisinicline, demonstrating strong patient retention and tolerability.
  • The company has convened a Scientific Advisory Board with leading experts, highlighting the excitement and potential of cytisinicline in treating nicotine dependence.
  • Achieve Life Sciences Inc (ACHV) has a strong cash position of $23.2 million as of March 31, 2025, and is committed to financial discipline to support key priorities.

Negative Points

  • Achieve Life Sciences Inc (ACHV) reported a net loss of $12.8 million for the first quarter of 2025, reflecting high operating expenses.
  • The company faces the challenge of launching cytisinicline in a market that has not seen a new nicotine dependence drug in nearly 20 years.
  • There is uncertainty regarding the exact timing of the commercial launch post-NDA approval, which could impact revenue projections.
  • Achieve Life Sciences Inc (ACHV) is still in the process of finalizing its pricing and payer strategy, which could affect market access and reimbursement.
  • The company has not yet secured strategic partnerships for potential comorbid COPD studies, which could provide additional non-dilutive capital.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.