Contradictions Unveiled: Achieve Life Sciences' Q1 2025 Earnings Call Highlights Regulatory Challenges and Strategic Uncertainties

FDA interactions and focus, partnership and commercialization strategy, commercialization and launch strategy, FDA interactions and strategic focus, and ORCA-OL trial enrollment and data presentation are the key contradictions discussed in Achieve Life Sciences' latest 2025Q1 earnings call



NDA Submission and Regulatory Process:
- Achieve Life Sciences is on track to submit the NDA for cytisinicline in June, which is a significant milestone.
- The submission is based on the successful completion of the ORCA-OL study, reaching the requirement of having at least 100 participants with one year of cytisinicline exposure.

Clinical Trial Success and Safety Data:
- The ORCA-OL open label study achieved a high retention rate, with approximately 75% of the participants remaining on cytisinicline.
- The study's safety data was reviewed and approved by the Data Safety Monitoring Committee, with no concerns or modifications required.

Scientific Advisory Board and Regulatory Support:
- Achieve convened a Scientific Advisory Board with leading experts in nicotine and tobacco cessation research to discuss NDA filing preparations and gather insights.
- The receipt of a 74-day letter from the FDA acknowledging the acceptance of the submission is expected, followed by an anticipated 12-month approval process.

Commercialization and Awareness Strategies:
- Achieve is focusing on commercial readiness, including ensuring drug availability in the channel, finalizing pricing and payer strategies, and building marketing and digital platforms.
- The company is prioritizing efforts to bring smoking cessation back to the conversation with physicians and patients, emphasizing the differentiation of cytisinicline compared to existing treatment options.

Strategic Partnership and Opportunities:
- Achieve is considering strategic partnerships, particularly with COPD and respiratory companies, to explore the potential role of cytisinicline in enhancing treatment regimen efficacy.
- Discussions are ongoing with potential partners to specify the opportunity in this space and design clinical studies to demonstrate cytisinicline's impact.