Achieve Life Sciences reports Q3 EPS (28c), consensus (26c)

“The FDA’s acceptance of our NDA for cytisinicline in smoking cessation is an important milestone for Achieve, reflecting the strength of our clinical development program,” said Rick Stewart, Chief Executive Officer of Achieve Life Sciences (ACHV). “The NDA acceptance recognizes years of scientific and operational commitment to addressing nicotine dependence as a serious medical condition, in an indication that has not seen a new therapy in nearly 20 years. Additionally, the FDA’s recent award of the Commissioner’s National Priority Voucher for vaping cessation highlights the potential for cytisinicline to become the first and only FDA-approved therapy for nicotine dependence for vaping cessation. The vaping cessation market represents a significant and growing unmet medical need, with approximately 60% of the 17 million adult e-cigarette users in the United States expressing a desire to quit.”