Achieve Life shares surge 14.48% after-hours as FDA accepts NDA for cytisinicline and Citizens initiates coverage with $19 price target.
ByAinvest
Tuesday, Nov 25, 2025 5:00 pm ET1min read
ACHV--
Achieve Life Sciences (ACHV) surged 14.48% in after-hours trading following two key developments: the FDA’s acceptance of its New Drug Application (NDA) for cytisinicline, a smoking cessation treatment, and coverage initiation by Citizens with a “Market Outperform” rating and a $19 price target. The NDA acceptance, with a PDUFA date of June 20, 2026, marks a critical regulatory milestone, while the analyst report highlighted cytisinicline’s competitive differentiation and a 90% estimated approval probability. These events bolstered investor confidence in the company’s prospects, overshadowing a recent earnings miss and reinforcing optimism about its commercialization strategy and market potential.
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue

Comments
No comments yet