Achieve Life Sciences, Inc

Achieve Life Sciences appoints Mark Oki as CFO to oversee financial strategy and operations, aiming to commercialize cytisinicline for nicotine dependence. Oki's experience in biopharma will support the potential first new treatment in two decades, addressing a global health crisis.

Achieve Life Sciences announces successful End-of-Phase 2 FDA meeting for cytisinicline as a potential first-in-class vaping cessation therapy. The FDA agreed that one Phase 3 trial (ORCA-V2) along with the completed Phase 2 ORCA-V1 trial would suffice. The planned Phase 3 study will evaluate 3 mg cytisinicline three times daily versus placebo in approximately 800 adults who use e-cigarettes, targeting initiation in Q3 2025.

The 'Smoking Cessation - Pipeline Insight, 2024' report by ResearchAndMarkets.com covers 10+ companies and 12+ pipeline drugs, focusing on emerging therapies like Cytisinicline (Achieve Life Sciences), EMB-001 (Embera Pharmaceuticals), and SBP-9330 (Camino Pharma). The report provides insights into clinical and nonclinical stage products, therapeutic assessments, and pipeline development activities.

Zacks SCR sets $30 target price for Achieve Life Sciences, a 620% premium, due to FDA breakthrough therapy designation and clinical trial progress. The average analyst target is $15.60, with Achieve focusing on independent commercialization. The FDA seeks long-term safety data, delaying potential approval to Q3 2026.

Achieve Life Sciences announces Q3 2024 financial results, including a net loss of $12.5M, and updates on cytisinicline development, including successful enrollment in Phase 3 ORCA-OL trial and FDA Breakthrough Therapy designation for nicotine vaping cessation.

JonesTrading analyst Justin Walsh initiates Buy rating on Rapport Therapeutics, Inc. (RAPP) due to its innovative RAP platform for CNS disorder treatments, focusing on RAP-219 targeting TARPγ8 linked to epilepsy, pain, and bipolar disorder. The company plans Phase II trials by 2025 and potential integration of NeuroPace's RNS device, aiming for best-in-class status with minimal side effects.

Achieve Life Sciences completes enrollment for ORCA-OL trial with 479 participants, meeting FDA safety requirements for cytisinicline, a nicotine dependence treatment. The Data Safety Monitoring Committee found no safety concerns, allowing the study to proceed. Achieve plans to file a New Drug Application for cytisinicline in H1 2025.

E-cigarettes, often used to quit smoking, can lead to addiction; 60% of vapers want to quit. FDA hasn't approved them as cessation tools, but some medications for smoking may help. A new drug, cytisinicline, shows promise in trials and may be approved by 2027. Nicotine pouches like Zyn are used to wean off vaping, but caution is advised.

Cytisine, a plant-based smoking cessation treatment effective and with fewer side effects than nicotine patches and gum, awaits FDA approval in the U.S. after more safety data was requested. Approved in Canada and the UK, it could help over 70,000 Americans quit smoking annually. Clinical trials by Achieve Life Sciences show positive outcomes, but FDA delays push back potential approval.